Pfizer, BioNTech's emergency-use request for COVID-19 vaccine heads to FDA

Pfizer and BioNTech announced that they will submit a request to the FDA on Friday seeking emergency-use authorisation (EUA) of their mRNA vaccine candidate BNT162b2 against SARS-CoV-2. The companies noted that the filing will "potentially enable use of the vaccine in high-risk populations in the US by the middle to end of December."

Albert Bourla, CEO of Pfizer, remarked "we look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion," which is scheduled for December 10. The FDA held an advisory panel meeting on October 22 to discuss, in general, the development and authorisation of vaccines to prevent COVID-19, although it previously said that follow-up meetings would be required to review specific EUA requests.

Commenting on the timeline, John Taylor, who served as counsellor to the head of the FDA during the Obama administration, noted "I don't find that timeframe to be unreasonable in light of the amount of data the agency needs to analyse." Taylor added "it ensures that the agency can conduct a well run, well attended advisory committee in order to ensure maximum transparency, which I think will be an important factor in patients' willingness to take the vaccine."

Distribution "within hours" after authorisation

Pfizer and BioNTech noted on Friday that they "will be ready to distribute [BNT162b2] within hours after authorisation." The drugmakers currently expect to produce up to 50 million doses of the vaccine this year, and up to 1.3 billion doses by the end of 2021.

The companies have already initiated rolling submissions in other markets, including with the European Medicines Agency and the UK's Medicines and Healthcare products Regulatory Agency, as well as regulatory bodies in Australia, Canada and Japan.

The submission to the FDA comes a matter of days after Pfizer and BioNTech announced that BNT162b2 demonstrated an efficacy rate of 95% at the final efficacy analysis of a Phase III study. The results also showed that the efficacy of the vaccine in adults over 65 years of age was more than 94%, whilst it was consistent across age, gender, race and ethnicity demographics.

For related analysis, see ViewPoints: COVID-19 vaccines move into true game-changer territory, and read Physician Views results: Lack of durability, emergence of serious side effects top doctors' concerns about COVID-19 vaccines.

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