FDA Says Pfizer Vaccine Meets Success Criteria, No Safety Concerns That Would Block Approval

A patient receiving Pfizer's COVID-19 vaccine at the University of Maryland School of Medicine in Baltimore, Md., on May 4, 2020. Courtesy of University of Maryland School of Medicine via AP

The Food and Drug Administration (FDA) released an analysis of the Pfizer-BioNTech COVID-19 vaccine on Tuesday, concluding it is highly effective and finding “no specific safety concerns” that would prevent the agency from authorizing emergency use of the product.

The FDA’s analysis (pdf) was issued ahead of a Thursday meeting with a panel of independent medical advisors that will discuss whether scientific evidence supports the view that the vaccine, called BNT162b2, is effective in preventing COVID-19 in people aged 16 and older, and if the known benefits outweigh potential risks.

Pfizer and BioNTech have said their vaccine has demonstrated an efficacy rate of 95 percent, with no serious safety concerns. The companies said they expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021, which, with the FDA’s emergency use approval, could pave the way for millions of Americans to be vaccinated in the near future.

The agency’s analysis of Pfizer’s clinical trial, which involved some 44,000 people who received two doses roughly three weeks apart, concluded that the vaccine “met the prescribed success criteria.”

“For participants with and without evidence of SARS-CoV-2 infection before and during vaccination regimen, VE [vaccine efficacy] against confirmed COVID-19 occurring at least 7 days after Dose 2 was 94.6 [percent],” the FDA said in the document, confirming Pfizer’s efficacy data.

Vials of coronavirus vaccine and a medical syringe are seen in front of a displayed Pfizer logo on Oct. 31, 2020. Dado Ruvic/Reuters

Regarding safety, the FDA reviewed data from some 38,000 participants aged 16 and older, and found “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA [emergency use authorization].”

People who took part in the study did experience a number of side effects after taking the vaccine, with the FDA noting the most common were injection site reactions (84.1 percent), fatigue (62.9 percent), headache (55.1 percent), muscle pain (38.3 percent), chills (31.9 percent), joint pain (23.6 percent), and fever (14.2 percent).

“As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency noted.

If the advisory panel gives the vaccine a positive recommendation, the FDA could issue the authorization within days.

Health and Human Services Secretary Alex Azar said Sunday that he is optimistic the vaccine would soon be approved for emergency use.

“If things are on track, the advisory committee goes well, I believe we could see FDA authorization within days,” Azar told ABC News. “But it’s going to go according to FDA gold-standard processes … and I’m going to make sure it does.”

The FDA also released Pfizer and BioNTech’s own analysis of the vaccine’s effectiveness and safety (pdf), which indicated that data “did not suggest any serious safety concerns” and mirrored the FDA’s analysis on how effective their product is in preventing COVID-19 infection.

The companies were the first to seek emergency approval for a COVID-19 vaccine, with Moderna’s candidate, called mRNA-1273, scheduled for FDA review on Dec. 17.