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 will work quickly to authorize Pfizer’s COVID-19 vaccine for emergency use after an advisory panel voted in favor of it.

“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,” FDA Commissioner Stephen Hahn and Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

“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.”  

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