U.S. FDA formally approves Novavax’s non-mRNA COVID-19 vaccine — with restrictions

[TallGuyJohninBKK]

 

Nuvaxovid becomes the only non-messenger RNA COVID-19 vaccine approved by the FDA

 

The FDA has approved Novavax’s protein-based COVID-19 vaccine, giving some Americans another option besides messenger RNA vaccines to prevent SARS-CoV-2 infection.

 

The approval came with restrictions that the other COVID-19 vaccines do not have, reducing the number of people who will be eligible to receive the shot, branded as Nuvaxovid, which had been available under an emergency use authorization since 2022.

 

The FDA restricted approval of the single-dose adjuvanted vaccine to people aged 65 years or older, and adolescents or adults aged 12 to 64 years with at least one risk factor for severe COVID-19. The agency also will require Novavax to conduct post-approval studies to evaluate the occurrence of two heart conditions, myocarditis and pericarditis, rare side effects of COVID-19 vaccines.

 

(more)

 

https://www.healio.com/news/infectious-disease/20250519/fda-approves-novavaxs-covid19-vaccine-with-restrictions

 

 

[TallGuyJohninBKK]

U.S. FDA Approves BLA for Novavax's COVID-19 Vaccine

May 19, 2025

 

GAITHERSBURG, Md., May 19, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid™ for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking).

 

"Today's approval solidifies a pathway for Americans aged 65 and older and those aged 12 through 64 with an underlying condition that puts them at high risk for severe outcomes from COVID-19 to have access to a protein-based, non-mRNA COVID-19 vaccine," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option."

...

Novavax expects to be ready for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in the U.S. this fall in partnership with Sanofi, pending strain recommendation at the FDA Vaccines and Related Biological Products Advisory Committee meeting on May 22, 2025.  Nuvaxovid has been available for use in the U.S. under Emergency Use Authorization since July 2022 and has full market approvals in the European Union, United Kingdom, Japan, Canada, Australia, Taiwan and Singapore.

 

(more)

 

https://ir.novavax.com/press-releases/2025-05-19-U-S-FDA-Approves-BLA-for-Novavaxs-COVID-19-Vaccine

 

 

 

[connda]

Another vaccination I have no plans of taking.  Why? I've had Covid, I have antibodies and memory immune cells.  Why bother. It was a mild 2 1/2 day flu.  I don't expect to get it again.  Like the flu.  I haven't had the flu since I stop taking the flu shots 20 years ago.  Coincidence?  I don't think so.  But for ya'll who feel the need?  Go for it.  $130 to $225 a dose.  ฿4300 to ฿7500 per shot if you can get it in Thailand.  Feel free. 

In the meanwhile, we can see who the guinea pigs are.  They still don't have long-term testing and post-approval studies are required.  That doesn't give me a lot of confidence.  "Safe and Effective" I'm sure!
"The FDA restricted approval of the single-dose adjuvanted vaccine to people aged 65 years or older, and adolescents or adults aged 12 to 64 years with at least one risk factor for severe COVID-19. The agency also will require Novavax to conduct post-approval studies to evaluate the occurrence of two heart conditions, myocarditis and pericarditis, rare side effects of COVID-19 vaccines."