Pfizer COVID-19 vaccine is first to receive full FDA approval
The US Food and Drug Administration (FDA) has now fully approved Pfizer’s mRNA vaccine, making it the first COVID-19 vaccine to be completely authorized and marked as safe for use. The approval is hoped to instill confidence in those still hesitant to get vaccinated.
Pfizer’s COVID-19 vaccine, developed with BioNTech, was the first to become available in the United States after receiving an emergency use authorization (EUA) last December. The EUA was based on initial clinical trial data including around 40,000 people. Full FDA approval required additional efficacy data and a longer safety follow-up, which Pfizer and BioNTech submitted in May.
The updated trial data concluded the vaccine was 91 percent effective in preventing symptomatic COVID-19. About 12,000 subjects in the trial have been followed for over six months to affirm the vaccine’s long-term safety profile.
“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” says Albert Bourla, Pfizer’s CEO. “About 60 percent of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country. I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity.”
Pfizer indicates it has shipped 1.2 billion doses of its vaccine since December 2020. More than 120 countries have administered those doses.
Following the FDA approval the vaccine can now be marketed in the United States under its commercial name, Comirnaty. Pronounced koe-mir’-na-tee, the name is a portmanteau of COVID, mRNA and immunity.
The FDA’s full approval allows the vaccine to be administered to all adults over the age of 16. An EUA allows for 12 to 15 year-olds to receive the vaccine, while ongoing trials are yet to offer clarity on vaccination for younger children.
The full approval only covers the two-dose protocol. Despite a recent US government vaccine booster announcement, the FDA is yet to authorize third doses to the general population. However, the full approval does open the door to off-label uses of the vaccine. This means doctors and clinicians can offer third doses to patients if they so choose.
It is hoped this approval helps convince those yet to be vaccinated to take the leap. A recent poll found 30 percent of unvaccinated adults cited a lack of full FDA approval as the reason they have not yet had a shot. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, says he hopes this full approval helps the public understand this vaccine is safe and effective.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” says Marks. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”
The FDA’s full approval is also expected to lead to more large-scale organizations and businesses introducing vaccine mandates. While it is currently legal for businesses to require staff be vaccinated, many organizations have stated they would wait for full FDA approval before issuing mandates.
The Pentagon, for example, instantly announced a vaccine mandate for all military personnel following the FDA’s approval. This includes over one million active troops.
New York City also quickly followed the FDA announcement with a vaccine mandate for all public school teachers and staff. Encompassing almost 150,000 employees, the mandate requires all school employees, including contractors, to have a first vaccine dose by the end of September.