There’s a Vaccine For That

As we turn our sites towards the final weeks of the pandemic, we must now consider how the COVIDization of healthcare will affect the future of healthcare. There are many lessons to learn, and the inevitable shift towards patient empowerment and digital technologies has only accelerated how we will implement those lessons.

Many of these lessons are hard practical truths about healthcare that we can quickly address. But there are more conceptual takeaways that we must be aware of as well. Conceptual shifts in how we approach healthcare fundamentally.

Throughout the course of the past fifty years of healthcare, we have gravitated towards medications as treatments and technologies as therapeutics. To the point that it has become reflexive. If a patient has a disease, treat the patient with medication. If the patient needs a procedure, find the latest, greatest technology to use in that procedure.

COVID-19 has introduced another key player that will be adopted in much the same way – vaccines.

One of the unexpected benefits from the pandemic was the widespread discussion of vaccine technology, and the untapped potential that technology has for healthcare. Not just for infections, but for a whole array of diseases. Soon we will have numerous vaccines attempting to preemptively address medical conditions long before they start.

And in many ways, these novel vaccines may be used in conjunction with medications in a unique, hybrid treatment. Instead of just taking daily medications for your diabetes, you would take an annual vaccine and daily medications for your diabetes.

If you have chronic pain, then you would take an annual opioid vaccine to prevent the likelihood of developing an addiction to the prescribed opioids.

The National Institute of Health has established the NIH HEAL Initiative, Helping to End Addiction Long-term Initiative, to study whether a vaccine can treat opioid use disorder.

In general, vaccines work by teaching the body’s immune system to create antibodies that can recognize an antigen, a foreign substance or toxin like seasonal flu or the bacteria Tetanus. An opioid vaccine would teach the body to make antibodies that recognize a targeted opioid. When the target opioid molecules appear in the body, the antibodies stick to them and prevent the opioids from entering the brain, triggering addiction.

Normally, opioid molecules can get through the blood-brain barrier because they are very small. But an opioid molecule that is stuck to an antibody would be too big to get through the barrier and remain circulating in the blood where it would eventually be expelled by the kidney.

Opioid vaccines could work with other medications currently used to treat opioid use disorder, and they presumably would not interfere with overdose rescue drugs like naloxone. Also, because vaccines produce antibodies that are highly specific to an opioid target, they would not interfere with the body’s natural abilities to control pain or with other pain management approaches.

At least that is the hope in this first phase of vaccine development. The main goal of this first phase of vaccine testing is to monitor safety and see if participants develop antibodies against oxycodone. And whether those antibodies bind to the oxycodone molecule to block the addictive effects of oxycodone.

Before the first injection, each patient will have a test to find out what dose of oxycodone it takes for them to feel pleasurable effects. After each vaccination, the test will be repeated, to see if the vaccine makes the oxycodone less effective – balancing the effect of oxycodone on the peripheral nervous system to control pain against the central nervous system’s addiction pathways.

A different opioid molecule will also be used to test the specificity of the vaccine response. If the vaccine works as expected, participants should have a less pleasurable response to oxycodone while still controlling their pain.

The researchers will also study how long the vaccine’s protection can last, estimating for now that the vaccine might protect against oxycodone effects for a few months. Longer-acting forms of treatment like an annual vaccine would theoretically help this type of treatment fit into people’s lives. And reduce the number of clinical visits would help patients stay compliant with treatment.

This is the potential benefit vaccines can provide. But before you get too excited, remember that we are just in the first phase of this opioid vaccine. And there is no guarantee that the vaccine will advance beyond this point.

The HIV vaccine was first developed in 1987, three years after we first discovered HIV. The first NIH sponsored HIV vaccine clinical trial enrolled 138 healthy, HIV-positive volunteers. The vaccine showed no serious adverse effects, but did not show much benefit either, and research efforts stalled. It was not until 2000 that the first HIV vaccine studies were finally completed, with equivocal results.

Although research efforts in this field continue to develop incrementally more effective vaccines, we continue to struggle to find an effective vaccine for the viral disease.

