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1120 BioNTech Pfizer EUA
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Regulation

Dec. 10 FDA panel could be gateway to first emergency authorization of COVID-19 vaccine

BioNTech, Pfizer prepare to roll out mRNA vaccine

Nov 20, 2020 | 10:58 PM GMT

A Dec. 10 FDA advisory committee meeting could be the springboard for emergency use authorization for BNT162b2, enabling high-risk patients to receive by mid-December the first doses of the mRNA vaccine candidate against SARS-CoV-2 from BioNTech and Pfizer.

Rolling submissions for the vaccine from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) are under way in multiple other jurisdictions, including Australia, Canada, Europe, Japan and the U.K., and the partners plan to submit applications as soon as possible to other regulatory agencies around the globe.

BioNTech and Pfizer, which submitted their application on Friday, expect to produce globally up to 50 million doses by year-end and up to 1.3 billion doses by YE21, and said they will be able to distribute the vaccine within hours after FDA authorizes it. The companies are applying for authorization of a two-dose regimen. Pfizer, which did not receive Operation Warp Speed funding for R&D or manufacturing, plans to handle distribution of BNT162b2 to sites designated by Warp Speed. Earlier this week, Warp Speed officials dismissed concerns that requirements for cold storage of mRNA vaccines will cause difficulties for states or other jurisdictions.

BNT162b2 demonstrated a vaccine efficacy rate of 95%  in the companies’ Phase III trial, with a rate of 94% in volunteers 65 and older. No serious safety concerns have been observed by the trial’s data monitoring committee to date, according to the partners. The data include safety data in about 100 children aged 12-15. The partners said about 42% of global volunteers and 30% of U.S. participants in the study have racially and ethnically diverse backgrounds, and 41% of international and 45% of U.S. volunteers are 56-85 years old. The trial, which began on July 27,  has enrolled 43,661 participants, of whom 41,135 had received a second dose as of Nov. 13.

While the trial is designed to collect safety data for two years, it is very unlikely that it will remain unblinded that long. Pfizer has said it feels an ethical obligation following the vaccine’s authorization to allow trial participants to learn whether they received a placebo or the vaccine and to give those who received a placebo the option to receive the vaccine.  

Moncef Slaoui, Warp Speed’s chief scientific adviser, said at a briefing on Wednesday that the initiative is “working with the FDA and with the companies on when to cross-over the placebo group to the vaccine, and within the placebo group, whether that crossover should happen in a staged way, depending on the prioritization, for instance, that the CDC and the ACIP would have put forward.”

Unblinding and offering trial participants the option to receive the vaccine could happen when the EUA is issued, or at some later stage such as “when 10% of the population has been immunized for a particular strata of the population that has been prioritized,” Slaoui suggested.

The latest time point for unblinding and crossover would be when a BLA is approved, which is expected three or four months after issuance of an EUA, he added.

Washington Editor Steve Usdin contributed to this report.

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