The Food and Drug Administration on Monday granted full approval to the Covid-19 vaccine developed by Pfizer and its partner BioNTech, a long-awaited development that public health officials hope will persuade some people who remain hesitant about the vaccine to get the shot.
The vaccine is the first of the pandemic vaccines used in the United States to transition from emergency use status to full licensure, a major victory for a partnership that decided to forgo funding through the government’s Operation Warp Speed program on the belief that the development project could move faster without being part of the government fast-tracking program.
The FDA said the vaccine was now approved for use in people ages 16 and up, the only group for which Pfizer now has the required six months of followup safety data. Study of the vaccine in 12- to 15-year-olds began later, and the six-month followup is still underway. Until it can be submitted to the FDA and an extension of the license can be issued, the vaccine will continue to be used in 12- to 15-year-olds under the emergency use authorization.
Pfizer and BioNTech are still conducting a clinical trial to support the vaccine’s use in children 11 and younger.
“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 said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The FDA’s prescribing information for the vaccine includes its associated risk of myocarditis and pericarditis, two types of heart inflammation that have appeared rarely among people who’ve received the mRNA vaccines, mostly within seven days after the second shot, health officials said. Men under 40 appear to be at higher risk than women and older men, with the highest observed risk in boys age 12 to 17.
Health officials have said most cases of myocarditis and pericarditis reported so far after people received the vaccines have been mild. “Available data from short-term follow up suggests that most individuals’ symptoms have now resolved,” Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, said Monday on a call with reporters.
Meantime, U.S. health officials have said they plan to recommend a third dose of the vaccine as a booster shot, pending FDA approval, given some evidence that protection appears to wane over time. (A booster shot will also be recommended for people who received Moderna’s vaccine.) That recommendation, issued last week, swiftly drew concern from some experts, who said they believe the data aren’t strong enough to suggest an additional dose of vaccine is necessary.
Pfizer’s vaccine is sold under the brand name Comirnaty. Since it was first put into emergency use — in the United Kingdom last December — the vaccine has been given to hundreds of millions of people around the world. A handful of countries have already granted the vaccine a license and roughly 70 others have given it emergency use status.
To date, Pfizer and BioNTech have made 1.2 billion doses of vaccine. By the end of the year, that figure is expected to rise to 3 billion doses; in 2022 the companies project they will produce 4 billion doses. The U.S. government has purchased 1 billion doses of the vaccine — half for use in this country and half to donate to low-income countries.
Monday’s approval “affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in a statement. “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.”
The FDA has been under intense pressure to fast-track full approval of the vaccine, given that some people who remain unvaccinated have cited the emergency use authorization as the reason for their reluctance to get the jab. Approval was also expected to make it easier for some public and private organizations to require vaccination.
By law, the FDA had to rule on the application no later than eight months from the date when the final documents were submitted — May 21. But in the face of the political pressure to process the application well before the Jan. 21, 2022, deadline, the agency committed publicly to pull out all the stops to get the job done.
The application was based on a study of 44,000 people, half of whom were given two doses of the Pfizer vaccine. The other half received saline. Based on the six months of followup, the vaccine’s efficacy in preventing symptomatic Covid infection was 91.1%.
Physicians can generally prescribe approved products “off-label,” leading to speculation that some doctors will now prescribe the Pfizer vaccine to children under 12, particularly with school starting. But Woodcock said such a practice “would be of great concern,” noting that clinical trials in kids are still producing data on the shots’ safety in kids and on the proper dose for younger children.
“We need to get the information and data on uses in younger children,” Woodcock said on a call with reporters. “They are not just small adults, and we’ve learned that time and time again.”
Marks said the FDA understood the great interest in when it would authorize vaccines for younger children, but that the agency was still waiting on the companies to submit more data from their trials in kids.
“We will obviously move swiftly once those data are submitted,” Marks said.