The federal advisory board on Tuesday will vote on whether regulators should allow a Novovax-administered Covid-19 vaccine, an early beneficiary of the government’s Operation Warp Speed program.
Food and Drug Administration experts, scheduled to begin meeting at 8:30 a.m., will base the recommendation on the company’s clinical trial data, which is strong. But before the agency approves the plans, the FDA should also sign the Novavax manufacturing process, which has been stumbled over and over again every two years.
If the FDA approved a two-dose Novavax vaccine, it would be the fourth shot to get U.S. adult permission. But even if the company gets the green light, it is not clear when or to what extent the vaccine can be used. Plans from Pfizer-BioNTech, Moderna and Johnson & Johnson have been approved for more than a year, and the country has not missed a dose. And in many countries where Novavax has already been licensed, its use has been low.
The federal government is coordinating with Novavax to allow “a limited number of vaccines” to be approved and recommended in the United States, Health and Human Services spokesman Jorge Silva said in an email. “We remain committed to ensuring that every American who wants a vaccine can get one, including those who prefer the non-mRNA option.” (Pfizer and Modern shots are made with mRNA).
The Novavax vaccine contains nanoparticles composed of coronavirus surface proteins, which are fundamentally different in design from the three permitted planes.
In clinical trials, Novavax vaccine was found to be 90.4 percent effective in preventing mild, moderate, or severe infections with older variants of the virus. None of the volunteers who received the vaccine had a moderate or severe infection, achieving a 100 percent effectiveness.
The trial was conducted before the rise of Delta and Omicron variants, which have prevented the immunity of other vaccines.
In information documents released Friday, FDA scientists identified six cases of myocarditis and pericarditis, types of heart inflammation, in about 40,000 test volunteers.
“These events raise concerns about a causal relationship with this vaccine,” FDA documents state.
“We believe that there is not enough evidence to establish a cause-and-effect relationship,” Novavax said in a statement. “We will continue to monitor all adverse events, including myocarditis and pericarditis.”
Modern and Pfizer-BioNTech found no cases of myocarditis or pericarditis in the initial clinical trials. But after permission was given, once the vaccines were given to millions of people, they found that both boys and young people posed a small additional risk of myocarditis.
The Novavax vaccine has been licensed in dozens of countries, including India, South Africa and the United Kingdom, and has also been approved by the European Union and the World Health Organization.
But the vaccine falls far short of initial expectations, both in terms of the number of vaccines distributed around the world and the number of people receiving them. In February 2021, Novavax commissioned 1.1 billion doses to Covax, a United Nations program that provides plans to developing countries. But due to delays, Covax has not yet ordered a dose from Novavax.
Vaccine application in other countries also seems to be warm. Novavax shipped 42 million doses in the first quarter of this year to 41 countries. In its briefing documents, the FDA said that Australia, Canada, the European Union, New Zealand and South Korea provide data on how many people have actually received the vaccine. In those countries there were a total of less than 750,000 doses.
At the time of contact, Novavax did not deliver the full number of doses administered worldwide to other countries, such as India.
As part of Novavax’s initial research support, the United States agreed to purchase 110 million doses of the vaccine if it obtained permission. But two years later, as the country is already full of effective mRNA vaccines, the government needs no more.
Novavax planned to plant factories around the world to manufacture its vaccine, but the company struggled to increase production and went on to demonstrate that its processes met FDA standards. The Indian Serum Institute, the world’s largest vaccine manufacturer, is manufacturing the vaccine in Novavax and would be the supplier of all the doses sold in the United States.
The FDA said in its briefing documents that vaccine testing and manufacturing data were “still in the process” at the time of the review.
In an interview, Stanley Erck, CEO of Novavax, said the company was discussing with the government how many doses it would deliver. “I anticipate that several million doses will enter the U.S. and be approved within a week,” he said, referring to an emergency use permit.