The FDA has requested that vaccine companies expand their trials in several thousand children before seeking emergency authorization.

The changes to ongoing pediatric trials run by Moderna and Pfizer and its German partner, BioNTech, could delay the availability of the vaccines to children between 5 and 11 beyond the hoped-for timeline of early fall, although it is unclear by how much. As the country faces a surge fueled largely by cases in unvaccinated people and the school year approaches, pediatricians and families have impatiently awaited shots of protection.

At a CNN town hall meeting last week, President Biden said that children under 12 might have access to a vaccine “soon,” but the regulatory decision to increase the trial size will mean recruiting and vaccinating many more children.

A federal official, who spoke on the condition of anonymity because they were not authorized to speak publicly, predicted that authorization of a coronavirus vaccine for children 5 through 11 might come by late October or early November. The government is not expecting it will be a big problem to enroll more children because so many parents are eager to get their children vaccinated, the official said.

Get the full story at