FDA says it will work "rapidly" to issue emergency use authorization for Pfizer's COVID-19 vaccine
The U.S. Food and and Drug Administration said Friday it would work quickly to authorize Pfizer's COVID-19 vaccine for emergency use after an advisory panel voted in favor of it. But despite the FDA's promise to act in short order, White House chief of staff Mark Meadows called FDA Commissioner Dr. Stephen Hahn Friday and told him to approve the Pfizer vaccine or consider resigning, according to a senior administration official.
Hahn responded to reports about this by Washington Post and others and said in a statement, "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."
Hahn and Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement earlier Friday, "Following yesterday's positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization."
"The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution," they said.
An expert panel voted Thursday 17 to 4 in favor of recommending the drug for emergency use for people aged 16 years and older, with one of the members withholding. Once emergency use is approved by the FDA, a massive effort will kick off to get nearly 3 million doses of the vaccine to hospitals and drug stores across the country.
"We should be seeing the authorization of this first vaccine" in "the next couple of days," Health and Human Services Secretary Alex Azar said Friday on "Good Morning America."
"We could be seeing people getting vaccinated Monday, Tuesday of next week."
The nation is in the midst of a surge that is pushing hospitals and staff in some parts of the country to their limits. Over 290,000 people in the U.S. have died because of the disease, and more than 224,000 new cases were nationwide on Thursday — the second-highest number of infections reported in a single day since the start of the pandemic.
President Trump urged Hahn on Friday to move forward with the approval, tweeting: "Stop playing games and start saving lives!!!" and "Get the dam vaccines out NOW."
