COVID-19 Vaccine Authorization In Adolescents Would Raise Questions Around Routine Immunizations
US FDA not planning an advisory committee for Pfizer/BioNTech’s request for authorization in 12-15-year olds at this time, but CDC’s ACIP is likely to weigh how to balance timing of COVID vaccination with administration of other immunizations generally recommended for adolescents.
You may also be interested in...
Without giving ACIP a chance to vote on the change or providing additional data, CDC announces new guidance allowing coadministration of COVID-19 vaccines with other immunizations. Needless to say, the decision raised a few eyebrows.
Emergency use authorization in 12-15 year-olds follows announcement of a June advisory committee meeting on pediatric data requirements, including the FDA’s criteria for younger children. Authorization for US adolescents has raised ethical questions about prioritizing this lower-risk group over hard-hit populations overseas.
Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker