The Food and Drug Administration said vaccines cleared in the U.S. currently provide sufficient protection against severe disease and death from Covid-19 without additional doses, potentially complicating the Biden administration’s deliberations over the need for booster shots.
The FDA released the findings in a report analyzing data submitted by Pfizer Inc. and BioNTech SE as part of their request for authorization for their vaccine to be given as a booster shot in people 16 years and older.
Enough doses have now been administered to fully vaccinate 38.1% of the global population—but the distribution has been lopsided. Countries and regions with the highest incomes are getting vaccinated more than 20 times faster than those with the lowest.
An official at the World Health Organization (WHO) says the group has suspended its approval process for Russia’s Sputnik V coronavirus vaccine, after a number of manufacturing infringements were uncovered during an inspection in Russia earlier this year.
Jarbas Barbosa, assistant director at the Pan American Health Organization, the regional office of WHO for the Americas, suggested on September 15 that new inspections at one of the plants where the vaccine is being manufactured would be required before the vaccine is granted approval for emergency use.
The plant “needs to take this under advisement, make the necessary changes, and be ready for new inspections. The WHO is waiting for the manufacturer to send news that their plant is up to code,” Barbosa said.
Source: Radio Free Europe
The Department of Justice (DOJ) moved on Wednesday to block Purdue Pharma’s controversial bankruptcy deal that shields members of the Sackler family from being sued in future opioid-related lawsuits.
U.S Trustee for the DOJ William Harrington filed a request for an expedited stay to prevent the OxyContin-maker’s agreement that a federal judge signed off on earlier this month from going into effect. The DOJ throughout Purdue Pharma’s bankruptcy has blasted the settlement as “unlawful” and “unconstitutional.”
Through the deal in question, members of the Sackler family would give up ownership of Purdue Pharma and supply more than $4 billion in cash and charitable assets over nine years. The company’s assets would be sent to a new company focused on fighting opioid addiction.
Source: The Hill
When the CDC released its latest round of recommendations regarding seasonal flu vaccines, the agency made one notable update: Flu vaccines and COVID-19 vaccines can now be given simultaneously.
The guidance is a marked change from previous agency recommendations, which said that other vaccinations should not be administered within a 2-week window before or after the COVID-19 vaccine.
President Biden announced the most sweeping COVID-19 vaccine requirements yet on Thursday, which will affect roughly 100 million Americans. The new measures include a vaccine mandate for all federal workers and contractors, and a requirement that large companies must mandate vaccines or regular testing for employees.
“My job as president is to protect all Americans,” Mr. Biden said Thursday. “So tonight, I’m announcing that the Department of Labor is developing an emergency rule to require all employers with 100 or more employees that together employ over 80 million workers to ensure their workforces are fully vaccinated or show a negative test at least once a week.”
Mr. Biden noted that many large companies already require vaccinations. “The bottom line — we’re going to protect vaccinated workers from unvaccinated coworkers,” he said.
Source: CBS News
“There is room for optimism,” said Health Minister Nitzan Horowitz Friday morning in a Facebook post soon after his ministry updated that the country’s reproduction rate had dropped to 0.8.
The reproduction rate or “R” is the number of people a sick person infects. It has been declining for several days now, Friday morning reaching the target that decision makers had said previously would halt the spread of coronavirus.
“The low reproduction rate provides sufficient safety margins to prevent the resumption of the outbreak as a result of the opening of the education system,” a team of Hebrew University researchers that advise the government said on Friday in a report.
Source: The Jerusalem Post
The Delta variant of the Covid-19 virus appears well positioned to maintain its dominance over new variants such as Lambda and Mu, virologists say.
Delta accounts for 99% of new Covid-19 cases in the U.S. and roughly 88% of cases globally, according to data from the Centers for Disease Control and Prevention and Nextstrain, an open-source pathogen-tracking service. Virologists expect Delta to outcompete new variants of the SARS-CoV-2 virus, including Lambda and Mu, in their hunt for people susceptible to Covid-19.
For the first time since the original coronavirus outbreak closed China’s borders, the country is preparing to allow foreigners to enter again in large numbers for the winter Olympics next February.
This had not seemed like it would pose much of a problem. People had become accustomed to life without many Covid restrictions, with authorities stamping out each outbreak of the virus as it came along.
But everything changed when the highly-contagious Delta variant made its way into China via an airport in the eastern city of Nanjing.
In July and August it quickly spread to dozens of cities and towns, threatening China’s status of having the virus controlled.
As they had before, authorities pursued a goal of full elimination.
The strategy is always the same. Phone app health clearance is implemented in order to enter public buildings, track and trace methods go into overdrive and, as infected people are identified, their housing estates placed into lockdown.
Moderna plans to announce the development of a vaccine candidate that will protect against Covid-19 and the flu, to be known as mRNA-1073. The company will also announce a pediatric vaccine called mRNA-1365, which combines its experimental respiratory syncytial virus vaccine with its experimental human metapneumovirus vaccine.
The news came less than an hour before the company begins an investor event intended to discuss the company’s clinical development pipeline. Top Moderna (ticker: MRNA) executives, including CEO Stéphane Bancel, newly appointed chief medical officer Dr. Paul Burton, and the company’s president, Dr. Stephen Hoge, were due to appear.
No single factor can explain the recent swift collapse of the U.S.-backed Afghan government. But one underappreciated mistake has been Washington’s long‐running effort to suppress the cultivation of opium poppies in Afghanistan and, in turn, the production of heroin and other opioids. The campaign most likely had little effect on the amount of poppy grown. Instead it shifted cultivation to Taliban‐controlled territories, bolstering the militia’s revenues.
According to the United Nations Office on Drugs and Crime (UNODC), Afghanistan accounted for 85 percent of global opium production in 2020. Poppies are a labor‐intensive crop, perfectly suited to a country with a large agrarian population and few off‐farm income opportunities. Poppy also thrives in Afghanistan’s soil and climate conditions, as well as its weak governance and corruption.
American efforts to suppress poppy cultivation, either through direct eradication or through incentives to grow other crops, failed to account for the basics of supply and demand. Suppression policies focus on shrinking supply, which means a fixed quantity of opium will become more expensive to produce. These policies involve a mix of threats to destroy poppy fields and the provision of resources (such as fertilizers) to encourage farmers to cultivate other crops. But if demand is not very sensitive to price increases, the quantity demanded will change little in response to the reduction in supply.
Source: Cato Institute
The Biden administration’s decisions over when to administer coronavirus vaccine boosters are triggering turmoil within the Food and Drug Administration, frustrating regulators and sparking fear that political pressures will once again override the agency’s expertise.
FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters’ benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team’s top-down booster plan and former President Donald Trump’s attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.
To the Editor — On 4 August 2021, Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, called for a global moratorium on booster doses of vaccination against COVID-19, until the end of September, with a goal of having 10% of every nation’s population vaccinated. This comes on the heels of both Israel and Germany starting vaccine campaigns of a third dose, and provinces such as Quebec, Canada, giving third doses to provide an easier pathway for international travel. In the United States, on 12 August 2021, the US Food and Drug Administration authorized booster doses for certain immunocompromised people.
As more rich nations consider boosters, their local public-health communities need to wake up to the widening chasm of vaccine inequity and its devastating consequences, especially with the Delta variant ripping through populations. All of us need to look within and ask hard questions. Are we as a species willing to protect all humankind, or do we mostly care about optimizing protection for people in wealthy nations?
Any discussion of booster dose strategies requires an application of scientific as well as equity principles.
A third dose of the Moderna vaccine — given six months after the initial two doses — significantly boosts immunity, according to data the company submitted to the Food and Drug Administration on Wednesday.
The data comes from 344 volunteers who got an additional dose of the vaccine as part of a clinical study. Antibodies had waned six months after vaccination, the company said, but the third shot boosted antibodies to an even higher point than was seen after the initial shots, even though the booster was just half the original dose. The increased protection was “achieved across age groups, notably in older adults (ages 65 and above),” the company said.
Moderna made the announcement in a press release, but the research has not yet been peer-reviewed.
Members of the Sackler family who are at the center of the nation’s deadly opioid crisis have won sweeping immunity from opioid lawsuits linked to their privately owned company Purdue Pharma and its OxyContin medication.
Federal Judge Robert Drain approved a bankruptcy settlement on Wednesday that grants the Sacklers “global peace” from any liability for the opioid epidemic.
“This is a bitter result,” Drain said. “I believe that at least some of the Sackler parties have liability for those [opioid OxyContin] claims. … I would have expected a higher settlement.”
The complex bankruptcy plan, confirmed by Drain at a hearing in White Plains, N.Y., was negotiated in a series of intense closed-door mediation sessions over the past two years.
COVID-19 booster shots of the Pfizer and Moderna vaccines are set to become available for all U.S. adults beginning next month, the country’s top health officials announced.
“We know that even highly effective vaccines become less effective over time,” Dr. Vivek Murthy, the surgeon general, said at a White House briefing. “It is now our clinical judgment that the time to lay out a plan for COVID boosters is now.”
He added, “This includes our most vulnerable populations, like our health care providers, nursing home residents and other seniors. We will also begin delivering booster shots directly to residents of long-term care facilities.”
CMS has finalized an approximate $2.3 billion increase in hospital payments next year, including a 2.5 percent bump for hospital reimbursement rates under Medicare’s Inpatient Prospective Payment System (IPPS).
Just released, the IPPS final rule for fiscal year (FY) 2022 will increase hospital reimbursement rates starting October 1, 2021, alongside payments to hospitals diagnosing and treat COVID-19.
The final rule authorizes additional payments for diagnostics and therapies for COVID-19 during the public health emergency (PHE), which is expected to last through this year. CMS stated that the additional payments are meant to “mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments and to minimize any potential payment disruption immediately following the end of the PHE.”
Source: Revcycle Intelligence
Members of the family that owns OxyContin maker Purdue Pharma won’t contribute billions of dollars to a legal settlement unless they get off the hook for all current and future lawsuits over the company’s activities, one of them told a court Tuesday in a rare public appearance.
David Sackler, grandson of one of the brothers who nearly 70 years ago bought the company that later became Purdue, testified at a hearing in federal bankruptcy court in White Plains, New York, that unless the settlement is approved with those protections included, as they currently are, “I believe we would litigate the claims to their final outcomes.”
“We need a release that’s sufficient to get our goals accomplished,” Sackler said in response to questions from a lawyer for the U.S. bankruptcy trustee. “If the release fails to do that, we will not support it.”
That’s the heart of argument over the settlement plans of the family and the company, based in Stamford, Connecticut.
With the U.S. in the grips of a frightening surge of coronavirus cases, many parents are understandably eager to know when the COVID-19 vaccine will finally be available for children under 12.
This age group accounts for about 50 million Americans and currently none of them qualify for a shot. But scientists are racing to figure out how one of the COVID-19 vaccines currently available for adults could be given to this age group.
Pfizer and Moderna are both running large pediatric trials to study the effectiveness and safety of using their COVID-19 mRNA vaccines for children under 12.
Here’s what we can expect:
What do we know from the vaccine studies of children under 12?
Researchers have already shared some early findings about how a COVID-19 vaccine may be used in younger children.
In the clinical trial for the Pfizer vaccine, the data collected shows that one-third of the adult dose is the optimal range for children younger than 12 and older than 5, says Dr. Flor Muñoz at Texas Children’s Hospital and Baylor College of Medicine, who is running the Pfizer study.
‘Optimal’ meaning the dose that will give you a similar immune response that will be protective, as we have seen with adolescents, with the minimum amount of side effects,” she says.
Muñoz and her team have enrolled children as young as 6 months and up through age 11. Her team is now in the next phase of the study, where they randomly assign children either to receive a vaccine or a placebo. Comparing a vaccinated group with a placebo group allows researchers to be confident that any benefit or risk during the study is truly related to the vaccine.
The Pfizer study won’t test to see whether the vaccine actually prevents children from getting sick. Instead, it will look at their blood to see if they are making the kinds of antibodies that have been shown to prevent disease. Studies of the Pfizer COVID-19 vaccine in adults have already shown that such antibodies indicate that someone is well-protected from becoming severely ill with COVID-19. Children will remain part of the study for two years so researchers can determine how long protection lasts, whether any rare, long-term health issues arise, and whether a booster is needed.
Moderna is conducting a similar pediatric study of its COVID-19 vaccine. Children enrolling in the Moderna trial now have a 3 to 1 chance of getting the vaccine, because only 25% of the participants are in the placebo arm of the trial.
“We are testing different doses in the different age groups because younger children may not need the same dose as adults,” says Dr. Jacqueline Miller, senior vice president at Moderna.
This depends on how quickly the studies collect the necessary data and what regulators at the Food and Drug Administration ultimately decide when they review the results.
At the moment, it looks like the Pfizer vaccine will be the first shot available to children under 12. The vaccine-maker expects to have enough data by the end of September to support an emergency use authorization for its vaccine in children who are ages 5 to 11.
“We’re hoping to have authorization — depending on both results and, of course, a few decisions — not too long after the school year starts,” Dr. Phil Dormitzer, chief scientific officer for viral vaccines at Pfizer, told NPR recently.
The data for children under 5 will be submitted shortly thereafter, a Pfizer spokesperson told NPR.
Right now the other mRNA COVID-19 vaccine authorized for use in the U.S. — Moderna’s — can be given to individuals who are 18 and older. Moderna says it expects to have enough data by the end of the year to seek authorization for a shot that can be given to children who are between the ages of 6 and 11.
Moderna recently expanded the size of its trial and is now enrolling 12,000 children in an effort to increase the likelihood of detecting any rare, but serious adverse events. The Pfizer study currently plans to enroll up to 4,500 children, a company spokesperson told NPR.
“The safety profile so far is really comparable to the adults and, so far, no safety concerns,” says Miller, referring to the Moderna vaccine. Data for children under 6 could be submitted to the FDA by “early next year,” she says, “but that could be done more rapidly, depending on the rate of enrollment.”
Even with the emergence of new variants, the risk of severe illness from COVID-19 remains quite low for younger children compared to the adult population. But with so many infections each day in the U.S., a huge number of children are now being exposed to the virus and testing positive.
More than 120,000 COVID-19 cases were reported among children between Aug. 5 and 12 — about 18% of the total weekly case count, according to the American Academy of Pediatrics.
“They do have a milder illness and lower likelihood of becoming infected,” says Muñoz of Texas Children’s Hospital. “But they can be infected. They can have severe illness and they can transmit the virus.”
And with such high numbers of infections nationally and no protection from a vaccine if they do get infected, more children are at risk of becoming one of the unlucky few who do get seriously ill or face long-term symptoms post-infection — a syndrome widely known as “long COVID.”
Dr. Paul Offit, a pediatric vaccine specialist at Children’s Hospital of Philadelphia, says a vaccine for younger children can’t come soon enough, given the growth in cases.
“We have more pediatric patients right now hospitalized with COVID than at any point prior in this pandemic,” says Dr. LouAnn Woodward, who oversees the University of Mississippi Medical Center. “We are seeing a younger group of patients that are getting very sick with this.”
In a letter sent earlier this month, the head of the AAP urged the FDA to work “aggressively toward authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible.”
“Simply stated, the delta variant has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults,” wrote AAP president Dr. Lee Savio Beers.
Many parents do not want to risk their children’s health, especially as the school year begins — a fact that’s also reflected in the outpouring of interest from parents who are trying to enroll their kids in the clinical trials.
“I get multiple emails a day asking, and unfortunately we just have limited spots,” says Baylor College of Medicine’s Dr. Erin Nicholson, who is running a study of the Moderna vaccine in children under 12.
The Pfizer–BioNTech and Oxford–AstraZeneca COVID-19 vaccines are effective against the highly infectious Delta variant of SARS-CoV-2 — but their protection drops away over time, a study of infections in the United Kingdom has concluded.
Researchers at the University of Oxford, UK, and the country’s Office for National Statistics analysed a vast data set comprising the results of 2,580,021 PCR tests to check for SARS-CoV-2 from 384,543 UK adults between 1 December 2020 and 16 May 2021 — when the Alpha variant was dominant — and 811,624 test results from 358,983 people between 17 May and 1 August 2021, when the Delta variant was more prevalent.
The results, published in a preprint on 19 August1, suggest that both vaccines are effective against Delta after two doses, but that the protection they offer wanes with time. The vaccine made by Pfizer in New York City and BioNTech in Mainz, Germany, was 92% effective at keeping people from developing a high viral load — a high concentration of the virus in their test samples — 14 days after the second dose. But the vaccine’s effectiveness fell to 90%, 85% and 78% after 30, 60 and 90 days, respectively.
