The Biden administration announced on Monday it would buy 3.2 million doses of a Covid-19 vaccine from Maryland pharmaceutical company Novavax, which is expected to be approved soon in the United States.
If approved by regulators, Novavax’s two-dose vaccine would become the fourth coronavirus vaccine available in the United States. It would initially be available as a primary immunization series for adults. After this initial approval, the Food and Drug Administration could later approve the vaccine as a booster dose.
The company hopes its protein-based shot, a vaccine technology that has been widely used for decades, will appeal to Americans who have declined to be vaccinated with shots using messenger RNA technology. About two-thirds of people in the United States are fully vaccinated.
The federal government did not initially say how much it would pay for the contract.
The government order fell far short of original plans for Novavax’s product, which was part of Operation Warp Speed’s portfolio of six vaccine candidates selected for billions of dollars in federal funding. In 2020, the Trump administration pre-ordered 110 million doses of Novavax’s vaccine.
But a series of delays, largely due to Novavax’s manufacturing difficulties, meant the vaccine was unavailable last year when the United States needed large quantities of vaccine doses.
A month ago, expert advisers to the Food and Drug Administration recommended that regulators approve Novavax for injection. But the agency’s deliberations on Novavax have taken longer than those on the other coronavirus vaccines because the company has yet to prove its manufacturing process meets FDA standards. Monday’s government announcement said Novavax is expected to complete its quality testing “within the next few weeks,” a step needed for the product to be released.
The Serum Institute of India, the world’s largest vaccine manufacturer, now manufactures the injection of Novavax. India recently exported 3.2 million doses of the Novavax vaccine to the United States, according to the Indian government’s Covid vaccine export records.
In clinical studies, Novavax’s vaccine proved to be highly effective in preventing serious illnesses and infections. However, these studies were conducted before the Omicron variant became dominant, raising questions about how effective it will be now.
Trials have also shown Novavax’s shot to work well as a booster shot, and the company is expected to seek approval for such use soon.