Updated: Pfizer files EUA for COVID vaccine; FDA sets adcomm for 10 December

Regulatory NewsRegulatory News | 20 November 2020 |  By 

With favorable results from a completed Phase 3 clinical trial of their jointly developed vaccine against COVID-19, Pfizer and BioNTech have submitted an emergency use authorization (EUA) application to the US Food and Drug Administration (FDA) according to Pfizer CEO Albert Bourla.

The agency has set a 10 December date for the Vaccines and Related Biological Products Advisory Committee to review the EUA request. The meeting will be broadcast live on Facebook, Twitter, and YouTube, in addition to being livestreamed on FDA's website.

“The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted," said FDA Commissioner Stephen Hahn, MD, in announcing the advisory committee meeting. "While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner," he said.
“It is with great pride and joy – and even a little relief – that I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA’s hands. This is a historic day; a historic day for science and for all of us,” said Pfizer CEO Albert Bourla in a 20 November videotaped statement.

The messenger RNA (mRNA) vaccine developed jointly by Pfizer and the German firm BioNTech, BNT162b2, has demonstrated 95% efficacy and participants experienced few serious adverse events within a median 2 months after completing the 2-dose vaccination sequence.
The 2-month mark was set by FDA as the required safety milestone in its October 2020 guidance for sponsors seeking EUAs for their COVID-19 vaccines. (RELATED: FDA issues COVID-19 vaccine EUA guidance after clash with White House, Regulatory Focus 6 October 2020)
“Today, we were able to submit a very robust dataset that we believe meets, and in many cases, exceeds the FDA’s high standards, said Bourla. He pointed out that the EUA for the vaccine was filed 248 days after the two firms entered into their development collaboration.
In addition to announcing the US FDA filing, Bourla noted that the vaccine is already under rolling review in Europe, Japan, Australia and Canada.
In an 18 November press release announcing the completion of the Phase 3 clinical trial, Pfizer reported that their COVID-19 vaccine had observed efficacy in older adults – those over 65 years of age – of over 94%. The figures were obtained after over 43,000 participants received the two-dose vaccines series; in this Phase 3 cohort, 170 cases of COVID-19 developed, with all but eight of the cases occurring in participants who received placebo. Of the 10 severe COVID-19 cases, 9 were in those who received placebo.
Pfizer’s EUA filing news comes days after Moderna announced that its COVID-19 vaccine candidate, jointly developed with the National Institutes of Health, was also nearly 95% effective. Neither sponsor has yet submitted Phase 3 data for peer review and publication, though each firm says it plans to do so. (RELATED: NIH director: Efficacy for co-developed Moderna vaccine nears 95%, Regulatory Focus 16 November 2020)
This week, AstraZeneca, together with its development partner Oxford University, published favorable Phase 2 data for its chimpanzee adenovirus-vectored vaccine, ChAdOx1 nCoV-19 in The Lancet. The vaccine produced high levels of neutralizing antibody titers across all age groups, including older participants, with less reactogenicity in the older population.
“We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks,” said Secretary of Health and Human Services Alex Azar in a press conference on 18 November that followed Pfizer’s announcement of its positive efficacy and safety data.
Azar explained that the government’s Operation Warp Speed (OWS) COVID-19 vaccines and therapeutic accelerator has been working with pharmaceutical companies to speed and de-risk development and pre-authorization production of vaccines. “Because of this work, by the end of December, we expect to have about 40 million doses of these two vaccines available for distribution, pending FDA authorization,” said Azar. Because two doses are required for both mRNA vaccines, about 20,000,000 people could be vaccinated by the end of 2020.
Bourla said that Pfizer and BioNTech will be prepared to produce up to 50 million doses globally in 2020, and up to 1.3 billion by the end of 2021.

20 November: This article was updated with Bourla's announcement of the EUA filing and the date of the FDA advisory committee meeting.


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Tags: coronavirus, FDA, US

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