At a recent HIMSS21 session, National Coordinator for Health IT Micky Tripathi laid out some of ONC’s priorities under the Biden-Harris administration, as well as discussing some specifics of the recently imposed information-blocking regulations.
“What are the things we want to accomplish?” he asked. “Well, we certainly want a health IT system that directly serves patients, providers, payers and public health workers. We want a platform-based business and technical model that allows for a rich and private technology ecosystem and complements the EHR systems that are in place today.
“We want health information networks that operate in the background to make basic clinical data available universally across the continuum in a commoditized, i.e. low-cost, high-consistency, way. And we want systems that help us identify health inequities and facilitate interventions that prevent such inequities from further turning into healthcare disparities,” he continued.
ONC intends to use a number of levers to accomplish this goal, including regulation like the Cures Act, but also convening the industry to collaborate and, if necessary, nudge it along from the bully pulpit.
“So what is it you should expect out of ONC under the Biden-Harris Administration? First, a focus on what’s practical and feasible, and at times pushing the envelope on what’s practical and feasible, without losing sight of the vision,” he said. “Letting the market lead when it can, and providing enough leverage to put it in a position to lead when it can’t. And doing that with as much transparency as federal processes will allow.”
Tripathi laid out five priority areas for ONC:
Continued COVID-19 response and support of the public health system.
A renewed focus on “the spirit and the letter” of 21st Century Cures.
Promotion and adoption of EHR interoperability standards.
An enhanced focus on health equity.
Alignment and collaboration with other federal agencies.
Source: Healthcare IT News
Health care workers on the front lines in the fight against COVID are suffering from unprecedented levels of burnout amid the latest surge.
Why it matters: America’s health care workers are already burnt out from previous waves of the pandemic. But as hospitals in hotspots are filling up, and sick COVID patients are once again requiring life-saving care, the stress is being compounded by the battle over public health measures.
“There’s a lot of rage and frustration in the workforce where it’s like, ‘God, we could be done with this,'” Meredith Duke, a bariatric surgeon at Vanderbilt told Axios.
The amended emergency use authorization paves the way for people who have had an organ transplant, or those with a similar level of weakened immune system, to get an extra dose. The patients may consult with their doctor to see if they are eligible, FDA spokesperson Abby Capobianco said.
“After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines,” Janet Woodcock, U.S. FDA’s acting commissioner, said in a tweet.
“Others who are fully vaccinated are adequately protected & do not need an additional dose of COVID-19 vaccine at this time.”
The vulnerable group makes up less than 3% of U.S. adults, Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), had said before the authorization.
Dr. Robert Redfield, the former director of the Centers for Disease Control and Prevention, predicted that the fall will have a dark turn in the coronavirus pandemic.
Redfield said on Fox News Channel’s “The Story” that he thinks the coronavirus will continue to replicate quickly among humans, and so the risk of variant evolution is high.
“You know we dealt with the U.K. variant; everyone thought that was pretty bad, it was twice as infectious, but lo and behold three, four months later we had the delta variant and now it’s a dominant variant in the United States,” Redfield said.
He then predicted that there will be another, more dangerous coronavirus variant by the fall.
“Within, you know two, three, four months we’re going to have another variant and that variant’s going to be more infectious than the delta variant,” Redfield said.
Redfield said the coronavirus became one of the most infectious viruses in humans, which allowed it to mutate quicker.
Source: Deseret News
As soon as the Food and Drug Administration issues a full approval for a COVID-19 vaccine, there will be “a flood” of vaccine mandates at businesses and schools across the nation.
Mandates aren’t going to happen at the federal level, but vaccine approval will embolden many groups, he predicted.
“Organizations, enterprises, universities, colleges that have been reluctant to mandate at the local level will feel much more confident,” he said.
“They can say, ‘If you want to come to this college or this university, you’ve got to get vaccinated. If you want to work in this plant, you have to get vaccinated. If you want to work in this enterprise, you’ve got to get vaccinated. If you want to work in this hospital, you’ve got to get vaccinated.'”
Fauci doesn’t see more lockdowns in the nation’s future. They were issued early in the pandemic to keep hospitals from being overwhelmed, known as “flattening the curve.”
Source: USA Today
A New England Journal of Medicine study yesterday details breakthrough COVID-19 infections in 39 of 1,497 fully vaccinated Israeli healthcare workers, with most cases mild or moderate but 19% with symptoms lingering for more than 6 weeks.
A team led by Tel Aviv University researchers used diagnostic testing, antibody assays, genomic sequencing, and contact tracing to evaluate healthcare workers who were symptomatic or had been exposed to an infected person.
All workers had received a second dose of the Pfizer/BioNTech vaccine 11 days before the study began on Jan 20. The study ran for 14 weeks, during which time Israel experienced its third and largest COVID-19 case surge.
The researchers also matched workers with COVID-19 and antibody concentrations obtained within a week before diagnosis with four or five uninfected controls and used generalized estimating equations to predict average antibody levels and the ratio between the levels in the two groups.
Source: New England Journal of Medicine
The Biden administration announced that it would extend the pause on federal student loan payments until the end of January following growing pressure from Congressional Democrats, including progressives who want to cancel large swaths of the outstanding debt.
The pandemic relief — which benefits more than 40 million federal student loan borrowers — had been set to expire at the end of September. The Education Department said those benefits would now be continued until Jan. 31, describing the reprieve as a “final” extension.
President Joe Biden’s stunning decision to revive the eviction ban in response to intense pressure from progressives has left one of Washington’s most influential business coalitions feeling angry and betrayed on the sidelines of power.
Biden’s move to reinstate a federal eviction moratorium Tuesday after letting it lapse days earlier marked a huge political loss for the National Association of Realtors and its housing industry allies, who each year shower candidates in both parties with millions of dollars in contributions and often get their way in big policy fights.
Key Findings: The top-performing countries overall are Norway, the Netherlands, and Australia. The United States ranks last overall, despite spending far more of its gross domestic product on health care. The U.S. ranks last on access to care, administrative efficiency, equity, and health care outcomes, but second on measures of care process.
Conclusion: Four features distinguish top performing countries from the United States: 1) they provide for universal coverage and remove cost barriers; 2) they invest in primary care systems to ensure that high-value services are equitably available in all communities to all people; 3) they reduce administrative burdens that divert time, efforts, and spending from health improvement efforts; and 4) they invest in social services, especially for children and working-age adults.
Source: The Commonwealth Fund
Israel’s prime minister on Thursday announced that the country would offer a coronavirus booster to people over 60 who have already been vaccinated.
The announcement by Naftali Bennett makes Israel, which launched one of the world’s most successful vaccination drives early this year, the first country to offer a third dose of a Western vaccine to its citizens on a wide scale.
“I’m announcing this evening the beginning of the campaign to receive the booster vaccine, the third vaccine,” Bennett said in a nationally televised address. “Reality proves the vaccines are safe. Reality also proves the vaccines protect against severe morbidity and death. And like the flu vaccine that needs to be renewed from time to time, it is the same in this case.”
The decision comes at a time of rising infections and signs that the vaccine’s efficacy dwindles over time.
Vaccinated people infected by Delta variant appeared to carry as much virus as those in unvaccinated cases
President Joe Biden has signed into law a bill to help fight the growing opioid crisis across the country.
The DUMP Opioids Act, authored by Senator John Kennedy, will allow certain VA medical centers to have drop boxes so anyone can drop off unused medications. The Senate unanimously passed the legislation in April, and the House of Representatives did the same earlier this week.
With the wind of the pandemic at its back, the biopharma industry saw a surging tide of fundraising in 2020 that has only exponentially grown this year. But with VC dollars flowing like never before, are there some cracks showing in biopharma’s gold-tinted façade?
In the first half of 2021, total healthcare venture spending in the US has already outstripped 2020’s record-breaking totals across biotech, healthtech and beyond, putting the industry on a funding pace that could be hard to match in coming years, according to a new report from Silicon Valley Bank released Wednesday.
For the US healthcare industry writ large — which includes biotech, healthtech, diagnostics and devices — venture capital was responsible for $21.9 billion in fundraising in the first half, well past the industry’s total of $16.8 billion in 2020.
Source: Endpoints News
The positive social media response to Simone Biles withdrawing from Olympic competition highlights how the artificial line between health care and mental health care is finally beginning to dissolve. And startup investors have taken notice.
By the numbers: Venture capital investments in mental health startups rose 72.6% between Q1 2020 and Q1 2021, per CB Insights.
GIMBHI reports that mental and behavioral health deals more than doubled between 2019 and 2020, and in Q1 2021, it accounted for 19% of all digital health funding.
Driver No. 1: Soaring customer demand, much of which has been driven by the pandemic, without adequate provider supply (particularly in non-urban areas). Not just among adults, but also for kids and teens.
Google searches for both therapists and psychiatrists soared over the past 18 months, while most any corporate HR rep can tell you that employee burnout has become one of their most pressing issues.
Driver No. 2: Greater acceptance of telehealth, partially enabled by improved video chat technologies. This is true of patients, providers and insurers — helping encourage some “tech” entrepreneurs and investors to enter the space.
Driver No. 3: Last year’s Mental Health Parity and Addiction Equity Act makes it harder for insurance companies to deny care.
Driver No. 4: Valuation momentum for early VC-backed companies like Lyra Health (now worth $4.6 billion). Nothing attracts venture capitalists like when other venture capitalists pay high prices.
The bottom line: COVID-19 exposed many of America’s health system gaps, and we’re seeing money rush in to fill them.
The American Medical Association (AMA) today urged advisers to the Centers for Disease Control and Prevention (CDC) Injury Center to recommend an overhaul of the CDC’s problematic guideline on opioid prescriptions that has proved devastating for patients with pain.
The AMA comments mirror those of the Opioid Workgroup, which was established for the purpose of reviewing draft revisions to the CDC’s 2016 guideline for prescribing opioids. The resulting Opioid Workgroup report outlines the foreseeable misapplication of the guidelines and points to more productive ways to move forward. The report was just presented to the Board of Scientific Counselors, which voted Friday to endorse it with few amendments.
The AMA is urging the CDC to remove arbitrary thresholds, restore balance and support comprehensive, compassionate care as it revises the guideline. In comments to the CDC Injury Center’s Board of Scientific Counselors, AMA Board of Trustees Chairman Bobby Mukkamala, M.D., pointed out that the opioid epidemic is becoming more lethal despite the CDC restrictive guideline due to illicitly manufactured fentanyl, fentanyl analogs, heroin, methamphetamine and cocaine. At the same time, patients are suffering from the undertreatment of pain and the stigma of having pain.
Mukkamala, who also is chair of the AMA task force focused on pain management and the drug overdose epidemic, wrote, “CDC’s threshold recommendations continue to be used against patients with pain to deny care. We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”
States and insurers have turned the guideline into laws and unbending regulations, preventing physicians from treating patients as individuals with specific needs. The AMA outlined its concerns and recommendations last year in a letter to the CDC.
According to the CDC, it is anticipated that a revised guideline will be posted for public comment in late 2021.
Vaccinated individuals accounted for three-quarters of Singapore’s COVID-19 infections in the last four weeks, but they were not falling seriously ill, government data showed, as a rapid ramp-up in inoculations leaves fewer people unvaccinated.
While the data shows that vaccines are highly effective in preventing severe cases, it also underscores the risk that even those inoculated could be contagious, so that inoculation alone may not suffice to halt transmission.
Of Singapore’s 1,096 locally transmitted infections in the last 28 days, 484, or about 44%, were in fully vaccinated people, while 30% were partially vaccinated and just over 25% were unvaccinated, Thursday’s data showed.
While seven cases of serious illness required oxygen, and another was in critical condition in intensive care, none of the eight had been fully vaccinated, the health ministry said.
This being America, the lawsuit capital of the world, it was probably inevitable that businesses would eventually settle the crush of opioid suits as a ransom to put the issue behind them. On Wednesday state Attorneys General trumpeted a rich opioid settlement with drug distributors and Johnson & Johnson , and there will surely be more.
Thousands of lawsuits have been filed around the country that seek to hold drug manufacturers, distributors and retailers liable for the opioid epidemic. Politicians and plaintiff attorneys claim the companies hooked hundreds of thousands of Americans on opioids with deceptive marketing and negligent dispensing practices to boost their bottom line.
The main problem with this argument is that opioids such as oxycodone require a doctor’s prescription. Thousands of doctors would have to have been complicit in the conspiracy. Ditto the Drug Enforcement Administration, which is supposed to monitor and control opioid shipments by distributors to pharmacies.
Opioid prescriptions have been declining since 2012, and the vast majority of overdose deaths are now from fentanyl sold on the street, often laced with other drugs. The Centers for Disease Control and Prevention reported last week that opioid deaths increased by nearly 40% last year to 69,710 in 2020, though only 13,637 were from prescription painkillers.
But actual legal liability doesn’t count for much when the U.S. mass tort industry gets rolling. Businesses settle because they know they risk getting slammed with enormous jury verdicts if they go to trial.
Yesterday a settlement was announced between several states and the pharmaceutical distributors McKesson, Cardinal Health, and Amerisource Bergen, along with drug maker Johnson and Johnson, who were accused of contributing to the opioid overdose crisis. The three distributors agreed to pay the states $21 billion over 18 years and Johnson and Johnson agreed to pay $5 billion over 5 years, ostensibly to go towards drug treatment and education programs. Johnson and Johnson and the three distributors continue to dispute the allegations while agreeing to the settlement.
Some, like the editors of the Wall Street Journal, criticize the outcome because roughly 10 percent of the settlement goes toward legal fees. They also argue that the defendants were wrongly accused:
They have a point. But the suit was even more misguided because the overdose crisis was never caused by doctors “hooking” their patients on opioids. That’s a false narrative that is convenient for politicians searching for a scapegoat and an easy solution. As I have written before, data from the Centers for Disease Control and Prevention as well as the National Survey on Drug Use and Health show no correlation between the number of opioid prescriptions written by doctors and the non‐medical use of opioids or opioid use disorder. And Drs. Nora Volkow and Thomas McLlellan of the National Institutes on Drug Abuse pointed out in the New England Journal of Medicine in 2016 that, “Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with preexisting vulnerabilities.”
Policymakers and the press continue to confuse chemical dependency with addiction. They are two completely different things.
Source: Cato Institute
German Chancellor Angela Merkel warned on Thursday that new cases of Covid-19 in her country were rising “exponentially”, driven by the Delta variant, as EU officials said more than half of all European adults had been fully vaccinated, short of a 70% target set for the summer.
The EU said the number of fully vaccinated Europeans had passed the 200-million mark, more than half of the adult population but still short of a 70% target set for the end of July.
The fresh data came as Merkel urged more Germans to get jabs, sounding the alarm over a fresh spike in Covid-19 cases in Germany.
“We are seeing exponential growth,” she told a news conference in Berlin, adding that “every vaccination … is a small step towards a return to normality”.
Germany has seen an incidence rate of 12.2 new cases per 100,000 people over the past seven days – more than double rates in early July.
“With a rising incidence rate, it could be that we need to introduce additional measures,” she said.
Germany joins a number of European nations that have seen cases climb in recent weeks fuelled by the Delta variant, first detected in India.
The European Central Bank said uncertainty over the wave of infections meant it was keeping the cash taps open to ensure the nascent economic recovery isn’t snuffed out.
ECB chief Christine Lagarde said the bank would keep its vast stimulus for the eurozone firmly in place following a meeting of its 25-member governing council.
“The euro area economy is rebounding strongly,” Lagarde said, but the Delta variant could damp the post-lockdown recovery “in services, especially in tourism and hospitality”, she said.
Source: France 24
The current COVID-19 surge in the U.S. — fueled by the highly contagious delta variant — will steadily accelerate through the summer and fall, peaking in mid-October, with daily deaths more than triple what they are now.
That’s according to new projections released Wednesday from the COVID-19 Scenario Modeling Hub, a consortium of researchers working in consultation with the Centers for Disease Control and Prevention to help the agency track the course of the pandemic.
It’s a deflating prospect for parents looking ahead to the coming school year, employers planning to get people back to the workplace, and everyone hoping that the days of big national surges were over.
Please see the attached documents.
Surgeon General Vivek Murthy stopped just short of outright saying Fox News is killing people with COVID-19 misinformation on Sunday, telling CNN that conservative media’s anti-vaccine rhetoric is “having a real cost that can be measured in lives lost.”
With COVID-19 cases and hospitalizations surging across the nation among the unvaccinated, prompting some areas to reimpose coronavirus restrictions and mask mandates, the White House sounded the alarm on the impact misinformation is having on the administration’s vaccination campaign and mitigation efforts.
