Pfizer to File With FDA for Emergency Use of Vaccine, Moderna Soon to Follow

November 20, 2020 Updated: November 20, 2020

Health and Human Services Secretary Alex Azar said Thursday that Pfizer and its partner BioNTech would file for emergency use authorization of their experimental COVID-19 vaccine on Friday, and that he expects Moderna will soon follow with its candidate.

Pfizer confirmed in a press release that it and BioNTech will on Friday submit an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization of their vaccine candidate, called BNT162b2, a move that “will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.”

The experimental vaccine showed an efficacy rate of 95 percent and no serious safety concerns, Pfizer said.

“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine,” Pfizer Chief Executive Officer Albert Bourla said in a statement.

Besides seeking an emergency use nod in the United States, Pfizer and BioNTech have already applied for approval in Australia, Canada, Europe, Japan, and the UK, and plan to submit applications to other regulatory agencies around the world.

Moderna is expected to be the next company to petition the FDA for an emergency use authorization of its experimental COVID-19 vaccine. An initial analysis of data from its late-stage trial showed the vaccine was 94.5 percent effective, with final results and safety data expected in the coming days or weeks.

“Over the last two weeks, we’ve seen just unprecedented historic news about vaccines, two vaccines, each with 95 percent efficacy, rivaling the 98 percent efficacy of our measles vaccine,” Azar said at a briefing of the White House Coronavirus Task Force on Nov. 19.

He said the two vaccines were “produced in some of the largest vaccine clinical trials ever conducted in history, over 40,000 patients in each of these clinical trials, demonstrating good safety profiles.”

“This was done in 10 months, and now, Pfizer’s partner, BioNTech, has announced that tomorrow they intend to file for emergency use authorization at the FDA. We would expect to see Moderna filing soon also,” he added.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said at the task force briefing that the accelerated process of vaccine development did not cut corners on safety and sought to allay concerns people may have about taking the vaccines if they’re ultimately approved.

“The process of the speed did not compromise at all safety, nor did it compromise scientific integrity,” he said. “It was a reflection of the extraordinary scientific advances in these types of vaccines, which allowed us to do things in months that actually took years before.”

Fauci said an “independent body of people who have no allegiance to anyone, not to the administration, not to me, not to the companies, that looked at the data and deemed it to be sound,” adding that both the FDA and a vaccine advisory panel would evaluate the emergency use authorization application before giving it a final nod.

“So we need to put to rest any concept that this was rushed in an inappropriate way,” he said, adding, “this is really solid.”

Both the Pfizer/BioNTech and Moderna vaccines work using a new technology to trigger an immune response known as synthetic messenger RNA that can be produced at scale much more quickly than traditional vaccines.

Of dozens of drugmakers and research institutions racing to develop COVID-19 vaccines, the next late-stage data is expected to come from AstraZeneca, which is working with the University of Oxford, in November or December.

Johnson & Johnson said it expects to have data needed to seek U.S. authorization for its experimental vaccine by February.

Reuters contributed to this report.

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