Novavax Pharmaceutical Co said on Monday that it had submitted an application to the Food and Drug Administration for permission for a long-delayed protein-based coronavirus vaccine.
It is unclear, if any, what role Novavax’s vaccine will play in the United States if it wins a license. The federal government has ordered 110 million doses of the vaccine in two agreements reached with the company in 2020, but the United States is now ready with other vaccines and does not need additional supplies.
Stan Erck, Novavax’s chief executive officer, said in a statement that the company is working closely with the US government “to develop a plan that includes dosage, manufacturing, timing and trial studies. Ongoing clinical trials for boosters and pediatric patients to support their pandemic response. ”
Novavax’s vaccines use a more conventional approach than rapidly developed and licensed vaccines. That could make it appealing to those who are hesitant to get an injection vaccines like those from Pfizer-BioNTech and Moderna use newer messenger RNA technology. Product use of Novavax small seed are attached to viral proteins, mixed with an immune-boosting compound called an adjuvant. The vaccine is given in two doses, three weeks apart.
Novavax’s vaccine is found to protect against illness caused by earlier versions of the virus. The company has said their vaccine can create an immunity reacts against the Omicron variant, although it remains to be seen how strong the protection will be.
During the early months of the pandemic, Novavax’s vaccine was one of six selected for funding in Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development. But Novavax, a Maryland company that has never brought a product to market, has lagged behind other vaccine developers. It has struggled to build production capacity and demonstrate vaccine purity to regulators.
Novavax Warp Speed Operation Contract initial promised the company $1.6 billion in research and production support in exchange for 100 million doses for the United States. Up to the most recent time of Novavax submit the application according to regulations in November, the contract cap was revised to $1.8 billion and the company reported that it received around $900 million.
The Serum Institute of India, the world’s largest vaccine producer, has obtained a license to manufacture a version of Novavax’s vaccine and recently start dosing to Indonesia and the Netherlands.
https://www.nytimes.com/2022/01/31/business/novavax-vaccine-fda.html Novavax files for FDA approval for a Covid vaccine