Source: Daily Beast
If the second half of 2021 is anything like the first, there will be few notable records left in VC that weren’t broken by this year’s hypersonic pace of investing, fundraising, and public listings.
The latest PitchBook-NVCA Venture Monitor in partnership with Silicon Valley Bank details how a virtuous cycle of investments and returns has turbocharged this rapidly changing asset class.
Medical schools and teaching hospitals should require their workers to get the COVID-19 vaccine, the Association of American Medical Colleges told its members Friday.
Source: Modern Healthcare
The pandemic laid bare the racial health disparities in the United States while at the same time shining a light on the urban-rural divide in American health care – something that has long plagued small towns.
Scores of hospitals serving rural areas have closed over the past decade, for a variety of reasons, including low patient volume, workforce shortages, budget cuts and a broader movement to outpatient care. The COVID-19 pandemic has also accelerated and exposed the inequities in quality of care between urban and rural parts of the country – from access issues to lower COVID-19 vaccination rates among rural seniors compared to their urban peers.
Source: US News
Shortly after Pfizer announced its intention to seek FDA authorization for a third COVID-19 vaccine shot on Thursday, the CDC, FDA and National Institutes of Health countered with a joint statement the same day saying, essentially, it’s still too soon.
In a battle of the booster shot statements, the vaccine manufacturer and the U.S. government are drawing very different conclusions based on the evidence to date.
The Biden administration is taking the right approach in fighting the highly contagious Covid-19 delta variant by deploying response teams to vulnerable communities, Dr. Scott Gottlieb said Thursday.
“I think that the administration is doing the right thing, in terms of shifting their strategy,” Gottlieb, the former FDA chief under former President Donald Trump, told CNBC’s “The News with Shepard Smith” about the new administration’s grassroots approach.
Gottlieb explained that the targeted response can help teams focus on vaccinating those communities vulnerable to Covid and the delta variant.
“Right now, we need to shift to a grassroots strategy and try to put resources into local communities to allow local groups to encourage people to get vaccinated, put the vaccines into the hands of doctors, and find ways to get more vaccines into the hands of small providers who can encourage their patients to get vaccinated,” Gottlieb said.
The delta variant is driving a sharp increase in new Covid cases across the nation, and currently makes up about 25% of sequenced new cases in the U.S. Officials say they expect it to become the dominant strain in the country, eclipsing the currently dominant alpha variant.
Centers for Disease Control and Prevention Director Rochelle Walensky attributed the spike, in part, to lagging vaccination rates. The CDC director added that about one-third of all counties across the nation have so far vaccinated less than 30% of their population. She said the majority of them are in the South and Midwest.
“We believe that our vaccine offers durable protection against COVID-19 and elicits neutralizing activity against the Delta variant,” Paul Stoffels, J&J’s chief scientific officer, said in a statement. “This adds to the robust body of clinical data supporting our single-shot vaccine’s ability to protect against multiple variants of concern.”
The company also said that the immune response produced by the vaccine lasts at least eight months.
“Current data for the eight months studied so far show that the single-shot Johnson & Johnson COVID-19 vaccine generates a strong neutralizing antibody response that does not wane; rather, we observe an improvement over time,” Mathai Mammen of Johnson & Johnson said in a statement.
Source: US News
VA will stick with Cerner for EHR modernization
Following a three-month review of the program, Veterans Affairs Secretary Denis McDonough said this week that the department would stay the course with the Millennium-based platform, despite scheduling setbacks.
Source: Healthcare IT News
United Healthcare, the largest insurer in the US, recently announced a new policy it said would help hold down health care costs: It would review claims for emergency department care, opening up the possibility that the company might deny coverage if a patient’s medical needs were not actually an emergency.
After outcry from doctors and patients, the insurer said it would delay implementation until the Covid-19 pandemic has passed — but it still plans to institute the policy eventually.
United Healthcare framed the maneuver as a way to contain costs, as the New York Times reported. But there are problems with that idea, according to the half dozen health policy experts I spoke to. It’s not clear emergency room misuse is actually a rampant problem. And even if some patients do unnecessarily visit the ER, United’s new policy risks discouraging people from seeking necessary care without any guarantee that it will actually bring down costs.
“Too blunt and the wrong problem” is how Tom Tsai, a health policy researcher at Harvard University and a surgeon at Brigham and Women’s Hospital, succinctly put it to me.
“We shouldn’t reduce emergency department visits because we expect to save money,” Laura Burke, a physician at Beth Israel Deaconess Medical Center in Boston who has studied emergency room use, told me. “Because there is no evidence that’ll actually happen.”
The problem is not that patients overuse or misuse the emergency room, said Katherine Hempstead, senior policy adviser at the Robert Wood Johnson Foundation. Emergency department visits have actually been stable for years and, after a drop during the Covid-19 pandemic, have not yet recovered to previous levels.
The White House is sending “surge teams” to hot spot communities in an attempt to blunt the spread of the delta variant. St. Louis is recommending everyone wear masks indoors, and Oklahoma’s Medicaid expansion took effect.
We’ll start with the administration:
White House to send ‘surge teams’ to delta variant hot spots
The White House is readying COVID-19 “surge teams” to send to communities with low vaccination rates to help combat the rapidly spreading delta variant of the coronavirus, officials announced Thursday.
The teams will work with local public health authorities to conduct contact tracing, and will distribute supplies as needed or requested by states, such as therapeutics and additional tests.
The teams will also help augment staffing at local vaccination sites.
White House coronavirus coordinator Jeff Zients said the administration will also increase advertisements about the benefits of vaccinations in hot spot communities.
Source: The Hill
The U.S. Food and Drug Administration said on Wednesday it plans to move quickly to add a warning about rare cases of heart inflammation in adolescents and young adults to fact sheets for the Pfizer/BioNTech, and Moderna COVID-19 vaccines.
U.S. Centers for Disease Control and Prevention (CDC) advisory groups, meeting to discuss reported cases of the heart condition after vaccination, found the inflammation in adolescents and young adults is likely linked to the vaccines, but that the benefits of the shots appeared to clearly outweigh the risk.
The US overdose crisis has only worsened during the coronavirus pandemic, and public health experts are calling for more drastic measures to get it under control.
More than 91,000 people died of drug overdoses nationwide in 2020, according to initial CDC data, a 30% increase in one year. But it’s unclear how far the Biden administration is willing to go to address the crisis, which experts say could take unprecedented and divisive interventions like safe injection sites for people who use drugs.
Source: Buzzfeed News
Novavax has released positive results from its pivotal PREVENT-19 trial of its Covid-19 vaccine, which enrolled almost 30,000 participants at 119 sites across the US and Mexico. Due to decreasing vaccination rates and high supplies of messenger ribonucleic acid (mRNA) vaccines, this vaccine may not experience much uptake in the US. A large amount of the first available doses will likely go to other countries that have a more urgent need for vaccines.
NVX-CoV2373 can serve as an alternative to adenovirus vector-based vaccines because of its easier storage requirements and higher efficacy levels. This vaccine should also be less expensive than the mRNA options, and therefore be more accessible to lower-income countries.
The trial results show that NVX-CoV2373 was 93% effective against the predominant SARS-CoV-2 variants in the trial population in the US and Mexico. A relatively high percentage of the 77 subjects who contracted Covid-19 were sequenced in this trial. Two cases were found to be caused by variant B.1.351 (Beta) and 35 caused by variant B.1.1.7 (Alpha), while the causes of the other cases were undisclosed.
Source: Clinical Trials Arena
On Monday, June 7, the Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer’s disease, a condition that affects over 6 million people in the United States.1 The drug is a first-of-its kind therapy, according to the FDA.
“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement.1
The drug is intended to slow the progression of Alzheimer’s disease. It is not a cure.
The news about Aduhelm’s approval is both exciting and controversial. It’s exciting because it is the first new drug approved to treat Alzheimer’s since 2003. It’s controversial because it’s not clear from the clinical trial that the drug will actually work. Last year, an FDA panel concluded there wasn’t enough evidence to prove the drug was effective.
A new study from the Cleveland Clinic in Ohio has found that people who’ve already had COVID-19 may not necessarily benefit from vaccination.
The research indicates that out of a large pool of healthcare workers, there were nearly 0 cases of SARS-CoV-2 infection among those who had:
-previously contracted the virus and were unvaccinated
-previously contracted the virus and were vaccinated
-never contracted the virus and were vaccinated
There was, however, a steady increase in cases among unvaccinated people who hadn’t previously contracted SARS-CoV-2.
According to the researchers, the findings suggest that natural infection provides immunity similar to vaccination. Therefore, people who haven’t had COVID-19 can be prioritized for vaccination.
Experts say that more research is needed to determine how long immunity lasts after a case of COVID-19. Until we have that data, some infectious disease specialists are recommending that people who’ve had COVID-19 still get one dose.
Asian immigrants have faced multiple challenges in the past year. There has been a rise in anti-Asian hate crimes, driven, in part, by inflammatory rhetoric related to the coronavirus pandemic, which has spurred the federal government to make a recent statement condemning and denouncing acts of racism, xenophobia, and intolerance against Asian American communities and to enact the COVID-19 Hate Crimes Act. At the same time, immigrants living in the U.S. have experienced a range of increased health and financial risks associated with COVID-19. These risks and barriers may have been compounded by immigration policy changes made by the Trump administration that increased fears among immigrant families and made some more reluctant to access programs and services, including health coverage and health care. Although the Biden administration has since reversed many of these policies, they may continue to have lingering effects among families.
Limited data are available to understand how immigrants have been affected by the pandemic, and there are particularly little data available to understand the experiences of Asian immigrants even though they are one of the fastest growing immigrant groups in the U.S. and are projected to become the nation’s largest immigrant group over the next 35 years. To help fill these gaps in information, this analysis provides insight into recent experiences with racism and discrimination, immigration-related fears, and impacts of the COVID-19 pandemic among Asian immigrant patients at four community health centers.
Source: Kaiser Family Foundation
Two vaccines made using messenger RNA (mRNA) have proved spectacularly successful at warding off COVID-19, but a third mRNA-based candidate has flopped in a final-stage trial, according to an initial report released this week. Researchers are now asking why — and some think that choices about the type of mRNA chemistry used might be to blame. Any insight could help to guide the future design of mRNA vaccines against COVID-19 or other diseases.
The company behind the beleaguered trial, CureVac, based in Tübingen, Germany, announced preliminary data on 16 June from a 40,000-person trial, which showed that its two-dose vaccine was just 47% effective at preventing disease.
CureVac’s mRNA vaccine was expected to be cheaper and to last longer in refrigerated storage than the earlier mRNA vaccines made by Pfizer–BioNTech and Moderna. Many had hoped that it could help to expand the reach of mRNA-based vaccines in lower-income countries, and European countries were expecting to order hundreds of millions of doses.
The Group of Seven nations are set to commit to sharing at least 1 billion coronavirus shots with the world, British Prime Minister Boris Johnson announced Thursday, with half coming from the U.S. and 100 million from the U.K. as President Joe Biden urged allies to join in speeding the pandemic’s end and bolstering the strategic position of the world’s wealthiest democracies.
Johnson’s announcement on the eve of the G-7 leaders’ summit in England came hours after Biden committed to donating 500 million COVID-19 vaccine doses and previewed a coordinated effort by the advanced economies to make vaccination widely and speedily available everywhere.
“We’re going to help lead the world out of this pandemic working alongside our global partners,” Biden said, adding that on Friday the G-7 nations would join the U.S. in outlining their vaccine donation commitments. The G-7 also includes Canada, France, Germany, Italy and Japan.
One Medical has announced its plans to acquire human-centric, value-based primary care group Iora Health in an all-stock transaction valued at approximately $2.1 billion.
The agreement will allow One Medical, a human-centered and technology-powered primary care organization, and Iora Health to work together to accelerate and expand their missions to improve healthcare for consumers, employers, payers, providers, and health networks.
“We are delighted to announce plans to combine with Iora Health, a technology-powered primary care leader delivering outstanding member-based, value-based care for adults 65+ enrolled in Medicare Advantage and other at-risk reimbursement models,” said Amir Dan Rubin, chair and chief executive officer of One Medical.
Source: Rev Cycle Intelligence
The number of new COVID-19 cases in the United States continues to decline steadily, with increases reported in only three states.
According to figures from the Centers for Disease Control and Prevention (CDC), the average number of new U.S. cases dipped to under 14,000 a day this past week, about 2,000 fewer than the previous week.
Overall, the number of new cases in the United States fell to slightly under 100,000 this past week, more than 40,000 fewer than the previous week.
The number of COVID-19 deaths declined to 2,708 this past week, almost 2,000 fewer than the previous week’s total.
Hospitalizations now stand at fewer than 15,000, about 4,000 fewer than a week ago.
Overall, the United States has reported more than 33 million COVID-19 cases since the pandemic began.
COVID-19-related deaths in the United States have now surpassed 598,000.
Experts say they’re encouraged by the declining weekly numbers, but noted we still need to be cautious.
“I expect the downward trend in cases to continue. However, we need to keep vaccinating because there are substantial areas of the country that remain substantially undervaccinated. The COVID virus will continue to smolder in these undervaccinated areas, causing disease and hospitalizations,” Dr. William Schaffner, an infectious disease expert from Vanderbilt University in Tennessee, told Healthline last week.
Another expert noted that even with declining cases, there are long-term health issues to consider.
“From my perspective, the impacts of the pandemic are far beyond the simplicity of health indicators,” Dr. Jamila Taylor, director of healthcare reform and a senior fellow at The Century Foundation, told Healthline last week.
“Recovery will be over the long haul. We need to recover from the health impacts as well as the economic and social impacts. While the daily average in cases is lowering, thousands of Americans have ongoing health challenges that are the result of getting COVID-19, and millions are still experiencing economic disadvantage (including job loss, lack of insurance coverage, the threat of eviction, and food insecurity) brought on by the pandemic,” she said.
The Biden administration is buying 500 million doses of Pfizer’s coronavirus vaccine to donate to the world as the United States dramatically increases its efforts to help vaccinate more of the global population, three people familiar with the plans said Wednesday.
The first 200 million doses will be distributed this year, with the subsequent 300 million shared in the first half of next year. The doses will be distributed by Covax, the World Health Organization-backed initiative to share doses around the globe, and they will be targeted at low- and middle-income countries. Pfizer is selling the doses to the United States at a “not-for-profit” price, according to the people familiar with the deal, who spoke on the condition of anonymity to share details that were not yet public.
President Biden is slated to announce the plan this week at the Group of Seven meeting in Britain, where he is expected to be joined by Pfizer CEO Albert Bourla. The deal comes amid growing calls for the United States and other rich countries to play a more substantial role in boosting the global supply of coronavirus vaccines.
Source: Washington Post
Essentially the company’s SPAC is saying that it’s going to be a better tech enabled version of Oak Street or Agilon. Babylon has put less effort into the medical group management side of the puzzle than Oak Street or Agilon but it hasn’t done nothing. It’s been running GP clinics in the UK for years and now has two Medicare Advantage networks in California w 52k lives. It only did $79m in rev in 2020 but that was presumably mostly in software. They’re aiming for $320m in rev in 2021 (presumably mostly from the medical groups) & $710m in 2022.
Source: THCB Reader
The latest KFF Health Tracking Poll finds majorities of the public saying many current health care proposals being discussed by lawmakers are important priorities for Congress to focus on in the coming months, and few (less than one five) saying each of the health priorities “should not be done.” While majorities of the public say each of the health care priorities asked about is important for Congress to work on, proposals aimed at lowering prescription drug prices are a top priority for Democrats, independents, and Republicans.
Source: Kaiser Family Foundation
President Joe Biden turned to his old boss, former President Barack Obama, on Saturday to help him encourage Americans to sign up for “Obamacare” health care coverage during an expanded special enrollment period in the pandemic.
Biden used his weekly address for a brief Zoom chat with Obama to draw attention to the six-month expanded enrollment period that closes August 15.
Meanwhile, the government released a report that nearly 31 million Americans — a record — now have health coverage through the Affordable Care Act.
Source: Voice of America
People most vulnerable to Covid-19 could require a booster of the BioNTech/Pfizer vaccine later this year, according to scientists who said the shot elicited a lower antibody response against the Delta variant first identified in India.
A study by researchers at the Francis Crick Institute and UCLH Biomedical Research Centre found that levels of neutralising antibodies in recipients of two shots of the vaccine were, on average, more than five times lower against the Delta variant than the original strain that emerged in Wuhan, China.
