FDA advisers advocate approval of the Novavax coronavirus vaccine

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

Experts voted 21 in favor of approving the Novavax vaccine, with one abstention. However, it remained unclear when doses will be available. An immediate FDA decision is unlikely as the manufacturing data is still being reviewed. Novavax on Friday submitted updated manufacturing information to support its vaccine approval.

The Novavax shot is a protein-based vaccine of traditional technology used against influenza and shingles. Many experts are eager to add one more vaccine to the toolbox, particularly as the Johnson & Johnson vaccine is now only recommended for people who cannot or do not want to take messenger RNA vaccines.

“In an ever-evolving pandemic, having a choice of vaccine platform is important,” said Gregory Poland, director of Mayo Clinic’s Vaccine Research Group and paid consultant to Novavax.

However, Novavax’s two-shot regimen is likely to have limited impact, arriving more than a year after other high-potency vaccines become available. Most of the population eligible for vaccination – people aged 18 and over – have already been vaccinated. According to the Centers for Disease Control and Prevention, about 27 million adults in the United States have not received a vaccine.

Experts on the committee noted that the data supporting the vaccine’s approval was old and showed its performance against a previous 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 had been shown to be generally safe and effective when clinical trials were conducted, but “we don’t know if that’s true today.” He said it is important to monitor the vaccine’s performance as it is used.

Given that other safe and effective vaccines are available, the panel discussed whether there was a need to allow another option. Some committee members expressed skepticism about whether vaccine hesitant people would take up the new vaccine.

However, one FDA official stressed the importance of having options.

“Having a protein-based alternative might be more comfortable for some in terms of vaccine acceptance,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “I’m going to use this as a bullying pulpit moment to say: We have a vaccine uptake problem that is very serious in the United States and everything we can do to help people accept these potentially life-saving ones.” Making products easier is something we’re compelled to do.”

The first vaccines approved in the US – by Pfizer and its German partner BioNTech, and by 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 was in development for years, but the pandemic was the first time it was approved – and the shots are now rife.

People who can’t or won’t take the mRNA vaccines may take the Novavax vaccines, but the vaccine’s ultimate use is likely to be a booster. In the future, the company plans to seek approval for injection 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 announced a year ago, but the vaccine has been repeatedly delayed by manufacturing challenges.

“It’s disappointing … that we don’t have more up-to-date information because we’re evaluating efficacy against strains that no longer exist,” said Eric J. Rubin, advisory board member, infectious disease specialist at Brigham and Women’s Hospital in Boston. Still, he said the case for the vaccine is “pretty compelling” considering some people who have avoided mRNA vaccines have shown interest in Novavax.

Manufacturing regulatory issues are one of the reasons behind the delay in approving the shot by Novavax, which filed its emergency permit application in January. Questions had arisen as to why it took so much longer for the shot to reach the US market. The Novavax vaccine is already approved in dozens of countries, including Japan and the UK.

FDA’s Marks said the agency isn’t following the lead of other countries, including in manufacturing.

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

The FDA’s analysis identified five cases of heart inflammation that occurred shortly after vaccination in 40,000 people in the company’s studies, raising concern that vaccination could carry the same rare risk as mRNA vaccines. Novavax executives dismissed the FDA’s concerns, noting that a company analysis showed that rates of heart disease myocarditis and pericarditis were extraordinarily low and approximately in the group that received the vaccine and in the group that received a placebo were the same.

“I think the story is incomplete here and we need to better understand what’s going on,” 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 to accelerate vaccine development. The government invested $1.6 billion in the Maryland company to help develop the recordings. Even with the influx of cash, the challenges of scaling were enormous.

“The messenger RNA vaccines are really remarkable. They are a great gift to humanity and they were the first to cross the finish line. But whether or not they will prove to be the optimal vaccine against these viruses is not clear,” said H. Cody Meissner, a pediatric infectious disease specialist at Tufts University School of Medicine. “I don’t think we want to rest on what we have at this point because there’s always a way to improve a vaccine.”

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