On Monday, the U.S. Food and Drug Administration granted full approval to Pfizer and BioNTech's COVID-19 vaccine for people 16 and older, making it the first in the country to move beyond Emergency Use Authorization.
On Dec. 11, 2020, the mRNA vaccine BNT162b was the first to be approved in the U.S. for Emergency Use Authorization, deeming it safe for human injection during a time of emergency, such as the COVID-19 pandemic. Now, however, it has received full approval status—a move that is expected to ease the way toward vaccine requirements and even sway a percentage of the population who has yet to be vaccinated.
The initial EUA was approved after Pfizer and BioNTech showed the vaccine had 95% efficacy in an ongoing phase 3 clinical trail with 8,000 participants who received both doses. After two months of follow-up safety data post-vaccination—a new safety guideline required by the FDA for EAU during the pandemic—Pfizer submitted data showing the vaccine was “well tolerated” among the randomized set of volunteers.
For this full approval, the FDA reviewed updated data from the clinical trial, which supported the EUA and included a longer duration of follow-up in a larger population. Specifically, the health agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose.
Based on results, the vaccine was 91% effective in preventing COVID-19. Additionally, half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months with no severe side effects. The most commonly reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever.
However, the label for the vaccine—which will now be marketed as Comirnaty—does include a warning about myocarditis and pericarditis. According to the FDA, safety surveillance data demonstrates increased risks for myocarditis and pericarditis, particularly within the seven days following the second dose of Comirnaty. The health agency says the observed risk is higher among males under 40 years of age compared to females and older males. The risk is highest in males 12 through 17 years of age.
“Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes,” reads an FDA press release.
More vaccinations ahead?
Despite emergency use authorizations of three separate vaccines, there are roughly 85 million eligible Americans who are currently unvaccinated. The Biden Administration and other experts are hoping this full approval of the Pfizer/BioNTech vaccine will persuade some of those currently on the fence.
According to The New York Times, experts have estimated the full approval might convince 5% of those who are unvaccinated, which would be about 4.25 million Americans.
Additionally, given today’s news, the Pentagon said they will be releasing guidelines to the country’s 1.4 million active-duty service members mandating they be vaccinated if they are not already. And even before this approval, some states and universities/colleges were mandating vaccines for their employees and students.
Moderna’s mRNA vaccine, the second approved for EUA, is still being considered for full approval. The FDA says that decision could take several more weeks. Johnson & Johnson, makers of the third and final EUA vaccine and the only one-dose, non-mRNA version, is expected to apply for full FDA approval soon.
The Pfizer-BioNTech vaccine will continue to be authorized for emergency use for children ages 12 to 15 while Pfizer collects the necessary data required for full approval. A decision on whether to authorize the vaccine for children younger than 12 could be at least several months away still.