FDA Vows Fast Pfizer Vaccine Action Amid Political Pressure

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The U.S. Food and Drug Administration said it’s working toward rapid emergency-use authorization ofPfizer Inc.’s Covid-19 vaccine that wasbacked Thursday by a panel of agency advisers.

The drug regulator has “notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” the FDA said Friday in astatement.

The FDA statement comes as the agency is under tremendous political pressure from President Donald Trump and his administration to clear the vaccine, which has already been approved by the U.K. and Canada. Weary Americans are also eager for an end to a pandemic that has killed nearly 300,000 and dealt a crippling blow to the economy.

Trump in a Friday tweet called the FDA “a big, old, slow turtle,” and demanded Stephen Hahn, the agency’s director, “get the dam vaccines out NOW.”

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Donald J. Trump

@realDonaldTrump

While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!1:11 PM · Dec 11, 2020

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Alex Azar, the Health and Human Services Secretary, said in an interview with ABC that the FDA will soon clear the vaccine, and Americans may start getting shots as quickly asMonday. He tweeted that Pfizer has already been advised that the authorization was coming.

Pfizer rose 1.7% in trading before U.S. markets opened. American depositary receipts of BioNTech SE, Pfizer’s partner in developing the shot, gained 0.8%.

On Thursday, an FDA advisory panel voted 17 to 4, with one abstention, in favor of authorizing the vaccine, which was shown to be 95% effective in a large clinical trial. While, if often follows the panel’s recommendations, the agency itself has final say in whether to grant the authorization.

Part of the panel’s discussion focused on whether there was enough data to support the vaccine’s use in 16 and 17 year olds, leaving some pediatricians on the advisory committee uncomfortable with voting in its favor. However, other members said data from older trial participants could be extrapolated to younger people.

A formal go-ahead from the FDA would set in motion a nationwide distribution effort, starting with 2.9 million doses being made available to states.

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