Pfizer, BioNTech’s COVID-19 Vaccine Bags Full FDA Approval

The FDA on Monday approved Pfizer and BioNTech’s BNT162b2, now known in the US as Comirnaty, to prevent COVID-19 in people ages 16 years and older, making it the first coronavirus vaccine to have its emergency-use authorization (EUA) converted into a full approval. “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,” stated Acting FDA Commissioner Janet Woodcock.

The news comes on the heels of a report in The New York Times citing unnamed sources that said a full approval could come as early as today.

Pfizer and BioNTech’s two-dose mRNA vaccine became the first to be authorized in the US when the FDA granted an EUA on December 11 for people 16 years and older based on phase 3 trial data suggesting an efficacy rate of 95%. Since then, the EUA was expanded to allow adolescents 12 through 15 years of age to receive the vaccine, and more recently for third doses to be given to certain immunocompromised individuals.

Post-EUA review

In reviewing the full approval filing, Center for Biologics Evaluation and Research director Peter Marks said the agency looked at “hundreds of thousands of pages” of scientific data and information. It also ran its own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities, he noted.

Specifically, the FDA analyzed effectiveness data from about 20,000 participants ages 16 and up who received the vaccine and 20,000 who were given a placebo injection. Based on updated results from the late-stage trial, the FDA said Comirnaty had an efficacy rate of 91% at preventing COVID-19, adding it was also “effective in preventing…potentially serious outcomes including hospitalization and death.”

Regarding safety, the agency looked at data from about 44,000 study participants, including over half who were followed for at least four months after the second dose, while roughly 12,000 recipients have been tracked for at least six months. Typical side effects associated with Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

Confirmed higher heart inflammation risk

In response to a possible heart inflammation link to mRNA vaccines, the FDA said it also conducted a “rigorous evaluation” of surveillance data regarding cases of myocarditis and pericarditis after people have received Comirnaty, concluding that “the data demonstrate increased risks,” particularly in the seven days after the second dose. The agency recently added a warning to Comirnaty’s fact sheet, as well as the one for Moderna’s mRNA coronavirus vaccine mRNA-1273, about rare cases of heart inflammation in adolescents and young adults.

On Monday, the FDA said the observed risk is higher among males under 40 years of age, compared to females and older males, and appears to be highest in the 12-to-17 age bracket. “Available data from short-term follow-up suggest that most individuals have had resolution of symptoms,” the agency noted, but “some individuals required intensive care support. Information is not yet available about potential long-term health outcomes.”

A nudge for the vaccine hesitant

While more than 60% of the total US population has had at least one dose of a COVID-19 vaccine, many are still reluctant about getting immunized, and some health officials hope the full approval will encourage more to change their minds. A survey from the Kaiser Family Foundation found that three in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines receives full approval. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the US,” Marks explained.

The two other COVID-19 vaccines currently available in the US include Moderna’s mRNA-1273 and Johnson & Johnson’s Ad26.COV2.S, which are both authorized for emergency use, but do not yet have full approvals. Last week, US health officials announced the country would be widely distributing third doses of mRNA COVID-19 vaccines starting next month, citing waning protection over time and the spread of the Delta variant. However, the plan is facing some pushback, with some scientists calling the move premature.

Have a look at this snap-poll we did of US infectious disease specialists and what they think the future of COVID-19 vaccinations will look like in the country.