Source: Financial Times
The COVID-19 pandemic has widened labor force participation gaps between mothers and fathers. The LFPR of mothers overall was about 3.5 percentage points lower in March 2021 than in January 2020 while fathers’ LFPR was down 1 percentage point. Moreover, the age of the children in the household contributes to differences in labor force participation rates (LFPR) during the COVID-19 pandemic. While LFPRs of mothers whose youngest child is a teenager have rebounded to about 1.5 percentage points below its January 2020 level
Source: Brookings Institute
Source: USA Facts
Scientific teams around the world have developed successful Covid-19 vaccines in incredibly short order. In a feat that even a couple of years ago would have seemed completely out of reach, vaccines to protect against the new disease were being used before the first anniversary of the disclosure that a new threat existed. This is truly extraordinary.
In the United States so far, three vaccines have been issued emergency use authorizations — green lights from the Food and Drug Administration to be put into use, even though they have not yet been fully licensed.
A vaccine developed by the partnership of Pfizer and German-manufacturer BioNTech came first in mid-December, followed closely by one developed by Moderna with assistance from the National Institute of Allergy and Infectious Diseases.
Saying it needs to “pivot from ambivalence to urgent action” and hold itself accountable for deeply embedded health inequities, the American Medical Association has vowed in a new strategic plan to use its influence as one of the world’s most powerful medical organizations to fight and dismantle white supremacy and racism in the U.S. health care system — and within its own walls.
The 83-page report on racial justice and health equity, which is the culmination of two years of work and was scheduled to be released on Wednesday, was obtained by STAT and has now been released by the AMA. By pledging to ground all of the AMA’s work in racial justice, the plan marks a major change for a 174-year-old organization marred by a racist history of excluding Black physicians for more than a century. More recently, critics say the AMA, which the report describes as “rooted in white patriarchy and affluent supremacy,” has paid scant attention to how racism has affected medicine and caused detrimental health outcomes for many communities of color, as the ongoing pandemic has sharply delineated.
The AMA catalogues in detail many of the ways it has excluded Black, brown, and Native physicians, espoused racism, and harmed people of color its members take an oath to not harm, and the report serves as a reckoning — with its racist past and its refusal to engage with many of the issues now roiling medicine and the country at large. The AMA is the largest trade and lobbying organization of U.S. doctors; its membership includes some 270,000 physicians and medical students.
Comparing data from 1,533 U.S. adults collected in February 2020 with data from 1,577 adults in December 2020, the survey revealed that People of Color (POC) are less likely to rate their overall health and wellness as “excellent” or “very good” compared with white Americans.
Moreover, COVID-19 specifically impacted the physical and mental health of POC.
“COVID-19 has brought to the forefront a tale of two pandemics. One of which has impacted every major system within our [country]: systemic racism. The other [pandemic], COVID-19, has made the general public aware of the inequities that exist within our systems of care as Black Indigenous Persons of Color (BIPOC) and those that identify as Latino or Latinx have always experienced disproportionate inequities in healthcare,” Andrea Heyward, deputy director of the Center for Community Health Alignment, told Healthline.
In 2019, nearly 50,000 people in the United States died from opioid-involved overdoses.1 The misuse of and addiction to opioids—including prescription pain relievers, heroin, and synthetic opioids such as fentanyl—is a serious national crisis that affects public health as well as social and economic welfare.
The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.2
Source: Drug Abuse, NIH
Outside an upscale Indian hospital last week, Baljeet Asthana put her phone on selfie mode, propped her eyeglasses on her head so she could stare directly into the camera, and hit record.
Through a white polka-dot mask, she described her family’s ordeal: Her 82-year-old mother was inside the hospital “struggling for her life,” Asthana said. Her mother desperately needed an intensive care unit bed, but the hospital — Fortis Hospital, one of the best-equipped private facilities in the capital, New Delhi — was full. Officials told the family to look for an ICU bed elsewhere.
“My mother is slowly dying,” reads her tweet accompanying her video.
The US Centers for Disease Control and Prevention on Thursday abruptly changed its guidance on masks and social distancing, saying people who are fully vaccinated against Covid-19 don’t have to wear masks indoors, and they don’t have to keep their distance from others.
“If you are fully vaccinated, you can start doing the things that you had stopped doing because of the pandemic,” CDC Director Dr. Rochelle Walensky said in a White House briefing. “We have all longed for this moment when we can get back to some sense of normalcy.”
Walensky said the science in three areas led to the change.
Two pharmaceutical companies have halted clinical trials of gene-targeting therapies for Huntington’s disease (HD), following the drugs’ disappointing performance.
Researchers had hoped that the treatments—known as antisense oligonucleotides (ASOs)—would be a game changer for HD, an incurable genetic condition that affects cognition, behaviour and movement. But back-to-back announcements from Roche, headquartered in Basel, Switzerland, and Wave Life Sciences, in Cambridge, Massachusetts, have dealt a crushing blow to those affected by the disease.
“I was really shocked, really tearful,” says Marion, a woman in London with HD, who was part of one of the trials. “We didn’t see it coming at all. I felt really frightened and worried about my future.” Marion requested that her last name be withheld to protect her privacy.
Source: Scientific American
A landmark programme to test potential COVID-19 therapies in dozens of countries is restarting with a fresh roster of treatments — this time aimed at tempering the raging immune responses that can worsen severe disease.
The clinical trial, named Solidarity and coordinated by the World Health Organization (WHO), will test three drugs that dampen inflammation, an approach that has already shown promise in people hospitalized with COVID-19.
All three drugs were carefully chosen on the basis of the promise they showed in smaller clinical trials and widespread availability, says John-Arne Røttingen, scientific director of the Norwegian Institute of Public Health and chair of the Solidarity trial’s international steering committee. “You need at least promising signals that some of them will work,” he says. “And we need study drugs that we can deliver in a broad group of countries.”
It was an American epidemic long before Covid-19.
Opioid addiction and overdoses have scythed through the US heartland, often compounding misery in regions already ravaged by economic desperation. Between 1999 and 2019, more than 247,000 people died in the US from overdoses involving prescription opioids, according to the Centers for Disease Control and Prevention. In 2019 alone, nearly 50,000 Americans were killed by overdosing on powerful synthetic drugs like fentanyl.
Who is to blame for this addictive cycle? The drug firms — some of which have been lauded for their role in the lightning-fast development of the Covid-19 vaccine — that pumped opioids into vulnerable communities? The pharmacies that distributed them? Or did doctors create the path for the epidemic by overprescribing new drugs for chronic pain?
These questions may start to be sorted out in West Virginia, where a trial has just opened with Big Pharma firms McKesson Corp., AmerisourceBergen and Cardinal Health on the stand. It will help test whether an opioid case can be successful at trial against pharmaceutical companies under a claim of “public nuisance” for failing to monitor, divert or report suspicious or excessive orders under the Controlled Substances Act.
President Biden’s sweeping infrastructure proposal, the American Jobs Plan, is the legislation that launched a thousand gripes.
From the day it was introduced, the package spawned not only the expected debates about its cost and how to pay for it, but also a charged debate about what should and should not be classified as “infrastructure.”
The disagreement over what constitutes infrastructure is particularly perplexing considering that we generally know what we mean when we talk about infrastructure in other contexts. For example, when we speak of a company having strong infrastructure, we know what that means, and it’s rare that we’re talking only about buildings and pipes.
We typically talk about people, process and technology—the necessary building blocks for the company’s financial success.
But when we talk about infrastructure in the American Jobs Plan, beyond roads and bridges, opinions diverge about investments in clean water, broadband, and especially investment in essential healthcare.
Source: Fierce Healthcare
As people move from lockdowns in India’s big cities to rural areas, Covid-19 continues to spread.
But rundown local hospitals and health centres are unable to cope with a crisis that they were never equipped for.
BBC India correspondent Yogita Limaye has been inside one to uncover the conditions that patients are facing.
Pfizer and its vaccine partner BioNTech have started an application to request the Food and Drug Administration’s approval for its COVID-19 vaccine.
Pfizer is the first coronavirus vaccine maker in the U.S. to request full approval. Like Pfizer, the Moderna and Johnson & Johnson vaccines had been previously cleared for use under the agency’s emergency use authorization — a less rigorous approval method to aid a swifter response to the pandemic.
An FDA approval for a vaccine means the agency has decided that its benefits outweigh the known risks following a review of the manufacturer’s testing results.
If granted, Pfizer’s full stamp of approval would only apply to the vaccine for people who are 16 and older. Meanwhile, the vaccine maker is seeking emergency use authorization for its COVID-19 vaccine to include children between 12 and 15.
Surveillance footage shows State Representative Mike Nearman opening a door to let protesters into the Capitol, in Salem, last year.
A Republican state legislator from Oregon who was captured on surveillance video allowing demonstrators to enter the State Capitol in December was charged on Friday in connection with the breach of the building, which led to a conflict between officers and protesters.
The lawmaker, Representative Mike Nearman, 57, was charged with official misconduct in the first degree and trespassing in the second degree, according to court documents.
Marion County prosecutors said in court documents that Mr. Nearman, “being a public servant, did unlawfully and knowingly perform an act which constituted an unauthorized exercise of his official duties, with intent to obtain a benefit or to harm another.”
Source: New York Times
President Joe Biden’s address to the nation on April 28th wasn’t just a victory lap for the accomplishments of his first 100 days: It was a declaration that the Biden administration’s highest ambition would be reviving America and its democracy from the sorry state his predecessor had left it in.
There have been real accomplishments, like the transformative American Rescue Plan. But in key policy areas, even ones where Trump’s approach deeply damaged America’s democratic image, the Biden administration has seemingly been content with continuing its predecessor’s policies. On immigration and the global Covid-19 response in particular, Biden has seemed unable or unwilling to move past Donald Trump’s worldview, giving “America First” a home in a Democratic White House.
In mid-April, the Biden administration announced it would maintain the Trump administration’s 15,000-person cap on refugee admittance — a break with its campaign promise, not to mention a continuation of one of Trump’s most noxious policies.
China turned attention to former President Donald Trump’s pandemic response on Friday and advised the new administration to “learn its lesson” and stop pointing fingers at Beijing.
The pandemic put added strain on an already precarious relationship between China and the United States, and when criticized, Beijing regularly shifts the conversation back to America’s actions. Having been accused of using the pandemic to conduct information warfare, China championed its own response and pointed to the high death toll in the United States.
“As the world’s No.1 superpower, the U.S. has done much damage to the international anti-epidemic cooperation, which has made the American people and many more in the world pay a heavy price,” Chinese foreign ministry spokesperson Wang Wenbin said on Friday.
On April 15, Gargi Shindé, a 43-year-old nonprofit executive, logged onto Zoom at 5 a.m. From her home in Charlotte, North Carolina, she watched her relatives huddle around a bright-yellow body bag at a crematorium in Pune, India. They were performing the final rites for Shindé’s aunt, Vijaya, who had just died from COVID-19. All she could do was watch. The bag was almost fully zipped, revealing only Vijaya’s face, which appeared tiny and blurry through Shindé’s phone. “The only contribution I had was writing an obituary,” she told me, “and I’m scared I’ll have to do another one soon.”
On top of the grief and anger she’s feeling, Shindé has been struggling to comprehend the “surreal, stark contrast” between her own safety in Charlotte—where restrictions are loosening—and the catastrophe upending life back home. Then, on Thursday, Shindé emailed to tell me that another one of her aunts had just died from COVID-19.
Over the past two weeks, tragedies like what Shindé experienced are becoming a horrific new reality for Indian Americans. Many are glued to WhatsApp through the night, checking in on relatives as India confronts one of the world’s worst coronavirus surges. Every day, India is breaking grim global pandemic records, and even these numbers may be dramatically lower than the actual toll. The situation has become so dire that it verges on apocalyptic: Hospitals are running out of beds and oxygen, and people are dying while waiting for treatment. Crematoria are so overcrowded that workers are building makeshift funeral pyres in car parks, where grieving families wait for up to 20 hours for access.
* U.S. CDC SAYS DELIVERED 312,508,205 DOSES OF COVID-19 VACCINE AS OF MAY 1 VERSUS 308,774,155 DOSES AS OF APRIL 30
* U.S. CDC SAYS ADMINISTERED 243,463,471 DOSES OF COVID-19 VACCINE AS OF MAY 1 VERSUS 240,159,677 DOSES AS OF APRIL 30
* U.S. CDC SAYS 146,239,208 INDIVIDUALS HAVE RECEIVED AT LEAST ONE DOSE OF COVID-19 VACCINE AS OF MAY 1 VERSUS 144,894,586 INDIVIDUALS AS OF APRIL 30
* U.S. CDC SAYS 103,422,555 INDIVIDUALS HAVE BEEN FULLY VACCINATED AGAINST COVID-19 AS OF MAY 1 VERSUS 101,407,318 INDIVIDUALS AS OF APRIL 30
* U.S. CDC SAYS 7,799,933 DOSES OF COVID-19 VACCINE ADMINISTERED IN LONG-TERM CARE HOMES AS OF MAY 1 VERSUS 7,797,395 DOSES ADMINISTERED AS OF APRIL 30
Daily reported cases in the last week increased to 68,900 per day on average compared
to 66,700 the week before, an increase of 3%
Daily deaths in the last week decreased slightly to 670 per day on average compared to
700 the week before. COVID-19 remains the number 2 cause of death in the
US this week.
The daily death rate is greater than 4 per million in Michigan.
We estimated that 30% of people in the US have been infected as of April 19.
Our estimate of the percent infected to date has increased considerably from last week
due to introducing corrections for waning antibodies in our analysis of seroprevalence
Effective R, computed using cases, hospitalizations, and deaths, is greater than 1 in 34
The infection-detection rate in the US is close to 40%. After correcting for
waning antibodies in seroprevalence surveys, our estimate of the infection-detection
rate is down from our previous estimates.
Based on GISAID and CDC sequence data combined with our variant spread model,
we estimate current prevalence of key variants. B.1.1.7 is becoming the
dominant variant in most of the US. While B.1.351 and P1 have been sequenced in
many states, as in Europe, these variants are not increasing in prevalence in the
presence of B.1.1.7.
India’s medical oxygen shortage has become so dire that a Sikh house of worship began offering free breathing sessions with shared tanks to COVID-19 patients waiting for a hospital bed.
They arrive in their cars, on foot or in three-wheeled taxis, desperate for a mask and tube attached to the precious oxygen tanks outside the gurdwara in a neighborhood outside the capital, New Delhi.
After having largely tamed the virus last year, India is in the throes of the world’s worst coronavirus surge and many of the country’s hospitals are struggling to cope with shortages of beds, medicines and oxygen.
Source: Associated Press
The United States can immediately resume use of Johnson & Johnson’s (JNJ.N) COVID-19 vaccine, top health regulators said on Friday, ending a 10-day pause to investigate its link to extremely rare but potentially deadly blood clots.
The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration said the risks of experiencing the syndrome involving severe blood clots and low platelets as a result of the vaccine was very low. They found 15 cases in the 8 million shots given.
On April 16, Attorney General Merrick Garland announced an investigation of the Minneapolis Police Department. The investigation will focus on patterns and practices of policing, not on an individual case.
This is the first “pattern and practice” investigation ordered by the Biden administration. Garland also revoked the Trump administration’s near-ban of these investigations.
The DOJ press release announcing the investigation said in part:
“The investigation will assess all types of force used by MPD officers, including uses of force involving individuals with behavioral health disabilities and uses of force against individuals engaged in activities protected by the First Amendment. The investigation will also assess whether MPD engages in discriminatory policing. As part of the investigation the Justice Department will conduct a comprehensive review of MPD policies, training and supervision. The department will also examine MPD’s systems of accountability, including complaint intake, investigation, review, disposition and discipline. The Department of Justice will also reach out to community groups and members of the public to learn about their experiences with MPD.
“’The investigation I am announcing today will assess whether the Minneapolis Police Department engages in a pattern or practice of using excessive force, including during protests,’ said Attorney General Garland. ‘Building trust between community and law enforcement will take time and effort by all of us, but we undertake this task with determination and urgency, knowing that change cannot wait.’…”
Pattern and practice investigations usually take more than a year. They begin with meetings with law enforcement, political leadership, and community groups. Investigations include review of supervision procedures, police training, and complaint processes. Heavy-duty data analysis includes arrest reports, disciplinary records, and complaints. Investigators interview victims and community members as well as past and present police officials.
The Department of Justice (DOJ) describes pattern and practice investigation as “a comprehensive analysis of the policies and practices of policing in a particular community.” That could include use of force, stops, searches, arrests, and charges. The focus is on racial discrimination and other violations of civil rights.
