Novavax Applies for FDA Authorization of Its Covid Vaccine

The pharmaceutical firm Novavax stated on Monday that it had submitted an utility to the Meals and Drug Administration searching for authorization for its long-delayed protein-based coronavirus vaccine.

It’s not clear what, if any, function Novavax’s vaccine will play in the USA if it wins clearance. The federal authorities ordered 110 million doses of the shot in two offers reached with the corporate in 2020, however the USA is now flush with different vaccines and doesn’t want extra provides.

Stan Erck, Novavax’s chief government, stated in a press release that the corporate was working carefully with the USA authorities “to develop a plan which incorporates doses, manufacturing, timing, and ongoing medical trial analysis for boosters and pediatrics to assist their pandemic response.”

Novavax’s vaccine makes use of a extra standard method than the vaccines that have been extra swiftly developed and approved. That might make it interesting to people who find themselves hesitant to be inoculated with vaccines like these from Pfizer-BioNTech and Moderna that use the newer messenger RNA know-how. Novavax’s product makes use of tiny particles studded with viral proteins, blended with an immune-boosting compound referred to as an adjuvant. The vaccine is given as two photographs, spaced three weeks aside.

Novavax’s vaccine was discovered to be protecting towards sickness brought on by earlier variations of the virus. The corporate has stated its vaccine can generate an immune response towards the Omicron variant, although it stays to be seen how sturdy the safety shall be.

Within the early months of the pandemic, Novavax’s vaccine was one in all six chosen for financing below Operation Warp Velocity, the Trump administration’s effort to speed up vaccine growth. However Novavax, a Maryland firm that has that has by no means introduced a product to market, lagged behind different vaccine builders. It struggled to construct up its manufacturing capability and to display the purity of its vaccines to regulators.

Novavax’s Operation Warp Velocity contract initially promised the corporate $1.6 billion in assist for analysis and manufacturing in alternate for 100 million doses for the USA. As of Novavax’s most up-to-date regulatory submitting in November, the contract ceiling had been revised as much as $1.8 billion, and the corporate reported that it had already acquired about $900 million.

The Serum Institute of India, the world’s largest vaccine producer, has a license to make its personal model of Novavax’s vaccine and not too long ago started exporting doses to Indonesia and the Netherlands.