After a Rocky Start, Novavax Vaccine Could Be Here by Summer

“Being in a clinical trial of an experimental vaccine gets them to a vaccine sooner, potentially, than they would otherwise,” he said.

If Novavax is successful, the new vaccine could add to a widening portfolio of shots in the United States by late spring. Moderna and Pfizer have deals with the United States to supply 400 million doses, enough to fully vaccinate 200 million people, by the middle of the year, and both companies are in talks to supply an additional 100 million doses each after that.

Johnson & Johnson, which recently reported that its one-dose vaccine was effective in a large U.S. trial, could receive authorization this month, but may not be able to supply the United States in significant numbers until April. AstraZeneca’s U.S. trial is also underway, and that company has a deal to supply Americans with 300 million doses of its two-shot vaccine.

But any number of obstacles could trip up Novavax’s progress. As other vaccines become more widely available, participants in Novavax’s trial could drop out of the trial. Even though its results in Britain were promising, the U.S. study could yield different results. Or the company could fail to prove to regulators that it can reliably manufacture its vaccine on a large scale. Given the likelihood that the United States may soon have three authorized vaccines available to the public, the company is under pressure to move quickly, or risk losing ground to competitors.

Novavax, based in Gaithersburg, Md., had struggled for years to bring a successful product to market, and in 2019 its stock was trading so low that it risked being delisted from the Nasdaq. Then, last spring and summer, two big deals rescued it from going under. In May, the Coalition for Epidemic Preparedness Innovations awarded the company up to $388 million to make its Covid vaccine available globally. In July, it was selected by the federal government’s Operation Warp Speed program to develop and sell its vaccine to the United States. Later in the summer, the company reported encouraging results in preliminary studies.

But the company struggled last fall to begin the U.S. trial by its earlier goal of October. Novavax has placed a big gamble on manufacturing, setting up plants around the world. But making these vaccines is a finicky and unpredictable process even for seasoned drug makers, and Novavax had trouble scaling up beyond the smaller batches needed for early trials.

“Things happen — small things happen,” said Stanley C. Erck, Novavax’s president and chief executive. “And so small things happen, and you lose weeks.”

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Jonny Richards

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