[W]ith COVID cases plummeting in the United States and children historically seeing far less serious cases than adults, a panel of expert advisors to the FDA was asked to discuss whether the agency could consider vaccines for this age group under the same standard.
A [biologics licence application, or] BLA typically means the agency considers a year or 2 of data on a new product, rather than just 2 months’ worth. Emergency use also allows products on the market under a looser standard — they “may be” safe and effective, instead of has been proven to be safe and effective.
Several committee members said they didn’t feel the U.S. was still in an emergency with COVID, and couldn’t see the FDA allowing a vaccine to be used in kids that wasn’t given the agency’s highest level of scrutiny, particularly with reports of adverse events like myocarditis coming to light.
“I just want to be sure the price we pay for vaccinating millions of children justifies the side effects, and I don’t think we know that yet,” [pediatric infectious disease expert Cody] Meissner says.