On Tuesday, the U.S. Food and Drug Administration (FDA) released a brief document stating that Pfizer’s COVID-19 vaccine (BNT162b2) appears to be adequately safe and effective for limited approval.
The document was posted ahead of the December 10 Vaccines and Related Biological Products Advisory Committee meeting (VRBPAC).
On November 20, Pfizer applied for the FDA’s emergency use authorization (EUA) for its vaccine, which is developed in association with BioNTech, according to Medscape Medical News.
Pfizer and BioNTech want FDA approval for use of their vaccine for people who are 16 and above, with a proposed dosage of two shots given 21 days apart.
The FDA said that findings from research involving about 38,000 participants “suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA” for Pfizer’s coronavirus vaccine.
The agency did note “a numerical imbalance of four cases of Bell’s palsy” among participants who received the vaccine. The “four cases in the vaccine group do not represent a frequency above that expected in the general population,” the U.S. drug regulatory body said.
“Otherwise, there were no notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic, neuroinflammatory, and thrombotic events) that would suggest a causal relationship to BNT162b2 vaccine,” the FDA wrote in the report.
The research data indicates that it will meet the FDA’s threshold for efficacy. The vaccine’s efficacy has been pegged at 95%, according to Pfizer.
Dr. Arnold Monto, acting chairman of VRBPAC, said in the meeting that the data on the vaccine appeared to have significantly surpassed the FDA’s targets.
“So we can expect that, unless there are surprises, that there will not be an issue in terms of efficacy, said Dr. Monto, who is a professor at the University of Michigan School of Public Health in Ann Arbor.
So far, the virus has claimed more than 1.5 million deaths, with the United States reporting more than 293,000 deaths.
The World Health Organization (WHO) said that over a dozen COVID-19 vaccine candidates have reached late-stage clinical trials.
The two leading experimental vaccines for the US market include the Pfizer/BioNTech vaccine and the vaccine developed by Moderna in association with the National Institute of Allergy and Infectious Diseases (NIAID). The FDA will review Moderna’s EUA application on December 17.
In the document, the FDA has stressed the conditional nature of an EUA approval. Even with an EUA, a COVID-19 vaccine would still be considered an “unapproved” until the companies successfully complete the agency’s procedures for a Biologics License Application (BLA).
The FDA said, to get a BLA, a vaccine developer will need to provide “greater assurance of safety based on larger numbers of vaccine recipients who have been followed for a longer period of time, and additional information about efficacy that addresses, among other questions, the potential for waning of protection over time.” For more information on the report, visit Medscape Medical News.
