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Updated: Pfizer COVID vax gets thumbs up from FDA's VRBPAC

Posted 11 December 2020 | By Kari Oakes 

Updated: Pfizer COVID vax gets thumbs up from FDA's VRBPAC

The benefits of the COVID-19 vaccine developed by Pfizer and the German firm BioNTech outweigh potential risks for people aged 16 years and up, according to a US Food and Drug Administration (FDA) advisory committee.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-4, with one abstention, to endorse the favorable benefit-risk profile put forward as the lone voting question for the committee’s 10 December meeting.
This vote paves the way for imminent issuance of an emergency use authorization (EUA) for the vaccine; the vaccines advisory committee of the Centers for Disease Control and Prevention (CDC) is holding a split meeting on the afternoons of 11 and 13 December. That committee will vote on a similar question at the end of the 13 December meeting. (RELATED: Redfield endorses ACIP's first-wave COVID-19 vaccine priorities, Regulatory Focus, 04 December 2020)

In a joint statement issued early on 11 December 2020, FDA Commissioner Stephen Hahn, MD, and Peter Marks, MD, director of FDA's Center for Biologics Evaluation and Research, said, "Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution."
In discussion before the vote, several VRBPAC committee members said they were in favor of issuing an EUA for the vaccine, but they were uncomfortable with the “thin” data for 16 and 17 year olds, as committee member Archana Chatterjee, MD, PhD, said. “If they were eligible they would not be making the decisions themselves to be vaccinated,” said Chatterjee, a pediatric infectious diseases expert and dean of Chicago Medical School who was among the “no” votes.
Many on the committee disagreed: “I support the statement as written,” said Paul Offitt, MD. “In terms of safety, we’re going to be doing followup,” said Offitt, a pediatric infectious diseases expert at the Children’s Hospital of Philadelphia. “The fact of the matter is 16- and 17-year-olds can get it… We have clear evidence of benefit and all we have on the other hand is theoretical risk.”
Some other concerns raised in the course of the day-long meeting centered around the relatively brief period of follow-up for both efficacy and safety data, though committee members generally agreed that the mounting crisis of COVID-19 deaths and hospitalizations justified the speed at which data were accrued.
Some committee members asked for additional data after the 14 November interim analysis that was used for the EUA submission. In response, FDA’s Doran Fink, MD, PhD, said, “No, we have not received additional datasets beyond the datasets that were submitted to us comprising a cutoff date of November 14th.
"As you can imagine, there is a tremendous amount of work that goes into preparing a dataset for submission, and so it really is infeasible for the sponsor and for FDA to be chasing our tails trying to get datasets that encompass more and more data as time goes on,” said Fink. “That being said, if the sponsor becomes aware of, or if we become aware of, any data that would potentially impact our benefit-risk assessment, we do have discussions with the sponsor regarding those data.” 
Other committee members asked about the process for transitioning a vaccine authorized under an EUA to full approval through a Biological License Application (BLA). FDA staff outlined the additional data, including more detailed manufacturing and quality data and more longitudinal safety and efficacy data, that will be required for a BLA. “We typically ask for at least six months of follow up in a substantial number of clinical trial participants to constitute a safety database that would support licensure,” said Fink.
Once the first vaccine receives a BLA, though, others may still come forward for authorization under the EUA process. “If a vaccine is approved that would not necessarily preclude issuance of an EUA for another investigative vaccine for COVID-19,” said Fink, since limited quantities, or approval for use in a limited population, may mean that the approved vaccine is not adequate to address needs during the public health emergency of the coronavirus pandemic.
FDA advisory committees customarily go through a post-vote round robin in which members may briefly share their thinking about why they cast the vote they did. No such opportunity was presented at the VRBPAC meeting called to assess the Pfizer-BioNTech vaccine: immediately after the vote, FDA’s Marion Gruber, MD, thanked the committee for their work and acting chair Arnold Monto, MD, a University of Michigan professor of epidemiology, closed the meeting.
On 17 December, VRBPAC reconvenes for another meeting to consider the Moderna messenger RNA (mRNA) vaccine candidate the firm co-developed with the National Institutes of Health. Both vaccines demonstrated efficacy of about 95% across a broadly representative population of adults, with few safety concerns. (RELATED: VRBPAC to hear of high – and early – efficacy for Pfizer’s COVID vaccine, Regulatory Focus 10 December 2020)
Two severe allergic reactions reported in the UK on the first day of administration of Pfizer’s vaccine are being investigated by Pfizer, and FDA’s Gruber said that international regulators are communicating about the incidents. For now, labelling and indications will advise those with a history of severe allergies not to receive the Pfizer vaccine, said Gruber.
Meeting materials, including slides and briefing documents, are available online. FDA livestreamed the meeting on its website, on C-SPAN, on YouTube, and on Twitter. FDA is not required to follow the recommendations of its advisory committees, though it usually does.

Michael Mezher contributed reporting to this article. The article was updated on 11 December to include remarks from Hahn and Marks.


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Tags: coronavirus, FDA, US

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