Preliminary results from an ongoing Phase IV trial showed that Moderna’s updated 2025-2026 Spikevax vaccine generated a strong immune response in preventing COVID-19.

According to the company, the results demonstrated more than an eight-fold increase in neutralizing antibodies against LP.8.1 in high-risk adults between the ages of 12 and 64 years as well as in those aged 65 years and older. The updated vaccine’s safety profile was also consistent with earlier formulations, with no new safety signals identified.¹

How is Moderna Advancing COVID-19 Protection for Children and High-Risk Populations?

The new data comes alongside another recent development for Spikevax. In July, Moderna announced that the FDA granted full approval of Spikevax for children aged six months through 11 years who are at increased risk for severe COVID-19.

At the time, approval was granted under Emergency Use Authorization (EUA).²

"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 July press release. "We appreciate the FDA's diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease."²

Spikevax Regulatory History and Variant Updates

Spikevax was initially granted EUA by the FDA in January 2022 for use in adults to prevent COVID-19. In 2023, its EUA was broadened to include children aged six months through 11 years. By 2024, the vaccine gained additional approval for people aged 12 years and older with a formulation specifically designed to target the KP.2 variant.

mNEXSPIKE Authorization Adds to Moderna’s Portfolio

The new data follows another recent development for Moderna in its ongoing COVID-19 vaccine efforts. In June, the FDA cleared mNEXSPIKE (mRNA-1283), Moderna’s next-generation COVID-19 vaccine, for adults aged 65 years and older and for individuals aged 12 to 64 years with at least one Centers for Disease Control and Prevention (CDC)-defined risk factor for severe COVID-19.

The approval was supported by results from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE was non-inferior to Spikevax.²

Alignment With Circulating COVID-19 Strains

According to the CDC, COVID-19 activity in the United States remains high, with the LP.8.1 variant and related strains continuing to dominate. Moderna stated that the updated Spikevax vaccine has demonstrated strong alignment with these circulating viruses.

The clinical data also build on earlier preclinical findings that supported FDA approval of the 2025–2026 formula, which is currently approved in the United States for high-risk patients aged six months through 64 years as well as those aged 65 years and older.

The updated vaccine has also secured approvals in several international markets, including Canada, Europe, Japan, Mexico, and Switzerland.¹

Recent COVID-19 Trends and Public Health Guidance

CDC data has shown that for the week ending September 6, 2025, COVID test positivity in the United States was 10.8%, down from 11.2% the previous week. Additionally, emergency department visits were at 1.5%, down from 1.7% the week prior.³

"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."²

References

1. Moderna Announces Updated COVID-19 Vaccine Against LP.8.1 Variant Generates Strong Immune Response in Humans. Moderna. September 16, 2025. Accessed September 16, 2025. https://feeds.issuerdirect.com/news-release.html?newsid=4519223994395939&symbol=MRNA
2. FDA Grants Full Approval to Moderna’s Spikevax COVID-19 Vaccine for High-Risk Children. PharmExec. July 10, 2025. Accessed September 16, 2025. https://www.pharmexec.com/view/fda-grants-full-approval-moderna-spikevax-covid-19-vaccine-high-risk-children
3. Surveillance and Data Analytics. CDC. Accessed September 16, 2025. https://www.cdc.gov/covid/php/surveillance/index.html