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FDA advisors recommend approving Novavax coronavirus vaccine

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

The experts’ vote was 21 for approval of the Novavax vaccine, with one abstention. But it remained unclear when doses will become available. An FDA decision is unlikely to be made immediately because a review of production data is still ongoing. On Friday, Novavax submitted updated production information to support its vaccine approval.

The Novavax syringe is a protein-based vaccine from traditional technology used against influenza and shingles. Many experts are eager to add a new vaccine to the toolbox, especially since the Johnson & Johnson syringe is now only recommended for people who cannot or will not take messenger RNA vaccines.

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

However, Novavax’s two-shot regimen is likely to have a limited effect as it comes more than a year after other highly effective vaccines became available. Most of the population eligible for the shot – people 18 years and older – have already been vaccinated. Approximately 27 million adults in the United States have not received an injection, according to data from the Centers for Disease Control and Prevention.

Experts in the committee noted that data supporting the approval of the vaccine were old, and showed its performance against an earlier iteration of the virus, before the current variants emerged.

Bruce Gellin, head of global public health strategy at the Rockefeller Foundation, abstained, but said he gave the vaccine a “conditional yes.” He said the vaccine was shown to be generally safe and effective when clinical trials were conducted, but that “we do not know if it is true today.” He said it was important to monitor the vaccine’s performance when it came into use.

Given that other safe, effective vaccines are available, the panel discussed whether it was necessary to approve another alternative. Some committee members expressed skepticism about whether vaccination-reluctant people would embrace the new shot.

But an FDA official stressed the importance of having alternatives.

“Having a protein-based alternative may be more comfortable for some in terms of their vaccine acceptance,” said Peter Marks, director of the FDA’s Center for Biological Evaluation and Research. “I want to use this as a moment on the bully’s chair 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 are forced to do. to do. “

The first vaccines approved in the United States – from Pfizer and its German partner, BioNTech, and from Moderna – were based on messenger RNA technology, which instructs the body’s cells to build proteins that teach the immune system to stop the coronavirus. The technology had been under development for years, but the pandemic was the first time it was approved – and the shots have now been widely used.

People who cannot or will not take the mRNA vaccines can embrace the Novavax shots, but the ultimate use of the vaccine is probably as a booster. Going forward, the company plans to seek authorization for the shot as a booster and for use in adolescents and children.

The Novavax vaccine was shown to be 90 percent effective in a clinical trial before the emergence of the omicron variant of the coronavirus. The results were published a year ago, but the vaccine has been repeatedly delayed due to production challenges.

“It’s disappointing … that we do not have more up-to-date information, because we are looking at the effect on strains that no longer exist,” said advisory committee member Eric J. Rubin, an infectious disease specialist at Brigham and Women’s Hospital in Boston. Nevertheless, he said that the case for the vaccine was “quite convincing” considering that some people who have avoided mRNA vaccines have shown interest in Novavax.

The regulatory issues regarding production are among the reasons for the delay in the approval of the shot from Novavax, which submitted its request for emergency authorization in January. Questions had arisen as to why it had taken so much longer for the shot to reach the US market. The Novavax vaccine is already authorized in dozens of countries, including Japan and the United Kingdom.

Marks, from the FDA, said the agency does not follow management from other countries, including on production.

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

The FDA’s 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 shot may have the same rare risk as mRNA vaccines. Novavax executives pushed back on the FDA’s concern, noting that a company analysis showed that the incidence of heart disease myocarditis and pericarditis was extremely low and about the same in the group that received the vaccine and in the study participants who received placebo.

“I think the story is incompletely written here, and we need to fully understand what is happening,” said Filip Dubovsky, Novavax’s chief medical officer.

The Novavax coronavirus shot was one of six candidates supported by Operation Warp Speed, the federal program established to accelerate vaccine development. The government invested $ 1.6 billion in the Maryland company to support the development of the shots. Even with the influx of cash, the challenges of scaling up were enormous.

“The messenger RNA vaccines are truly remarkable. They are a great gift to humanity, and they were the first to cross the finish line. But whether they will prove to be the optimal vaccine for these viruses is not clear,” said H. Cody Meissner. “I do not think we will rest on what we have at this time because there is always an opportunity to improve a vaccine,” said a specialist in infectious diseases for children at Tufts University.

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