The FDA’s advisors have given their approval to Novavax’s Covid vaccine, paving the way for its approval.

Novavax Vaccine

The vaccinations advisory group of the Food and Drug Administration supported Novavax’s long-awaited Covid-19 vaccine, stating that the benefits exceeded the dangers. In premarket trading on Wednesday, the stock was up 17% to $55.60.

With one abstention, the panel voted 21 to 0 in support of the vaccine’s benefits outweighing its hazards. The panel was disappointed, however, that more information on the vaccine’s effectiveness against more current viral strains was not available. The FDA must now decide whether or not to approve the vaccination as an emergency measure.

All indications point to the FDA approving the vaccination. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Leadership, stated early in Tuesday’s meeting that there is a huge demand in the United States for a Covid-19 vaccine that is not reliant on messenger RNA.

“Having a protein-based alternative may be more comfortable for some in terms of vaccination acceptability,” Marks said, referring to Novavax’s more traditional vaccine modality. “We do have a major problem with vaccination uptake in the United States, and everything we can do to make people feel more at ease so they can accept these potentially lifesaving medical items is something we feel driven to do.”

In early 2021, Novavax reported encouraging efficacy statistics on its Covid-19 vaccine. The company has been plagued by delays. While billions of Covid-19 shots have been given around the world, Novavax claims to have given out 744,000 doses of its vaccine as of the end of April.

At the meeting, Dr. Ofer Levy, a temporary voting member of the committee and a professor at Harvard Medical School, remarked, “It’s a little hard to draw any judgments as to how it will do against Omicron.”

Novavax said in a statement that the vaccination and placebo had the same rate of myocarditis in all of its placebo-controlled investigations. Dr. Paul Offitt, a professor of paediatrics at the Children’s Hospital of Philadelphia, questioned whether the myocarditis was caused by the Covid-19 vaccinations targeting the spike protein in general or the vaccine delivery systems themselves. “It’s incumbent upon us to know this, whether it’s about the protein itself or the way the protein is processed,” Offitt said, “so we can use that information to produce safer vaccinations for a disease that will be with us for decades, if not longer.”

Dr. Lucia Lee of the FDA’s Office of Vaccines Research and Review stated in a presentation that the effectiveness of the vaccine against the currently circulating viral strains was still unknown. Members of the committee expressed their desire for more updated data on the vaccine throughout the meeting.

Rubin, addressing near the end of the conference, said the data given seemed comparable to what the same committee saw when reviewing the Pfizer and Moderna vaccines for the first time in late 2020. “I don’t think it’s that difficult a judgement if we follow the same criteria as we did before,” Rubin added. “It’s disheartening… that we don’t have more up-to-date information, since we’re evaluating efficacy against strains that no longer exist.”

Dr. Henry Bernstein, a committee member and a professor of paediatrics at the Zucker School of Medicine, inquired late in the discussion about Novavax’s delay in submitting their emergency-use application. “What took the longest was the production of the assays demonstrating that we could create the product over and over again in the same way, then deploying those assays,” said Dr. Filip Dubovsky, Novavax’s chief medical officer.

 

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