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US allows emergency use of Pfizer’s vaccine to end Covid-19 pandemic

BI Report || BusinessInsider

Published: 18:26, 12 December 2020  
US allows emergency use of Pfizer’s vaccine to end Covid-19 pandemic

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Dhaka (Dec 12, 2020): The US on Friday gave the final go-ahead to the emergency use of Pfizer’s vaccine to end the pandemic of coronavirus that claimed around 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 authorised an emergency rollout of the strongly protective vaccine from Pfizer Inc. and its German partner BioNTech, UNB reports quoting AP.

Initial doses are scarce and rationed as the US 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 world desperately needs multiple vaccines for enough to go around, and the Pfizer-BioNTech shot is the first based on rigorous scientific testing to emerge from that worldwide race -- a record-setting scientific achievement that shaved years off the usual process.

“I don’t think you would have found a scientist on this planet that would have predicted this 11 months ago,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia who advises the FDA.

The US 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.

And China and Russia didn’t wait for final-stage tests before beginning vaccinations with some homegrown shots.

About 3 million doses of the Pfizer-BioNTech 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.

A Center for Disease Control and Prevention advisory committee is poised to recommend who’s first in line.

Expected to follow health workers and nursing homes are other essential workers, older adults and people at high risk because of other health problems.

The US authorities don’t expect enough for the general population before spring, and that’s assuming there are no manufacturing glitches.

In a still unfinished study of nearly 44,000 people, the FDA found the vaccine was safe and more than 90 percent effective across recipients of different ages, including older adults, races and those with health problems that put them at high risk from the coronavirus.

Emergency use means the vaccine still is experimental. Most important for would-be recipients to know:

Nagad
Walton