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

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

Experts from the Food and Drug Administration (whose meeting you can see here) will base their recommendation on the company’s clinical trial data, which is strong. But before the agency can authorize the shots, the FDA will also need to sign off on the production process of Novavex, which has stumbled repeatedly over the past two years.

If the FDA authorizes the Novavex two-dose vaccine, it will 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 not clear when and how widely the vaccine will be available. Shots from Pfizer-BioNTech, Moderna and Johnson & Johnson have been authorized for over a year, and there is no shortage of doses in the country. And in many countries where Novavex is already authorized, the uptake has been low.

The federal government is coordinating with NovaVex to receive a “limited amount of vaccine” if authorized and recommended in the United States, said George Silva, a government official at the Department of Health and Human Services, in an email. “We remain committed to ensuring that any American can get the vaccine they want, with a non-mRNA option.” (Shots from Pfizer-Bioentech and Modern are made with mRNA.)

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

In clinical trials, the Novavex vaccine has a 90.4 percent efficacy in preventing mild, moderate or severe infections with older strains of the virus. None of the volunteers who received the vaccine experienced a moderate or severe infection, which translates into 100 percent effectiveness.

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

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

“These incidents raise concerns about causal association with this vaccine,” FDA documents said.

“We believe there is not enough evidence to establish a causal relationship,” Novavex said in a statement. “We will continue to monitor all adverse events, including myocarditis and pericarditis.”

Moderna and Pfizer-Bioentech found no cases of myocarditis or pericarditis in their initial clinical trials. But after authorization, once millions of people were vaccinated, it posed a small additional risk of myocarditis in both boys and young men.

The Novavex vaccine is authorized in dozens of countries, including India, South Africa and the United Kingdom, and has been approved by the European Union and the World Health Organization.

But in terms of the number of vaccines distributed worldwide and the number of people receiving them, the initial expectations are falling far short. In February 2021, NovaVex pledged 1.1 billion doses to Covex, a United Nations program supplying shots to developing countries. But due to the delay, Covax has not yet ordered a dose from Novavax.

Demand for this specialty has grown significantly as a result of recent corporate scandals. Novavex shipped 42 million doses to 41 countries in the first quarter of this year. In its briefing documents, the FDA said Australia, Canada, the European Union, New Zealand and South Korea provided data on how many people actually received the vaccine. A total of less than 750,000 doses arrived in these countries.

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

As part of its initial support for Novavex’s research, the United States agreed to purchase 110 million doses of the vaccine if it is authorized. But two years later, the country is already full of effective mRNA vaccines, the government does not need more.

Novavex had planned for factories around the world to make its vaccine, but the company had difficulty increasing production and was slow to demonstrate that its process met FDA standards. The Serum Institute of India, the world’s largest vaccine manufacturer, is now producing NovaVax vaccine and will be a supplier of any dose sold in the United States.

The FDA stated in its briefing documents that testing and submission of product data on the vaccine at the time of its review was “still in process.”

In an interview, Stanley Erke, chief executive of NovaVex, said the company was discussing with the government how many doses it would supply. “I expect the EUA to have several million doses a week in the US,” he said, referring to the use of the emergency.

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