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Will a U.S. COVID-19 vaccine maker be able to stay in business?

Novavax plans cutbacks amid ‘significant uncertainty’

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A vial of the Phase 3 Novavax coronavirus vaccine is seen ready for use in a trial at St. George’s University.

In this Oct. 7, 2020, file photo, a vial of the Phase 3 Novavax coronavirus vaccine is seen ready for use in the trial at St. George’s University hospital in London.

Alastair Grant, Associated Press

The maker of the only traditional COVID-19 vaccine still widely available in the United States is raising doubts about its ability to stay in business.

Novavax, in use in the U.S. since mid-2022, warned it may not survive in its latest earnings report, released after the market closed on Tuesday, CNN reported. By Wednesday morning, the cable news network said Novavax shares had fallen 25%.

The report by the Maryland-based company said the forecast “is subject to significant uncertainty,” especially when it comes to future sales and funding from the federal government, CNN said.

“Given these uncertainties, substantial doubt exists regarding our ability to continue as a going concern,” the company report said, according to CNN.

New Novavax CEO John Jacobs, who joined the company in late January, told Reuters, “If we execute on our operating plan, we’ll be in a very strong position not only at the end of this year, but going into next year.”

But Jacobs added there are risks ahead, noting it takes longer to produce Novavax’s traditional protein-based vaccine than it does for those utilizing the new mRNA technology, from Pfizer and Moderna.

That’s an issue because the COVID-19 vaccines are going to need to be updated regularly to target the latest strains of the virus, similar to the formulation of the most recent booster dose.

The U.S. Food and Drug Administration is looking at requiring an annual reformulation for the coronavirus vaccine, in time for most Americans to be boosted every year, as part of an effort to simplify the shots.

“We don’t know what the strain selection is yet from FDA. We don’t know what global health authorities may want from a regulatory standpoint on how the new vaccine needs to look,” Jacobs told Reuters.

“The sooner we know that, the more clarity we have on our path forward,” the CEO said.

There will be cutbacks at Novavax, likely including the loss of jobs, since the company has been spending at a “hot rate,” Jacobs told the news service without offering any details.

Reuters said the U.S. government’s agreement with Novavax has not been extended beyond the end of the year, putting some of the deal at risk. The company is also in arbitration over some $700 million received from an international alliance for shots in other countries.

Less than 80,000 doses of Novavax COVID-19 vaccine have been administered in the United States as of Feb. 22, compared to more than 650 million doses of Pfizer and Moderna, according to Our World in Data.

In Utah, just 565 doses of Novavax have been administered compared to more than 5.7 million of Pfizer and Moderna, the Utah Department of Health and Human Services says, although 7,500 doses of Novavax vaccine have been delivered to the state.

A fourth COVID-19 vaccine authorized for use in the United States, the single-dose Johnson & Johnson, is no longer recommended by the Centers for Disease Control and Prevention for most people.