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FDA gives Pfizer coronavirus vaccine green light, Americans could get first shot as early as Monday

The emergency use authorization comes at a time when over 294,000 have died in the Covid-19 pandemic in the US

The US Food and Drug Administration (FDA) authorized Pfizer-BioNTech Covid-19 vaccine for emergency use on December 11, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days. The agency’s chief scientist Dr Denise Hinton told Pfizer in a letter on December 11 that she was authorizing the emergency use of the company’s vaccine.

"I have concluded that it is reasonable to believe that the known and potential benefits of Pfizer-BioNTech Covid‑19 Vaccine, when used to prevent Covid-19 and used in accordance with this Scope of Authorization, outweigh its known and potential risks. Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech Covid‑19 vaccine for the prevention of Covid-19,” it said. 

The vaccine can be given to people aged 16 and older. "The vaccine covered by this authorization will be administered by vaccination providers and used only to prevent Covid in individuals ages 16 and older; and Pfizer-BioNTech Covid-19 vaccine may be administered by a vaccination provider without an individual prescription for each vaccine recipient,” the letter stipulates.

The green light comes at a time when over 294,000 Americans have died in the Covid-19 pandemic and more than 15,834,960 cases have been reported from across the US. 

The FDA’s emergency use authorization (EUA) will now kickstart the federal government’s distribution of the potentially lifesaving doses to states and territories across the nation. Officials from Operation Warp Speed, the federal government’s vaccine distribution program, have said they will start shipping the vaccine to distribution sites across the US within 24 hours of FDA authorization. The government plans to distribute 2.9M doses of the vaccine within 24 hours, followed by an additional 2.9M doses 21 days later for patients to get their second dose. 

While the EUA allows shipping to begin, the vaccines cannot be administered until the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) recommends that the vaccine be deployed for use. The ACIP had a meeting scheduled for December 11 and expects to vote during another meeting that is scheduled for December 13.

Based on ACIP recommendations, the CDC had earlier issued guidelines that call for prioritizing healthcare workers and residents of long-term care facilities to get the vaccine first, but states can distribute the vaccine as they see fit.

Alex M Azar, Secretary for the Department of Health and Human Services (HHS), also informed on Friday, December 11, that the first Americans outside clinical trials could begin on Monday, December 14, or Tuesday, December 15. He told ABC’s 'Good Morning America' on December 11 that the FDA would work with Pfizer to get the vaccine shipped “so we could be seeing people get vaccinated Monday, Tuesday of next week". 

Azar had previously emphasized that "based on current production schedules, we expect to have enough doses to vaccinate 20 million Americans by the end of this year, 50 million total by the end of January, and at least 100 million total by the end of the first quarter.”

The decision followed reports claiming that White House Chief of Staff Mark Meadows told Dr Stephen M Hahn, FDA commissioner, to authorize Pfizer-BioNTech’s coronavirus vaccine on Friday, December 11, or submit his resignation. The two men had a call on Friday, according to a senior administration official. The warning from Meadows allegedly led the FDA to speed up its timetable for clearing America’s first Covid-19 vaccine from December 12 to December 11, according to the Post, which cited anonymous sources. 

A senior administration official told Reuters that Meadows’ comment about resigning "wasn’t a red line", but was more of a quip to urge the "FDA to act quickly and get the job done and stop the delays". A White House official said they do not comment on private conversations, but the "chief regularly requests updates on progress toward a vaccine". 

US President Donald Trump also tweeted directly at Hahn on Friday, complaining that FDA “is still a big, old, slow turtle". “Get the dam vaccines out NOW, Dr Hahn,” Trump said.

Dr Hahn disputed the description of the conversation, but the reports are likely to raise more questions about the extent to which the Trump administration is putting political pressure on the FDA to expedite its emergency use authorization of a coronavirus vaccine, and may also undermine Americans’ confidence in the effort. 

"This is an untrue representation of the phone call with the Chief of Staff. 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," said Hahn.

On December 10, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the agency grant EUA to Pfizer’s vaccine. In a statement issued on December 11, Dr Hahn had noted: "Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech Covid-19 vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the US Centers for Disease Control and Prevention (CDC) and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.” It was Peter Marks, director of the Center for Biologics Evaluation and Research, which reviews vaccines. 

The Pfizer vaccine was 95% effective in preventing coronavirus among clinical trial participants with eight Covid-19 cases in the vaccine group and 162 in the placebo group. Following the EUA, Dr Hahn issued a statement: "The FDA’s authorization for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the US and around the world." He emphasized, "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 EUA."