The Food and Drug Administration on Wednesday authorized a COVID-19 vaccine developed by Novavax, a biotechnology company in Maryland that received significant federal funding to produce the shot. Vaccines will be a new option for Americans as vaccination rates remain stable.
After two years of development, the vaccine has finally overcome manufacturing problems and has become the fourth shot to gain approval in the United States. Advisors from the Centers for Disease Control and Prevention will meet next week and are expected to discuss who should get the Novavax vaccine.
The two-dose vaccine was authorized as the primary vaccination series for adults rather than as a booster, which is likely to limit its market at first. The Biden administration said earlier this week that it would buy 3.2 million doses, enough to fully vaccinate 1.6 million people in the United States. Announcing its purchase, the government said Novavax was expected to finish quality testing “in the next few weeks”, a necessary step before doses are released.
Novavax hopes its vaccine will appeal to people who have turned down shots from Pfizer-BioNtech and Moderna, which use messenger RNA technology. About 22 percent of people in the United States have not received a single dose of the COVID vaccine.
The Novavax vaccine, given in doses spaced three weeks apart, works differently from mRNA vaccines. It stimulates the immune response with nanoparticles made of proteins from the surface of the coronavirus that causes COVID-19. Similar protein-based vaccines have been widely used around the world for decades.
But modest demand for the Novavax shot in other wealthy countries doesn’t make it clear whether the company’s predictions for the United States will hold true. In Europe, only 12.6 million Novavax doses were distributed between December, when the vaccine was authorized, and June 30. In contrast, more than a billion doses of Pfizer-BioNtech and Moderna vaccines have been distributed in Europe.
A Morning Consult poll released earlier this month suggests that Novavax may make up for a lack of similar enthusiasm in the United States. Only 10 percent of those not contacted for the poll said they would definitely or probably get a protein-based vaccine.
The authorization comes with a caveat that the Novavax vaccine is associated with an elevated but small risk of inflammation of the heart known as myocarditis and pericarditis. In reviewing Novavax’s data, FDA scientists identified six cases of side effects in nearly 40,000 trial volunteers.
The mRNA vaccines from Moderna and Pfizer-BioNtech are also associated with an increased risk of these conditions, but this link was not revealed until they were widely used. A warning about the risk was also added to their packaging.
Before the pandemic, Novavax was a little-known biotechnology company with several vaccines in the research pipeline, but no approved products. It rose to prominence when Operation Warp Speed, the federal government’s 2020 campaign to develop a coronavirus vaccine, chose it for support. The program initially agreed to pay up to $1.6 billion for vaccine development and purchase up to 100 million doses of the shot.
But a series of manufacturing delays meant the shot was no longer available in the United States for the initial surge of vaccinations in early 2021.
The manufacturing crisis has continued to haunt the company. Even after the FDA’s advisory committee recommended authorizing the vaccine in early June, it took weeks for the agency to give it the green light, as it needed more time to sign off on Novavax’s manufacturing process. Serum Institute of India, the world’s largest vaccine producer, is making the Novavax vaccine.
In several clinical trials, Novavax found that its vaccine was highly protective against symptomatic infections. But the original formulation probably isn’t as effective against the Omicron version, which emerged in November and has shied away from some of the protection offered by authorized vaccines from other companies.
Novavax is developing new versions of its vaccine that target Omicron and its highly infectious subtypes. Preliminary data from laboratory and animal studies indicate that a booster shot aimed at the previous omicron subvariant, BA.1, produced a strong immune response to the virus. The company says clinical trial results of that shot are expected in September, with the dosage ready in the last three months of this year.
The company says it plans to accelerate its research on shots made specifically for two new versions of Omicron, known as the BA.4 and BA.5.
Tests have also shown that Novavax’s shot works well as a booster, and the company expects to seek authorization for the booster soon. The company may then be able to attract vaccinated people who want to switch to a new option to protect against the new ones.
John Moore, a virologist at Weill Cornell, said he considers Novavax to be an excellent vaccine, but was not yet convinced that an Omicron-based booster would provide much more protection than the original version. “There is very little information,” he said.
Dr. Moore speculates that some people may switch to Novavax this fall because it produced relatively few cases of pain, fatigue, and other passing side effects in clinical trials. This was his experience as a volunteer in a trial of Novavax. “The only way I could tell the next day which hand I had the needle in was a Band-Aid,” he said.
If Novavax is authorized for a booster, Dr. Moore will happily return for another shot, he said: “At some point in the fall, I’ll have another dose, and it will be Novavax.”
(This story has not been edited by seemayo staff and is published from a rss feed)