If the DOJ finds systemic police misconduct, it issues public findings. Then it tries to negotiate a reform agreement. That usually means a “consent decree.”
The consent decree sets out institutional reforms that must be made. The decree allows a federal court to oversee those changes. The court appoints a monitoring team to assist. Oversight usually lasts several years.
Congress passed the law authorizing pattern and practice investigations in 1994. That was after the 1991 Rodney King beating. A California criminal court acquitted the police who beat him in 1991. Two of the officers were later convicted on federal civil rights charges. The law—42 USC 14141—allows investigation of “a pattern or practice of conduct by law enforcement officers.”
The first pattern and practice investigation began in April 1996. It focused on the Pittsburgh Police Bureau. In January 1997, the DOJ “identified a pattern or practice of excessive force; unlawful stops, searches and arrests.” In April 1997, the DOJ and the city entered into a consent decree. Court supervision lasted until September 2002. Additional monitoring continued into 2005.
That’s a lot of time and resources for a single investigation in a single city. While each investigation is different, all take years to complete. After the investigation is complete, arriving at an agreement takes more time. If no agreement is reached, the Department of Justice can sue to enforce changes. If an agreement is reached, supervision and monitoring follow, usually for several years.
Since 1994, 70 pattern and practice investigations have been conducted. Out of these, 41 ended in consent decrees or other agreements for police department reforms.
Source: Spokesman Reader
Johnson & Johnson privately reached out to Covid-19 vaccine rivals to ask them to join an effort to study the risks of blood clots and speak with one voice about safety, but Pfizer Inc. and Moderna Inc. declined.
As concerns mounted last week over rare cases of blood clots, J&J asked AstraZeneca PLC as well as Pfizer and Moderna to join its efforts looking into the reports, people familiar with the matter said. J&J, through emails and phone calls, also sought to build an informal alliance to communicate the benefits and risks of the shots and address any concerns raised among the public by the blood-clot cases, some of the people said.
Six women who got J&J’s vaccine developed clots, and one died, out of more than seven million doses administered across the U.S., according to federal health officials. The specific adverse event hasn’t been reported by people who received the Pfizer and Moderna shots, the officials said.
Source: Wall Street Journal
Pfizer CEO Albert Bourla says people are likely to need a booster dose of the vaccine six to 12 months after their first round.
From there, it will be an annual re-vaccination.
Bourla shared the news during a CVS Health live event posted to Facebook Thursday.
He also added that real-world data shows the Pfizer vaccine is effective against a worrying variant of coronavirus first seen in South Africa.
Source: CNN News Source
As India’s daily tally of Covid-19 infections surged by a record 200,000-plus cases on two consecutive days, public health experts worry that a new — possibly more virulent — coronavirus variant could be racing through the crowded nation of more than 1.3 billion people.
The new variant, which has a so-called double mutation, is thought to be fueling India’s deadlier new wave of infections that has made it the world’s second worst-hit country, surpassing Brazil, and has already begun to overwhelm its hospitals and crematoriums. The Asian nation has reported more than 14 million Covid cases so far and more than 174,300 fatalities.
“This is a variant of interest we are following,” Maria Van Kerkhove, the World Health Organization’s technical lead officer on Covid, told reporters Friday. “Having two of these mutations, which have been seen in other variants around the world, are concerning,” she said, adding that there was a similarity with mutations that increase transmission as well as reduce neutralization, possibly stunting the ability of vaccines to curb them.
The new strain underscores the insidious nature of viruses and threatens to thwart containment efforts in India, despite stringent measures such as the world’s largest lockdown last year. An exploding outbreak in India risks undoing a hard-won victory over the pathogen for others too, especially as this strain has now jumped to at least 10 other countries.
The Biden administration on Friday announced its plans to invest $1.7 billion into tracking and combating COVID-19 variants as new strains make up about half of all infections across the nation.
The administration unveiled its planned distribution of federal funding from the American Rescue Plan directed at assisting the Centers for Disease Control and Prevention (CDC) and state and local governments in detecting and monitoring COVID-19 variants.
“Our ability to spot variants as they emerge and spread is vital, particularly as we aim to get ahead of dangerous variances before they emerge, as they are in the Midwest right now,” Andy Slavitt, senior White House pandemic adviser, said at a Friday COVID-19 response team briefing.
“This investment will give public health officials the chance to react more quickly to prevent and stop the spread,” he added.
Part of the commitment involves designating money to improve genomic sequencing of COVID-19 samples, which helps scientists identify variants and “potentially deadly mutations.”
In February, the U.S. was sequencing about 8,000 samples per week until the administration funneled almost $200 million to increase the pace.
Source: The Hill
The coronavirus variant discovered in South Africa can “break through” Pfizer/BioNTech’s COVID-19 vaccine to some extent, a real-world data study in Israel found, though its prevalence in the country is low and the research has not been peer-reviewed.
The study, released on Saturday, compared almost 400 people who had tested positive for COVID-19, 14 days or more after they received one or two doses of the vaccine, against the same number of unvaccinated patients with the disease. It matched age and gender, among other characteristics.
The South African variant, B.1.351, was found to make up about 1% of all the COVID-19 cases across all the people studied, according to the study by Tel Aviv University and Israel’s largest healthcare provider, Clalit.
But among patients who had received two doses of the vaccine, the variant’s prevalence rate was eight times higher than those unvaccinated – 5.4% versus 0.7%.
This suggests the vaccine is less effective against the South African variant, compared with the original coronavirus and a variant first identified in Britain that has come to comprise nearly all COVID-19 cases in Israel, the researchers said.
Source: New York Post
Pfizer on recently requested to expand use of its Covid-19 vaccine to adolescents ages 12 to 15.
The request asks the Food and Drug Administration to amend the emergency use authorization, which the FDA originally granted late last year for people ages 16 and up.
Last week, Pfizer-BioNTech said its Phase 3 clinical trials showed its vaccine was safe and 100 percent effective in 12- to 15-year-olds, though the findings have not been peer-reviewed.
“The hope of starting to vaccinate this age group before the start of the next school year,” CEO Albert Bourla said in a statement when those results were released.
Source: NBC News
NIH Begins Testing New Moderna Vaccine Against South African Variant
The National Institutes of Health (NIH) initiated tests of a new COVID-19 vaccine from Moderna targeting the South African variant, B.1.351. It is being tested in about 210 healthy adults. It will also include about 60 adults who participated in Moderna’s first COVID-19 vaccine trials last year and about 150 people who have not yet received a vaccine. The trial is recruiting volunteers in Atlanta, Cincinnati, Seattle, and Nashville.
“Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and White House chief medical advisor. “However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.”
Europe’s drug regulator said it is reviewing reports of rare blood clots in four people who received Johnson & Johnson’s COVID-19 vaccine and has expanded its probe into AstraZeneca’s shot to include reports of a bleeding condition.
Of the four serious cases of clotting and low platelets, three occurred in the United States during the rollout of J&J’s vaccine from its Janssen unit, the European Medicines Agency (EMA) said on Friday, adding that one person had died and that one case was reported in a clinical trial.
It was the first news of EMA’s probe of the J&J vaccine, while AstraZeneca’s coronavirus vaccine has been dogged for weeks over possible links to rare blood clots in the brain and abdomen, which the EMA has confirmed.
U.S.-based J&J said that it was aware of the reports of blood clots possibly related to its COVID-19 vaccine and others, and is working with regulators to assess the data and provide relevant information.
Researchers at the Lindsley F. Kimball Research Institute find that as variant strains emerge, we will need to reevaluate vaccine efficacy by testing the inhibition of viral infection in vivo rather than by quantifying the antibodies produced after in vitro exposure.
Reliable proof of immunity through vaccination may only come through reinfection challenge experiments or through longitudinal studies of postvaccination subjects.
The paper is part of the spring 2021 edition of the Brookings Papers on Economic Activity, the leading conference series and journal in economics for timely, cutting-edge research about real-world policy issues. Research findings are presented in a clear and accessible style to maximize their impact on economic understanding and policymaking.
Source: The Brookings Institute
The European Union is rich, scientifically advanced and endowed with excellent health-care and welfare systems and a political consensus tilted strongly towards looking after its citizens. Yet during the pandemic it has stumbled.
In the brutal and blunt league table of fatalities, the EU as a whole has done less badly than Britain or America, with 138 recorded deaths per 100,000, compared with 187 and 166 respectively—though Hungary, the Czech Republic and Belgium have all fared worse than either.
However, it is in the grip of a vicious surge fuelled by a deadly variant. That underlines the peril of Europe’s low rate of vaccination.
Source: The Economist
Researchers say that a World Health Organization (WHO) report on the pandemic’s origins offers an in-depth summary of available data, including unseen granular details. But much remains to be done to establish the provenance of the virus — knowledge that will help to prevent future pandemics.
The report was the result of a joint investigation between Chinese and international researchers that included a four-week trip earlier this year to Wuhan, China, where COVID-19 was first detected.
The details in the report were helpful, but didn’t include much new information, says David Robertson, a virologist at the University of Glasgow, UK. “The extensive data presented confirmed a lot of what was already known, particularly on the timing of events and early cases in Wuhan.”
Challenges remaining include finding the animal that probably carried the virus from bats to humans, and determining how that spillover into people occurred.
Source: World Health Organization & Nature
Variant of Concern
A variant for which there is evidence of an increase in transmissibility, more severe disease (increased hospitalizations or deaths), significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures.
Possible attributes of a variant of concern:
In addition to the possible attributes of a variant of interest
Evidence of impact on diagnostics, treatments, and vaccines
Widespread interference with diagnostic test targets
Evidence of substantially increased resistance to one or more class of therapies
Evidence of significant decreased neutralization by antibodies generated during previous infection or vaccination
Evidence of reduced vaccine-induced protection from severe disease
Evidence of increased transmissibility
Evidence of increased disease severity
Variants of concern might require one or more appropriate public health actions, such as notification to WHO under the International Health Regulations, reporting to CDC, local or regional efforts to control spread, increased testing, or research to determine the effectiveness of vaccines and treatments against the variant. Based on the characteristics of the variant, additional considerations may include the development of new diagnostics or the modification of vaccines or treatments.
Source: Centers for Disease Control and Prevention
The Heritage Foundation released a Special Report that conducts a statistical analysis of COVID-19 data. The report begins by examining Centers for Disease Control and Prevention data and analyzing the spread and mortality of COVID-19 throughout 2020, identifying specific facets of the population at most risk. The authors then conduct an analysis of the geographic spread of COVID-19, finding that the disease has largely been concentrated in varying hotspots throughout the course of the year. Subsequently, the authors conduct an analysis of Google mobility data to understand the public’s response to COVID-19 before and after the virus had been declared a pandemic. Lastly, the authors conduct a survival analysis examining the effect of behavioral responses to COVID-19 alongside government policies. The authors’ work provides insights to policymakers to continue to combat COVID-19 as well as to prepare for future potential public health crises.
Source: Heritage Foundation
In a K-shaped recovery, there is a separate trajectory for different segments of the economy. Economic and political relationships play a role in shaping that trajectory. So, what happens when those relationships become disconnected?
On the final day of the Wire’s series on the COVID economy and Washington’s K-shaped recovery, we take a look at what economic and political relationships are impacting recovery in urban and rural Washington.
Downtown Seattle Association President Jon Scholes says that about 70 percent of the 350,000 people who worked downtown stopped frequenting the area during the pandemic. Throughout that the public health crisis, Scholes says that a fractured relationship between the City Council and the private sector has made recovery more difficult.
Across Lake Washington, Robert Wallace, CEO of Wallace Properties, a Bellevue based commercial real estate firm, says Seattle’s posture toward business is misguided. Why the different approach? He traces it back to more private sector experience among city leaders.
This is a story about pandemic-era market relationships in urban Washington– between business and government, the public and the private sectors. In rural Washington, a relationship of concern is the one between the state and foreign markets that receive exports from agricultural producers.
Jon Devaney, President of the Washington State Tree Fruit Association, says these relationships have been impacted by years of trade disputes, retaliatory tariffs, and now a global pandemic.
Source: Washington State Wire
IHME released on March 6th new projections that demonstrate a projected death toll of 600,000 by July 2021.
See the full model here: https://covid19.healthdata.org/united-states-of-america?view=total-deaths&tab=trend
Far-right extremists behind election disinformation are now pivoting to spreading alarmist warnings and misinformation about COVID-19 vaccines, according to a New York Times investigation.
“They rode the shift in the national conversation away from Trump to what was happening with the massive ramp up in vaccines,” Devin Burghart, the head of the Seattle-based Institute for Research and Education on Human Rights, told the New York Times, referring to followers of QAnon. “It allowed them to pivot away from the failure of their previous prophecy to focus on something else.”
Public health officials have been warning about the dangers of vaccine misinformation as the country seeks to inoculate enough Americans to reach herd immunity. Just this week the CEOs of Facebook, Google and Twitter were questioned before Congress on their responsibility to combat disinformation spread on their platforms as well as their role in the organization of the insurrection on the United States Capitol. Ahead of the hearing, a group of 12 state attorneys general sent a letter to Facebook and Twitter calling for “immediate steps to fully enforce your companies’ guidelines against vaccine misinformation.”
A recent report from the Center for Countering Digital Hate and Anti-Vax Watch found that most of the anti-vaccine content circulating online can be tied to 12 people, several of whom are figures in the health and wellness spheres. But The New York Times investigation found that far-right groups are increasingly joining the anti-vaccination movement, fueled by a mistrust in the government.
Source: The Hill
What is a “double mutant” variant?
Like all viruses, the coronavirus keeps changing in small ways as it passes from one person to another.
The vast majority of these mutations are inconsequential and don’t alter the way the virus behaves.
But some mutations trigger changes in the spike protein that the virus uses to latch on to and enter human cells – these variants could potentially be more infectious, cause more severe disease or evade vaccines.
Vaccines against respiratory pathogens like SARS-Cov2, the virus that causes Covid-19, protect us by stimulating our bodies to make antibodies.
The best type to protect us are the “neutralizing antibodies” because they block the virus from being able to enter the human cells.
Indian genome scientists have detected a so-called “double variant” of the novel coronavirus.
The government said that an analysis of the samples collected from the western state of Maharashtra showed “an increase in the fraction of samples with the E484Q and L452R mutations” compared with December last year.
“Such [double] mutations confer immune escape and increased infectivity,” the health ministry said in a statement.
Dr Jeremy Kamil, a virologist at Louisiana State University Health Sciences Center Shreveport, says the E484Q is similar to E484K – a mutation seen in the B.1.351 (South Africa) and P.1 (Brazil) variants, which have emerged independently several times.
If enough mutations happen in a viral family tree or a lineage, the virus can begin to function differently and the lineage can become a so-called ‘variant of concern’.
As far as the L452R mutation – also found in the “double mutation” in India – it first got attention as part of B.1.427/B.1.429 lineage in the US, which is sometimes called the “California variant”, Dr Kamil told me.
Brazil is in the throes of a battle against the new Covid-19 variant from the Amazon that threatens to send shock waves across the globe.
Home to less than 3% of the world’s population, Brazil currently accounts for almost a third of the daily global deaths from Covid-19, driven by the new variant. More than 300,000 have died, and daily deaths now top 3,000, a toll suffered only by the far more populous U.S.
“We’re in the trenches here, fighting a war,” said Andréia Cruz, a 42-year-old emergency-ward nurse in the southern Brazilian city of Porto Alegre. In the past three weeks alone, the surrounding state of Rio Grande do Sul has seen nearly 5,000 people die from Covid-19, more than in the final three months of last year.
The spread of the virus in Brazil threatens to turn this country of 213 million into a global public-health hazard. The so-called P.1 strain, present in more than 20 countries and identified in New York last week, is up to 2.2 times more contagious and as much as 61% more able to reinfect people than previous versions of the coronavirus, according to a recent study.
Source: Wall Street Journal
Looking at vaccinated health care workers at two University of California campuses, researchers found a tiny number tested positive for the virus. This finding highlights the need to keep wearing a mask and to keep social distancing, the researchers said.
“Because of the compulsory daily symptom screening of health care personnel, patients and visitors, and the high testing capacity at both UC San Diego Health and UCLA Health, we were able to identify symptomatic and asymptomatic infections among health care workers at our institutions,” said researcher Dr. Jocelyn Keehner. She is an infectious disease fellow at University of California, San Diego (UCSD) School of Medicine.
“Moreover, we were able to describe the infection rates in a real-world scenario, where vaccine roll-out coincided with a surge of infections. We observed a low overall positivity rate among fully immunized health care workers, supporting the high protection rates of these vaccines,” she said in a school news release.
