Pfizer and BioNTech’s coronavirus vaccine candidate meets the FDA’s requirements for emergency use authorization (EUA), according to documents posted ahead of the agency’s scheduled Dec. 10 meeting. The documents did not flag any new concerns or safety issues regarding the vaccine after reviewing the submitted data.
“The data submitted in this EUA request were consistent with the recommendations set forth in the FDA Guidance on Emergency Use Authorization for Vaccines to prevent COVID-19 and met prespecified success criteria established in the protocol,” the documents stated.
In their findings, the FDA listed reduction in risk of confirmed COVID-19 occurring at least seven days after Dose 2, reduction in the risk of confirmed COVID-19 after Dose 1 and before Dose 2 and reduction in the risk of confirmed severe COVID-19 at any time after Dose 1.
The agency found no specific safety concerns among subgroup analyses, but did list several unknowns that will need to be investigated further, including how long the vaccine will offer protection. The FDA also said it could not evaluate vaccine effectiveness in certain populations at high risk of severe COVID-19 such as immunocompromised individuals, or in those who were previously infected with SARS-CoV-2. The data on pediatric patients is also too limited to evaluate the effectiveness in groups younger than 16.
Data regarding effectiveness among asymptomatic infection was also too limited to assess, as was vaccine effectiveness against long-term effects of COVID-19 disease, mortality and transmission of SARS-CoV-2.
Fatigue, headache, muscle pain, chills, joint pain and fever were all listed as reported adverse reactions, but were categorized as mild to moderate. Serious adverse events remained uncommon and “represented medical events that occur in the general population at similar frequency as observed in the study.”
The documents note that six deaths were reported among the 43,448 enrolled participants between April 29 and Nov. 14, including two participants who received the vaccine and four others who received the placebo. However, one of the vaccine recipients who died experienced cardiac arrest 62 days after Dose 2, and the other died from arteriosclerosis, or hardening of arteries, three days after Dose 1. The FDA noted that “all deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.”
The agency’s meeting is scheduled for two days after the U.K. began distributing the vaccine to its first group of citizens on Tuesday. The U.K. jumped out in front of the E.U., and U.S. when it granted emergency approval to Pfizer’s vaccine last week. The move was criticized by regulatory bodies elsewhere in the world, who opted for a more stringent review process involving a larger group of data.
A 90-year-old woman named Margaret Keenan went into the history books as the first person to receive the vaccine on Tuesday morning. Keenan, who received the vaccine in Coventry, England, reportedly said she felt “privileged” to be the first in line.