FDA approves Modernas next-generation COVID vaccine for adults 65 or older
3 minute readPublished: Saturday, May 31, 2025 at 9:19 am
Moderna's Next-Gen COVID Vaccine Approved for Older Adults and High-Risk Groups
The US Food and Drug Administration (FDA) has given the green light to Moderna's next-generation COVID-19 vaccine, mNEXSPIKE, for individuals aged 65 and older, as well as those aged 12-64 with underlying health risks. This approval marks a significant development in the ongoing fight against the virus, particularly as regulatory scrutiny on vaccines has increased.
Moderna announced the approval on Saturday, highlighting the vaccine's potential to protect vulnerable populations from severe COVID-19. The company anticipates the vaccine will be available for the 2025-2026 respiratory virus season. The FDA's decision follows a tightening of requirements, including a mandate for drugmakers to test booster shots against a placebo in healthy adults under 65.
mNEXSPIKE offers advantages in terms of storage and distribution, as it can be stored in refrigerators, potentially extending its shelf life and simplifying logistics, especially in regions with supply chain challenges. The approval was based on late-stage trial data, which demonstrated the vaccine's non-inferiority to Moderna's original Spikevax vaccine in individuals 12 and older, and superior efficacy in adults 18 and older.
This approval comes amidst a backdrop of shifting regulatory landscapes. The Department of Health and Human Services, under new leadership, is implementing changes that have raised concerns about potential disruptions to vaccine reviews. The CDC has also clarified its stance on COVID-19 vaccines for children, stating that they remain an option when recommended by parents and doctors.
Moderna is banking on its mRNA vaccines to maintain market share, particularly as demand for its original COVID vaccine wanes. The company recently withdrew an application for a combined flu and COVID vaccine, awaiting further efficacy data.
BNN's Perspective: This approval is a positive step in protecting vulnerable populations from COVID-19. While the increased regulatory scrutiny is understandable, it's crucial to ensure that the review process remains efficient and doesn't unduly delay access to potentially life-saving vaccines. The focus on older adults and those with underlying conditions is appropriate, given the higher risk of severe illness in these groups.
Keywords: Moderna, COVID-19 vaccine, mNEXSPIKE, FDA approval, older adults, high-risk groups, vaccine, mRNA vaccine, regulatory scrutiny, CDC, booster shot, Spikevax, vaccine efficacy, respiratory virus season.