The Biden administration announced on Monday that it would buy 3.2 million doses of a Covid-19 vaccine from the Maryland pharmaceutical company Novavax that is expected to soon receive authorization in the United States.
If cleared by regulators, Novavax’s two-dose vaccine would become the fourth coronavirus vaccine available in the United States. It would be available at first as a primary immunization series for adults. After that initial authorization, the Food and Drug Administration could later authorize the vaccine as a booster shot.
The company hopes that its protein-based shot, a vaccine technology that has been widely used for decades, will appeal to Americans who 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 immediately disclose how much it would pay for the order.
The government’s order fell far short of its original plans for Novavax’s product, which was part of the Operation Warp Speed 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 the product of Novavax’s struggles with manufacturing, meant that the vaccine was not available 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 authorize Novavax’s shot. But the agency’s deliberations over Novavax have taken longer than those over the other coronavirus vaccines, because the company still needed to demonstrate that its manufacturing process meets F.D.A. standards. The government’s announcement on Monday said that Novavax is expected to finish its quality testing “in the next few weeks,” a step needed for the product to be released.
The Serum Institute of India, the world’s largest vaccine producer, is now manufacturing Novavax’s shot. 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 trials, Novavax’s vaccine was found to be highly effective in preventing severe disease and infection. But those trials were conducted before the Omicron variant became dominant, raising questions about how effective it will be now.
Trials have also shown that Novavax’s shot works well as a booster, and the company is expected soon to seek authorization for it to be used that way.