On Tuesday, a federal advisory committee will vote on whether regulators should approve the Covid-19 vaccine, developed by Novavax, a primary beneficiary of the government’s Operation Warp Speed program.
Experts from the Food and Drug Administration, whose meeting is scheduled to begin at 8:30 a.m. Eastern, will make recommendations based on the company’s clinical trial data, which is strong. But before the agency can approve the shots, the FDA will also have to sign off on the production process of NovaVax, which has stumbled repeatedly over the past two years.
If the FDA approves the two-dose vaccine of NovaVax, it will be the fourth shot fired in the United States for adults. But even if the company gets the green light, it is not clear when or how widely the vaccine will be available. Shots from Pfizer-BioNTech, Moderna and Johnson & Johnson have been approved for over a year, and doses are low in the country. And in many countries where Novavax has already been approved, adoption has been low.
The federal government is coordinating with Novavax to obtain “limited quantities of vaccines” if approved and recommended in the United States, Health and Human Services spokesman George Silva said in an email. “We are committed to ensuring that any American who wants a vaccine can get one, including those who prefer a non-mRNA option.” (Pfizer and Modern shots made with mRNA.)
The Novavax vaccine contains nanoparticles made of proteins from the surface of the coronavirus, a design that is fundamentally different from the three approved shots.
In clinical trials, the Novavax vaccine has been shown to be 90.4 percent effective in preventing mild, moderate or severe infections with older forms of the virus. None of the volunteers who received the vaccine experienced a moderate or severe infection with a 100 percent efficacy.
The experiment took place before the emergence of the Delta and Omicron variants, which avoided some resistance to other vaccines.
In a briefing document released Friday, FDA scientists identified six cases of myocarditis and pericarditis, forms of heart inflammation, among about 40,000 trial volunteers.
“These incidents raise concerns about a causal link to this vaccine,” the FDA document said.
“We believe there is not enough 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 initial clinical trials. But once approved, once millions of people are vaccinated, they create a small additional risk of myocarditis in both boys and adolescents.
The novavax vaccine has been approved in dozens of countries, including India, South Africa and the United Kingdom, and has received clearance from the European Union and the World Health Organization.
But vaccines are falling far short of initial expectations, both in terms of the number of vaccines distributed worldwide and the number of people receiving them. In February 2021, Novavax pledged 1.1 billion doses to Covax, a UN program that provides shots to developing countries. But due to delays, Covax has not yet ordered any dosage from Novavax.
Demand for this specialty has grown significantly as a result of recent corporate scandals. Novavax shipped 42 million doses to 41 countries in the first quarter of this year. In its briefing document, the FDA said it provided data on how many people in Australia, Canada, the European Union, New Zealand and South Korea actually received the vaccine. Grand has received less than 750,000 doses in these countries.
When contacted for comment, NovaVax did not deliver the total dose administered globally to other countries, such as India.
As part of initial support for Novavax research, the United States agreed to purchase 110 million doses of the vaccine if approved. But two years later, with the already effective mRNA vaccine in the country, the government needs nothing more.
NovaVax had plans for factories around the world to make its vaccine, but the company had trouble 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 developing the Novavax vaccine and will be the supplier of any dose sold in the United States.
The FDA said in its briefing document that the issue of vaccine testing and production data submission was “still under process” at the time of the review.
In an interview, Stanley Erk, chief executive of NovaVax, said the company was in talks with the government about how much to supply. “I expect millions of doses to arrive in the United States within a few weeks of the EUA,” he said, referring to emergency use approvals.