FDA advisers recommend licensing of the Novavax coronavirus vaccine

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A panel of independent vaccine experts recommended Tuesday that the Food and Drug Administration authorize a coronavirus vaccine developed by the Maryland biotechnology company Novavax, paving the way for the fourth episode in the United States.

The expert vote was 21 in favor of licensing the Novavax vaccine, with one abstention. But it is still not clear when the doses will take place become available. It is not likely that a decision will be made by the Food and Drug Administration immediately because a review of data on manufacture is still ongoing. Novavax on Friday provided updated manufacturing information to support licensing of the vaccine.

Novavax is a protein-based vaccine from traditional technology used against influenza and herpes zoster. Many experts are eager to add another vaccine to their toolbox, especially because Johnson & Johnson’s dose is now recommended only for people who can’t or won’t take mRNA vaccines.

“It is important to have choices in vaccine platforms in the event of an ever-evolving pandemic,” said Gregory Poland, director of the Vaccine Research Group at Mayo Clinic and a paid advisor to Novavax.

But Novavax’s two-dose regimen is likely to have limited effect because it arrives more than a year after other highly effective vaccines become available. Most people who are eligible for the vaccine — people 18 or older — have already been vaccinated. About 27 million adults in the United States have not received an injection, according to data from the Centers for Disease Control and Prevention.

Experts on the committee noted that the data supporting the vaccine’s licensing was outdated, indicating its performance against a previous recurrence of the virus, before the current variants emerged.

Bruce Gillen, head of global public health strategy at the Rockefeller Foundation, abstained from the vote but said he was giving the vaccine a “conditional yes.” He said the vaccine has generally been shown to be safe and effective in clinical trials but “we don’t know if that is true today.” It is important to monitor the performance of the vaccine when using it, he said.

As other safe and effective vaccines are available, the team discussed whether it was necessary to allow another option. Some committee members expressed doubts about whether the vaccine would be hesitant people would accept the new shot.

But a US Food and Drug Administration official stressed the importance of having options.

“Obtaining a protein-based alternative may be more comfortable for some in terms of their acceptance of the vaccine,” said Peter Marks, director of the Food and Drug Administration’s Center for Biology Evaluation and Research. “I’m going to use this as a moment on the bully pulpit to say: We have a very serious vaccine problem in the United States, and anything we can do to make people more comfortable accepting these potentially life-saving products is something we’re compelled to do.”

The first vaccines licensed in the United States — from Pfizer and its German partner BioNTech and from Moderna — were based on messenger RNA technology, which directs the body’s cells to build proteins that teach the immune system to stop the coronavirus. The technology has been in development for years, but the pandemic was the first time it was licensed — and the footage is now widely used.

People who can’t or won’t take mRNA vaccines may adopt Novavax injections, but the end-use of the vaccine may be a booster. Going forward, the company plans to obtain permission to obtain the shot as a booster and for use in teens and children.

The Novavax vaccine was proven to be 90 percent effective in a clinical trial conducted before the omicron variant of the coronavirus emerged. The results were announced a year ago, but the vaccine has been repeatedly delayed due to manufacturing challenges.

Advisory Committee member Eric J. Infectious Disease Specialist at Brigham and Women’s Hospital in Boston. Still, he said, the vaccine case was “very compelling” given that some people who have avoided mRNA vaccines have expressed interest in Novavax.

Regulatory issues related to manufacturing are among the reasons for delays in licensing the shot from Novavax, which filed for emergency authorization in January. Questions arose about why the shot took so long to reach the US market. The Novavax vaccine is already authorized in dozens of countries, including Japan and Britain.

Marks, of the Food and Drug Administration, said the agency does not follow the lead of other states, including manufacturing.

“We take manufacturing very seriously,” Marks said, adding that the FDA has a “very high standard,” which is why it’s sometimes referred to as the gold standard.

A U.S. Food and Drug Administration analysis identified five cases of heart inflammation that occurred shortly after vaccination among 40,000 people in the company’s trials, raising concerns that the vaccine could carry the same rare risks as messenger RNA vaccines. Novavax executives disputed the FDA’s concerns, noting that the company’s analysis showed rates of heart disease, myocarditis and pericarditis were very low and about the same in the vaccine group and in study participants who received placebo.

“I think the story is imperfectly written here, and we need to fully understand what is going on,” said Philip Dubowski, Novavax’s chief medical officer.

The Novavax coronavirus shot was one of six candidates supported by Operation Warp Speed, the federal program created to accelerate vaccine development. The government has invested $1.6 billion in a Maryland company to support the development of the footage. Even with the money flowing, the expansion challenges were enormous.

mRNA vaccines are really cool. It is a great gift to humanity, and they were the first to cross the finish line. Cody Meisner, a pediatric infectious disease specialist at Tufts University School of Medicine, said whether or not they would become the optimal vaccine for these viruses. “I don’t think we want to be content with what we have at this point because there is always a chance to improve the vaccine.”

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