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# CBER Director Overrides Staff to Limit Vaccine
- URL: https://www.fdaweb.com/cber-director-overrides-staff-to-limit-vaccine/
- Published: 2025-07-15T12:00:00.000Z
- Updated: 2026-09-14T15:16:33.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159510

CBER director **Vinay Prasad** has again overridden medical reviewers to limit a Covid vaccine’s use, according to a just-posted [“decisional memo.”](https://www.fda.gov/media/187542/download?attachment&ref=fdaweb.com) The latest incident involves the agency’s 7/9 approval of Moderna’s sBLA for Spikevax, the company’s Covid-19 vaccine, in children aged six months through 11 years who are at increased risk for Covid-19 disease. Last month, Prasad also overrode career staff at the agency to limit the approvals of Covid-19 shots from Novavax and Moderna ([see story](https://www.cbsnews.com/news/rfk-jr-fda-officials-overrode-career-staff-covid-shots/?ref=fdaweb.com)).

In limiting Moderna’s pediatric vaccine use last week to children with a risk factor, Prasad’s memo said his decision was partly based on the consideration that severe Covid-19 disease, hospitalization and death is extremely low at pediatric ages, and has fallen recently. “These rates are lower in healthy kids than kids with risk factors,” he wrote.

Additionally, Prasad said that much of Moderna’s submission concerned immunogenicity data. “Make no mistake — antibody titers are a surrogate endpoint,” he said. “They can and do correlate with improved clinical outcomes in some, but not all circumstances. Antibodies are not gold standard science, and one cannot be certain of net-clinical benefit merely because antibodies are increased… Vaccine doses can increase antibodies, but fail to further improve clinical outcomes. The proper interpretation of surrogate endpoints is key to understanding this application. CBER has shown flexibility and will accept these surrogate endpoints for children at high risk of severe COVID-19 outcomes, but will not for healthy children.”

Several other factors were considered in Prasad’s decision to limit the vaccine and are outlined in the memo.