FDA advisers meet on Covid Shots by Novavax

FDA advisers meet on Covid Shots by Novavax

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

Food and Drug Administration experts (whose meeting you can watch here) will base their recommendation on the company’s strong clinical trial data. But before the agency can clear the shots, the FDA would also have to approve Novavax’s manufacturing process, which has stumbled over and over again over the past two years.

If the FDA clears the two-dose Novavax vaccine, it would become the fourth vaccine to gain clearance for adults in the United States. But even if the company gets the green light, it’s unclear when or how widely the vaccine might be available. Injections from Pfizer-BioNTech, Moderna and Johnson & Johnson have been licensed for over a year, and the country has no shortage of doses. And in a number of countries where Novavax has already obtained approval, adoption has been low.

The federal government is coordinating with Novavax to receive “a limited amount of vaccine” if it is licensed and recommended in the United States, Department of Health and Human Services spokesman Jorge Silva said in an e-mail. mail. “We remain committed to ensuring that any American who wants a vaccine can get one, including those who prefer an mRNA-free option.” (Pfizer-BioNTech and Moderna injections are made with mRNA.)

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

In clinical trials, the Novavax vaccine was found to be 90.4% effective in preventing mild, moderate or severe infection with older variants of the virus. None of the volunteers who received the vaccine experienced moderate or severe infection, which translates to 100% efficacy.

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

In briefing papers released Friday, FDA scientists identified six cases of myocarditis and pericarditis, forms of heart inflammation, in about 40,000 volunteers.

“These events raise the question of a causal association with this vaccine,” the FDA documents state.

“We believe there is insufficient evidence to establish a causal relationship,” Novavax said in a statement. “We will continue to monitor all adverse events, including myocarditis and pericarditis.”

Moderna and Pfizer-BioNTech found no cases of myocarditis or pericarditis in their early clinical trials. But after licensing, once the vaccines were given to millions of people, they were both found to create a small additional risk of myocarditis in boys and young men.

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

But the vaccine is well below initial hopes, both in terms of the number of vaccines distributed around the world and the number of people who receive them. In February 2021, Novavax pledged 1.1 billion doses to Covax, the United Nations program providing vaccines to developing countries. But because of the delays, Covax has yet to order doses from Novavax.

Vaccine demand also appears tepid in other countries. Novavax shipped 42 million doses in the first quarter of this year, to 41 countries. In its briefing documents, the FDA said Australia, Canada, the European Union, New Zealand and South Korea provide data on the number of people who actually received the vaccine. The grand total in these countries was less than 750,000 doses.

When contacted for comment, Novavax did not provide the total number of doses administered worldwide in other countries, such as India.

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 approval. But two years later, with the country already brimming with effective mRNA vaccines, the government needs little more.

Novavax had planned factories around the world to manufacture its vaccine, but the company struggled to ramp up production and was slow to demonstrate that its process met FDA standards. The Serum Institute of India, the world’s largest vaccine producer, now manufactures Novavax’s vaccine and would be the supplier of all doses sold in the United States.

The FDA said in its briefing documents that testing and submission of manufacturing data for the vaccine “was still ongoing” at the time of its review.

In an interview, Stanley Erck, the chief executive of Novavax, said the company was in talks with the government about how many doses it would supply. “I anticipate that several million doses will arrive in the United States in the weeks following the EUA,” he said, referring to an emergency use authorization.

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