F.D.A. Advisers Meet on Covid Shots by Novavax

A federal advisory committee on Tuesday will vote on whether regulators should authorize a Covid-19 vaccine made by Novavax, an early beneficiary of the government’s Operation Warp Speed program.

The experts to the Food and Drug Administration (whose meeting you can watch here) will base their recommendation on the company’s clinical trial data, which is strong. But before the agency could authorize the shots, the F.D.A. would also need to sign off on Novavax’s manufacturing process, which has stumbled again and again over the course of two years.

If the F.D.A. authorizes the Novavax two-dose vaccine, it would become the fourth shot to win clearance for adults in the United States. But even if the company does get the green light, it is unclear when or how widely the vaccine might be available. Shots from Pfizer-BioNTech, Moderna and Johnson & Johnson have been authorized for well over a year, and the country is not short of doses. And in a number of countries where Novavax has already earned authorization, uptake has been low.

The federal government is coordinating with Novavax to receive “a limited quantity of vaccine” if it is authorized and recommended in the United States, Jorge Silva, a spokesman for the Department of Health and Human Services, said in an email. “We remain committed to ensuring that any American who wants a vaccine can get one, including those that prefer a non-mRNA option.”

Pfizer-BioNTech and Moderna’s shots are made with mRNA, while the shot from Johnson & Johnson, the use of which has been limited in the United States, uses a non-mRNA approach.

The Novavax vaccine contains nanoparticles made up of proteins from the surface of the coronavirus, a fundamentally different design than the three authorized shots.

At Tuesday’s meeting, Dr. Peter Marks, who oversees vaccine regulation for the F.D.A., said there was a need for alternative vaccine options. “We do have a problem with vaccine uptake that is very serious in the United States, and anything we can do to get people more comfortable to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do,” he said.

In clinical trials, the Novavax vaccine was found to have an efficacy of 90.4 percent at preventing mild, moderate or severe infection with older variants of the virus. None of the volunteers who got the vaccine experienced moderate or severe infection, translating to an efficacy of 100 percent.

The trial took place before the rise of the Delta and Omicron variants, which have evaded some of the immunity from other vaccines.

In briefing documents released on Friday, F.D.A. scientists identified six cases of myocarditis and pericarditis, forms of heart inflammation, in about 40,000 trial volunteers. The F.D.A. documents said that the cases raised concern that the vaccine was the cause and that the rates of the problems could turn out to be higher than with mRNA vaccines.

Moderna and Pfizer-BioNTech did not find any cases of myocarditis or pericarditis in their initial clinical trials. But after authorization, once the vaccines were given to millions of people, they were both found to create a small extra risk of myocarditis in boys and young men.

In their presentation on Tuesday, Novavax officials defended their vaccine against those concerns. Their analysis found that myocarditis and pericarditis cases were balanced across the group of volunteers that received the vaccine and the group that received a placebo. In the real world, there were reports of one case of likely myocarditis and eight cases of likely pericarditis out of 744,000 doses given in rich countries that have authorized the vaccine, the company said.

“We believe that the totality of the clinical evidence here is not enough to establish an overall causal relationship with the vaccine,” said Dr. Denny Kim, Novavax’s chief safety officer.

The Novavax vaccine has been authorized in dozens of countries, including India, South Africa and Britain, and has also received clearance from the European Union and World Health Organization.

But the vaccine is falling far short of initial hopes, both in terms of the number of vaccines distributed around the world and the number of people who are receiving them. In February 2021, Novavax pledged 1.1 billion doses to Covax, the United Nations program supplying shots to developing countries. But because of the delays, Covax has not yet ordered any doses from Novavax.

Demand for the vaccine also appears to be tepid in other countries. Novavax has shipped 42 million doses through the first quarter of this year, to 41 countries.

As part of its initial support for Novavax’s research, the United States agreed to buy 110 million doses of the vaccine if it won authorization. But two years later, with the country already flush with effective mRNA vaccines, the government has little need for more.

Novavax had planned for factories around the world to manufacture its vaccine, but the company had trouble scaling up production and was slow to demonstrate that its process met F.D.A. standards. The Serum Institute of India, the world’s largest vaccine producer, is now manufacturing Novavax’s vaccine and would be the supplier of any doses sold in the United States.

The F.D.A. said in its briefing documents that testing and submission of manufacturing data on the vaccine “were still in process” at the time of its review.

In an interview, Stanley Erck, the chief executive of Novavax, said that the company was in discussions with the government about how many doses it will supply. “I anticipate that there will be several million doses coming into the U.S. within weeks of the E.U.A.,” he said, referring to an emergency use authorization.

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