An all-day regulatory meeting scheduled to take place Thursday is the next step toward the likely authorization of the first COVID-19 vaccine in the U.S.
The Food and Drug Administration this week plans to convene a meeting of its Vaccines and Related Biological Products Advisory Committee, which is made up of a group of independent medical experts, who will discuss the risks and benefits of BioNTech
and Pfizer Inc.’s
experimental COVID-19 vaccine before voting on whether the FDA should authorize the vaccine. The regulator isn’t required to follow the committee’s recommendations but often does.
The advisory committee meeting, referred to as an AdCom by industry insiders, is the final step before the FDA makes a decision about whether to approve a new therapy or vaccine. In this case, the regulator is expected to grant an emergency-use authorization, a less rigorous but faster type of regulatory clearance that it has relied on during the coronavirus pandemic to speed up the arrival of new treatments and now vaccines to the American public.
This meeting, which is scheduled to begin Thursday at 9 a.m. Eastern time and end at 6 p.m., will be webcast. (A similar meeting for Moderna Inc.’s
vaccine candidate has been scheduled for Dec. 17.) Federal officials have said that they expect the Pfizer–BioNTech vaccine to be authorized within days of the meeting and that the first vaccinations may take place within the week.
“Within 24 hours of FDA greenlighting with authorization, we’ll ship to all of the states and territories that we work with,” Health and Human Services Secretary Alex Azar told “Fox News Sunday” this weekend. “And within hours they can be vaccinating.”
FDA officials reportedly told the Wall Street Journal that they expect to make a decision within four days of the meeting.
What’s the purpose of an advisory committee meeting?
The rationale for an “AdCom” meeting is twofold: It’s a chance for FDA reviewers to gather outside clinical expertise, and it’s good for the public to see a transparent regulatory process, according to Mark Senak, a lawyer and partner with the public-relations firm Fleishman-Hillard.
“Therapeutics will only be utilized under circumstances where a person is ill. Vaccines are going to everybody,” he said. “You have already a reservoir of vaccine hesitancy that is strong in the United States with the anti-vaxx movement. But, on top of that, you have the perceived politicization of the process through the election cycle, and that added a layer of concern among people who would normally take a vaccine.”
This may be why the FDA publicly committed to holding AdCom meetings for vaccine authorization. (In comparison, the regulator did not convene advisory committees for Gilead Sciences Inc.’s
COVID-19 treatment Veklury, which was formally approved in October, or Eli Lilly & Co.’s
coronavirus therapy baricitinib, which received authorization in November.)
California and New York have also said they plan to vet the data behind the vaccines before allowing them to be administered to state residents.
The United Kingdom became the first Western country to authorize a COVID-19 vaccine when it granted emergency approval to BioNTech and Pfizer’s BNT162b2 on Dec. 2, a decision that the government later defended for its speed.
“One of the differences between how the United States approaches this and other countries may approach it is: The FDA, when they get the data from the company, the application, they don’t rely on the application data; they go through it all and crunch it,” Senak said. “And that takes a little more time.”
What do we know so far about how BNT162b2 works?
The companies have previously stated that the late-stage clinical trial demonstrated an overall efficacy rate of 94.6%.
However, on Tuesday, FDA reviewers shared additional clinical details about the investigational vaccine’s performance in clinical trials in a document published in advance of the advisory committee meeting. This is a normal part of the application and approval process.
The regulator said the number of COVID-19 infections among trial participants who received the placebo or the vaccine was the same until 14 days after the first dose was administered. At that point, participants who were vaccinated were less likely to contract COVID-19. Though people who received the first dose of the two-dose vaccine had an efficacy rate of 88.9% after the first dose, the FDA said it does not support utilization of a single dose.
The FDA document shows that the efficacy varies slightly across age groups, with a slightly lower efficacy rate, of 92.9%, in 65- to 74-year-olds.
The agency also cited several unknowns about the vaccine, including durability of protection, how the vaccine protects children and people who are immunocompromised, such as those with HIV/AIDS, and if the vaccine can prevent reinfection in people who have already been infected with the coronavirus.
What happens next?
The committee is expected to vote on whether the vaccine should be authorized. That vote will be conducted publicly on Thursday.
It will then be up to the FDA to decide whether to move forward with authorization and to establish the “label” for the vaccine. (“The committee is there to look at safety and efficacy and make an assessment about the risk-benefit ratio,” Senak said. “They’re not there to determine price. They’re not there to determine distribution.”)
The so-called indication will include prescribing information, such as what age groups should receive the vaccine and what side effects providers should be aware of. (The FDA document said four patients in the clinical trial’s vaccination group reported cases of Bell’s palsy, a type of temporary facial paralysis. No cases of Bell’s palsy were reported in the placebo group.)
Wall Street analysts expect a near-immediate authorization after the meeting. “FDA appears supportive of emergency use authorization (EUA) for Pfizer–BioNTech COVID vaccine,” Raymond James analyst Steven Seedhouse told investors in a note on Tuesday. “We expect a positive AdCom vote on Dec. 10 and EUA within days.”
So far this year, BioNTech’s stock has soared 276.6%, and shares of Pfizer are up 13.2%. The S&P 500
has gained 14.2.%.