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a federal advisory committee on Tuesday will vote on whether regulators should allow a Covid-19 vaccine made by one of the government’s first beneficiaries, Novavax. Operation Warp Rate program.

Food and Drug Administration experts, East meeting scheduled to start at 8:30will base its recommendations on the company’s robust clinical trial data. But the FDA would also have to sign off on Novavax’s manufacturing process before the agency would allow the filming. have stumbled upon over and over for two years.

If the FDA authorizes Novavax two doses of the vaccine, it would be the fourth shot to gain approval for adults in the United States. But even if the company gives the green light, it’s unclear when or how widely the vaccine will become available. Filming by Pfizer-BioNTech, Moderna, and Johnson & Johnson has been allowed for over a year, and there’s no shortage of doses in the country. And in some countries where Novavax is already authorized, uptake is low.

Jorge Silva, spokesman for the Department of Health and Human Services, said in an email that the federal government is coordinating with Novavax to receive a “limited amount of vaccine” if authorized and recommended in the United States. “We are committed to ensuring that any American who seeks the vaccine, including those who choose a non-mRNA option, is vaccinated.” (Pfizer and Moderna filmed with mRNA.)

Novavax vaccine contains nanoparticles It consists of proteins on the surface of the coronavirus, a fundamentally different design from the three authorized vaccines.

In clinical trials, the Novavax vaccine 90.4 percent efficiency in the prevention of 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 effectiveness.

The trial preceded the rise of Delta and Omicron variants, which missed some of the immunity from other vaccines.

Inside briefing documents Published Friday, FDA scientists identified six cases of myocarditis and pericarditis, forms of heart inflammation, in nearly 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. Said. “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 their initial clinical trials. But after the permission was granted, after the vaccines were given to millions of people, the vaccines were made. both found To create a small extra risk of myocarditis in boys and young men.

The Novavax vaccine is authorized in dozens of countries, including: India, South Africa and Britainand also got permission European Union and world Health Organization.

But the vaccine falls far short of initial hopes, both in terms of the number of vaccines distributed worldwide and the number of people who receive them. Novavax in February 2021 pledge 1.1 billion doses to Covax, the United Nations program that provides vaccines to developing countries. But due to delays, Covax has yet to order any doses from Novavax.

Vaccine demand appears to be weak in other countries as well. Novavax shipped 42 million doses to 41 countries in the first quarter of this year. In 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. The total dose in these countries reached less than $750,000.

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

As part of its initial support of Novavax’s research, the United States agreed to purchase 110 million doses of the vaccine, if authorized. But two years later, with the country already flooded with effective mRNA vaccines, the government needs little more.

Novavax had planned for factories around the world to produce its own vaccine, but the company was having trouble growing production and was slow to show that its process met FDA standards. The Serum Institute of India, the world’s largest vaccine manufacturer, currently manufactures Novavax’s vaccine and will be the supplier of any dose sold in the United States.

The FDA said in its briefing documents that testing of the vaccine and submission of production data is “still in progress” at the time of review.

Stanley Erck, Novavax’s CEO, said in an interview that the company is in talks with the government about how many doses to supply. “I estimate that the EUA will arrive in the US several million doses within weeks,” he said, referring to the emergency use authorization.