Moderna recently announced that the FDA has approved its lower-dose Covid-19 vaccine, mNEXSPIKE, for adults aged 65 and older, as well as individuals aged 12 to 64 with at least one medical condition increasing their risk of severe Covid. This approval applies only to those who have previously received a Covid vaccine. The new vaccine, which contains one-fifth of the original Spikevax dose, is expected to be available in the U.S. before the 2025-26 respiratory virus season. This update follows Moderna’s application in May to target the LP.8.1 variant.
While the new vaccine offers a lower-dose option, it is not intended to replace existing vaccines. Individuals who are young and healthy will not be eligible, despite having participated in the clinical trials for mNEXSPIKE. The FDA has recently limited the approval of updated Covid vaccines to older adults and younger individuals with underlying health conditions, a move aligned with previous restrictions established during the Trump administration. Secretary of Health and Human Services Robert F. Kennedy Jr. has also announced changes in CDC recommendations on Covid vaccines for healthy children and pregnant women, suggesting consultations with healthcare providers for vaccinations for children aged 6 months and older.
Moderna’s new vaccine was tested in a trial of approximately 11,400 participants and was compared against its original shot, demonstrating higher antibody levels and fewer local reactions, such as redness or swelling at the injection site. The main side effects reported for mNEXSPIKE included injection site pain, fatigue, headache, and muscle pain, while systemic reactions were comparable to those of the original vaccine. The approval marks a significant step amid evolving vaccine strategies.
Note: The image is for illustrative purposes only and is not the original image associated with the presented article. Due to copyright reasons, we are unable to use the original images. However, you can still enjoy the accurate and up-to-date content and information provided.
