FDA Clears Pfizer Vaccine for emergency use in USA

USA: The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use recently, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days.

The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.

The FDA’s decision followed an extraordinary sequence of events recently when the White House chief of staff, Mark Meadows, told the FDA commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done 11 Dec 2020, 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 US government to supply 100 million doses of the vaccine by next March. Under that agreement, the shots will be free to the public.

Every state, along with six major cities, has submitted to the federal government a list of locations — mostly hospitals — where the Pfizer vaccine is to ship initially. In populous Florida, the first recipients will be five hospitals, in Jacksonville, Miami, Orlando, Tampa and Hollywood. In tiny, rural Vermont, only the University of Vermont Medical Center and a state warehouse will get supplies.

How Many Vaccine Doses Will Your State Get?

The New York Times surveyed all 50 states for their estimates of coronavirus vaccine doses they expect to receive before the end of the year.

McKesson Corporation, a giant medical supplier, is sending kits of syringes, alcohol pads, face shields and other supplies to the same sites, where they will meet up with the vaccines that Pfizer is shipping in special boxes, packed with dry ice, designed to keep them at minus 94 degrees Fahrenheit.

The Pfizer packaging will include a device that tracks the location of the box, plus a thermal probe that will make sure the deep freeze is maintained throughout the journey from the company’s distribution sites in Michigan and Wisconsin.

The decision is a victory for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago. Vaccines typically take years to develop. The companies’ late-stage clinical trial, which enrolled nearly 44,000 people, was found to be 95 percent effective.

An expert panel advising the FDA on Thursday gave its approval of Pfizer’s vaccine for people 16 and older, and the agency was planning to release the formal authorization on Saturday. That timeline was accelerated by half a day after President Trump attacked Dr. Hahn for failing to authorize a vaccine more quickly. But the accelerated announcement was not expected to speed up the delivery of vaccines around the country.

Mr. Trump told Dr. Hahn on Twitter on Friday morning to “stop playing games and start saving lives!!!” He called the FDA “a big, old, slow turtle,” flush with funds but mired in bureaucracy.

Mr. Trump has repeatedly accused the FDA and the drugmakers themselves of slow-walking the approval process in order to harm him politically. Allies of Dr Hahn have been on tenterhooks for weeks, expecting him to be fired any day.

The president wrote that with “my pushing,” the administration had shaved years off the development of vaccines. “Get the dam vaccines out NOW, Dr Hahn,” he wrote, misspelling the expletive.

-Courtesy by New York Times