CDC Panel Supports Full Pfizer Shot Approval

CDC Panel Supports Full Pfizer Shot Approval

Roberto Ortega, 16, awaits the Pfizer COVID-19 vaccine administered by registered nurse Amy Berez-Ortega of Ultamed Health Services on August 17, 2021 in Los Angeles, California.

Frederick J. Brown | AFP | Getty Images

On Monday, a major advisory group from the Centers for Disease Control and Prevention unanimously supported full approval of Pfizer and BioNTech’s COVID-19 vaccine for Americans 16 and older.

The approval by the agency’s advisory committee on immunization practices comes a week after the Food and Drug Administration gave full approval to the shot. The approval – the first in the United States to earn the coveted designation – has inspired a new wave of vaccine mandates from private companies and schools across the country.

While the recommendation is not binding, CDC director Dr Rochelle Valensky is expected to accept panel support soon.

Prior to full approval, the mRNA vaccine, which is marketed as Comirnati, was on the US market under emergency use authorization that was granted by the FDA in December. Since then, more than 209 million shots of Pfizer have been administered, according to data compiled by the CDC.

The vaccine for children aged 12 to 15 is still being submitted to the EUA as the company collects more data. The FDA’s main vaccine regulator, Dr Peter Marks, said last week that the agency would “speed up” the approval of the vaccine for children under 12 after the company submitted data.

Pfizer and BioNTech are also asking federal regulators to approve a third dose as a booster shot for all eligible Americans as the vaccine’s effectiveness wanes. President Joe Biden said on Friday that U.S. regulators were considering giving people Covid booster shots five months after completing their primary vaccinations.

The CDC advisory group is expected to discuss the need for booster shots on Monday. The slide meeting released prior to a presentation said that the data needed to properly assess booster injections for the general population is currently limited.



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