The experts at the Food and Drug Administration, whose meeting is scheduled to begin at 8:30 a.m. Eastern, will base their recommendation on the company’s clinical trial data, which is strong. But before the agency can authorize the shots, the FDA must also sign the Novavax manufacturing process, which has tripped time and again over the course of two years.
If the FDA approves the two-dose Novavax vaccine, it would become the fourth chance it will be approved for adults in the United States. But even if the company gets the green light, it’s unclear when and how widely the vaccine could be available. Shots from Pfizer-BioNTech, Moderna and Johnson & Johnson have been approved for over a year, and the country has no shortage of doses. And in a number of countries where Novavax has already been authorised, adoption has been low.
The federal government is coordinating with Novavax to receive “a limited amount of vaccine” if it’s approved 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 every American who wants a vaccine can get one, including those who prefer a non-mRNA option.” (The Pfizer and Moderna recordings were made with mRNA.)
The Novavax Vaccine contains nanoparticles composed of proteins from the surface of the coronavirus, a fundamentally different design than the three authorized shots.
In clinical studies, the Novavax vaccine was found to have: efficacy of 90.4 percent 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 percent efficacy.
The trial took place before the emergence of the Delta and Omicron variants, which have evaded some of the immunity of other vaccines.
In briefing documents Released Friday, FDA scientists identified six cases of myocarditis and pericarditis, forms of heart inflammation, in about 40,000 trial volunteers.
“These events raise concerns about a causal relationship with this vaccine,” the FDA documents said.
“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 initial clinical trials. But after authorization, once the vaccines were given to millions of people, they were… found both to create a small additional risk of myocarditis in boys and young men.
But the vaccine falls far short of initial expectations, both in terms of the number of vaccines being distributed around the world and the number of people receiving them. In February 2021, Novavax committed 1.1 billion doses of Covax, the United Nations program that supplies injections to developing countries. But because of the delays, Covax has not yet ordered doses from Novavax.
Demand for the vaccine also appears to be lukewarm in other countries. Novavax 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 are providing data on how many people actually received the vaccine. The total in these countries was less than 750,000 doses.
When Novavax was contacted for comment, it did not provide a 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 purchase 110 million doses of the vaccine if approved. But two years later, with the country already awash with effective mRNA vaccines, the government has little need for more.
Novavax had planned factories around the world to produce its vaccine, but the company struggled to scale production and was slow to demonstrate that the process met FDA standards. The Serum Institute of India, the world’s largest vaccine producer, now produces Novavax’s vaccine and is said to 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 on the vaccine was “still ongoing” at the time of the review.
In an interview, Novavax CEO Stanley Erck said the company was in talks with the government about how many doses it will provide. “I expect several million doses to come to the US within weeks of the EUA,” he said, referring to an emergency use authorization.