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 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.
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.
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.