For the study, Keehner’s team pooled data from health care workers who received either the Pfizer or Moderna vaccines between December 16, 2020, and February 9, 2021. There were more than 36,600 first doses, and more than 28,000 were fully vaccinated (two doses).
Among those vaccinated, 379 tested positive on at least one day following vaccination, with the most (71%) testing positive within the first two weeks after the first dose of vaccine. However, 37 workers tested positive after receiving two doses, when they are supposed to have maximum protection.
The researchers estimated that the absolute risk of testing positive for COVID-19 after vaccination was about 1% for health care workers, which was higher than the risk seen in clinical trials, which were not limited to health care workers.
Source: UCSD & US World Report
The most mutated variant of the coronavirus yet was found in travelers from Tanzania, prompting scientists to call for greater monitoring in a country that has largely ignored the pandemic.
A report submitted to the World Health Organization and regional bodies shows the strain has 10 more mutations than found on any other version, according to Tulio de Oliveira, director of Krisp, a scientific institute that carries out genetic testing for 10 African nations. Krisp, which discovered a new strain in South Africa last year that propelled a resurgence of infections in the country, found the new variant in travelers arriving in Angola from Tanzania.
On March 16, the FDA posted a new web page on FDA.gov, Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs. This resource is intended for schools, workplaces, communities and others looking to establish testing programs to screen people without symptoms and with no known or suspected exposure to COVID-19. The FDA also posted a new template for test developers to help facilitate submission of an emergency use authorization (EUA) request for certain COVID-19 tests for screening using a serial testing approach.
Source: Food and Drug Administration
Some countries in the European Union have temporarily suspended use of the AstraZeneca COVID-19 vaccine as a precautionary measure based on reports of rare blood coagulation disorders in persons who had received the vaccine. Other countries in the EU – having considered the same information – have decided to continue using the vaccine in their immunization programmes.
Vaccination against COVID-19 will not reduce illness or deaths from other causes. Thromboembolic events are known to occur frequently. Venous thromboembolism is the third most common cardiovascular disease globally.
In extensive vaccination campaigns, it is routine for countries to signal potential adverse events following immunization. This does not necessarily mean that the events are linked to vaccination itself, but it is good practice to investigate them. It also shows that the surveillance system works and that effective controls are in place.
WHO is in regular contact with the European Medicines Agency and regulators around the world for the latest information on COVID-19 vaccine safety. The WHO COVID-19 Subcommittee of the Global Advisory Committee on Vaccine Safety is carefully assessing the latest available safety data for the AstraZeneca vaccine. Once that review is completed, WHO will immediately communicate the findings to the public.
At this time, WHO considers that the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue.
Source: World Health Organization
Former President Donald Trump’s Mar-a-Lago club in Palm Beach, Florida, has been partially closed after staff members tested positive for the coronavirus.
That’s according to several people, including one familiar with club operations, who said Mar-a-Lago had “partially closed” a section of the club and quarantined some of its workers “out of an abundance of caution.” The person spoke on condition of anonymity because they were not authorized to discuss the situation by name.
An email sent to members said that service had been temporarily suspended in the club’s dining room and at its beach club because some staff members had recently tested positive. It said the club had undertaken “all appropriate response measures,” including sanitizing affected areas,” and that banquet and event services remain open.
Source: Associated Press
Every day, more Americans become eligible for the COVID-19 vaccine, yet nearly half of all frontline health care workers remain unvaccinated, even though they were given priority access to the first available doses.
Only 52% of all frontline health care workers say they have received even a first dose of a COVID-19 vaccine, according to a new report from the Kaiser Family Foundation and the Washington Post.
That leaves 48% of health care workers on the frontlines of the fight against COVID-19, including doctors, nurses, housekeepers and home health aides, entirely unprotected against and vulnerable to the virus.
Source: Kaiser Family Foundation
More than 1 in 5 Americans have received at least one dose of COVID-19 vaccine. Each day millions more people are being vaccinated, providing hope that we can soon gather with our friends and family safely. On March 12, 2021, the US reached 100 million vaccine doses administered in just 88 days—thanks to three safe and effective vaccines that have been distributed throughout the United States.
CDC recently released recommendations for fully vaccinated people as the first step in safely returning to normal activities.
After more than a dozen European countries stopped distribution of the AstraZeneca/Oxford Covid-19 vaccine due to concerns about blood clots, the European Union’s top pharmaceutical regulator on Thursday concluded the vaccine was safe.
“The committee has come to a clear scientific conclusion: This is a safe and effective vaccine. Its benefits in protecting people from Covid-19 with the associated risks of deaths and hospitalizations outweigh the possible risks,” said Emer Cooke, executive director of the European Medicines Agency (EMA), during a press conference. “The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.”
The agency’s guidance echoed that of the World Health Organization, which said on Wednesday that “the benefits of the AstraZeneca [Covid-19] vaccine outweigh its risks” and recommended that vaccinations continue.
The two public health heavyweights were forced to weigh in after several reports surfaced in Europe of severe side effects such as bleeding and blood clots (also known as thrombosis) in patients earlier this month following injections of the Covid-19 vaccine developed by the pharmaceutical giant AstraZeneca and the University of Oxford. The cases emerged out of more than 17 million recipients of the vaccine between the United Kingdom and the EU to date.
The complications of concern so far are rare, with 37 reported cases.
Several European countries have instituted new lockdown restrictions, while others are considering tightening their rules in order to curb the spread of the coronavirus as case numbers across the continent are surging once again.
In France, a new partial lockdown took effect at midnight on Friday. Some 21 million people across 16 regions, including Paris, are affected by the new measures. The French government decided to take the step amid fears of a third wave.
The new lockdown is less restrictive than previous ones. People will be allowed to exercise outdoors and schools will remain open. However, non-essential businesses have been forced to shut down, while others, such as hairdressers, can remain open if they follow strict guidelines.
The ‘relative severity ratio’ compares COVID-19 mortality to the pre-pandemic mortality profile of individual countries. This involves two comparisons. The first comparison is made through the severity ratio itself, which compares COVID-19 mortality with all-cause mortality in 2019. The second one is the comparison of the severity ratio with cause-specific proportionate mortality rates (the share of deaths due to a specific cause in total deaths).
These comparisons are useful as the expression of mortality in relative terms speaks to the fact that countries may have adapted to their specific patterns of mortality. Deviations from this pattern may create pressure points, such as, for example, on the health system. Comparisons with previous patterns give a country-specific flavor of the severity of the COVID-19 pandemic, which could be used to corroborate realities on the ground.
Comparisons with top causes of death are with reference to the 133 disease families of the 2019 Global Burden of Disease study (at the third level of ICD-10). We select the top nth cause of death, which most closely approximates the peak COVID-19 severity ratio from below. More details on the concept of relative severity are in the paper of Schellekens and Sourrouille (2020) that developed the concept, which can found here.
Source: World Bank
Investigative report coming at the heels of calls to impeach NY Governor Cuomo shows systemic fraud rampant across nursing homes.
Source: NY Times
As enterprises pivot from the harsh reality of the COVID-19 pandemic to the unknowns of post-vaccination, return-to-work scenarios, one certainty stands out: re-opening offices and safely bringing back employees will require an agile IT infrastructure. CIOs still grappling with massive remote work initiatives must now also contend with new ways of safely using office space by employees who move fluidly between home, work, and customers.
Automated hoteling space management, air quality monitoring, overcrowding detection, and usage-dependent cleaning services will all be part of the post-pandemic office. To work effectively, these services require situational knowledge, or “hyper-awareness,” based on a mash up of Internet of Things (IoT) device data and network-generated contextual data. IoT data includes presence, people count, air samples, and space reservation indicators. Contextual data includes location, identity, applications in use, and security posture.
The locus for converged IoT and contextual data is the IT infrastructure that’s generating the latter and carrying both. Pan-enterprise wired and wireless IT networks enable pervasive data collection and conveyance, over existing infrastructure, that was designed from the ground up to connect and protect the people and machines that use it. There’s no need for overlay networks or shadow IT, and costs are minimal since the IT infrastructure is already deployed.
The U.S. could help drive a powerful global economic recovery this year, as it plays a more central role in the comeback than after the financial crisis, reflecting the unusual nature of the Covid-19 shock and the flexibility of the American economy.
The world economy is likely to grow by around 6% this year, according to Oxford Economics, the fastest rate in almost half a century, as vaccine campaigns allow pandemic restrictions to be lifted and businesses to snap back.
For the first time since 2005, the U.S. is expected this year to make a bigger contribution to global growth than China, said the research firm. After the 2008 financial crisis, the global economic recovery was powered by China, as the U.S. experienced the weakest revival since the Great Depression.
Source: Wall Street Journal
President Biden’s direction to states to make all adults eligible for coronavirus vaccines by May 1 will pressure governors and local officials to increase the pace of their rollouts, as the U.S. surpassed 100 million vaccinations on Friday, March 12 2021.
The milestone comes as the inoculation drive gains pace in the U.S. and as new cases of Covid-19 have dropped in recent weeks. The Centers for Disease Control and Prevention’s data-tracker website showed Friday that some 101 million doses of the three vaccines approved for use in the U.S. have been administered so far.
Source: Wall Street Journal
Federal aid has so far been suboptimal in allocating economic assistance to those who need it the most. Over half of coronavirus aid went directly to businesses, many of which were not compelled to keep their employees or prove that they were negatively impacted by the pandemic. By contrast, only about a fifth went directly to workers and families, and the aid that did was not always well-targeted. For example, initial direct payments (stimulus checks) excluded children if they had one parent who was an undocumented immigrant. Direct stimulus payments were also administered slowly, with millions of American families waiting months to receive their funds.
For the purpose of this analysis, the most well-targeted program was supplemental unemployment insurance. By tracking unemployment and incorporating a broader definition of unemployed workers, enhanced unemployment benefits should have flown disproportionately to those in more impacted industries such as leisure and hospitality. As a result, enhanced benefits did more to support the economies of Las Vegas and Orlando than their relative impact in San Francisco, Seattle, and Washington, D.C. Likewise, we would expect Hispanic or Latino workers to make up a disproportionate number of claims given that they faced disproportionately high unemployment. Herein lies one serious potential problem. Many states continue to struggle with significant difficulty in administering the new unemployment insurance aid.
Multiple factors are at play, including specific states’ difficulty modernizing their systems to accommodate the new federal rules and the sudden spike in demand. Florida, for example, had an archaic system that made it difficult for newly eligible workers to qualify. Nevada’s difficulty in expanding eligibility and processing record levels of unemployment claims were also well-documented, leading to a class-action lawsuit against the state’s employment department. Delays in processing claims and providing payments are particularly harmful for people with little savings and difficulty accessing short-term credit at a reasonable cost, burdens that apply disproportionately to Hispanic or Latino Nevadans. This could be one reason why enhanced unemployment insurance benefits were not equitably taken up by those who need it; about the same proportion of workers who filed for unemployment benefits are Hispanic or Latino as are in the workforce, even though Hispanic or Latino workers were disproportionately unemployed.
The heralded Paycheck Protection Program (PPP), which offered affected businesses and workers forgivable loans (in effect grants), saved many fewer jobs than the lofty anticipated 30 million; in the first two months of the program, researchers estimate that only 2.3 million jobs were saved, at a price of $286,000 each. The PPP grants that were distributed seemed mismatched with the unemployment rate in those sectors. According to a Washington Post analysis, 32% of jobs lost were in the lodging, restaurants, and bar industry (a core component of hospitality and leisure), but the industry only received 8% of PPP grants. Similarly, the arts, entertainment & recreation industry had a job loss rate three times higher than the portion of PPP grants it received. Correspondingly, finance and insurance companies that relatively prospered throughout the pandemic received over $8 billion in PPP funds. Put another way, finance and insurance received over $350,000 in PPP funding per job lost from February to April as compared to about $8,000 in arts, entertainment, and recreation, and $7,800 in accommodation and food services.
Source: Brookings Institute
Many health experts are optimistic that the end of the pandemic in the United States is in sight, although it’s not clear what the transition to “normal” will look like.
Some experts are more optimistic than others.
“I expect Covid will be mostly gone by April, allowing Americans to resume normal life,” wrote Dr. Marty Makary, a surgeon and a professor at the Johns Hopkins School of Medicine and Bloomberg School of Public Health, in a commentary in The Wall Street Journal.
He points to the sharp drop in COVID-19 cases in recent weeks as a sign that parts of the country are nearing, or have reached, herd immunity.
This decline in cases is “in large part because natural immunity from prior infection is far more common than can be measured by testing,” he wrote.
He estimates that the number of people who have recovered from a coronavirus infection — and likely have some immunity to the virus — is 6.5 times the 28 million confirmed cases. That would mean that about 55 percent of Americans have natural immunity.
If you combine this with the 150 million people that Makary estimates will be vaccinated by the end of March, that brings the country close to the herd immunity threshold.
Not every health expert, though, agrees that the country will be open for business by April.
White House COVID-19 adviser Dr. Anthony FauciTrusted Source said last week that the country won’t return to “normal” until after the summer, reports Newsweek.
The US Food and Drug Administration on Friday said that people should not use ivermectin to attempt to treat or prevent Covid-19. The drug is typically used to treat parasites, such as lice and scabies.
“There seems to be a growing interest in a drug called ivermectin to treat humans with COVID-19. Ivermectin is often used in the U.S. to treat or prevent parasites in animals. The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses,” the agency’s announcement said.
The Centers for Disease Control and Prevention is finalizing guidance aimed at clarifying what Americans who have received COVID-19 vaccines should and shouldn’t do, according to two sources at the agency familiar with its drafting.
The upcoming guidance, first reported by Politico, is expected to include that fully vaccinated individuals should be able to gather in small groups with other people who have also been vaccinated. The CDC currently does not recommend in-person gatherings with the general public, saying “gathering virtually or with the people you live with is the safest choice.”
Even for people who have been fully vaccinated, other mitigation measures will still be recommended, including wearing a mask in public and social distancing.
Four pharmaceutical companies in settlement talks with states to resolve claims related to their involvement in the national opioid crisis stand to reap about $1 billion each in tax breaks if a combined payout of more than $26 billion is finalized, according to company filings.
The drug distributors McKesson Corp. , AmerisourceBergen Corp. and Cardinal Health Inc., along with Johnson & Johnson , plan to deduct the payouts from their taxes, filings show.
Cardinal, which expects to pay $6.6 billion as part of the settlement, said in a regulatory filing earlier this month that it anticipates receiving a $943 million tax benefit as a result of losses it incurred because of the payout charge. The company said it has filed for an income tax refund it expects to receive in the next 12 months.
Cardinal, based in Dublin, Ohio, said $420 million of the benefit would come from offsetting profits from prior tax years when there was a higher corporate income-tax rate, taking advantage of a provision created by Congress as part of its Covid-19 economic-relief package last March
Source: Wall Street Journal
As the medical community unearths troubling consequences for people who put off routine or emergency health care during the coronavirus pandemic, an urgent message is going out to patients: There are some medical appointments you just shouldn’t put off any longer, even if you’re nervous about venturing into a clinic or emergency room.
In the first days of the COVID-19 pandemic, I was one of many primary care doctors making tough decisions about who needed to be seen in person and who could wait a few weeks. But as weeks have turned into nearly a year, our calculus has changed.
“There was a time, early in the pandemic, when we didn’t know much about this virus. So at that time, I think hospitals and clinics closing — that made sense,” Dr. Ned Sharpless, director of the National Cancer Institute, tells NPR. “But that time is over. We can have patients come in and get these tests and see their doctors in person in a way that is both safe for the caregiver and safe for the patient, and the risk of transmission is low.”
Since mid-May 2020, CDC has been tracking reports of multisystem inflammatory syndrome in children (MIS-C), a rare but serious condition associated with COVID-19. Many questions remain about why some children and adolescents develop MIS-C after a COVID-19 illness or contact with someone with COVID-19, while others do not.
Since reporting began in mid-May, 48 states, New York City, Puerto Rico, and Washington, DC, have reported at least one case of MIS-C to CDC. Because of the small number of cases in some states and to protect the privacy of patients and their families, CDC is not reporting individual states’ case counts.
At least four founding members of Time’s Up Healthcare resigned Thursday from the organization following a lawsuit that suggests two other founders did not respond appropriately to reports of sexual harassment and assault in their separate jobs at Oregon Health and Science University.
Both Esther Choo and Laura Stadum are mentioned in a legal complaint filed in February in an Oregon federal court by an anonymous employee of the Veterans Affairs hospital, in which the employee alleges that a resident who is well-known on Twitter and TikTok harassed her, sending her “sexually-charged social media messages” and once pushed his erect penis against her body.
