Skip to main content

Moderna's New Lower-Dose COVID-19 Vaccine, mNexspike, Approved by FDA

By Stephanie Brown HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on June 4, 2025.

via HealthDay

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.

Read this next

West Coast Governors Form Health Alliance to Guide Immunization Recommendations

THURSDAY, Sept. 4, 2025 -- The governors of California, Oregon, and Washington state announced plans for a new West Coast Health Alliance to provide vaccine recommendations to...

Florida Plans to End All Vaccine Mandates

THURSDAY, Sept. 4, 2025 — Florida may soon become the first state in the U.S. to eliminate all vaccine mandates, a major shift in health policy that may increase risk of...

One Dose of RSV Vaccine May Shield Older People for Two Seasons

WEDNESDAY, Sept. 3, 2025 — A single dose of RSV vaccine might protect seniors for two cold and flu seasons in a row, a new study says. Vaccination reduced seniors&rsquo...

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.