Moderna's New Lower-Dose COVID-19 Vaccine, mNexspike, Approved by FDA
By Stephanie Brown HealthDay Reporter
TUESDAY, June 3, 2025 -- The U.S. Food and Drug Administration has approved a new lower-dose vaccine for active immunization against COVID-19 caused by severe acute respiratory syndrome coronavirus 2.
The new vaccine (mNexspike [COVID-19 Vaccine, mRNA]) represents a significant step forward in the development of next-generation coronavirus vaccines, the Associated Press reported. The innovative design of mNexspike allows for a much lower dose, about one-fifth of the dosage used in the current vaccine (Spikevax), a reduction achieved by refining the vaccine's target to elicit a more focused immune response.
The vaccine is not a replacement for the current Moderna COVID-19 vaccine. The lower-dose vaccine is intended to be a second option.
mNexspike is approved for use in individuals who have been previously vaccinated with any COVID-19 vaccine and are 65 years of age and older or 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. This is the same limited use the FDA set in licensing the Novavax COVID-19 vaccine last month.
This fall, Moderna anticipates offering both Spikevax and mNexspike as COVID-19 vaccines. Their current vaccine, which is already available for individuals aged 6 months and older, does not currently have limitations on who can receive it, the AP reported.
The approval "adds an important new tool to help protect people at high risk of severe disease from COVID-19," Stephane Bancel, Moderna CEO, said in a statement Saturday.
Approval of mNexspike was granted to Moderna.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted June 2025
Further Support and Information on COVID-19
Read this next
FDA Approves Prefilled Syringe Presentation for Shingles Vaccine
MONDAY, July 21, 2025 -- The U.S. Food and Drug Administration has approved a prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted) for the...
Few Babies Getting RSV Antibody Shot, Beyfortus, Study Says
THURSDAY, July 17, 2025 — A new antibody shot that protects babies against RSV infection could be struggling to gain traction, researchers report. Only about a third (35%)...
WHO, UNICEF Say More Than 14 Million Infants Worldwide Remain Unvaccinated
WEDNESDAY, July 16, 2025 -- Data released this week by the World Health Organization and UNICEF indicate modest gains in childhood vaccination rates, but globally, more than 14...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.