COVID-19 boosters approved by FDA
Gabrielle M. Etzel
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The Food and Drug Administration approved updated COVID-19 vaccinations ahead of schedule on Monday as hospitalizations have increased and public health officials are monitoring new strains of the virus.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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The Centers for Disease Control and Prevention will be holding an advisory meeting on Tuesday to discuss recommendations for obtaining the Pfizer-BioNTech and Moderna vaccines. With CDC Director Mandy Cohen‘s final approval, millions of doses of the new vaccinations will be shipped to pharmacies and health clinics across the country.
Earlier this summer, the FDA’s Vaccines and Related Biological Products Advisory Committee met to recommend that vaccine manufacturers produce a product targeted at the omicron XBB.1.5 variant. At the time, this variant was what virologists and epidemiologists estimated would be the dominant strain heading into the fall and winter seasons.
The World Health Organization is currently monitoring several new strains of SARS-CoV-2, the virus that causes COVID-19, including the BA.2.86 and EG.5 strains as well as two variations of the omicron XBB lineage.
WHO COVID-19 Technical Lead Maria Van Kerkhove told reporters last week that their data suggest the new monovalent XBB vaccine “will protect against … severe disease and death” from both BA.2.86 and EG.5, “but the data is quite limited so far.”
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The FDA approval announcement clarifies that the new vaccines “appears to be of a similar magnitude to the extent of neutralization observed with prior versions of the vaccines,” indicating that the new vaccines will be “a good match for protecting against the currently circulating COVID-19 variants.”
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Marks.