The U.S. Food and Drug Administration (FDA) has taken a significant step by granting full approval to Moderna's COVID-19 vaccine, Spikevax, for young children with certain health vulnerabilities. The decision, announced on July 10, 2025, allows pediatric use of the vaccine for children aged six months to 11 years who have underlying health conditions that increase their risk for severe illness from COVID-19.
This approval marks Spikevax as the first pediatric COVID vaccine to receive full authorization in the United States, albeit with a limited scope. The announcement comes amid broader vaccine policy changes under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. Earlier this year, Kennedy Jr. ended federal recommendations for routine COVID-19 vaccination of healthy children and pregnant women, aligning with updated data and revised risk assessments.
Moderna confirmed that the FDA had approved a supplemental application for Spikevax, extending full licensure to the specified pediatric group. The vaccine has been fully approved for individuals aged 12 and older since 2022. Additionally, Moderna revealed that an updated formulation of the vaccine would be available in time for the 2025–26 respiratory virus season.
According to current guidance, a two-dose regimen is recommended for unvaccinated children aged six to 23 months, and a single dose for older children or those who have already completed a primary series. This FDA decision follows the disbandment of the CDC's Advisory Committee on Immunization Practices (ACIP), which had been evaluating vaccine recommendations for children.
Dr. Fiona Havers, a medical epidemiologist and former member of the CDC's respiratory virus hospitalization network, expressed concern about the limited eligibility. She pointed out that a significant number of children hospitalized for COVID-19 are under age two and do not have any underlying health conditions. Havers resigned from the CDC following the policy changes and highlighted that infants under six months—who are ineligible for the vaccine—have some of the highest COVID hospitalization rates.
The narrowing of vaccine eligibility has prompted some health experts to warn that it could lead to confusion among parents and potentially limit access to the vaccine. With federal recommendations now withdrawn for the broader pediatric population, physicians might exercise more caution in advising off-label use without strong government backing.
Moderna CEO Stéphane Bancel supported the FDA's decision, stating, "COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization."
Despite the approval, the decision has been met with criticism from some conservative figures. Gunther Eagleman, a conservative commentator, questioned the move, citing concerns over myocarditis risks. Blaze TV host Steve Deace and epidemiologist Nicholas Hulscher also expressed disapproval, with Hulscher calling the regulatory agencies "completely compromised."
As the debates continue, families with young children are left to navigate the complexities of vaccine safety and government involvement in health decisions.
