The New York Times, August 5, 2021
Novavax, the Maryland company that won $1.6 billion from the U.S. government last year to develop a Covid vaccine, on Thursday announced that continued production problems would delay the vaccine’s use in the United States until the end of the year.
But the two-shot vaccine, which performed well against the virus in clinical trials, might soon be used in other parts of the world. In partnership with the Serum Institute of India, Novavax has applied for emergency authorization in India, Indonesia and the Philippines, the company announced on an earnings call.
“This is a big step for us,” Dr. Gregory Glenn, the president of Novavax, said in an interview.
The company also presented data showing that a single dose of its protein-based vaccine acts as a powerful booster shot against Covid-19. In clinical trials, the Novavax booster produced higher levels of antibodies against the coronavirus than its original two-dose vaccination did, the company said. Those antibodies were also potent against the highly contagious Delta variant.
Although Novavax has lagged behind its competitors, its vaccine offers impressive protection. In June the company reported that it has an efficacy of 90 percent against symptomatic Covid-19, and 100 percent against severe disease.
That trial ended, however, before the Delta variant surged to dominance across the world, making it impossible to directly measure the vaccine’s efficacy against that highly contagious version of the virus.
Novavax has carried out studies with vaccine antibodies in the laboratory suggesting that two doses of its vaccine provided fairly strong protection against the Delta variant.
What’s more, volunteers who got a booster shot ended up with antibody levels many times higher than with the original two doses. Antibodies that worked against Delta and other variants also rose to very high levels, the company reported.
British researchers are also testing the use of Novavax boosters in people who received two doses of other vaccines and are expecting results next month.
The Novavax vaccine has some advantages over other types. It can remain stable in a refrigerator, for example.
But its development has been dogged by supply shortages, a fire at one of the company’s factories and other mishaps. As a result, Novavax has repeatedly delayed its plans to seek authorization from U.S. regulators.
Today’s applications to India, Indonesia, and the Philippines suggest that the company is starting to overcome these hurdles at last.
Stanley Erck, the chief executive of Novavax, said during the earnings call that he was confident the company would apply for F.D.A. authorization in the fourth quarter of the year.
“It’s a matter of the mechanics of getting all the final data assembled and submitted,” he said. “We’re talking weeks here, we’re not talking months.”
Mr. Erck said Novavax would have 100 million doses ready to ship by the end of the month. By the end of the year, they plan to make 150 million doses per month.
John Moore, a virologist at Weill Cornell Medicine who participated in the Novavax clinical trial, has been impressed by the vaccine’s performance in trials, but disappointed by the company’s struggle to mass-produce the shots.
“I’m sure it all works just fine, but it’s irrelevant until they get their act together with regulatory filings,” he said.
Copyright 2021 The New York Times Company. Reprinted with permission.