Neither Stadum, the Title IX coordinator at OHSU, or Choo, an emergency medicine physician and a professor at OHSU, is named as a defendant. Instead, the plaintiff alleges that Choo discouraged another person from reporting separate alleged harassment.
Walmart Inc. isn’t giving up.
The retail giant said it would appeal the decision of a Texas federal judge to dismiss a Walmart lawsuit that sought to preemptively block the U.S. government from blaming the company for its alleged role in fueling the nation’s opioid crisis.
U.S. District Judge Sean Jordan said the government had not waived its sovereign immunity from Walmart’s “sweeping” challenge to the Department of Justice’s and Drug Enforcement Administration’s enforcement of laws governing opioid prescriptions by pharmacies and pharmacists.
In a statement, Walmart said it will appeal the court’s ruling “to seek clarity on the roles and legal responsibilities of pharmacists and pharmacies in filling opioid prescriptions written by DEA approved doctors.” The retailer also said that pharmacists and patients “deserve better than the current patchwork of inconsistent, conflicting and contradictory demands from federal and state regulators.”
Walmart sued the U.S. Department of Justice and the Drug Enforcement Administration in October in what was seen as a pre-emptive move against an impending opioid-related civil lawsuit against the retail giant from the Justice Department. In December, the DOJ filed a lawsuit Walmart Inc. alleging violations of the Controlled Substances Act. The civil complaint alleged that Walmart unlawfully dispensed controlled substances from its pharmacies and unlawfully distributed controlled substances to those pharmacies throughout the height of the prescription opioid crisis.
The federal government has partnered up with Moderna, Pfizer, Johnson & Johnson, Novavax, and AstraZeneca to help develop, produce, and administer COVID-19 vaccines as quickly as possible.
Under Operation Warp Speed, the federal government has pledged close to $9 billion to fund the development and production of the vaccines.
Moderna received nearly $1 billion for its COVID-19 vaccine development and is set to receive an additional $1.5 billion for 100 million doses.
Pfizer, with its German partner BioNTech, will be given $1.95 billion for 100 million doses, but received no federal funding for the research and development of their vaccine.
Johnson & Johnson received $456 million for vaccine research and development and will be paid $1 billion for 100 million doses.
Novavax will get $1.6 billion in federal funding for research, development, and 100 million doses.
AstraZeneca is set to receive $1.2 billion that will cover 300 million doses along with certain costs pertaining to phase 3 clinical trials and manufacturing.
The federal government will likely purchase additional doses in the coming months.
Already, the government has pledged to purchase an additional 500 million doses from Pfizer and may buy 200 million more from Johnson & Johnson.
“The huge [amount of] money that we spent in this case is unprecedented. It’s never happened before,” said Haizhen Lin, an associate professor of business economics and public policy at the Indiana University Kelley School of Business and a faculty research fellow at the National Bureau of Economic Research.
It’s worth noting that many details included in these contracts have not been made public, said Lin.
The cost for each dose ranges from $3 to $37, depending on the vaccine.
Moderna, a two-dose vaccine, recently announced each dose will go for around $32 to $37.
The Pfizer vaccine, also given in two doses, is expected to cost $19.50 a dose.
Each dose for Johnson & Johnson’s two-dose vaccine will cost an estimated $10, and AstraZeneca’s two-dose vaccine could be the cheapest at just $3 to $4 a dose.
Novavax’s two-dose vaccine is estimated to be $16 a dose.
No individuals — regardless of whether they’re uninsured, have private health insurance, or have Medicare or Medicaid — will pay out of pocket for the vaccine itself, federal health officials have previously stated.
“Vaccine doses purchased with U.S. taxpayer dollars will be given to the American people at no cost,” the Centers for Disease Control and Prevention (CDC)Trusted Source states.
Certain vaccine providers may charge an administration fee for giving the shot, but individuals can have that fee reimbursed.
“Vaccine providers can get this fee reimbursed by the patient’s public or private insurance company or, for uninsured patients, by the Health Resources and Services Administration’s Provider Relief Fund,” the CDC states.
The decline in Covid-19 cases reported in the U.S. since early January may be flattening, a concerning shift as highly transmissible variants threaten to exacerbate infections, the head of the U.S. Centers for Disease Control and Prevention said Friday.
“Over the last few weeks, cases and hospital admissions in the United States have been coming down since early January, and deaths have been declining in the past week,” CDC Director Dr. Rochelle Walensky said during a press briefing. “But the latest data suggest that these declines may be stalling, potentially leveling off at still a very high number.”
Source: Centers for Disease Control
A new report from the US Centers for Disease Control and Prevention (CDC) shows relatively low rates of adverse events from the coronavirus disease 2019 (COVID-19) vaccine.
Overall, between Dec. 14 and Jan. 13 there was more than 13.7 million vaccine doses administered and 6994 reports of adverse events following vaccination. Of the adverse events, 6354 (90.8%) were deemed non-serious and 640 (9.2%) were classified as serious.
To monitor vaccine safety and report adverse events, the CDC relies on the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system and v-safe, an active surveillance system.
Source: Centers for Disease Control
Epidemiologists say there could be a few reasons for that decline: we’re past the holiday seasons surge and people changed their behavior in response to the winter spikes. And by now, many people have antibodies against the virus because of a previous infection. But vaccines probably aren’t a driving factor in that drop — not enough people had been fully vaccinated against COVID-19 when the decline started, and vaccination rates are still relatively low.
Some groups of people, though, have high enough rates of vaccination that the benefits are starting to show. Connecticut was one of the first states to finish vaccinations in long-term care facilities and nursing homes. All residents who wanted a vaccine got their first dose by January 8th, and most were fully vaccinated by the end of January.
These victories are still only in subsets of the population. But even though vaccinations may not be driving down overall case numbers quite yet, we could start to see their impacts on hospitalizations and deaths soon. Older adults, who are the most likely to be hospitalized or die from COVID-19, are among the first groups getting vaccinated across the country. Higher percentages of that group have received shots than in the population at large. As that number ticks up, hospitalizations could start to fall, even if younger people are still getting sick.
Experts point to the 75 to 80 percent threshold as the point when enough people would be vaccinated that the spread of COVID-19 would start to stall out. Still, the vaccines could start flattening overall trends in the US much sooner than that. One modeling study found that if even just 40 percent of the population is vaccinated, cases would fall and hospitalizations and deaths would drop by between 60 and 70 percent.
That isn’t showing up in the data quite yet, and it’s still critical to stick to the COVID-19 prevention measures that are actually driving the US case numbers down: masks, avoiding gatherings, and so on. But there are flickers of hope from the pockets where most people are vaccinated, and eventually, those will start to expand.
Source: The Verge
A global initiative called COVAX run by the World Health Organization, GAVI and the Coalition for Epidemic Preparedness Innovations is trying to bring equitable access to vaccines around the globe, providing free or reduced-cost vaccines to nations in need.
But even COVAX isn’t disclosing exactly how much it’s paying for each vaccine. “In terms of the individual agreements with manufacturers, that is proprietary information and not something that we’re planning on sharing, given the nature of those types of commercial and legal agreements,” said Seth Berkley, the head of GAVI, the Vaccine Alliance in a call with reporters in December.
And while it appears to be close to starting deliveries so far it hasn’t administered a single dose.
Even middle income countries that hosted clinical trials for vaccine manufacturers are finding it difficult to negotiate deals with the very companies they helped. Argentina hosted a major Phase 3 trial for Pfizer yet has been unable to reach an agreement with the company to buy its highly successful product.
South Africa is reportedly paying $5.25 a dose for a version of the vaccine manufactured in India while a poorly redacted version of the contract between AstraZeneca and the European Commission shows Europeans paying only $3.50 per shot. Uganda seems to have gotten an even worse deal paying $8.50 a dose according to Reuters and government officials quoted in Health Policy Watch. Even if the difference in price is just a few dollars a dose, multiply that by millions of doses needed and the impact can be huge.
According to the available data, the cost of some other vaccines varies even more wildly. Reported prices for the inoculation from the Chinese government-backed company Sinopharm varies even more dramatically. They range from$18.50 per shot in Senegal to $44 inside China to up to $72.50 a dose. That for a vaccine that still hasn’t won authorization from any major regulator outside of China.
- As COVID-19 cases surged last fall, non-COVID-19 hospital admissions fell substantially, particularly in the Midwest and West, according to a new analysis by the Kaiser Family Foundation of 2020 inpatient admission data from electronic medical records through Dec. 5.
- The analysis also highlights admission trends by age and sex, and found that patients 65 and over — those most at risk of complications from the novel coronavirus — delayed care at greater rates than those under 65 again in the fall. Still, the discrepancy between visits based on age was more pronounced in the spring.
- On average, males and females had almost identical admission patterns throughout the entire year. Though looking at the raw numbers, women’s total admissions trended above their male counterparts, which researchers attributed to childbirth.
Source: Kaiser Family Foundation
Despite the slow roll-out of COVID-19 vaccination in the U.S., the pace of vaccination has begun to pick up across the country. U.S. vaccine supply is running at about 11 million doses per week, with an average of 1.7 million doses being administered per day; shots are now getting into people’s arms as fast as they’re becoming available. This is in part due to the easing of vaccine supply constraints, as the Biden administration has released more doses and provided more predictability to states, and production schedules have sped up. Still, the number of people eligible in states is increasing, and these next few weeks will be critical ones in the race to vaccinate as many people as possible, due to continued spread of COVID-19 and the emergence of viral variants. Given what we know about projected supply, where could we be with vaccination by the end of the first quarter of this year (March 31)?
To answer this question, we looked at the number of doses estimated to be delivered by Pfizer and Moderna, the two manufacturers with authorized vaccines in the U.S., between now and the end of March. The U.S. has purchased 600 million doses (300 million from each company) which, given the two-dose regimen required by these vaccines, is enough to vaccinate 300 million people. Even without the addition of any new vaccine, this would go far in achieving U.S. population immunity (though it is widely expected that the FDA will authorize Johnson &Johnson’s one shot vaccine soon, increasing supply to more than enough to reach the entire U.S. population).
Pfizer has said that it expects to deliver 120 million doses to the U.S. by the end of March, 20 million ahead of its original schedule. Moderna has said it will deliver 100 million doses. Assuming these production schedules hold, that means that 220 million doses, enough to fully vaccinate 110 million people, will be delivered within a month and a half from today.
Source: Kaiser Family Foundation
The COVID-19 Vaccine Monitor finds a gender difference among Black adults in the level of concern about certain aspects of the COVID-19 vaccine. While large shares of Black men share the concerns Black women have about long term effects of the vaccine, safety and effectiveness, larger shares of Black women than Black men say they are concerned they might experience serious side effects (87% vs. 61%) or that they might get COVID-19 from the vaccine (68% vs. 38%), indicating that there may be a greater need for messaging and information to address these concerns among Black women in particular.
Source: Kaiser Family Foundation
Guidelines from the Centers for Disease Control and Preventions released in December rank a person with type 2 diabetes as someone who “is at increased risk” of more severe illness from COVID-19. That means people with that condition will follow health care workers and people living in long-term care settings, getting their vaccines in Phase 1c of the rollout. Data behind that ranking are considered “strongest and most consistent evidence.”
People with type 1 diabetes are in Phase 2, deemed to be patients who “might be at an increased risk” for severe illness. Data behind that ranking are classified as “limited evidence.”
New drugs tout potential therapeutic benefit against symptomatic COVID-19 patients.
A potential treatment for Covid using blood plasma does not reduce deaths among hospital patients, trials show.
The results are a blow to researchers and the NHS, which led the drive to collect plasma donations.
This arm of the Recovery trial, which is investigating a number of promising Covid treatments, has now been closed.
The Oxford researchers involved say they are “incredibly grateful” for the contribution of patients across the country.
Donations of plasma were temporarily suspended, according to NHS Blood and Transplant.**
There had been huge international interest in the role of convalescent plasma as a possible treatment for hospital patients with Covid-19.
“At this time, CDC is not recommending required point of departure testing for domestic travel,” according to a CDC statement sent to CNN Friday night. “As part of our close monitoring of the pandemic, in particular the continued spread of variants, we will continue to review public health options for containing and mitigating spread of COVID-19 in the travel space.”
Some states, and perhaps soon the federal government, are considering increasing the minimum wage. President Joe Biden voiced his support for raising the federal minimum wage to $15 per hour while on the campaign trail, and also included it in his recent economic stimulus package. A ballot initiative in Florida to raise the statewide minimum by 2026 passed in November 2020. While discussions around raising the minimum wage typically center on the economic benefits and potential labor force impacts that would affect low-wage workers, there are also population health benefits to consider. These range from better physical and mental health outcomes to indirect influences on individual behaviors that affect health—but the existing research is limited at best. However, what we do know suggests that raising the minimum wage may not be uniformly helpful. Should policy makers pursue raising the minimum wage, it will be key to do so in a way that does not exacerbate long-standing inequities in both income and health.
A New England Journal of Medicine study finds many common metrics like kidney filtration rates are influenced by decades of racially discriminatory biases rendering future clinical decision-making impossible to distill without future racial biases.
The consulting firm has reached agreements with 49 states because of its sales advice to drugmakers, including Purdue Pharma, the manufacturer of OxyContin.
Source: NY Times
Because of the slow and disjointed rollout of vaccinations, the Covid-19 pandemic could last seven more years if distribution continues at its current rate.
A gloomy calculation from Bloomberg shows it could take most of a decade using two-dose vaccines for herd immunity to be reached. Previous calculations by White House chief medical advisor Dr. Anthony Fauci claimed 70-85 percent of the population will need the vaccine in order to achieve herd immunity.
Currently, the US is on track for that mark to be reached by 2022. But serious distribution complications and lack of vaccines in other countries are far from that figure.
New coronavirus cases are on the decline in the United States following staggering post-holiday peaks last month, but experts say it’s too early for new COVID-19 vaccines to be having an impact.
The positive trend also is not assured to continue, as new and more transmissible variants threaten to reverse it, according to Centers for Disease Control and Prevention Director Dr. Rochelle Walensky.
“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer,” she said this week.
The decline in cases is likely due to a natural depression after record travel followed by indoor holiday gatherings triggered a surge in infections, said Dr. Sarita Shah, associate professor at Emory University’s Rollins School of Public Health.
Source: USA Today
Limited initial supply of SARS-CoV-2 vaccine raises the question of how to prioritize available doses. Here, we used a mathematical model to compare five age-stratified prioritization strategies. A highly effective transmission-blocking vaccine prioritized to adults ages 20-49 years minimized cumulative incidence, but mortality and years of life lost were minimized in most scenarios when the vaccine was prioritized to adults over 60 years old. Use of individual-level serological tests to redirect doses to seronegative individuals improved the marginal impact of each dose while potentially reducing existing inequities in COVID-19 impact. While maximum impact prioritization strategies were broadly consistent across countries, transmission rates, vaccination rollout speeds, and estimates of naturally acquired immunity, this framework can be used to compare impacts of prioritization strategies across contexts.
There are two main approaches to vaccine prioritization: directly vaccinate those at highest risk for severe outcomes and protect them indirectly by vaccinating those who do the most transmitting. Model-based investigations of the tradeoffs between these strategies for influenza vaccination have led to recommendations that children be vaccinated due to their critical role in transmission and have shown that direct protection is superior when reproduction numbers are high but indirect protection is superior when transmission is low. Similar modeling for COVID-19 vaccination has found that the optimal balance between direct and indirect protection depends on both vaccine efficacy and supply, recommending direct vaccination of older adults for low-efficacy vaccines and for high-efficacy but supply-limited vaccines. Rather than comparing prioritization strategies, others have compared hypothetical vaccines, showing that even those with lower efficacy for direct protection may be more valuable if they also provide better indirect protection by blocking transmission. Prioritization of transmission-blocking vaccines can also be dynamically updated based on the current state of the epidemic, shifting prioritization to avoid decreasing marginal returns. These efforts to prioritize and optimize doses complement other work showing that, under different vaccine efficacy and durability of immunity, the economic and health benefits of COVID-19 vaccines will be large in the short and medium terms. The problem of vaccine prioritization also parallels the more general problem of optimal resource allocation to reduce transmission, e.g., with masks.
Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Sometimes new variants emerge and disappear. Other times, new variants emerge and persist. Multiple variants of the virus that causes COVID-19 have been documented in the United States and globally during this pandemic.
