Moderna announced that the FDA has approved its lower-dose Covid-19 vaccine, mNEXSPIKE, for adults aged 65 and older, and for those aged 12 to 64 with medical conditions increasing their risk of severe Covid. The approval, granted on Friday, is limited to individuals who have previously received a Covid vaccine. Moderna anticipates that this new vaccine will be available in the U.S. by the fall of the 2025-26 respiratory virus season.
mNEXSPIKE contains just one-fifth of the dose of Moderna’s original vaccine, Spikevax, catering to those who prefer a lower-dose option, but it is not a substitute for existing vaccines. Notably, young, healthy adults are excluded from eligibility despite participating in clinical trials for this vaccine. Similar restrictions were imposed on Novavax’s vaccine when it received FDA approval last month.
Last month, the FDA announced it would limit approvals of updated Covid shots to older adults and younger individuals with underlying health issues. Additionally, Health and Human Services Secretary Robert F. Kennedy Jr. stated that the CDC would no longer recommend Covid vaccinations for healthy children and pregnant women, suggesting that parents consult doctors regarding vaccinations for children aged 6 months and older.
The FDA’s requirement for new Covid vaccines includes clinical trials with an inert placebo, although Moderna’s new vaccine was tested using an active comparator, a method involving comparisons with an older approved version. In trials with approximately 11,400 participants, mNEXSPIKE generated higher antibody levels and had fewer local reaction complaints than the original vaccine, with side effects primarily including pain at the injection site, fatigue, headache, and muscle pain.
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