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Product Development

Success of BioNTech-Pfizer COVID-19 vaccine shifts focus to deployment, additional vaccines

Dec 9, 2020 | 1:05 AM GMT
Pfizer-BioNTech COVID-19 vaccine begins to confer protection 14 days after first dose
Source: FDA

An FDA advisory committee is expected to recommend authorization of an mRNA COVID-19 vaccine from Pfizer and BioNTech Thursday, setting the stage for a greenlight from the agency and shifting the pandemic response focus in the U.S. to deployment.

The committee will be briefed on plans of Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) to collect sufficient data to gain full approval of BNT162b2, as well as on strategies for testing additional vaccine candidates when the public has access to vaccines that have received emergency use authorizations of BLAs.

The strength of the efficacy signal from the Phase III trial of BNT162b2 is likely to push aside concerns Vaccines and Related Biological Products Advisory Committee members expressed at a meeting in October about the safety of COVID-19 vaccines, especially mRNA vaccines.

FDA briefing documents released Tuesday confirm safety and efficacy data that Pfizer and BioNTech have reported about their COVID-19 vaccine candidate.

FDA’s analysis of data submitted by the partners show that the BNT162b2 mRNA vaccine started protecting against COVID-19 symptoms 14 days after administration of the first dose in the two-dose regimen and efficacy continued through the completion of the 119-day observation period.

“Efficacy in preventing confirmed COVID-19 occurring at least 7 days after the second dose of vaccine was 95.0%, with 8 COVID-19 cases in the vaccine group and 162 COVID-19 cases in the placebo group,” FDA stated.

The agency added, “Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.”

Although efficacy was observed following a single dose and prior to the second dose, FDA stated that the observation “cannot support a conclusion on the efficacy of a single dose of the vaccine, because the time of observation is limited by the fact that most of the participants received a second dose after three weeks” and there was no single-dose comparator arm.

In addition to voting at Thursday’s meeting on a recommendation to authorize BNT162b2, the committee will discuss the future of COVID-19 vaccine development. Steven Goodman, associate dean of clinical and translational research at Stanford University School of Medicine, will make a presentation on “considerations for placebo-controlled trial design if an unlicensed vaccine becomes available.”

Nancy Messonnier, director of National Center for Immunization and Respiratory Diseases at CDC, will brief the committee on vaccine safety and effectiveness monitoring.

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