U.S. FDA Authorizes Pfizer-BioNTech COVID-19 Booster Dose for Emergency Use for 16- and 17-Year-Olds

The United States Food and Drug Administration (FDA) on Dec. 9 granted emergency use authorization for the Pfizer-BioNTech COVID-19 booster dose for people aged 16 and 17 years.

The Pfizer-BioNTech COVID-19 booster dose will now be available to about 2.6 million U.S. 16- and 17-year-olds at least six months after they received their second dose of the primary series with the same vaccine.

“Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group. A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups,” FDA Center for Biologics Evaluation and Research Director Peter Marks said.

Pfizer Chairman and Chief Executive Albert Bourla called the authorization “a critical milestone.”

“While new variants, including Omicron, emerge across the globe, we believe that the best way to minimize the spread of COVID-19 and any future variants is getting all eligible people fully vaccinated with the first two-dose series and a booster dose as recommended,” Bourla said.

A few hours later, Centers for Disease Control and Prevention Director Dr. Rochelle Walensky gave the final approval for the booster dose.

According to Walensky, initial data suggested that COVID-19 booster shots increases protection against the Omicron variant, as well as other variants.

“We know that COVID-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster,” Walensky said in a statement.


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