Thursday, April 22, 2021

US Advisory Board Approves Pfizer-BioNTech COVID-19 Vaccine | United States and Canada

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The critical decision opens the door for the United States Food and Drug Administration to officially approve the COVID-19 vaccine.

A United States government advisory committee has approved the Pfizer-BioNTech COVID-19 vaccine, a critical step toward final approval of the vaccine for possible distribution across the country.

On Thursday evening, a panel of external advisers from the U.S. Food and Drug Administration (FDA) voted 17 to 4 in favor of the vaccine, with one abstention, deciding that its benefits outweigh the risks for use by patients. people aged 16 and over.

The FDA is expected to authorize distribution of the vaccine in the coming days.

This means that millions of doses of the vaccine could soon be distributed in the United States, which has the highest number of COVID-19 infections and deaths from the novel coronavirus in the world.

“The Americans want us to do a scientific review, but I think they also want us to make sure we don’t waste time on paperwork rather than going ahead with the decision,” the commissioner said. of the FDA, Stephen Hahn, before the meeting.

The UK and Canada have already cleared the Pfizer-BioNTech vaccine, with the first doses being given in the UK earlier this week. Canada has said the vaccines will be ready for administration as of next Monday.

The United States has recorded more than 15.5 million cases of COVID-19 since the start of the pandemic, according to a count from Johns Hopkins University, and more than 291,000 deaths have been reported.

The country has seen a recent surge in COVID-19 cases as colder weather pushes people indoors, where the virus can more easily spread.

Hospitals have been overwhelmed and local authorities in several US states have instituted lockdowns to stem the spread of infections. Many are hoping that the distribution of an approved vaccine can bring the pandemic under control.

Citing people familiar with the FDA’s planning, The New York Times reported on Thursday that the agency planned to issue emergency use authorization for the Pfizer-BioNTech vaccine on Saturday.

The agency will begin with an initial shipment of 6.4 million doses, the US newspaper reported, citing federal officials, who said those doses would leave warehouses within 24 hours of FDA clearance.

Initial supplies are expected to be reserved for healthcare workers and nursing home residents, with other vulnerable U.S. citizens lining up to receive the vaccines.



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