Federal Advisory Board on Tuesday Vote Whether regulators should approve the Covid-19 vaccine produced by Novavax, an early beneficiary of the government’s Operation Warp Speed program.
Food and Drug Administration expert, The meeting is scheduled to begin at 8:30 am in the eastMakes recommendations based on strong company clinical trial data. But before the FDA approves the shot, the FDA must approve the Novavax manufacturing process, which has stumbled many times over the two years.
If the FDA approves the Novavax double-dose vaccine, it will be the fourth shot to obtain adult approval in the United States. However, even if the company gives a green light, it is unclear when and how widely the vaccine will be available. Shots from Pfizer-BioNTech, Moderna, Johnson & Johnson have been licensed for over a year and the country is not in short supply. And in many countries where Novavax is already licensed, penetration is low.
The federal government is coordinating with Novavax to receive a “limited amount of vaccine” if licensed and recommended in the United States, a spokesman for the Department of Health and Human Services, Jorge Silva, in an email. I am saying. “We continue to work to ensure that the vaccine is available to all Americans who want the vaccine, including those who prefer the non-mRNA option.” (Pfizer and Modana shots on mRNA. It is made.)
The Novavax vaccine contains nanoparticles composed of proteins from the surface of the coronavirus. This is a radically different design than the three shots allowed.
Clinical trials have shown that the Novavax vaccine is 90.4 percent effective in preventing mild, moderate, or severe infections from older variants of the virus. Vaccinated volunteers did not experience moderate or severe infections. This is equivalent to 100% effectiveness.
This study was conducted prior to the emergence of Delta and Omicron variants that evaded some of the immunity from other vaccines.
of Briefing document FDA scientists, announced on Friday, identified six cases of heart inflammation, myocarditis and pericarditis, in about 40,000 study volunteers.
“These events raise concerns about causality with this vaccine,” the FDA document 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 did not find any cases of myocarditis or pericarditis in the first clinical trial. However, after approval, when the vaccine was given to millions of people, they both found to create a slight extra risk of myocarditis in boys and young men.
The Novavax vaccine is licensed in dozens of countries, including: India, South Africa When UKAnd also with permission from european union When World Health Organization..
However, vaccines are far below initial expectations in terms of both the number of vaccines distributed worldwide and the number of people receiving them. In February 2021, Novavax promised 1.1 billion doses to Covax, a UN program that supplies shots to developing countries. However, due to the delay, Covax has not yet ordered the dose from Novavax.
Demand for vaccines seems to be weak in other countries as well. By the first quarter of this year, Novavax had shipped 42 million doses to 41 countries. In the briefing document, the FDA stated that Australia, Canada, the European Union, New Zealand and South Korea provide data on the number of people actually vaccinated. The total number of these countries is less than 750,000.
When contacted for comment, Novavax did not provide the total dose administered worldwide in other countries such as India.
As part of the initial support for Novavax’s research, the United States has agreed to purchase 110 million doses of vaccine if approved. But two years later, the country is already full of effective mRNA vaccines, so the government has little need for it anymore.
Novavax planned to manufacture vaccines in factories around the world, but the company struggled to expand production and took time to demonstrate that the process met FDA standards. rice field. The Serum Institute of India, the world’s largest producer of vaccines, is currently producing Novabax vaccines and will be the supplier of all doses sold in the United States.
In its briefing document, the FDA stated that testing and submission of manufacturing data on vaccines was “still in progress” at the time of the review.
In an interview, Novavax CEO Stanley Erck said the company is discussing with the government how many doses to supply. “We expect millions of doses to be given to the United States within a few weeks of the EUA,” he said, referring to an emergency use authorization.
