A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

For the new program, the FDA will issue a limited number of national priority vouchers to companies aligned with U.S. national priorities, the agency said in a statement. The special designation will ...

CDC official overseeing COVID-19 vaccine recommendations resigns Moderna's new COVID-19 vaccine mNexspike approved by FDA CDC now says kids "may receive" COVID-19 vaccines COVID-19 Vaccine RFK Jr.

The mNexspike vaccine is supplied as a single-dose prefilled syringe containing 1 dose of 0.2mL. The single 0.2mL dose should be administered at least 3 months after the last dose of COVID-19 vaccine.

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.

But the new restrictions have already been applied to the new Novavax shot approved on May 16 — as well as Moderna’s next-generation COVID vaccine (mNexspike), which the FDA approved on May 31.

The primary outcome of the study was to demonstrate noninferior vaccine efficacy against COVID-19 starting 14 days after mNexspike compared with that after the comparator vaccine. Findings showed ...