CDC panel advocates full approval of Pfizer Shot
Roberto Ortega, 16, awaits the Pfizer Covid-19 vaccine to be administered by Amy Berecz-Ortega of AltaMed Health Services in Los Angeles, California on August 17, 2021.
Frederic J. Brown | AFP | Getty Images
A key advisory group at the Centers for Disease Control and Prevention unanimously approved the full approval of Pfizer and BioNTech’s Covid-19 vaccine for Americans 16 and older on Monday.
Approval by the Agency’s Advisory Committee on Immunization Practices comes one week after the Food and Drug Administration issues full approval of the vaccination. The approval – the first in the United States to receive the coveted award – sparked a new wave of vaccine mandates from private companies and schools across the country.
Although the recommendation is not binding, CDC Director Dr. Rochelle Walensky is expected to accept the panel’s approval shortly.
Prior to full approval, the mRNA vaccine marketed as Comirnaty was on the US market under emergency approval granted by the FDA in December. Since then, more than 209 million Pfizer shots have been administered, according to the CDC.
The vaccine is still subject to an EEA for children aged 12-15 as the company collects more data. Dr. Peter Marks, the FDA’s top vaccine regulator, said last week that the agency would approve vaccination for children under the age of 12 as “soon” as possible once the company provides the data.
Pfizer and BioNTech are also calling on federal regulators to approve a third dose of a booster dose for any eligible Americans as the vaccine becomes less effective. President Joe Biden said Friday that U.S. regulators are considering giving Covid booster vaccinations five months after the basic immunizations are completed.
The CDC advisory group is expected to discuss the need for booster injections later Monday. Slides released prior to a presentation of the meeting stated that the data needed to properly evaluate booster vaccinations for the general population are currently limited.