HomeHealthUS drug authority gives full approval to Pfizer-BioNTech COVID-19 vaccine

US drug authority gives full approval to Pfizer-BioNTech COVID-19 vaccine


The US Food and Drug Administration (FDA) gave full approval to the Pfizer-BioNTech’s COVID-19 vaccine on Monday, nine months after it rolled off assembly lines under a special emergency use authorization.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said acting Commissioner Janet Woodcock in a statement. “The public can be very confident that this can meet the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”

The FDA said it did clinical trials on around 40,000 people to test the effectiveness of the vaccine, and concluded it was 91% effective in preventing COVID-19 infection.

The approval was widely expected, and could lead to more workplaces, universities, restaurants, gyms, and entertainment venues requiring full vaccination – a step many public health experts see as key in more effectively battling the virus.

US Surgeon General Vivek Murthy told Fox News on Sunday that he hoped full approval would also convince more hesitant people to get the shot.

Additionally, as the FDA continues to look at also granting full approval of the Moderna and Johnson & Johnson vaccines, US agencies are poised to begin rolling out vaccine booster shots, starting on Sept. 20.

US health officials said last week that it is “very clear” vaccine immunity from the virus starts to drop about six months after an individual receives their second dose of the Pfizer and Moderna jabs.





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