WASHINGTON — The Food and Drug Administration has issued a long-awaited approval of Novavax ... based coronavirus vaccine – and until now it had emergency authorization from FDA for use ...

The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as ...

The U.S. approved a new COVID-19 vaccine made by Moderna but with limits on who can use it — not a replacement for the company’s existing shot, but a second option.

Novavax's combo and standalone flu vaccines showed strong immune responses and good safety in a Phase 3 trial of adults 65 ...

The new vaccine is indicated for individuals who have been previously vaccinated with any COVID-19 vaccine and are 65 years or older, or 12 to 64 years of age with at least 1 underlying condition that ...

Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors ...

Novavax's COVID-19-influenza vaccines show strong immune response in older adults, paving the way for regulatory approval.

The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials ...

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the Center for Biologics Evaluation and research at the FDA, and Dr. Martin ...