Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

mNEXSPIKE is a vaccine to protect against COVID-19. mNEXSPIKE is for people who have received a COVID-19 vaccine before and are: • 65 years of age and older, or • 12 years through 64 years of ...

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and ...

Moderna said mNEXSPIKE was approved by the FDA for use in adults aged 65 and up, as well as some individuals aged 12 to 64. ... “Covid-19 remains a serious public-health threat, ...

The primary efficacy was to demonstrate the vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared with Spikevax, Moderna's updated COVID-19 vaccine approved on Sept. 6, 2024.

• 65 years of age and older, or • 12 years through 64 years of age at high risk for severe COVID-19. Vaccination with mNEXSPIKE may not protect all people who receive the vaccine.