US FDA to hold advisory panel meeting on use of COVID-19 vaccines in children

A health worker does a coronavirus disease (COVID-19) test as people wait at a drive-through COVID-
A health worker does a coronavirus disease (COVID-19) test as people wait at a drive-through COVID-19 testing center in a local street, in Newark, New Jersey, on Apr 2, 2021. (Photo: REUTERS/Eduardo Munoz)

WASHINGTON: The US Food and Drug Administration said on Monday (May 10) it will hold a meeting of its independent panel of advisers on June 10 to discuss the use of COVID-19 vaccines in children.

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 and BioNTech SA's request to expand the US Emergency Use Authorization (EUA) of their vaccine into younger children.

That vaccine is currently authorised for use in people 16 or older in the United States. The vaccine makers have asked to expand that authorisation 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 authorisations, 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 authorisation and biologics license applications for vaccines intended to prevent COVID-19 in this paediatric age range," Dr Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. 

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Source: Reuters