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


Benzinga | May 10, 2021 02:42PM EDT

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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