U.S. FDA advisory panel to meet on COVID-19 vaccines in children

This post was originally published on this site

The committee will not discuss any specific products, the agency said. FDA spokesperson Stephanie Caccomo said the meeting has nothing to do with Pfizer Inc (NYSE:PFE) and BioNTech SA’s request to expand the U.S. Emergency Use Authorization (EUA) of their vaccine into younger children.

That vaccine is currently authorized for use in people 16 or older in the United States. The vaccine makers have asked to expand that authorization to children as young as 12, and Pfizer said last week it expects the FDA response soon.

The FDA said last month it did not plan to hold an advisory committee meeting for the Pfizer-BioNTech expansion.

“As with the initial COVID-19 vaccine authorizations, 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,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

(Reporting Kalluvilaby Manojna Maddipatla in Bengaluru and Michael Erman in New York; Editing by Sriraj)