Yet we have plenty of reasons to remain hopeful as we improve vaccine design and development. Particularly since the widespread adoption of mRNA vaccines.

The mRNA vaccines have several benefits compared to other types of vaccines including shorter manufacturing times, and a greater potential for targeting a wider range of diseases. The process can also be standardized and scaled more easily, making vaccine development more cost effective than traditional methods. In addition, mRNA vaccine development techniques can make both existing DNA and RNA vaccines that are already used for other infections.

Previously, vaccines used part of a virus or another very similar virus to trigger an immune response, or a preemptive reaction to the actual virus. These parts could be a DNA strand of the virus, or an RNA strand, or some protein the virus, or a related virus creates when it reproduces in our cells. Now, with the mRNA technology, we do not need the actual viral part, we can synthetically create specific parts of a virus, or inflammatory markers from a disease, or proteins from a cancer cell. Essentially any biological molecule that we would like to trigger an autoimmune response towards.

We can create vaccines against all these diseases by creating mRNA based vaccines to trigger an immune response to these synthetically created viral parts, inflammatory markers, or cancer cells. While no widespread study has been conducted in humans, lab studies show that we can create mRNA vaccines that create immune responses to a whole array of triggering biochemicals.

Given the diverse and rapid manufacturing techniques mRNA vaccine provide, we may be able to use the technology to develop vaccines for a range of diseases at the same rate we developed the COVID-19 vaccine. And in large part due to the pandemic, we devised rapid, cost-effective manufacturing techniques to create mRNA vaccines.

In many ways, the recent techniques have increased the relative ease of manufacturing and ability to target non-infectious antigens by providing the necessary infrastructure that we can use for future vaccines.

Which is really the basis for the recent excitement for mRNA vaccines in the medical community. The technology may work, but it will not be adopted if it is too difficult to standardize.

The pandemic has brought a bright light back onto vaccines. We hope the medical community leverages this momentum to implement vaccines into more widespread use across a range of diseases.

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Vaccine Passports: what we need to know

The COVID-19 pandemic has killed more than half a million people in the US and has seriously impacted our daily lives. The granting of Emergency Use Authorizations for COVID-19 vaccines has been a game changer in helping to reverse the pandemic onslaught. Demand for the vaccines currently far exceeds supply nationwide. They have become the golden ticket that can transport us back to a time when routine activities, such as attending school or taking vacations, didn’t seem fraught with danger. What’s the best way to go about re-establishing these activities? One idea that’s getting discussed seriously is giving those who have been immunized a vaccination passport (VP).

What is a vaccination passport?

Let’s start by clarifying some terminology. VPs are documents that show that someone has been given a vaccine(s) and is therefore presumed to be immune from getting and sharing that disease. These are distinct from diagnostic tests to determine if a person is or is not infected with a particular virus (PCR and viral antigen tests) or has been exposed to a virus (antibody tests). VPs are the modern day equivalents of the “letters of transit” that played a key role in the film Casablanca. They’ll enable you to travel freely.

Why give vaccine passports?

Vaccinated people are unlikely to transmit the virus that causes COVID-19 with others, though this has yet to be definitely proven. So, what’s the primary rationale for giving vaccination passports? It seems the goal is to incentivize people to get vaccinated. Folks might be more likely to seek out the vaccine if it bestows upon them certain privileges, such as being able to travel freely. While the idea might sound appealing at one level, the road to vaccine passports is pockmarked with political potholes and littered with logistical land mines.

Administrative issues

There are a lot of important questions that need to be answered before VPs can become widespread; it’s unlikely there will be a “one size fits all” solution. What might VPs look like? Pieces of paper (that could easily be lost or counterfeited), or a digital key or document you store on your smartphone (that many older folks still don’t have)? If you lost one, how would you get it replaced? Would your vaccination records be tied to your other medical records, and if so, what kind of privacy and security protections would be needed to safeguard your data? How would the passport administrator verify that you got vaccinated in the first place? Who is responsible for correcting any errors that crop up? Given how much we’ve struggled as a nation to simply solve the scheduling of vaccinations, VPs might be significantly more difficult to manage.

