FDA Approves Moderna’s COVID-19 Vaccine For Children Aged 6 Months Through 11 Years

The FDA has approved the company’s COVID-19 vaccine, mRNA-1273 (Spikevax), in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The vaccine was previously available for pediatric populations under the FDA’s Emergency Use Authorization (EUA). ¹

"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," Moderna CEO Stéphane Bancel, said in a statement.¹

Changing Vaccine Guidance, Changing Vaccine Indications?

In a previous article by Contagion, a discussion around the changing and confusing guidance presented by the federal government agencies was reported. Specifically, back in late May, the leaders of the National Institutes of Health, Health and Human Services, and FDA, announced the removal of the COVID-19 vaccine from the Centers for Disease Control and Prevention (CDC) immunization schedule for pregnant women and healthy children.²

"I couldn't be more pleased to announce that, as of today, the COVID-19 vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Health and Human Services Secretary Robert F. Kennedy said in a video at that time announcing the changes and was distributed on social media.²

However, since that post, and during the same week, the federal government changed its stance on the vaccine and healthy children. On the CDC's Child and Adolescent Immunization Schedule by Age, the COVID-19 vaccines are available to the pediatric population under what is called shared clinical decision-making in the guidance.²

This addresses children who are aged 6 months through 17 years, and who are not moderately or severely immunocompromised. It says the following: "Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances," the CDC writes on the website.²

With this changing guidance, it may leave the general public and clinicians uncertain about who is eligible for the vaccines, especially in this case with this latest Moderna approval. Additionally, there is no updated guidance for pregnant women.²

“I think the vaccine community is looking forward to, shall we say, how these new policies actually are implemented. They're a little bit different than in the past, and changes always raise questions. There's that old saying, ‘the devil is in the details.’ And so as these new policies come forward and are implemented, everybody will be looking at them very, very carefully,” William Schaffner, MD, professor of Medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine, said in a recent interview with Contagion.²

Separately, but related, the FDA approved another Moderna COVID-19 vaccine (mNEXSPIKE) at the end of May, and it is indicated for use in all adults 65 and older, as well as individuals aged 12-64 years with at least 1 or more underlying risk factor as defined by the CDC.³

Important to note, this vaccine won't be eligible for the pediatric groups who are aged 6 months through 11 years.

References
1.Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease. Moderna press release. July 10, 2025. Accessed July 11, 2025.
https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx
2. Parkinson J. Federal Government Changes Course Again on COVID-19 Vaccine Policy. Contagion. June 2, 2025. Accessed July 11, 2025.
https://www.contagionlive.com/view/federal-government-changes-course-again-on-covid-19-vaccine-policy
3. Moderna Receives U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE. Moderna press release. May 31, 2025. Accessed June 11, 2025.
https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx