The U.S. Food and Drug Administration just approved the Pfizer/BioNTech COVID-19 vaccine. The vaccine, now known as Comirnaty, is the first to receive full FDA approval.
Pfizer’s two-dose mRNA vaccine first received an emergency use authorization (EUA) from the FDA back in December 2020 for use in people ages 16 and older. And the EUA expanded in May of this year to make the vaccine available to people ages 12 to 15 as well.
Now the vaccine is fully FDA approved to prevent COVID-19 disease in people age 16 and up. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” acting FDA commissioner Janet Woodcock, M.D., said in a press release. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The FDA typically uses EUAs to quickly make treatments, vaccines, and diagnostic tests available to the public during a public health emergency (like, say, a pandemic). Although the EUA process is scientifically rigorous and involves analyses of preclinical and clinical trial data, the full FDA approval process requires even more effort. One of the biggest differences is that, for an EUA, the FDA only requires the researchers to track trial participants for two months after vaccination to monitor for any possible side effects. But for the full FDA approval, participants need to be followed up with for six months. (That’s why the approval only applies to those age 16 and older, who were covered by the original EUA.)
To make the approval decision, the FDA weighed the evidence from the EUA as well as updated evidence from participants since the original authorization. In all, the data included information from 22,000 people who received the vaccine and 22,000 people who received a placebo, the FDA press release explains. Of those participants, about half were followed for at least four months after their second dose, and 12,000 people were under monitoring for at least six months. With that data, the FDA concluded that the vaccine is 91% effective at preventing COVID-19 disease.
The news comes a little over a week after the FDA and a panel at the Centers for Disease Control and Prevention panel recommended that people who are immunocompromised receive a third shot of the mRNA COVID-19 vaccines (including those from Pfizer and Moderna). And last week, a group of public health and White House officials announced a plan to offer third doses of the vaccines to people about eight months after their initial round of shots.
With full FDA approval of the vaccine, employers and local officials may feel more comfortable instituting vaccine requirements. And some people who may have been hesitant to get the vaccines previously could finally decide to get the shots now with this added layer of confidence. The full approval also opens up the window for providers to prescribe the vaccines for “off-label” use, such as doctors’ administering the vaccine to kids younger than 12. However, there’s not enough data yet in that age group to know if doing so could be helpful or what the proper dose would be.
Still, the first full FDA approval for a COVID-19 vaccine is a huge moment in public health and represents a major breakthrough in our efforts to contain the pandemic. And, as the delta variant continues to surge across the country, the approval will hopefully convince more people to get vaccinated.