Novavax seeks FDA clearance for its Covid vaccine

Pharmaceutical company Novavax said on Monday it had submitted an application to the Food and Drug Administration seeking authorization for its long-delayed protein-based coronavirus vaccine.

It’s unclear what role, if any, Novavax’s vaccine will play in the United States if it receives approval. The federal government ordered 110 million doses of the vaccine under two deals with the company in 2020, but the United States is now overflowing with other vaccines and does not need more supplies.

Stan Erck, chief executive of Novavax, said in a statement that the company is working closely with the United States government “to develop a plan that includes clinical trial doses, manufacturing, timing and research in courses for boosters and pediatrics to support their response to the pandemic. ”

Novavax’s vaccine uses a more conventional approach than vaccines that were developed and licensed more quickly. That could make it appealing to people who are hesitant to get vaccinated with vaccines like those from Pfizer-BioNTech and Moderna that use new messenger RNA technology. Novavax’s product uses tiny particles studded with viral proteins, mixed with an immune-boosting compound called an adjuvant. The vaccine is given in two injections, spaced three weeks apart.

Novavax’s vaccine has been shown to be protective against diseases caused by earlier versions of the virus. The company said its vaccine can generate an immune response against the Omicron variant, but 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 under Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development. But Novavax, a Maryland company that never brought a product to market, lagged behind other vaccine developers. It has struggled to build manufacturing capacity and demonstrate the purity of its vaccines to regulators.

Novavax’s Operation Warp Speed ​​contract originally promised the company $1.6 billion in research and manufacturing support in exchange for 100 million doses for the United States. In Novavax’s last regulatory filing in November, the contract cap was revised to $1.8 billion, and the company said it had already received about $900 million.

The Serum Institute of India, the world’s largest vaccine producer, has a license to manufacture its own version of Novavax’s vaccine and has recently started exporting doses to Indonesia and the Netherlands.

Paul N. Strickland