FDA Advisory Committee Recommends Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine with 17-4 Vote

On the 10th local time, experts discussed this core issue at the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting convened by the U.S. FDA. The most intense debate centered on whether there was sufficient data to authorize the use of the vaccine in children aged 16 and 17 years. Ultimately, the FDA’s COVID-19 vaccine panel voted 17 in favor, 4 against, and 1 abstention, concluding that the benefits of the Pfizer/BioNTech COVID-19 vaccine outweigh the known risks for individuals aged 16 and older. The FDA’s COVID-19 vaccine panel recommended approval of Pfizer’s COVID-19 vaccine.

FDA Commissioner Hahn stated in an earlier media interview that the agency would make a swift decision following the advisory committee’s recommendation. The FDA’s formal Emergency Use Authorization (EUA) could be granted as early as tomorrow. If authorized, BNT162b2 would become the first available COVID-19 vaccine in the United States, marking a milestone moment.

If granted EUA authorization, 2.9 million doses of the BNT162b2 vaccine will be immediately distributed nationwide in the United States, and the government has committed to distributing 20 million doses by the end of the month. The CDC committee will meet tomorrow to discuss who will receive priority for vaccination, but states retain final authority on this matter.

In addition, the advisory committee meeting on Moderna’s mRNA vaccine is scheduled for next Thursday.

Regarding the Phase 2/3 Study

The ongoing Phase 3 clinical trial of BNT162b2 is based on BioNTech’s proprietary mRNA technology. A total of 43,548 participants were enrolled in this Phase 3 trial; following randomization, 43,448 received vaccinations, with 21,720 receiving BNT162b2 and 21,728 receiving placebo injections. Seven days or more after the second dose (booster vaccination), 7 participants in the BNT162b2 group developed COVID-19 (symptomatic infection), compared to 162 cases in the placebo group. The vaccine efficacy of BNT162b2, representing the gold standard for assessing vaccine effectiveness, was 95% (95% CI: 90.3–97.6%). Vaccine performance remained stable across subgroups stratified by age, sex, race, BMI, and underlying medical conditions, demonstrating consistent protective efficacy. As of the publication date, 10 cases of severe COVID-19 occurred among all participants, with only one case in the BNT162b2 vaccination group. This study would benefit from supplementary data on the correlation between antibody and neutralizing antibody titers and vaccine-induced protection.

BNT162b2 demonstrated a favorable safety profile. Within two months post-vaccination, short-term adverse reactions included mild to moderate injection-site pain, fatigue, and headache. The incidence of serious adverse events was low and comparable between the vaccine group and the placebo group. Additionally, the UK reported yesterday two cases of allergic reactions following vaccination in individuals with a history of allergies.

Controversy Over Pfizer/BioNTech’s COVID-19 Vaccine Persists

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are currently still evaluating Pfizer’s vaccine data.

During the meeting, the committee and FDA representatives raised several key issues, including how to handle long-term follow-up and the use of the placebo group after Emergency Use Authorization (EUA). However, they only requested the committee to vote on one question: “Based on the totality of scientific evidence, do the benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals aged 16 years and older outweigh its risks?” There was little debate on this issue, and ultimately, the Pfizer/BioNTech COVID-19 vaccine was determined to have benefits that outweighed the known risks.

However, the committee expressed concern about rare safety issues in the trial, including four cases of Bell’s palsy (i.e., facial paralysis) in the vaccine group versus none in the placebo group. The FDA requested that Pfizer track allergic reactions among trial participants during the hearing.

Furthermore, some have questioned the stringency of the study endpoints, pointing out that Pfizer did not test whether the vaccine could prevent asymptomatic infection and that their definition of “severe” COVID-19 cases did not require hospitalization or death.

The committee members also emphasized the need for long-term follow-up, noting that the median follow-up duration for participants was only two months. Although they considered a two-month follow-up period sufficient to demonstrate safety, particularly in light of the U.S. pandemic situation, the advent of Emergency Use Authorization (EUA) would raise new questions. The most immediate question is: How should Pfizer’s ongoing Phase 3 clinical trial be conducted? The FDA requested the committee to discuss this issue but not to vote on it.

In their discussion, Pfizer disclosed plans, stating that the company would complete preclinical DART studies within a few days, thereby enabling them to test the vaccine in pregnant women. Pfizer is also planning to conduct some form of antibody testing to determine whether the vaccine can prevent asymptomatic infection.

Reference Source:

BREAKING: Advisory committee votes 17-4 to recommend FDA authorize Pfizer-BioNTech vaccine, opening door to rapid EUA

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