The virus that causes COVID-19 is a type of coronavirus, a large family of viruses. Coronaviruses are named for the crown-like spikes on their surfaces. Scientists monitor changes in the virus, including changes to the spikes on the surface of the virus. These studies, including genetic analyses of the virus, are helping scientists understand how changes to the virus might affect how it spreads and what happens to people who are infected with it.
Multiple variants of the virus that causes COVID-19 are circulating globally:
The United Kingdom (UK) identified a variant called B.1.1.7 with a large number of mutations in the fall of 2020. This variant spreads more easily and quickly than other variants. In January 2021, experts in the UK reported that this variant may be associated with an increased risk of death compared to other variant viruses, but more studies are needed to confirm this finding. It has since been detected in many countries around the world. This variant was first detected in the US at the end of December 2020.
In South Africa, another variant called B.1.351 emerged independently of B.1.1.7. Originally detected in early October 2020, B.1.351 shares some mutations with B.1.1.7. Cases caused by this variant have been reported in the US at the end of January 2021.
In Brazil, a variant called P.1 emerged that was first identified in travelers from Brazil, who were tested during routine screening at an airport in Japan, in early January. This variant contains a set of additional mutations that may affect its ability to be recognized by antibodies. This variant was first detected in the US at the end of January 2021.
Source: Centers for Disease Control
Janssen’s clinical trial tracked participants after they only got just one dose of its vaccine, a potentially sizable advantage. All other vaccines available or in late stage clinical trials require two doses—which complicates the logistics of distribution. On top of that, Janssen’s shot only requires regular refrigeration to be shipped and stored. Together, those two factors could make it significantly easier to quickly inoculate large swaths of the global population.
In a press conference, Janssen announced that it’d be reporting these data to the US Food and Drug Administration (FDA) within the coming week. Based on the regulatory agency’s review of the data, it could grant emergency use authorization, making it the third vaccine available in the US, behind the Moderna and the Pfizer-BioNTech vaccines. Here’s what we know, and don’t know, about the vaccine so far.
The World Health Organization on Friday reversed its guidance on pregnant women receiving the coronavirus vaccine created by Moderna, now saying it recommends the jab for expectant persons.
“While pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy. Nevertheless, based on what we know about this kind of vaccine, we don’t have any specific reason to believe there will be specific risks that would outweigh the benefits of vaccination for pregnant women,” the WHO said in the updated guidance.
Source: Times of Israel
In certain places, the COVID-19-vaccine effort has hit a few speed bumps; stockpiles have accumulated, and deployment to vulnerable countries and at-risk groups has been slower than expected. Nonetheless, experts have expressed confidence that safe and highly efficacious vaccines are reaching the market, and we are beginning to see “the light at the end of the tunnel” of this devastating pandemic. The epidemiological end to the COVID-19 pandemic seemed like an optimistic dream a few short months ago, but, with the development, approval, and rollout of several vaccines, it is now practically realizable in much of the world.
To arrive at the postpandemic era, in which populations experience herd immunity, vast numbers of dedicated individuals will need to continue working intensely in the months and years ahead.
With all the many issues and delays, it is safe to assume we are less confident about reaching herd immunity in Q3 of 2021.
Source: McKinsey & Co.
India will begin commercial shipments of Covid-19 vaccines to Brazil and Morocco Friday, followed by Saudi Arabia and South Africa, as Prime Minister Narendra Modi attempts to burnish his credentials as a key global leader.
”There’s huge international demand for our vaccines,” Foreign Secretary Harsh Shringla told Bloomberg TV in an interview. “We expect to see more global players cooperating with their Indian counterparts in the pharma and healthcare sectors. This is likely to go beyond shifting parts of supply chains to India. We expect to see collaborations, manufacturing and R&D tie ups in this field.”
New Jersey based Inspira Health has announced that it will reschedule appointments for first doses of the COVID-19 vaccine because of a supply shortage.
The move is effective for appointments already scheduled for Saturday and beyond at Inspira’s hospital vaccination clinics in Mullica Hill and Vineland.
For those who already received their first dose from Inspira, second doses will still be administered by the healthcare provider, the company confirmed.
Source: New York Times
Since 2017, large outbreaks of hepatitis A among adults have been occurring in a number of US cities and states, resulting in increased demand for vaccine. Initially, supplies of adult hepatitis A vaccine in the US were constrained. In response, CDC took a number of steps to mitigate the supply issues. Specifically, CDC (1) worked directly with public health officials in affected jurisdictions to provide guidance about targeting vaccine in response to local epidemiology; (2) collaborated with manufacturers to understand options for managing supplies in the private sector and increasing national supply; (3) implemented ordering controls in the public sector; and (4) increased vaccine availability on CDC’s adult vaccine contracts.
Nevertheless a shortage has formed in 2020-2021
In December, the UK reported a Covid-19 variant of concern, commonly referred to as the B117 variant, which appeared to be more transmissible. Since then, scientists have established that B117 is somewhere between 50% to 70% more transmissible than other variants. If more people are getting sick, there is more pressure on health systems, and in the UK health services are so overloaded a country-wide lockdown has been enforced.
While many scientists say B117 does not appear more deadly, researchers on the UK government’s New and Emerging Respiratory Virus Threats Advisory Group found it may increase the death rate by 30% to 40%, though their sample size was small and they said more research is needed. With B117 now detected in more than 50 countries, understanding the variant is urgent.
But other variants of concern have also been identified, including in California, South Africa and Brazil.
Source: The Guardian
The Centers for Disease Control and Prevention updated its guidance on Thursday on the administration of the two coronavirus vaccines currently approved for Emergency Use Authorization.
The guidance clarifies several questions public health practitioners have recently asked. Can the two doses of the Pfizer and Moderna vaccines be split, and how long do patients have to get the second dose of the vaccine?
Both doses of the vaccine require patients to return for a booster. For the Pfizer vaccine, the second dose is recommended three weeks after the first dose. The second dose of the Moderna vaccine is due four weeks later.
The CDC said that it continues to recommend that the same type of vaccine be administered to patients. But if only the opposite type of vaccine is available, the CDC said that the other vaccine can be administered and is considered effective.
In less than a year, Covid-19 has killed almost 400,000 Americans.
And in just the next month, another 100,000 lives could be lost to the disease, the incoming director of the US Centers For Disease Control and Prevention said.
“By the middle of February, we expect half a million deaths in this country,” Dr. Rochelle Walensky told CBS’ “Face the Nation” on Sunday.
“That doesn’t speak to the tens of thousands of people who are living with a yet uncharacterized syndrome after they’ve recovered,” said Walensky, who was chief of infectious diseases at Massachusetts General Hospital before President-elect Joe Biden picked her to lead the CDC.
As the COVID-19 virus wreaks havoc with the healthcare system, telemedicine is stepping up into the spotlight and helping healthcare provider organizations and caregivers better respond to the needs of Americans who have contracted the virus and Americans who need to touch base with their providers on the status of their health.
Telemedicine is making a very positive contribution to healthcare during the pandemic, and is being used in a variety of ways. But telehealth technologies do have certain limitations when it comes to treating patients during a pandemic. Further, there is a chance telemedicine could add to hospitals being overwhelmed, unless it’s used well. But hospitals are learning to adapt to telehealth during a pandemic.
Telehealth is bridging the gap between people, physicians and health systems, enabling everyone, especially symptomatic patients, to stay at home and communicate with physicians through virtual channels, helping to reduce the spread of the virus to mass populations and the medical staff on the frontlines, said Dedi Gilad, CEO and co-founder of Tyto Care, a telemedicine technology company. Critically, hospitals are quickly adopting telehealth to treat quarantined patients infected with COVID-19, he added.
“In addition, the CDC is urging the public and medical staff to use telehealth solutions for non-urgent communication in an effort to reduce the pressures facing emergency rooms and clinics,” he explained. “By deploying telehealth solutions and programs, people who are suffering from other medical ailments during this time can receive care from home, without entering medical facilities, minimizing their risk of contracting the virus.”
Telemedicine is being used extensively in the “forward triage” of patients long before they arrive in the primary care clinics, said Dr. Siaw Tung Yeng, founder and CEO of MaNaDr, a telemedicine technology and services company.
Source: Healthcare IT News
The American College of Emergency Physicians (ACEP) applauds the U.S. Department of Health and Human Services’ (HHS) decision to effectively remove the “X-waiver” requirement for physicians, expanding their ability to utilize medication-assisted treatment (MAT) for patients struggling with opioid use disorder (OUD).
“As emergency physicians, we see every day the devastating effects that the opioid crisis has had on the communities we serve—a crisis that has unfortunately only worsened during the COVID-19 pandemic,” said Mark Rosenberg, DO, MBA, FACEP, president of ACEP. “Buprenorphine is the most important medication in our arsenal for treating opioid use disorder, which is currently one of the most lethal diseases for Americans.”
Information about the characteristics of these variants is rapidly emerging. Scientists are working to learn more about how easily they might spread, whether they could cause more severe illness, and whether currently authorized vaccines will protect people against them. At this time, there is no evidence that these variants cause more severe illness or increased risk of death.
Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Sometimes new variants emerge and disappear. Other times, new variants emerge and persist. Multiple variants of the virus that causes COVID-19 have been documented in the United States and globally during this pandemic.
The virus that causes COVID-19 is a type of coronavirus, a large family of viruses. Coronaviruses are named for the crown-like spikes on their surfaces. Scientists monitor changes in the virus, including changes to the spikes on the surface of the virus. These studies, including genetic analyses of the virus, are helping us understand how changes to the virus might affect how it spreads and what happens to people who are infected with it.
COVID-19 project believes infections estimates should include all infected individuals of the SARS-CoV-2 virus, not just those that took a COVID-19 test and tested positive. As of January 2021, they estimate the true number of infected individuals in the US to be roughly 2-4x higher than the reported cases (20-50% detection rate). See our writeup, Estimating True Infections, for a more detailed look into this subject. Because not all currently infected individuals are infectious, they recommend dividing the “currently infected” estimate by 2-4 to get a sense of the number of currently infectious individuals.
Source: COVID-19 Projections
Claims that Britain has “abandoned science completely” by mixing doses of the two available vaccines have been refuted by the head of immunisations at Public Health England and the editor of the British Medical Journal.
A report in The New York Times suggests Britain is opting for a “mix-and-match vaccine regimen” with the two approved jabs, in which patients are allowed to receive a second dose from a different manufacturer to the first.
A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
Source: New England Journal of Medicine
India, the world’s biggest vaccine-maker, plans to vaccinate 300 million people in the first half of 2021. People in India are expected to start getting their shots as early as next week.
The COVID-19 pandemic forced most U.S. healthcare systems to quickly pivot to virtual care. However, since peaking in late April, care has largely shifted back to in-person. Health systems are now challenged to further develop and integrate useful, usable, and sustainable virtual care tools into their broader care model in ways that benefit their organizations and the communities they serve.
At the start of 2020, very few U.S. healthcare systems had embraced virtual care at scale1. Incentives to use these tools were generally not strong enough to overcome considerable barriers to change. By March, in the face of the COVID-19 pandemic, most systems quickly pivoted to virtual care to preserve care access, protect their patients, sustain their workforces, and maintain revenue. Within weeks, most systems were providing more virtual care—including video and phone visits, eVisits, eConsults, and messaging with clinicians and chatbots—in a single day than they had the entire prior year.
However, since peaking in late April 2020, care has largely shifted back from virtual to in-person2,3, sometimes because in-person care is more clinically appropriate, but often simply because it is more familiar, more accessible, and easier to provide. Healthcare systems are now at a crossroads. Some will continue to build on their virtual care platforms to benefit their patients and advance their organizational goals. Others will backslide to business as usual, sacrificing their recently hard-earned gains and jeopardizing their long-term positions.
In an extraordinary time, British health authorities are taking extraordinary measures to beat back Covid-19. But some experts say that, in doing so, they are also taking a serious gamble.
In recent days, the British have said they will stretch out the interval between the administration of the two doses required for Covid-19 vaccines already in use — potentially to as long as three months, instead of the recommended three or four weeks. And they have said they will permit the first dose and second dose for any one person to be from different vaccine manufacturers, if the matching vaccine is not available.
Source: STAT News
The US coronavirus outbreak has continuously shattered records this winter, but Saturday marked a particularly gruesome milestone: one month of more than 100,000 consecutive, daily coronavirus hospitalizations.
Average daily cases also reached an all-time high of more than 275,000 on Saturday, according to data from the COVID Tracking Project. The US death toll has surpassed 350,000.
Source: Business Insider
In August, in partnership with the Harvard Global Health Institute, Google launched a set of models — the COVID-19 Public Forecasts — that provide projections of COVID-19 cases, deaths, ICU utilization, ventilator availability, and other metrics for U.S. counties and states. Today, the two organizations released what they claim are significantly improved models — trained on public data from Johns Hopkins University, Descartes Labs, the United States Census Bureau, and elsewhere — that expand beyond the U.S.
The COVID-19 Public Forecasts are intended to serve as a resource for first responders in health care, the public sector, and other affected organizations, Google says. The forecasts allow for targeted testing and public health interventions on a county-by-county basis, in theory enhancing users’ ability to respond to the rapidly evolving pandemic. For example, health care providers could incorporate the forecasted number of cases as a datapoint in resource planning for PPE, staffing, and scheduling. Meanwhile, state and county health departments could use the forecast of infections to inform testing strategies and identify areas at risk of an outbreak.
A new study conducted by researchers at the University of Connecticut has revealed a correlation between the prevalence of particular clades of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the growth rate of the associated illness coronavirus disease 2019 (COVID-19).
Researchers found that models of early COVID-19 growth dynamics that included the different clades the virus has mutated into significantly improved growth rate predictions.
Including clades in the models was also more important than incorporating the SARS-CoV-2 variant D614G, which has been associated with increased viral load and infectivity.
More specifically, a higher prevalence of the clades 19A and 19B, which emerged during the Wuhan outbreak, correlated with lower growth rates. Higher prevalence of the clades 20A and 20C, which emerged from 19A and was prominent early on in the European outbreak, correlated with higher growth rates.
The researchers say that without intervention, COVID-19 has the potential to grow more quickly in regions dominated by the 20A and 20C clades, which includes most of South and North America.
Original study can be found on the medRxiv server and is currently under peer review: https://www.medrxiv.org/content/10.1101/2020.09.29.20202416v1
President Trump announced on Twitter early Friday morning that he and first lady Melania Trump have “tested positive for COVID-19.”
Almost half the US is reporting increased numbers of new Covid-19 cases as health experts warn of a potential coronavirus surge in the fall and winter.
As of Sunday, September 27th, the number of new coronavirus cases has increased by at least 10% or more compared to the week before in 21 states, most of them in the West, according to a CNN analysis of data from Johns Hopkins University.
Cases are rising in Alabama, Alaska, Colorado, Idaho, Maine, Michigan, Minnesota, Montana, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Oregon, South Carolina, South Dakota, Texas, Utah, Washington state, Wisconsin and Wyoming.
While predicting the course of an epidemic is difficult, predicting the course of a pandemic from an emerging virus is even more so. The validity of most predictive models relies on numerous parameters, involving biological and social characteristics often unknown or highly uncertain. Data of the COVID-19 epidemics in China, Japan, South Korea and Italy were used to build up deterministic models without strong assumptions. These models were then applied to other countries to identify the closest scenarios in order to foresee their coming behaviour. The models enabled to predict situations that were confirmed little by little, proving that these tools can be efficient and useful for decision making in a quickly evolving operational context.
Multiple societies have put forth recommendations to modify delivery of cancer care in order to minimize patient exposure to the virus. Cancer survivors, especially patients with head and neck cancer, have been disproportionately affected by rising unemployment levels and economic recessions in the past, both of which are linked to higher cancer mortality. Patients who rely on employer-provided insurance and do not qualify for Medicaid may lose access to life-saving treatments.
The University of Washington institute’s model, which is one of several the Centers for Disease Control and Prevention uses to track the pandemic, has been criticized for often including high degrees of uncertainty, which can lead to imprecise predictions. Early on, the model underestimated the number of Covid-19 deaths nationwide, projecting that the U.S. could hit 60,415 by the end of August.
Still, the model is updated frequently, and refinements are made as data on case numbers, hospitalizations and a host of other factors become available. By June, the institute’s model was estimating that the U.S. death toll could hit 200,000 by Oct. 1, a projection that ended up being accurate to within two weeks.
A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.
A possible scenario sees 415,090 Covid-19 deaths by January, the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Missouri said in its latest forecast. The worst-case scenario is 600,000 deaths by January 1.
Total vaccine doses per 100 people
“There remains a shocking imbalance in the global distribution of vaccines,” WHO Director General Tedros Adhanom Ghebreyesus told a news conference.
Source: BBC News