FDA authorizes Pfizer-BioNTech vaccine for emergency use

Regulatory NewsRegulatory News | 11 December 2020 |  By 

The US Food and Drug and Drug Administration (FDA) on Friday authorized Pfizer and BioNTech’s COVID-19 vaccine for emergency use in individuals ages 16 and older just one day after the agency’s advisory panel voted 17-4 in favor of the vaccine.
Now that the vaccine has been authorized just three weeks after Pfizer and BioNTech submitted their emergency use authorization (EUA) request, a nationwide rollout of the vaccine is set to begin.

FDA Commissioner Stephen Hahn called the move a “significant milestone in battling this devastating pandemic,” which has so far claimed the lives of nearly 300,000 people in the US and caused more than 1.5 million deaths globally.
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” Hahn said.
In the coming days, 2.9 million of the US’ initial supply of 6.4 million doses of the mRNA vaccine will be distributed to the states. Another 2.9 million doses will be withheld for the booster dose of the two-injection regimen and an additional 500,000 are being reserved for unforeseen circumstances. According to US Army General and Operation Warp Speed Chief Operating Officer Gustave Perna, other required supplies are already arriving at the 636 locations across 64 jurisdictions destined to receive the vaccine, which must be transported at sub-zero temperatures and used within five days of thawing.
The US has so far agreed to buy 100 million doses of the Pfizer-BioNTech vaccine for $1.95 billion, with the option to purchase an additional 500 million doses, though additional doses beyond the first 100 million may not be available until June or July 2021.
Vaccines are initially to be distributed to jurisdictions on a per capita basis; individual jurisdictions will make final decisions about local vaccine allocation. The Centers for Disease Control and Prevention’s vaccines advisory committee has recommended that health care workers and individuals living in long-term care facilities be first in line to receive the initial tranche of vaccines.
In an unusual move, FDA Commissioner Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director Peter Marks, the agency’s top official overseeing vaccines, early Friday said the agency was “rapidly” working to finalize the EUA and had already informed Pfizer and other US authorities so that they could prepare and execute their plans for distributing the vaccine.
While FDA seemed poised to authorize the vaccine within days of the meeting, the decision comes amid reports that White House Chief of Staff Mark Meadows told Hahn to authorize the vaccine before Saturday or potentially lose his job, though Hahn disputed such characterizations of the conversation. Nonetheless, the authorization follows months of pressure from President Donald Trump for FDA to quickly authorize a vaccine, including a tweet Friday morning where the outgoing president ordered Hahn to “Get the dam vaccines out NOW.”
In the leadup to the advisory committee meeting, Marks gave a more conservative estimate for how quickly the authorization could come, saying it would be “days to a week” after the 10 December Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting.
However, the agency itself was inclined to authorize the vaccine after its favorable assessment of the data submitted by Pfizer and BioNTech. That fact, together with increasing pressure on the agency to issue an authorization after regulators in the UK, Canada, Bahrain and Saudi Arabia beat it to the punch, sped the finalization of the EUA package so it could be issued just one day after the VRBPAC vote.
The authorization also follows a public tussle between FDA and the Trump administration over the standards the agency would hold vaccines to for emergency use, particularly regarding the median two-month safety follow-up the agency prescribed. (RELATED: FDA issues COVID-19 vaccine EUA guidance after clash with White House, Regulatory Focus 6 October 2020).
An EUA is different from the traditional pathway for vaccine approval, or biologics license application (BLA), and allows for the use of a medical product under emergency conditions based on less evidence than would be required for a full approval. The statutory requirements for issuance of an EUA are vague and only require evidence that a product may be effective and that its potential benefits outweigh its potential risks in the context of a public health emergency. However, FDA officials including Marks have said that the data required to support a COVID-19 vaccine EUA would be closer to those required for full licensure than for other products.
“It’s going to really be like an emergency use authorization-plus,” Marks said in September. “The substantial information about efficacy and the most important information regarding safety will be there.”
While FDA’s Vaccines and Related Biologics Products Advisory Committee (VRBPAC) overwhelmingly supported an EUA for the vaccine, most of the members who did not vote “yes” on the sole question posed to the committee have since explained that their objection was due to the inclusion of 16- and 17-year-olds and that they would have voted “yes” had the question been limited to adults 18 and older. (RELATED: Pfizer COVID vax gets thumbs up from FDA's VRBPAC, Regulatory Focus 10 December 2020).
Efficacy was high across all subgroups of the 44,000-participant Phase 3 randomized, double-blinded placebo-controlled trial. At the 14 November data cutoff for Pfizer’s EUA submission, vaccine efficacy in preventing confirmed COVID-19 cases was 95% overall at 7 days after the second dose. Even in older individuals who may have a blunted immune response to some vaccines, efficacy still topped 90% for most subgroups. (RELATED: VRBPAC to hear of high – and early – efficacy for Pfizer’s COVID vaccine, Regulatory Focus 8 December 2020).
Serious adverse events were generally rare and balanced between those receiving vaccine and the placebo arm. By contrast, both local and systemic reactions indicative of reactogenicity were common, especially in younger vaccine recipients. Systemic events were more common after the second vaccination, an observation in keeping with the second dose’s booster effect on the immune system.
Kari Oakes contributed reporting to this article.


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