The vaccine is one of six the U.S. bet on but is likely to have its biggest impact globally
Novavax, a Maryland biotechnology company that endured delays in developing a coronavirus vaccine, revealed results Monday showing that the world is close to having another shot that prevents illness and death, stops virus variants — and proves easy to store. The two-shot regimen was 90 percent effective at preventing people from falling ill in a 30,000-person trial conducted when variants had begun to complicate the pandemic in the United States and Mexico.
Vaccinated people were completely protected against severe and even moderate cases of illness. There were no cases of hospitalization or death among people who received the vaccine. The shots also may be the most tolerable yet tested. Side effects included fatigue, headaches and muscle pain, but reactions tended to be less frequent than those triggered by some already authorized vaccines.
“It’s really very impressive,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, noting the vaccine was on par with the most effective shots developed during the pandemic. “It’s very important for the world’s population to have, yet again, another highly efficacious vaccine that looks in its trial to have a good safety profile.”
Kathleen Neuzil, professor of vaccinology at the University of Maryland School of Medicine, said she often cautions people not to compare vaccine trials because there are so many differences in how and when they are conducted.
“Once you get to 90 to 100 percent effective, it’s hard to even decipher differences. … The efficacy looks great,” Neuzil said. “We need the manufacturing, obviously, to get it to the world.”
The good news comes with a caveat: The vaccine may not begin to have a large impact on the pandemic until late summer or fall.
Stanley C. Erck, Novavax’s chief executive, said in an interview that Novavax will apply for regulatory clearance from a half-dozen countries in the third quarter, which begins in July. It has an inventory of tens of millions of doses and plans to scale up to manufacturing 100 million doses a month by the end of September. The company said it expects to hit its target of 150 million doses a month in the last three months of the year.
In the United States, Novavax still needs to file for emergency authorization. The data, which was presented in a news release, will be examined by regulators at the Food and Drug Administration and by an external committee of vaccine advisers. Erck said the U.S. process may take longer than elsewhere in the world, and he anticipated the vaccine will have its biggest initial impact globally, through the World Health Organization’s Covax initiative.
“A lot of our vaccine is going to be targeted in the early stages for Covax … and so a lot of those doses are going to get into the low- and middle-income countries first, which is a good thing,” Erck said. Novavax has pledged 1.1 billion doses to Covax.
The Novavax vaccine was one of six candidates the U.S. government made a huge bet on, investing $1.6 billion to pay for research and development and preorder 110 million doses.
The decision to back Novavax — a 34-year-old Gaithersburg, Md., company that has never pushed a vaccine across the finish line and had to sell off its manufacturing facilities to stay financially afloat months before the pandemic hit — raised eyebrows.
Then, early tests showed that Novavax’s vaccine triggered an impressive immune response, generating high levels of virus-fighting antibodies capable of blocking the pathogen from invading cells. In January, the vaccine made a big splash when a large United Kingdom trial showed it was nearly 90 percent effective — even once a more transmissible variant had taken hold.
Over the past five months, the world has impatiently waited on the next steps — confirmatory evidence from a U.S. trial twice as large as the U.K. study, regulatory okays and the delivery of hundreds of millions of doses badly needed to help end the pandemic.
The U.S. trial, originally intended to launch in October, did not start until the last days of December, due in part to manufacturing delays. By then, people in the United States were becoming eligible for authorized vaccines. Novavax pushed back its timelines as it worked on manufacturing steps, including laboratory tests to show its product is consistent and potent.
Meanwhile, the United States secured more than enough shots from the three companies with authorized vaccines — Pfizer-BioNTech, Moderna and Johnson & Johnson — to satisfy demand. A fourth, from AstraZeneca, reported results in March.
As the course of the pandemic changed, Novavax began formulating a new version of its vaccine against a particularly worrisome variant and devising strategies in which its vaccine might be used as a booster. A small South African trial suggested that vaccine efficacy dropped against the variant that emerged there, but there were only two cases caused by that variant noted among the people who fell sick in the North American trial.
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