FDA Gives Approval to Moderna’s Spikevax COVID-19 Vaccine for Children 6 Months Through 11 years… But Only If at High Risk

On July 9, 2025, the U.S. Food and Drug Administration (FDA) released its decision to approve the supplemental Biologics License Application (BLA) for SPIKEVAX, but only for use in individuals 6 months through 11 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. This decision came after Moderna submitted a revised application on June 19, 2025, that revised the labeling to remove the indication for healthy children.

Vinayak Prasad, MD, MPH, director of the Center for Biologics Evaluation and Summary Research (CBER) at FDA, wrote:

“The review team has done a commendable job in summarizing and analyzing the submission to date. Nevertheless, I feel differently about certain aspects of their conclusions and instead reach the conclusion described below.”

He later writes:

“FDA has a regulatory duty to only grant marketing authorization in settings where we have substantial certainty the benefits outweigh the risks. For healthy children that standard is not met. This view is in line with the majority of the globe that does not pursue vaccination in healthy children. Future randomized trials measuring clinical endpoints and safety are needed to alter this position.”

It is helpful to finally have full FDA approval for the Moderna vaccine for this high-risk population of children. However, once the emergency use authorization (EUA) is canceled, administration of the vaccine to healthy children under shared clinical decision making will be “off-label.” There are two ways to look at this: 1) this FDA approval removes the indication for healthy children and may make healthcare providers less willing to stock and administer the Moderna COVID-19 vaccine to healthy children, even if the parent requests it, and 2) having FDA approval should quiet the objections to giving the vaccine while it’s under EUA and cannot be changed as easily as an EUA can be removed.

The Bottom Line:

• Moderna vaccine is FDA approved for children ages 6 months through 11 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
• When the Moderna vaccine EUA is canceled, use of the vaccine in children who do not meet the criteria listed above (i.e., healthy children) will be “off label.” This could impact coverage if commercial insurance companies start requiring prior authorization to give the vaccine to healthy children and may make healthcare providers less willing to stock and administer the vaccine, even when requested by a parent
• Novavax (“Nuvaxovid”) vaccine is only FDA approved for individuals ages 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 and for all adults ages 65 years and older. Use of the Novavax vaccine in healthy individuals under age 65 years is “off label” and may face the same concerns around access and payment that were outlined above.
• Pfizer vaccine is still under EUA for children and can be used for children 6 months and older who are at high risk for severe outcomes from COVID-19 or in healthy children with “shared clinical decision making.”

At the end of the day, the guidelines continue to be fluid and often confusing. AIM will continue to keep you updated with the latest and try to anticipate the pitfalls that might lie ahead.

You can read the full communication from CBER on Moderna’s BLA decision here.