Another updated COVID-19 vaccine gets federal approval — here’s what makes this one different

A COVID-19 vaccine at Salt Lake County Health Center in Salt Lake City on Wednesday, Oct. 4, 2023.
A COVID-19 vaccine at Salt Lake County Health Center in Salt Lake City on Wednesday, Oct. 4, 2023. | Jeffrey D. Allred, Deseret News

There’s now a third choice in the United States for an updated COVID-19 vaccine, from Novavax.

The federal government signed off in mid-September on new shots from Pfizer and Moderna that target a recently circulating variant of the coronavirus. But final authorization for the similarly updated Novavax vaccine didn’t come until last week.

The U.S. Food and Drug Administration announced Oct. 3 that anyone 12 and older can get the updated Novavax shot, as long as they haven’t already received an updated Pfizer or Moderna vaccine.

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Those who’ve never gotten vaccinated against the virus will need two doses of Novavax, the FDA said, and the immunocompromised may need more. Dosage also varies for the Pfizer and Moderna shots, which have been approved for anyone 6 months and older.

Novavax, a more traditional, protein-based vaccine, offers an alternative to the Pfizer and Moderna vaccines that utilize new mRNA technology that teaches cells to make the proteins needed for an immune response.

The Centers for Disease Control and Preventions advisory panel that discussed the updated vaccines “highlighted the urgent need for a protein-based option,” John C. Jacobs, Novavax president and CEO, said in a news release.

Data collected by the company shows between 25% and 30% of people prefer a protein-based vaccine, Silvia Taylor, Novavax’s chief corporate affairs and advocacy officer, told CNBC.

“We look forward to meeting this demand and more in the wake of new variants and rising COVID cases,” Taylor said in a statement to the business news channel. Novavax reportedly started shipping doses Monday.

With the end of the national pandemic emergency, COVID-19 vaccinations are now commercialized. That made for a rocky rollout for the Pfizer and Moderna shots, which have not been widely available or always covered by insurance as required.

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Wall Street analysts see Novavax as able to “catch up and compete this fall” with Pfizer and Moderna, CNBC said, even though the U.S. Department of Health and Human Services has said around 4 million updated COVID-19 vaccinations were received in September.

The reason for their optimism is that Novavax’s updated vaccine received broader authorization than previous versions, CNBC reported. Last year’s Novavax booster shot was limited by the CDC to those 18 and older who “cannot or will not receive mRNA vaccines.”

This time, the CDC said there was no need for an additional review by its advisory panel.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the updated Novavax vaccine “addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death.”

Marks said the FDA’s authorization of Novavax “provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”