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.
Opioid epidemic in one chart – correlation conflated with causation
There is no cause-and-effect relationship between prescribing and overdose mortality. But millions of patients are being denied safe and effective pain care.
Seniors over age 62 are prescribed opioids for pain three times more often than youth under age 19. But youth have overdose rates three times higher than seniors. No medical model can explain these demographics.
Source: Richard A Lawhern, PhD, Patient Advocate