Key Takeaways
- FDA Grants Full Approval to Spikevax for High-Risk Children: Moderna’s Spikevax is now fully approved for children aged six months to 11 years at increased risk for COVID-19, transitioning from its prior Emergency Use Authorization.
- Moderna Expands Respiratory Vaccine Portfolio with mNEXSPIKE: The FDA recently approved mNEXSPIKE, Moderna’s next-generation COVID-19 vaccine, for older adults and at-risk individuals based on non-inferiority to Spikevax in the Phase III NextCOVE trial.
- Public Health Data Reinforce Vaccine Relevance: Centers for Disease Control and Prevention and World Health Organization data highlight ongoing COVID-19 activity globally and in the United States, underscoring the importance of updated vaccines ahead of the 2025–2026 respiratory season.
The FDA has granted full approval to Moderna’s Spikevax (mRNA-1273) for use in children aged six months through 11 years who are at increased risk for COVID-19. The regulatory action transitions the vaccine’s prior availability under Emergency Use Authorization (EUA) for this age group.1
Why Did the FDA Fully Approve Spikevax for High-Risk Young Children?
"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," said Stéphane Bancel, CEO, Moderna, in a press release. "We appreciate the FDA's diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease."
Spikevax Approval Builds on Broader Vaccine Momentum
Spikevax first received FDA approval in January 2022 in adults for COVID-19 prevention.2 In 2023, the vaccine was expanded under EUA in pediatric patients between six months and 11 years of age.3 In 2024, it was granted further approval for individuals over 12 years of age, specifically for a formulation targeting the KP.2 variant of COVID.4
Next-Generation COVID Vaccine Strengthens Moderna’s Respiratory Portfolio
The approval provides a boost to Moderna’s respiratory vaccine profile. In June, the FDA approved mNEXSPIKE (mRNA-1283), Moderna’s next-generation COVID-19 vaccine, for use in adults aged 65 years and older and individuals aged 12 to 64 years who have at least one risk factor for severe disease as defined by the Centers for Disease Control and Prevention (CDC). Approval was based on data from the Phase III NextCOVE trial, which showed that mNEXSPIKE was non-inferior to Spikevax.5
Government Funding Accelerates Pandemic Preparedness
The approval comes a year after Moderna was awarded increased funding. In July 2024, the Biomedical Advanced Research and Development Authority granted Moderna a $176 million project award under the Rapid Response Partnership Vehicle Consortium, aiming to expedite the development of mRNA-based pandemic influenza vaccines.6
CDC and WHO Data Reinforce Continued Need for Vaccination
At the same time, public health data continue to highlight the importance of COVID-19 vaccination. For the week ending June 28, 2025, data from the CDC indicated a 3.1% positivity rate for COVID in the United States, a slight decline of 0.1% from the previous week. Additionally, emergency department visits were reported to be at 0.4%, remaining on the same level from the previous week. Hospitalizations were at 0.7%, a 0.1% increase from the previous week. Deaths were at 0.3%, remaining consistent from the previous week.7
In May, the World Health Organization (WHO) reported that global SARS-CoV-2 activity has been increasing since February. WHO data show that test positivity rates have reached 11%, the highest level recorded since July 2024. The rise in cases has been most notable in the Eastern Mediterranean, South-East Asia, and Western Pacific regions.8
Moderna Plans Distribution Ahead of Respiratory Season
Moderna stated that it intends to make the vaccine available ahead of the 2025-2026 respiratory virus season.1
"COVID-19 remains a leading cause of death in the US and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season,” said Bancel, in a 2023 press release. “As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season. We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time."3
References
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. July 10, 2025. Accessed July 10, 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
Spikevax (Moderna COVID-19 Vaccine) FDA Approval History. Drugs.com. Accessed July 10, 2025. https://www.drugs.com/history/spikevax-moderna-covid-19-vaccine.html
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine. Drugs.com. Accessed July 10, 2025. https://www.drugs.com/newdrugs/moderna-receives-u-s-fda-approval-updated-covid-19-vaccine-6091.html
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2. Drugs.com. Accessed July 10, 2025. https://www.drugs.com/newdrugs/moderna-receives-u-s-fda-approval-updated-covid-19-vaccine-targeting-kp-2-variant-sars-cov-2-6358.html
FDA Approves Moderna’s mNEXSPIKE COVID-19 Vaccine for High-Risk Populations. PharmExec. June 2, 2025. Accessed July 10, 2025. https://www.pharmexec.com/view/fda-approves-moderna-mnexspike-covid-19-vaccine-high-risk-populations
Moderna Awarded $176 Million from the Biomedical Advanced Research and Development Authority to Expedite Development of mRNA-Based Influenza Vaccines. PharmExec. July 3, 2024. Accessed July 10, 2025. https://www.pharmexec.com/view/moderna-awarded-176-million-biomedical-advanced-research-development-authority-expedite-development-mrna-based-influenza-vaccines
COVID Data Tracker. CDC. Accessed July 10, 2025. https://covid.cdc.gov/covid-data-tracker/#datatracker-home
COVID-19 - Global Situation. WHO. May 28, 2025. Accessed July 10, 2025. https://www.who.int/emergencies/disease-outbreak-news/item/2025-DON572
