US Allows Emergency COVID-19 Vaccine in Bid to End Pandemic

By LAURAN NEERGAARD, MATTHEW PERRONE and JONATHAN LEMIRE

FILE - This May 4, 2020, file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. On Monday, Nov. 9, 2020, Pfizer said an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19. (Courtesy of University of Maryland School of Medicine via AP, File)

WASHINGTON (AP) — The U.S. gave the final go-ahead Friday to the nation’s first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.

Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.

Initial doses are scarce and rationed as the U.S. joins Britain and several other countries in scrambling to vaccinate as many people as possible ahead of a long, grim winter. It will take months of work to tamp down the coronavirus that has surged to catastrophic levels in recent weeks and already claimed 1.5 million lives globally.

While the FDA decision came only after public review of data from a huge ongoing study, it has also been dogged by intense political pressure from the Trump administration, which has accused the agency of being too slow and even threatened to remove FDA chief Stephen Hahn if a ruling did not come Friday.

The move sets off what will be the largest vaccination campaign in U.S. history — but it also has global ramifications because it’s a role model to many other countries facing the same decision.

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

Europe is set to make its own decision on the Pfizer-BioNTech and Moderna shots later this month, an important step as some other candidates that multiple countries were anxiously awaiting have hit roadblocks. Friday, Sanofi and GSK announced a months-long delay after early tests showed their vaccine didn’t work well enough in older adults.

About 3 million doses of the vaccine are expected in the first shipments around the country, according to officials with Operation Warp Speed, the Trump administration’s vaccine development program. A similar amount is to be held in reserve for those recipients’ second dose.
If emergency use of Moderna’s vaccine also is authorized, the U.S. expects to vaccinate 20 million people by the end of December. They hope to have enough for another 30 million people in January and 50 million in February.

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