Who’s going to run the program?

A coalition of health tech leaders (including Epic, the Mayo Clinic, Microsoft and Salesforce) has started the Vaccination Credential Initiative to create an internationally accepted digital health card. Its vision – as stated on its website – is “to empower individuals to obtain an encrypted digital copy of their immunization credentials to store in a digital wallet of their choice. Those without smartphones could receive paper printed with QR codes containing World Wide Web Consortium (W3C) verifiable credentials.” Some European countries (e.g. Denmark) are working on developing their own immunization passports, and the President of the European Union Commission has voiced support for them.

We already have a hodgepodge system designed to keep folks with COVID-19 from traveling. Many airlines are requiring proof of non-infectivity to board a plane – these are distinct from VPs. The methods adopted vary from airline to airline: United uses Travel Ready Center, American uses VeriFly while others use Common Pass. Saga cruises are the first in the UK to demand proof of vaccination, but not everyone is on board with the concept. The World Travel and Tourism Council stated its opposition to allowing travel only by those who have been vaccinated, on the grounds that it is discriminatory.

Discrimination concerns

The concept of gaining advantage from one’s immunological status is not a new one. In New Orleans in the mid 19th century, great economic value was attached to those who survived the onslaught of epidemic waves of yellow fever. A mix of structural racism and a system valuing “immunocapital” ranked men and women highly if they were yellow fever survivors. Those that had not had the disease yet found it difficult to obtain work or obtain credit and women could not marry. Slaves were similarly revalued, with larger assessments attached to survivors. This legacy of viral discrimination casts a long shadow over current discussions surrounding vaccination passports.

Also problematic is the fact that not everyone will be eligible for VPs. Some people can’t be vaccinated for medical reasons but would still like to participate in whatever activities the passports enable (such as travel opportunities). These individuals will likely file complaints if they are denied VPs, arguing that they’re discriminatory in nature. Vaccine opponents will no doubt also file lawsuits seeking to block the use of VPs, claiming they represent an attack on their freedoms and personal choice.

Others may be shut out of VP programs because they don’t have the computer skills to register online, a problem that’s turned out to be widespread with the vaccinations. Don’t have any ID? In some places this prevents the most vulnerable from getting the COVID-19 vaccine, and therefore VPs as well. Many Black and marginalized communities are already deeply suspicious of the medical establishment, and wary of receiving a COVID-19 vaccine. Restrictions that prevent these groups from participating in various societal activities because they don’t have VPs will echo the Jim Crow days of poll taxes and literacy tests that were required to vote.

Enforcement issues

VPs bring up a similar issue as mask mandates: who is going to enforce them? It is one thing for a cruise line to do so, since reservations are required and extensive paperwork needs to be filled out in advance. Who is going to keep non-vaccinated people out of restaurants or concerts that require proof of vaccination? We’ve already seen anti-maskers storm department stores, ignore requirements to wear masks on planes and even kill a security guard who confronted them.

Black market for vaccine passports

Many airlines are now requiring proof of a negative COVID-19 test before they will let their customers fly. This has led to a black market for fake negative COVID-19 test results for those who are looking to game the system. Similarly, bogus cards claiming that the cardholder was exempt– for medical reasons – from having to wear a mask, have been manufactured and distributed. It’s not hard to imagine that a similar market will emerge for VPs.

Overcoming vaccine hesitancy

Given the multitude of issues and concerns listed above, moving forward with issuing vaccination passports seems highly problematic. If the primary purpose of having VPs is to drive up immunization rates, that can be better accomplished by running public service announcements and ads illustrating how liberating it is to start doing normal activities once vaccinated. A nationwide campaign to do just that is already in the works. I personally can think of a better use for the time and money that will be spent on establishing VPs: use them to focus efforts on overcoming vaccine hesitancy in concert with combatting the high tide of online vaccine misinformation and disinformation.

Source: Technology Networks

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