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Regulation

As U.S. joins U.K., Canada in authorizing BNT162b2 for COVID-19, all eyes turn to deployment 

Next up: Moderna

The decision by the U.S., U.K. and Canada marks a turning point in the most ambitious effort to apply science and technology to defeat an existential threat since World War II.

Dec 12, 2020 | 4:22 AM GMT

In a decision that marks a turning point in the most ambitious effort to apply science and technology to defeat an existential threat since World War II, FDA has joined regulatory agencies from the U.K. and Canada in authorizing use of a COVID-19 vaccine from BioNTech and Pfizer. 

It is the first emergency use authorization (EUA) for a COVID-19 vaccine in the U.S. and comes a week after the U.K. began to roll out BNT162b2 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX). Canada authorized the vaccine on Wednesday.

The vaccine is already in place to be deployed throughout the U.S.

Paul Mango, HHS deputy chief of staff for policy, described Operation Warp Speed’s distribution plans in a press briefing on Dec. 7. “We already have somewhere between six and eight million doses of the [Pfizer-BioNTech] vaccine ready to ship today as soon as the EUA is approved,” he said.

Following the authorization, controversy over the Trump administration’s management of pandemic countermeasures will shift from FDA’s reviews to Operation Warp Speed’s procurement and deployment strategies. One of the most consequential points of disagreement concerns Warp Speed’s decision to hold half of the U.S. vaccine supply in reserve to ensure the availability of the second dose of two-dose vaccine regimens.

Warp Speed has procured 100 million doses of BNT162b2.

Indeed, the vaccine’s success will depend not only on how well-thought-out the distribution is, but on how much governments and industry can learn on the fly to respond in real time to needs and data as they arise, BioCentury Editor in Chief C. Simone Fishburn wrote in an Editor’s Commentary.

95%

FDA briefing documents released ahead of Thursday’s meeting of the Vaccines and Related Biological Products Advisory Committee to discuss the vaccine as well as detailed results of Pfizer and BioNTech’s Phase III trial published in The New England Journal of Medicine this week underscored the strength of the efficacy signal of BNT162b2.

FDA’s analysis of data submitted by the partners show that the 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 said.

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.”

Committee concerns

The advisory committee meeting on Thursday could have been the culmination of a historic development program, but it failed to live up to its promise. If the meeting had been handled correctly, Dec. 10, 2020, would have been remembered as the day a jury of scientists and physicians publicly weighed the evidence, declared that a vaccine safely and effectively protects individuals against COVID-19, and reassured Americans about the integrity and quality of the vaccine’s development and review.

Instead, the public was left with no explanation for why four of the committee’s 22 voting members voted that the benefits of the BNT162b2 vaccine do not outweigh its risks for individuals 16 years of age and older, or why one member abstained.

Just as importantly, the 17 members who voted in favor were not given an opportunity to explain their votes. Many of them did not speak at all during the meeting — and those who did speak were often barely audible or forgot to unmute their microphones.  

The acting chairman of the committee, Arnold Monto, had said that he would give members an opportunity to explain their votes, which is a common practice at these meetings. Instead, Monto, a professor of public health and epidemiology at the University of Michigan School of Public Health, abruptly ended the meeting after the vote.

At least some “no” votes seemed to have been triggered by concerns that there were insufficient data to support use of the vaccine in individuals who are 16 and 17 years old.

Archana Chatterjee, who voted “no,” said that “among all the scientific data presented, the thinnest was for the 16- and 17-year-olds.” Chatterjee, a pediatrician, is dean of the Chicago Medical School at Rosalind Franklin University.

Following the meeting, Chatterjee said in a statement that she supports use of the vaccine in adults 18 and older. She added that “unfortunately there wasn’t an opportunity to explain my vote at the meeting. I considered voting to abstain, but thought it would be important for the FDA to make note of the concerns of those of us who noted ‘no’.”

Other “no” votes were cast by Michael Kurilla, director of the Division of Clinical Innovation at NIH’s National Center for Advancing Translational Sciences; A. Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School; and David Kim, director of the Division of Vaccines at the HHS Office of Infectious Disease and HIV/AIDS Policy. Kurilla, Fuller and Kim did not explain the reasons for their votes.

H. Cody Meissner, professor of pediatrics at Tufts University School of Medicine, abstained. Meissner also expressed concerns about the strength of the safety data in 16- and 17-year-olds.

Other advisory committee members who expressed concern about the paucity of data about 16- and 17-year olds, including Mark Sawyer, professor of clinical pediatrics at the University of California San Diego School of Medicine, voted “yes.”

One of the pediatricians on the committee, Paul Offit, said he believed concerns about 16- and 17-year-olds are not warranted. “We have seen certainly reports, as well as kids in the hospital, who have had cardiac anomalies as 16- and 17-year-olds,” Offit, professor of pediatrics at the Children’s Hospital of Philadelphia, said. “If you can prevent this disease safely and effectively, we have clear evidence of the benefit. All we have on the other side is theoretical risks.”

Pfizer and BioNTech plan to submit a BLA in April, Pfizer representatives said at the meeting.

In the end, FDA granted the emergency use authorization for those 16 years of age and older.

FDA officials said at the meeting that approval of a BLA for a COVID-19 vaccine would not automatically preclude the issuance of EUAs for other COVID-19 vaccines. EUAs could be granted if manufacturing capacity of approved vaccines was insufficient to meet demand or to a vaccine that protected a limited population that was not well-served by approved products.

Underlining the urgency of the meeting, Aron Hall, co-leader of CDC’s Epidemiology Task Force, told the committee that reports of the numbers of Americans infected with SARS-CoV2 underestimate the actual spread of the disease. CDC estimates that 52.9 million Americans have been infected and 44.8 million have fallen ill from COVID-19, he reported.

Next up: Moderna

Authorization of a second vaccine is likely to come quickly. Moderna’s mRNA-1273, which it developed with NIH, comes before FDA’s vaccines advisory panel on Dec. 17. 

On Friday, Moderna and the U.S. government announced that the U.S. exercised its option to purchase an additional 100 million doses of the vaccine. Moderna plans deliver about 20 million doses by year-end and an additional 80 million doses in 1Q21. The additional 100 million doses will be delivered in 2Q21, the company said.

In addition to commitments to the U.S. government, Moderna said it has contracts to supply 80 million doses to the European Union. The EU has an option for an additional 80 million doses. Other Moderna COVID-19 vaccine commitments include 50 million doses to Japan; 40 million doses to Canada and an option for an additional 16 million doses; 7.5 million to Switzerland; 7 million doses to the U.K.; and 6 million doses to Israel.

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