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Coronavirus update: Pfizer vaccine emergency authorization imminent, first shots expected early next week

Following an advisory committee vote Thursday to recommend emergency use authorization (EUA) for Pfizer (PFE) and BioNTech’s (BNTX) COVID-19 vaccine, the U.S. Food and Drug Administration (FDA) is preparing to issue the EUA.

[Read more: FDA advisory committee recommends Pfizer/BioNTech vaccine authorization]

FDA Commissioner Stephen Hahn said Friday the agency has notified the companies of its intention to issue an EUA and alerted Operation Warp Speed officials and the U.S. Centers for Disease Control and Prevention (CDC) so they can prepare to deliver the vaccines as soon as the FDA gives the green light.

“FDA is finalizing the necessary documents to ensure that patients and providers have the information that they need to make informed decisions and to safely administer the vaccine. This is a critical part of what the agency does to promote and protect the public health,” Hahn said.

While many experts anticipated the green light to come anywhere between Friday night and Saturday, reports of pressure from the White House could affect public confidence in the approval. The Washington Post reported that President Donald Trump’s chief of staff told Hahn to approve the vaccine Friday or resign.

The time to authorize rests on finalizing details of who should receive the vaccine among specific sub-groups. Following reports of two allergic reactions in the U.K., which spurred a warning against vaccinating anyone with allergies, could result in a significant drop of qualified individuals.

Dr. Peter Hotez, a top vaccine expert and dean of the School of Tropical Medicine at Baylor College of Medicine, told Yahoo Finance Friday that he hopes the FDA can narrow down specific allergies.

“We’ve got so many people carrying EpiPens who have allergies. If they do what they did in the U.K., it would have a chilling effect. It would drop out a lot of people in the pool ... and the public perception would be damaging,” Hotez said.

In addition, the FDA must provide guidance on whether or not pregnant women should receive the vaccine. The agency has a lot to consider in a short period of time, Hotez noted.

A person walks past the Pfizer Headquarters building in the Manhattan borough of New York City, New York, U.S., December 7, 2020. Picture taken December 7, 2020. REUTERS/Carlo Allegri
A person walks past the Pfizer Headquarters building in the Manhattan borough of New York City, New York, U.S., December 7, 2020. Picture taken December 7, 2020. REUTERS/Carlo Allegri

U.S. Health and Human Services (HHS) Sec. Alex Azar told ABC’s Good Morning America Friday that the first shots could be delivered as early as Monday or Tuesday, indicating the EUA could come late Friday or over the weekend to allow time for shipments.

Hotez said he hopes shipments will begin ahead of the expected EUA so that vaccinations can begin the minute it is granted. “My recommendation would be to give the green light to ship out so they can have it all in place,” Hotez said.

The first group of recipients will be frontline health workers and nursing home residents and staff. Some health systems have scheduled vaccinations for their frontline workers for as early as Tuesday. Walgreens’ (WBA) chief medical officer told NBC’s Today Show nursing home vaccinations will begin on December 21.

The U.S. anticipates vaccinating 20 million individuals in December, including with Moderna’s (MRNA) vaccine, and 50 million by January. Moderna has its vaccine advisory committee next week, and is also likely to receive swift authorization.

Meanwhile, the world is watching and waiting.

“Any decision made now and in the near future by the FDA will have global effects, even though the FDA has no direct jurisdiction outside the U.S.,” said Dr. Noam Tau, a physician and researcher at Sheba Medical Center in Israel, noting that as soon as the FDA greenlights the vaccine, other countries are likely to follow suit and begin vaccinations.

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