Feds, Western States Approve Boosters for Adolescents Ages 16 and 17
Following a formal request from Pfizer-BioNTech last week, the U.S. Food and Drug Administration (FDA) on Thursday amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to authorize the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination.
The FDA took its steps without the convening its Vaccines and Related Biological Products Advisory Committee (VRBPAC) after the agency reviewed data supporting effectiveness, including an evaluation of the benefits and risks of administering a booster dose among this population. The FDA determined the booster request dose not raise questions that would benefit from an additional discussion by VRBPAC members.
Following the FDA’s actions, U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky strengthened its booster recommendations and encouraged everyone 16 and older to receive a COVID-19 booster dose. Walensky, in updating the agency’s booster recommendations, did not convene the CDC’s Advisory Committee on Immunization Practices (ACIP).
U.S. Health and Human Services Secretary Xavier Becerra, following the updated guidance, issued a statement encouraging all eligible Americans to receive a booster dose.
The Western States Scientific Safety Review Workgroup similarly assessed the available data on booster doses among 16- and 17-year olds, ultimately issuing a recommendation to expand eligibility for boosters among the age group in California.