Moderna’s New Lower-Dose COVID-19 Vaccine Approved by FDA

By Stephanie Brown HealthDay Reporter

WEDNESDAY, June 4, 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.

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