FDA Advances Toward Covid-19 Vaccine Authorization

The U.S. Food and Drug Administration said it was finalizing the work needed to clear…

The U.S. Food and Drug Administration said it was finalizing the work needed to clear a Covid-19 vaccine developed by

Pfizer Inc.

and German partner

BioNTech SE,

after the injection was endorsed by an expert panel.

“We could see people getting vaccinated Monday, Tuesday of next week,” Health and Human Services Secretary

Alex Azar

said on ABC’s “Good Morning America.”

Because of limited supplies, the first doses are expected to go to health workers treating Covid-19 patients and nursing-home residents.

In its vote to endorse the Pfizer and BioNTech Covid-19 vaccine, the Food and Drug Administration advisory panel said the benefits of the vaccine outweigh the risks for people 16 years of age and older. Photo: Daniel Acker/Bloomberg News

More shots will become available to more Americans, starting with people such as essential workers, as vaccine production increases. Yet most Americans won’t get vaccinated until spring or summer, according to health authorities.

Supplies won’t be sufficient to make a serious difference in the coronavirus pandemic this winter, said BioNTech Chief Executive

Ugur Sahin.

BioNTech and Pfizer are scaling up production with the aim of being able to produce up to 100 million doses by January at the latest, he said.

“Ideally, we should be able to produce even more than that,” Dr. Sahin said in an interview.

FDA Commissioner

Stephen Hahn

and

Peter Marks,

director of the FDA’s center for biologics, said they had told the drugmakers and the government’s Operation Warp Speed of the agency’s efforts.

The agency “will rapidly work toward finalization and issuance of an emergency use authorization,” the officials said.

They issued their statement after President Trump criticized the pace of the agency’s review on Twitter, saying the FDA was “a big, old, slow turtle” and urging Dr. Hahn to clear the vaccine immediately.

White House chief of staff Mark Meadows told Dr. Hahn in a phone call Friday that he would need to look for a new job if the FDA didn’t authorize the vaccine by the end of the day, according to a senior administration official, prompting the FDA to speed up its plans.

Dr. Hahn, in a statement, denied that his job was threatened on the call, which was earlier reported by the Washington Post.

“This is an untrue representation of the phone call with the Chief of Staff,” Dr. Hahn said. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”

Vaccines normally take years to develop and months to review. The launch of the Pfizer-BioNTech vaccine would happen in less than a year, a record time.

Given the urgent need, the FDA conducted a faster review of the shot than it normally does. The result will be the agency issuing an authorization for emergency use, rather than the typical approval.

The FDA has issued several emergency-use authorizations for drugs during the pandemic. Its emergency-use authorization of the Pfizer-BioNTech vaccine is expected to become final Friday or over the weekend.

The Pfizer-BioNTech vaccine was 95% effective and generally well-tolerated in a 44,000-person late-stage trial. On Thursday, a panel of independent medical advisers recommended that the FDA clear the inoculation for wide use.

In the U.S., the first recipients are slated to be hospital and first-line medical workers, as well as residents of nursing homes. Federal officials have said the distribution is expected to commence within 24 hours of a final FDA decision.

The Pfizer-BioNTech vaccine has already been cleared by regulators in the U.K. and Canada. After two health workers in the U.K. developed allergic reactions, the country’s health authorities warned that people who have a history of serious allergic reactions shouldn’t get inoculated.

Also on Friday, the U.S. government exercised an option to purchase an additional 100 million doses of

Moderna Inc.’s

Covid-19 vaccine, doubling the contracted supply to 200 million doses by the end of June 2021 if the shot is authorized, the government and the company said.

Pfizer offered over the summer to provide more doses than the initial 100 million, but federal officials declined. The company and the government are now discussing a deal for an additional supply.

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Moderna has also requested FDA authorization of its Covid-19 vaccine. An FDA decision may come in about a week. In August, the federal government agreed to buy 100 million doses from Moderna for $1.5 billion, with options to buy more.

Both the Pfizer and Moderna vaccines are given in two doses per person, three or four weeks apart.

Moderna said it expects to supply about 20 million doses to the U.S. by the end of December, and the rest of the initial 100 million by the end of March. It plans to deliver the new supply of an additional 100 million doses by the end of June, subject to government authorization.

The government has options to purchase an additional 300 million doses of Moderna’s vaccine.

Write to Thomas M. Burton at [email protected] and Bojan Pancevski at [email protected]

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