The US Food and Drug Administration (FDA) has approved Moderna’s next-generation COVID-19 vaccine, mNEXSPIKE, for adults who are above 65 and above. The shot is also cleared for individuals between 12 and 64 years of age who are at least one risk factor as defined by the Centers for Disease Control and Prevention (CDC), the company stated on Saturday.
The approval comes amid stricter regulatory rules under the Department of Health and Human Services, now being supervised by vaccine skeptic Robert F. Kennedy Jr. Moderna stated it expects to manufacture the vaccine for the 2025-2026 respiratory viral season.
Vaccine approved for 65 and above, and younger individuals with higher risks
‘’The FDA approval for our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,’’ Moderna CEO Stephane Bancel said.
In a change from earlier practice, the FDA mentioned on May 20 that in the future, COVID-19 booster approvals will require trials conducted on a placebo group in healthy adults under 65. This norm will limit the use of such vaccines to older adults and those who are at higher risk of severe illness.
Unlike earlier mRNA-based vaccines, mNEXSPIKE can be stored in standard refrigerators to enhance its viability for global distribution. This will be especially beneficial in low-resource regions where maintaining cold chains is a logistical issue.
The CDC, which is also administered by Kennedy, clarified that COVID shots continue to be an option for healthy children if deemed mandatory by physicians and parents.
Analysts observed that this modified the prior concern after Kennedy indicated at removing the vaccine from the CDC’s immunization schedule.
Moderna changes policy after facing lower demands
After receiving low demand for its original COVID vaccine Spikevax and modest surge of its RSV vaccine, Moderna is banking on new-generation mRNA products. Late-stage trial data indicated mNEXSPIKE is similar to Spikevax’s effectiveness in those who are 12 and older, and outperformed it in adults over 18.
Meanwhile, Moderna has stalled its application for a combined flu-COVID shot and has decided to wait for additional flu trial data. Novavax’s protein-based COVID-19 vaccine was also sanctioned this month, but is limited to at-risk individuals aged 12 and older.
