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Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.
FDA has posted briefing documents from FDA and Pfizer–BioNTech in advance of a Dec. 10, 2020 meeting where FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to review the Emergency Use Authorization (EUA) for the Pfizer–BioNTech COVID-19 vaccine, BNT162.
The Pfizer-BioNTech document details the company’s data for the investigational vaccine, which is based on a SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA formulated in lipid nanoparticles. The safety, immunogenicity, and efficacy data from clinical trials fulfill the EUA requirements, the companies report. The document further details the demographics and responses for various patient populations in the study, adverse events, and a pharmacovigilance and pharmacoepidemiology plan.
In its briefing document, FDA described the two-dose vaccine as “highly effective” in preventing symptomatic COVID-19, noting that some protection is against the disease was demonstrated after the first dose. The agency also reported the clinical trial data “suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA.”
FDA also noted that the chemistry, manufacturing, and controls data submitted for the vaccine thus far is “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19” and the agency “has determined that the Sponsor has provide adequate information to ensure the vaccine’s quality and consistency for authorization of the product under EUA.”
In the December 10 meeting, VRBPAC will discuss and provide recommendations on whether—based on available data—the Pfizer–BioNTech COVID-19 vaccine may be effective in preventing COVID-19 in people 16 years of age or older, if the known and potential benefits outweigh the know and potential risks, and what additional studies should be conducted following the issuance of an EUA to further assess the safety and effectiveness of the vaccine.
The FDA (PDF) and Pfizer-BioNTech (PDF) briefing documents are available for download from the FDA website. Details about the meeting, which will be streamed online, can be access via this link.