FDA to Hold Virtual Advisory Meeting Regarding EUA for Child Vaccines
Next Tuesday the U.S. Food and Drug Administration will hold a virtual advisory meeting to discuss vaccines and related biological products.
The committee will meet to discuss a request to amend the emergency use authorization of the Pfizer-BioNTech COVID-19 mRNA vaccine for children six months through four years of age.
In October 2021 the FDA authorized the Pfizer-BioNTech COVID-19 vaccine for use in children aged 5-11, and recently authorized the use of a single booster dose for individuals aged 12-15 and older.
As of Dec. 19, 2021, records from the Centers for Disease Control and Prevention show that already 8.7 million vaccinations have been given to kids aged 5-11.
“The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.
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