Pfizer, BioNTech ask FDA for emergency approval of coronavirus vaccine.

Pfizer and BioNTech on Friday said they are submitting an application to the Food and Drug Administration for emergency approval of their coronavirus vaccine, days after the companies released new study data showing their shot to be 95% effective in preventing COVID-19.

Their application sets in motion a regulatory review that, if positive, could clear the shot for initial use by the middle to end of next month, Pfizer and BioNTech said. The FDA said later on Friday that it will convene an advisory committee hearing on Dec. 10 to publicly vet the data supporting the vaccine.

Pfizer and BioNTech's vaccine is the first coronavirus shot to reach this point, a milestone in drugmakers' race to design and develop a preventive treatment in record time. Moderna, which also recently said its vaccine was highly effective in protecting against COVID-19, could soon follow with an application of its own.

Pfizer and BioNTech's application begins one of the most consequential reviews in the FDA's history.

While the strongly positive results supporting the companies' vaccine will make the agency's job easier, the regulator will still need to carefully review the data and ensure the shot is sufficiently safe to make available for use in first millions, and then likely tens of millions, of Americans.

The FDA will also need to vet the processes Pfizer and BioNTech use to manufacture their vaccine, checking whether they can reliably make consistent, uncontaminated batches of the shot.

Peter Marks, head of the FDA division that reviews vaccines, last month said he expects emergency use applications to run into the hundreds, or even thousands, of pages — details the agency must verify and validate.

Although the agency will be moving urgently, the review is still likely to take several weeks. The advisory committee meeting on Dec. 10 will be a key moment, both to vet the data and to build public confidence around the FDA's eventual decision on approval.

So far, Pfizer and BioNTech have only released limited results from their large clinical trial, which began in July and enrolled nearly 44,000 volunteers. The coronavirus' surging spread in the U.S. brought the study quickly to its conclusion, which the companies announced was reached in mid-November.

One hundred and sixty-two participants who received a placebo got sick with COVID-19, compared to only eight of those who were vaccinated in the trial — a case split that translates to 95% efficacy in protecting against COVID-19. That number is well above the 50% efficacy threshold the FDA set as a minimum bar for approval back in June, and was well above expectations.

Importantly, vaccination seemed to protect older adults as well as younger people, a critical characteristic given the deadliness of COVID-19 in elderly individuals.

Results also showed the vaccine was generally well tolerated, with no significant safety concerns reported to date. On Friday, Pfizer and BioNTech said their application would include data on side effects from 38,000 trial participants who had been followed for a median of two months — meeting a requirement set by the FDA for emergency use authorizations.

The companies are also submitting information from about 8,000 individuals on side effects that they specifically asked participants about.

Should the FDA approve Pfizer and BioNTech's vaccine for emergency use, the shot would be given first to higher-risk individuals, according to plans drafted by health advisory groups in the U.S. Supplies would be extremely limited initially, with only about 25 million doses available this year. The vaccine is given over two doses.

Pfizer and BioNTech expect they can produce as many as 1.3 billion doses next year.

In addition to the FDA, health regulators in the EU and the U.K. have already begun rolling reviews of Pfizer and BioNTech's vaccine. The companies plan to submit applications in other countries "in the coming days."

While this is the first vaccine to be reviewed by the FDA, the agency has authorized several COVID-19 treatments, most recently Eli Lilly's arthritis drug Olumiant, which was tested in combination with Gilead's approved drug Veklury.

Editor's note: This article was updated to reflect the FDA's scheduling of an advisory committee meeting on Pfizer and BioNTech's vaccine for Dec. 10.

Author:Ned Pagliarulo

Published: https://www.biopharmadive.com/news/pfizer-biontech-apply-fda-emergency-approval/589471/