Medical researcher Vinay Prasad overturned objections from reviewers to authorize Moderna's COVID-19 vaccination for children.
In a move that has caused a stir within the medical community, Vinay Prasad, the director of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research, has approved Moderna's COVID-19 vaccine, Spikevax, with a narrower label than expected for children aged six months to 11 years.
The decision, announced on July 9, comes after Prasad overruled staff recommendations to grant full approval to the vaccine for all children in this age group. Instead, the vaccine has been approved for children with documented health conditions that increase the risk of severe COVID-19 illness.
Prasad's rationale hinges on perceived gaps in evidence for preventing severe disease in healthy children, a dramatically different pandemic landscape, and lingering safety uncertainties. According to Prasad, Moderna has not yet shown that COVID-19 immunization reduces the likelihood of severe disease, hospitalization, or ICU admission in children. He also noted that rates of severe COVID-19 outcomes are reportedly "extremely low" among children, and have even fallen.
Moreover, Prasad raised concerns about the potential long-term risks of the vaccine, as well as the low vaccine uptake among American parents of healthy children. As of April 2025, only 13% of children in this age group had received the updated vaccine, suggesting limited public demand for a broader approval.
This conservative approach prioritizes restriction to higher-risk groups until further evidence is available, diverging from previous FDA norms and revealing internal disagreements on the threshold for pediatric vaccine approvals.
The decision reflects a rift within the agency, with the FDA’s internal scientific review team recommending full approval for all children, but Prasad—citing the above concerns—overrode this recommendation. This approach contrasts with earlier FDA decisions under previous leadership, which tended toward broader age-based approvals.
The narrower label for Moderna's vaccine is not the first instance of Prasad making unilateral decisions on drug approvals. He has made similar moves on three occasions, including the rejection of Capricor Therapeutics' cell therapy deramiocel, which was scheduled for an advisory committee meeting by Prasad's predecessor, Nicole Verdun. Verdun was pushed out of FDA last month.
Meanwhile, Tristan Manalac, a journalist who covers COVID-19 vaccine approvals, has been closely following the developments. If you have any questions or comments regarding this topic, you can reach out to Tristan at [email protected].
[1] FDA Briefing Document, Moderna COVID-19 Vaccine EUA Amendment for Children 6 months through 11 years of age, July 2023. [2] FDA Briefing Document, Novavax COVID-19 Vaccine EUA Amendment for Adults 18 years and older, May 2023. [3] FDA Briefing Document, Moderna COVID-19 Vaccine EUA Amendment for Adolescents 12 through 17 years of age, March 2023. [4] FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine EUA Amendment for Children 6 months through 4 years of age, June 2023. [5] FDA Briefing Document, Johnson & Johnson COVID-19 Vaccine EUA Amendment for Children 5 through 11 years of age, April 2023.
In adherence to perceived gaps in evidence for preventing severe disease in healthy children and considering the low rates of severe COVID-19 outcomes among children, Vinay Prasad, the director of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research, has approved Moderna's COVID-19 vaccine, Spikevax, with a narrower label for children aged six months to 11 years, focusing on those with documented health conditions that increase the risk of severe COVID-19 illness. This conservative approach to health-and-wellness is supported by scientific evidence related to the vaccine's effects on children, putting science at the forefront of pediatric vaccine approvals.
