FDA authorizes emergency use of COVID-19 vaccine

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CVS and Walgreens expect to administer COVID-19 vaccines to residents of long-term U.S. nursing homes on December 21.

WASHINGTON — The Food and Drug Administration on Friday authorized Pfizer’s coronavirus vaccine for emergency use, kicking off a massive effort to initially deliver nearly 3 million doses of the vaccine to more than 600 sites nationwide. The approval comes just a day after the FDA’s advisory panel voted 17-4 in favor of approving the vaccine.

Dr. Stephen Hahn

“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 United States and around the world,” said FDA Commissioner Dr. Stephen Hahn.

“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 emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide,” he added.

Shots for health workers and nursing home residents are expected to begin shortly after the authorized emergency rollout of what promises to be a strongly protective vaccine from Pfizer and BioNTech.

CVS Health and Walgreens expect to administer the first COVID-19 vaccines to residents of long-term U.S. nursing homes on December 21, executives at the companies said.

Walgreens noted that it plans to hire about 25,000 people across the U.S., including up to 9,000 pharmacists and other health care workers, to administer the vaccine to long-term care facilities through a partnership with pharmacy service provider PharMerica, the companies said at a LinkedIn panel discussion event  held Friday on the vaccine rollout.

Walgreens’ chief medical officer, Dr. Kevin Ban, said during the event that initial doses of the vaccine will be taken to on-site clinics at long-term care facilities staffed with Walgreens pharmacists, the number of which the company is still determining.

CVS chief executive officer Larry Merlo said the company has 10,000 health care professionals ready to administer the shots in nursing homes and assisted living centers.

The pandemic has also increased demand for the flu shot, a valuable tool that public health officials are reccommending to keep Americans healthy and reduce confusion between COVID-19 and the flu’s similar symptoms. CVS said it expects to administer 18 million flu shots this year — a big jump from the 11 million the chain administered last year.

The FDA said that the Pfizer-BioNTech COVID-19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The U.S. is considering a second vaccine, made by Moderna, that could roll out in another week. In early January, Johnson & Johnson expects to learn if its vaccine is working in final testing.

 


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