The U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay.

Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to grant Novavax full approval – without restrictions -- by its April 1 target ...

Novavax’s vaccine had been on track for full approval April 1, but the FDA delayed the decision while it sought more data, a source told CNN. The new approval letter issued Friday requires ...

May 19, 2025 – The FDA has approved the Novavax COVID-19 vaccine, a protein-based alternative to mRNA shots, with some limits on who can get it. The vaccine, called Nuvaxovid, is mainly ...

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 ...

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 ...

The FDA approved Moderna’s lower-dose COVID-19 vaccine, but only for individuals aged 65 years or older and people aged 12 to ...

The Novavax COVID-19 vaccine has had emergency use authorization since 2022, and an updated version was approved in August. The brand name is Nuvaxovid. The FDA granted Pfizer-BioNTech full ...

Pfizer and Moderna’s vaccines have been FDA-approved for people 12 and up and remain available under emergency use authorization for children as young as 6 months. Novavax’s vaccine had been ...

Perspective from Aaron E. Glatt, MD, FACP, FIDSA, FSHEA The FDA has approved Novavax’s protein-based COVID-19 vaccine, giving some Americans another option besides messenger RNA vaccines to ...

non-mRNA COVID-19 vaccine,” said John C. Jacobs, President and Chief Executive Officer, Novavax. Along with the approval, the FDA also requested Novavax conduct a phase 4 randomized, double ...