The U.S. Food and Drug Administration (FDA) granted full approval of the two-dose Pfizer-BioNTechCovid-19 vaccine in August for those age 16 and older. The Pfizer vaccine and other brands had previously been available under “emergency-use authorization,” which provides access to medical products during public health emergencies.
The FDA’s approval is based on months of clinical data that found the vaccine was 91% effective in preventing Covid-19. Hundreds of millions of doses of Pfizer’s vaccine have been administered in the U.S. since December 2020, when it received emergency-use authorization from the FDA.
“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires,” said Acting FDA Commissioner, Dr. Janet Woodcock. “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”
The vaccine will now be marketed under the name Comirnaty. It will continue to be available to those ages 12 to 15 years old under emergency-use authorization, the FDA said.
Source: Crain’s New York Business