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F.D.A. clears Pfizer Covid-19 Vaccine and millions of doses begin shipping

The US green lighted the Pfizer-BioNTech Covid-19 vaccine late Friday, paving the way for millions of vulnerable people to receive their shots in the world’s hardest-hit country.

President Donald Trump immediately released a video on Twitter, where he hailed the news as a “medical miracle” and said the first immunizations would take place “in less than 24 hours.”

It comes as infections across America soar as never before, with the grim milestone of 300,000 confirmed deaths fast approaching.

The F.D.A.’s decision followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the F.D.A. commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day.

The authorization set off a complicated coordination effort from Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to get the first week’s batch of about three million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures.

Pfizer has a deal with the U.S. government to supply 100 million doses of the vaccine by next March. Under that agreement, the shots will be free to the public.

The government also said Friday that it is buying 100m more doses of the Moderna vaccine candidate, amid reports the government passed on the opportunity to secure more supply of the Pfizer jab. The purchase brings its total supply of Moderna doses to 200m, enough to immunise 100m people with the two-shot regimen that could be approved as early as next week.

Both frontrunners are based on mRNA (messenger ribonucleic acid), a major victory for a technology that had never previously been proven.

Two other vaccine candidates stumbled Friday: France’s Sanofi and Britain’s GSK said their vaccine would not be ready until the end of 2021.

 

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