The Centers for Disease Control and Prevention (CDC) quietly reinstated its July 2025 COVID-19 vaccination recommendations, including recommending the vaccine for “off-label” use among infants and children, Maryanne Demasi, Ph.D., reported.
According to the CDC’s updated webpage, the agency now recommends the COVID-19 shot for all adults ages 18 and older and for children ages 6 months to 17 years who are moderately to severely immunocompromised.
For children not at high risk — including males ages 12-24, who have the highest risk for vaccine-associated myocarditis — the CDC recommends the vaccine based on shared clinical decision-making.
The updated recommendations conflict with U.S. Food and Drug Administration (FDA) approvals for the vaccines.
There are currently no FDA-approved COVID-19 vaccines for healthy children and adults younger than 64. For those younger than 65, the vaccines are only FDA-approved for those at high risk of COVID-19 illness, at various ages depending on the vaccine.
The CDC acknowledges that use of the vaccine in that age group would be an “off-label” use.
Latest changes may be tied to court order in ongoing lawsuit
In May 2025, the U.S. Health Secretary Robert F. Kennedy Jr. announced that the CDC would no longer recommend COVID-19 vaccines for healthy children 6 months and older and healthy pregnant women.
In September 2025, the CDC Advisory Committee on Immunization Practices (ACIP) made the changes official when members voted that for people ages 6 months to 64 years, COVID-19 vaccination should be based on “individual-based decision-making.”
However, a court-ordered stay in March 2026 froze those recommendations. To comply with that order, the CDC is now reverting to its early 2025 recommendations.
The court-ordered stay, issued by U.S. District Judge Brian E. Murphy, stemmed from an ongoing lawsuit filed in July 2025 by the American Academy of Pediatrics (AAP) and several other medical groups.
The groups sued Kennedy and the U.S. Department of Health and Human Services (HHS) over changes to COVID-19 vaccine recommendations for children and pregnant women. They amended their lawsuit several times in response to new HHS and CDC policies and recommendations.
The U.S. Department of Justice is appealing Murphy’s ruling on behalf of Kennedy and HHS. Oral arguments are scheduled for Oct. 6 before the U.S. Court of Appeals for the 1st Circuit.
