FDA Panel Endorses Pfizer, BioNTech’s COVID-19 Vaccine
An FDA advisory panel that convened Thursday to discuss Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 voted 17-4, with one abstention, in favor of authorizing it for emergency use in people 16 years and older. The vote follows the release of briefing documents earlier this week in which FDA staff reviewers appeared to back the vaccine candidate’s efficacy and safety.
The advisory panel vote clears the way for the FDA to issue an emergency-use authorization (EUA), with some media reports suggesting that could come Friday, or even later Thursday evening, while frontline healthcare workers in the US could begin receiving doses of the vaccine as soon as next week. The vaccine received its first authorization for emergency use last week in the UK, with similar decisions following in Bahrain, Canada and Saudi Arabia.
“We will take what we’ve heard today into consideration when deciding on not only the EUA issuance, but also how to move on in the development and licensure of this product,” stated Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, after the panel votes were cast. Pfizer and BioNTech filed their EUA request last month shortly after BNT162b2, which is administered as two doses given 21 days apart, demonstrated an efficacy rate of 95% at the final analysis of an ongoing phase 3 study in which approximately 36,600 participants were randomized to receive the vaccine or placebo.
“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” stated Pfizer CEO Albert Bourla, adding that if the FDA issues an EUA, “we…stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic.”
More data needed after vaccine rollout
Meanwhile, Doran Fink, deputy clinical director of the FDA’s division of vaccines, said further evaluation of the vaccine after its release will be necessary to see if its benefits continue to outweigh its risk, and whether any labeling changes will be required. Earlier this week, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned that people who have a “significant history” of allergic reactions should not receive BNT162b2 after two NHS workers reported anaphylactoid reactions shortly after being dosed.
In a statement after the FDA panel vote, Pfizer said that data from the ongoing phase 3 study, including longer term safety, information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 17 years of age will be gathered “in the months ahead.” It also noted that more studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised. Prior to the vote, some experts in the meeting argued to limit its recommendation to people who are at least 18, saying the safety data on 16- and 17-year olds was insufficient. “I would like to just join that lineup of people who are advocating for that,” said panel member Mark Sawyer, adding the data are “very thin and it’s inadequate to really say we have safety given the low incidents of disease.”
Moderna AdCom next week
The FDA advisory panel is scheduled to meet again on December 17 to discuss Moderna’s EUA application for the COVID-19 vaccine mRNA-1273, which has demonstrated an efficacy rate of 94.1% at the final analysis of its phase 3 study. Moderna’s candidate is similar to the Pfizer/BioNTech vaccine as both use mRNA to stimulate an immune response to SARS-CoV-2.