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Pfizer’s potential Covid-19 vaccine is a "medical home run -- maybe a Grand Slam," says FDA commissioner

November 20, 2020. Summarized by summa-bot.

The data Pfizer and BioNTech have released so far on their Covid-19 vaccine candidate “are really exciting and give us great hope,” US Food and Drug Administration Commissioner Dr. Stephen Hahn said Thursday.

The data Pfizer and BioNTech have released so far on their Covid-19 vaccine candidate “are really exciting and give us great hope,” US Food and Drug Administration Commissioner Dr. Stephen Hahn said Thursday.

The companies said this week the data from the clinical trials show the potential coronavirus vaccine is 95% effective in preventing disease and that they plan to file for an emergency use authorization from the FDA on Friday.

Hahn said the agency needs to see the raw data on the vaccine.

“So what will be submitted to us is raw data around the clinical trial that would support a claim for safety and effectiveness of the vaccine, which of course is our primary responsibility here, with an emergency use authorization or an outright approval,” he said.

After the FDA receives the application, Hahn said the agency will set a date for a meeting of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC.

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