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# FDA Wants mRNA Vaccines Tested in More Kids
- URL: https://www.fdaweb.com/fda-wants-mrna-vaccines-tested-in-more-kids/
- Published: 2021-07-27T12:00:00.000Z
- Updated: 2026-09-14T17:07:53.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149794

FDA has asked Pfizer/BioNTech and Moderna to expand their trials of Covid vaccines to include several thousand school children before they seek final emergency use authorization for their vaccines. The *Washington Post* [reports](https://www.washingtonpost.com/health/2021/07/26/fda-asks-pfizer-moderna-test-their-vaccines-more-children-under-12-help-rule-out-safety-issues/?ref=fdaweb.com) the changes to ongoing pediatric trials could delay the availability of the vaccines for children ages 5 to 11 beyond the hoped-for timeline of early fall, although it is unclear how much of a delay there could be.

The expanded testing is intended to assess whether a rare inflammation of the heart muscle that has been seen in young adults shortly after vaccination is more common in younger age groups.

An anonymous federal official told the *Post* that authorization of a vaccine for children ages 5-11 could come by late October or early November.

A Moderna spokesperson said the company is consulting with FDA on a proposal to expand its trial but had not settled on final numbers.

The article says FDA is likely to require two months of follow-up data for the 5-11 age group, as it did for adolescents and adults. For children under age five, it says, the agency might require four to six months of follow-up data, meaning vaccines are unlikely to be available for several months for infants and young children.