U.S. authorizes updated Novavax COVID-19 vaccines; they will be available in the fall

Novavax’s updated formula vaccines are open to anyone 12 years of age or older.

U.S. health regulators have approved a third updated COVID-19 vaccine this fall: shots made by Novavax Inc. Last week, the Food and Drug Administration had approved doses from Pfizer and Moderna for use in adults and children 6 months and older.

According to the health regulator, the Pfizer and Moderna vaccines have been modified to better suit the latest strains of the ever-evolving coronavirus, with cases already rising across the country even as summer draws to a close. Vaccines using Novavax’s updated formula are available to anyone 12 and older.

Experts say winter COVID-19 outbreaks have been worse, and health officials are urging Americans to get vaccinated this fall. “Today’s authorization provides an additional COVID-19 vaccine option,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Novavax’s vaccine technology is different from its rivals

Maryland-based biotech giant Novavax says it makes a protein-based vaccine mixed with an immune booster, a different mechanism than the mRNA vaccines from Pfizer and Moderna.

The Associated Press reported that there has been another difference in the formulations this year, with the Pfizer and Moderna recipes tailored to a subtype of the virus called KP.2. Novavax’s formulation targets its original strain, called JN.1. The FDA considers both to be closely related to currently circulating strains to offer cross-protection.

The JN.1 strain was the predominant strain in the United States earlier this year. While it is no longer as prevalent, it accounted for an estimated 0.2 percent of cases during a two-week period ending Aug. 31, according to data from the Centers for Disease Control and Prevention.

However, the KP.2 variant is estimated to account for 3.1 percent, while KP.3.1.1 is now dominant at 42.2 percent. In June, the health regulator had changed its strain recommendation for COVID-19 vaccines from 2024-25 as it asked manufacturers to update new vaccines to target the KP.2 variant.

Hospitalizations and deaths related to COVID-19 have increased over the past three months across the country, yet demand for vaccines has fallen sharply since the peak of the pandemic.

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