FDA To Hold AdCom Meeting For Expanding Use COVID-19 Vaccine In Children

• The FDA’s Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee on June 10

• The virtual meeting will provide a status update on its approach to expand the emergency use authorization (EUA) of COVID-19 vaccines to those aged 12 – 15 years, the regulator said in a press release.

• The meeting will also discuss the data required to support a EUA and a biologics license application (BLA) for COVID-19 vaccines to children less than 12 years old.

• Any specific product will not be discussed, the agency said.

• “We want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range,” FDA said.

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