FDA authorizes late arrival of Novavax Covid-19 vaccine

The Food and Drug Administration (FDA, for its acronym in English) authorized on Wednesday a vaccine against covid-19 developed by Novavax, a biotechnology company in Maryland that received significant federal funds to produce the vaccine. The vaccine will be a new option for Americans as vaccination rates plateau.

After two years of development, the vaccine finally overcame manufacturing problems to become the fourth shot to be licensed in the United States. Advisors from the Centers for Disease Control and Prevention are meeting next week and are expected to discuss who should get the Novavax vaccine.

The two-dose vaccine was licensed as a primary immunization series for adults, rather than 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. In announcing its purchase, the government said Novavax was expected to finish quality testing “within the next few weeks,” a necessary step before dosages are released.

Novavax hopes its vaccine will appeal to people who have rejected the Pfizer-BioNTech and Moderna vaccines, 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 three weeks apart, works differently than mRNA vaccines. It provokes an immune response with nanoparticles composed 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 injection in other rich countries makes it unclear whether the company’s prediction for the United States will hold. In Europe, only 12.6 million doses of Novavax were distributed between December, when the vaccine was licensed there, and June 30. In contrast, more than a billion doses of the Pfizer-BioNTech and Moderna vaccines have been distributed in Europe.

A Morning Consult survey released earlier this month suggests that Novavax may find a similar lack of enthusiasm in the United States. Only 10 percent of unvaccinated people contacted for the survey said they would definitely or probably receive a protein-based vaccine.

The authorization comes with a warning that the Novavax vaccine is linked to an elevated risk of forms of heart inflammation known as myocarditis and pericarditis. In their review of Novavax data, FDA scientists identified six cases of the side effect in approximately 40,000 trial volunteers.

Moderna and Pfizer-BioNTech mRNA vaccines are also linked to an elevated risk of these conditions, but that link didn’t emerge until after they were put into wide-scale use.

Before the pandemic, Novavax was a little-known biotech company with several vaccines in the pipeline but no approved products. She rose to fame when Operation Warp Speed, the federal government’s 2020 campaign to develop coronavirus vaccines, chose her to support. Initially, the program agreed to pay up to $1.6 billion to fund vaccine development and purchase up to 100 million doses of the vaccine.

But a series of manufacturing delays made the vaccine unavailable for the initial vaccine surge in the United States in early 2021.

Manufacturing problems have continued to plague the company. Even after an FDA advisory committee recommended licensing the vaccine in early June, it took weeks for the agency to give it the green light, because it needed more time to approve Novavax’s manufacturing process. The Serum Institute of India, the world’s largest vaccine producer, is making Novavax’s vaccine.

In a series of clinical trials, Novavax found its vaccine to be highly protective against symptomatic infection. But the original formulation is probably not as effective against the Omicron variant, which emerged in November and has evaded some of the protection provided by licensed vaccines from other companies.

Novavax is developing new versions of its vaccine targeting Omicron and its highly contagious subvariants. Preliminary data from laboratory and animal studies indicate that a booster injection targeting an earlier subvariant of Omicron, BA.1, elicits strong immune responses to the virus. The company says it expects to have results from a clinical trial of that vaccine in September, with doses ready in the last three months of this year.

The company says it plans to speed up its research on sockets designed specifically for two newer versions of Omicron, known as the BA.4 and BA.5.

Trials have also shown that the Novavax injection works well as a booster, and the company is expected to seek authorization for the boosters soon. So the company can attract vaccinated people who want to switch to a new option to protect against new variants.

John Moore, a virologist at Weill Cornell, said he considered Novavax an excellent vaccine, but was still not convinced that an Omicron-based booster would provide much more protection compared to the original version. “There is very little information,” he said.

Dr. Moore speculated that some people might switch to Novavax for a booster this fall because it produced relatively few cases of pain, fatigue and other transient side effects in clinical trials. That was his experience as a volunteer in one of the Novavax trials. “The only way I could tell the next day which arm the needle was on was with the Band-Aid,” he said.

If Novavax is cleared for a booster, Dr. Moore would happily return for another injection, he said, “Sometime in the fall, I’ll take another dose, and that would be Novavax.”

Leave a Comment

Your email address will not be published.