U.S. FDA authorizes Pfizer COVID-19 vaccine for emergency use


© Reuters. Handout photos of preparation for COVID-19 vaccine


By Ankur Banerjee and Susan Heavey

(Reuters) – The U.S. Food and Drug Administration said on Friday it was working rapidly to issue an emergency use authorization (EUA) for Pfizer Inc (NYSE:)’s COVID-19 vaccine, with the green light coming possibly as soon as Friday evening, according to the New York Times.

The newspaper reported on Friday that the FDA is likely to issue the EUA by Friday evening, citing people familiar with the agency’s planning. It had reported on Thursday night that the FDA would announce the news on Saturday.

Swift clearance of the vaccine was widely expected after a panel of expert advisers to the FDA on Thursday endorsed its emergency use to help stem a pandemic that has killed more than 285,000 people in the United States.

The decision will set the stage for the first Americans to be immunized outside of clinical trials as soon as Monday or Tuesday, with healthcare workers expected to be among the first in line.

Pfizer has asked that the vaccine, developed with German partner BioNTech SE (NASDAQ:), be approved for use in people aged 16 to 85. A Pfizer spokeswoman said the company cannot speculate on when the emergency use authorization will come.

The companies last month said that a two-dose regimen of the vaccine was 95% effective in preventing illness from COVID-19.

Detailed data released in FDA documents ahead of the advisory panel meeting showed the vaccine began protecting recipients even before they received a second dose.

The UK approved the Pfizer/BioNTech vaccine last week and began a mass immunization program on Tuesday. Canada has also authorized the vaccine with inoculations expected to begin next week.

The FDA has notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed officials so that they can execute their plans for timely vaccine distribution, it said in a statement. (https://

In addition to healthcare workers, first responders and nursing home residents are expected to receive the first doses, but a wider rollout faces significant logistical challenges, given its need to be stored and transported in special ultra-cold freezers or on dry ice.

CVS Health Corp (NYSE:) and Walgreens Boots Alliance (NASDAQ:) Inc said they expect to administer the first Pfizer Inc COVID-19 vaccines to residents of long term care facilities on Dec. 21.

Another 2,902 U.S. deaths were reported on Thursday, a day after a record 3,253 people died from COVID-19, a pace projected to continue for the next two to three months until the vaccine can be widely distributed.

U.S. Department of Health and Human Services Secretary Alex Azar, which oversees the FDA, told ABC News that regulatory authorization should come within days and the federal government would work with the company to get the vaccine shipped out.

For months, U.S. President Donald Trump had pressured the FDA in tweets and news conferences to move more quickly, accusing staff and Pfizer of dragging their feet.

Shortly after the FDA’s statement, the outgoing president criticized the agency for what he said was its slow handling of the vaccines and FDA Commissioner Steven Hahn via tweet.

Trump said his “pushing” the agency had sped up new vaccine approval, but that the FDA was “still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!”

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