DCR Health & Policy:FDA authorizes the first coronavirus vaccine.☕☕☕

Ayyyeee… What’s Goodie Everyone. So I got some tea and It involves The coronavirus vaccine.

On Friday the Food and Drug Administration gave emergency use authorization to the nation’s first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed close to 300,000 Americans, devastated the nation’s economy.

The authorization of the vaccine from Pfizer and BioNTech for people age 16 and older, sets in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States to curb the pandemic.
December 11 at 9:45 PM EST
The FDA action came after White House Chief of Staff Mark Meadows on Friday told FDA commissioner Stephen Hahn to be prepared to submit his resignation if the agency did not clear the vaccine by day’s end, according to people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss what happened.

The FDA had planned to clear the vaccine Saturday morning, and accelerating the authorization to Friday night was not expected to change the delivery timeline of the first shots.

Federal officials said distribution of the first 2.9 million doses of the vaccine would begin within 24 hours of an authorization. Meanwhile, an advisory committee for the Centers for Disease Control and Prevention, which has recommended that healthcare workers and nursing home residents be the first recipients, was expected to bless the vaccine on Saturday, paving the way for inoculations to begin early next week.

Pfizer and its Germany based partner, BioNTech, created a fast, flexible genetic technology that had been in development for decades but never deployed in an approved medical product. It was used to build a vaccine that surpassed all expectations by being 95 percent effective at preventing disease in a clinical trial with tens of thousands of participants. The vaccine has already been approved in Britain, Canada, Saudia Arabia and Bahrain.

The FDA is working closely with the companies, conducted an accelerated review that compressed into three weeks the typical months long scrutiny of safety, effectiveness and data on manufacturing quality.
Operation Warp Speed, the administration’s effort to accelerate the development and distribution of coronavirus vaccines and treatments, has spent billions of dollars on a portfolio of vaccines, with Pfizer/BioNTech’s being the first to cross the finish line. Unlike the other companies, Pfizer and BioNTech did not take government money for research and development, but they did receive a $1billion contract for 100 million doses, about 25 million of which will be delivered this year.

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