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FDA Advisers Recommend Authorization of Novavax COVID Vaccine

Novavax COVID-19 vaccine vials, syringes

Tuesday, 07 June 2022 03:38 PM EDT

Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the agency authorize Novavax Inc's COVID-19 vaccine for use in adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics.

The panel of outside vaccine experts voted 21-0 with one abstention in favor of the vaccine for those 18 and older.

If the FDA follows the recommendation and authorizes the shot, it will be the fourth COVID vaccine available for use in adults in the United States.

Novavax's shot is a more traditional type of vaccine employing technology that has been used for decades to combat diseases including Hepatitis B and influenza.

Maryland-based Novavax is hoping to gain a foothold within the roughly 27 million U.S. adults who are yet to be vaccinated, particularly those who do not want to receive a vaccine like the Pfizer/BioNTech or Moderna Inc shots based on groundbreaking messenger RNA (mRNA) technology.

FDA officials agreed that having a protein-based shot like the one developed by Novavax may help drive more vaccine acceptance among the hesitant. "We do have a problem with vaccine uptake that is very serious in the United States," FDA official Peter Marks told the panel. "Anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do," he added.

That demand has not materialized in Europe, where Novavax also said it could drive up vaccination among the hesitant. Around 12.6 million doses of Novavax's vaccine have been distributed in the European Union, but only around 220,000 doses of the two-shot inoculation have been administered there since it was launched in December.

The number of Novavax shots available in the United States is likely to be limited in the near term, according to the Department of Health and Human Services (HHS). An HHS spokesperson said on Monday it is coordinating with Novavax "to receive a limited quantity of vaccine and will make that vaccine available to the American public" if the shot is authorized by the FDA and recommended by the Centers for Disease Control and Prevention.

Novavax filed for U.S. authorization in late January, almost a year behind its original plan, following development and manufacturing problems. The vaccine is also being made by Serum Institute of India.

About 41 million doses were delivered in 41 countries in the first quarter, Novavax said.

In briefing documents prepared for the meeting and released on Friday, the FDA said data showed it could reduce the chances of mild-to-severe disease. It also raised concerns about the risk of heart inflammation called myocarditis from the vaccine, a condition that has also been observed after mRNA vaccinations, primarily in young men.

© 2024 Thomson/Reuters. All rights reserved.

Advisers to the U.S. Food and Drug Administration on Tuesday voted to recommend authorization of Novavax Inc's COVID-19 vaccine for adults.
covid, fda, novavax, vaccine
Tuesday, 07 June 2022 03:38 PM
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