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Monday, June 24, 2024

FDA Advisers Propose Updated Covid Vaccine Formula for Fall Immunizations

A committee of advisers to the Food and Drug Administration (FDA) voted unanimously on Wednesday to update the formula for the Covid-19 vaccine in preparation for an expected fall immunization campaign. This annual adjustment aims to offer better protection against the prevalent virus strains.

The 16-member advisory committee recommended a formula targeting the JN.1 variant, which was the dominant strain in the United States as of February. However, recent data indicate that JN.1 has been overtaken by its descendants, KP.2 and KP.3. The FDA is expected to formalize a variant target for vaccine manufacturers for the next round of shots, scheduled for late summer or early fall. This decision involves a degree of educated guesswork, as any new vaccine formula won’t be available until months after a variant becomes dominant.

Jerry Weir, an official with the FDA’s vaccine division, acknowledged the difficulty in timing these decisions perfectly, stating, “It’s becoming clear that the ideal timing for a vaccine composition decision remains elusive.”

Dr. Peter Marks, who oversees the FDA’s vaccine division, urged the committee to encourage mRNA vaccine makers to focus on the latest virus versions in broader circulation. He highlighted the high cost of producing mRNA vaccines and the importance of having the most current versions, comparing the choice to selecting fresher milk at the grocery store.

The FDA advisers’ decision aligns with guidance from the World Health Organization (WHO), whose expert committee recommended in April that Covid vaccines switch to a JN.1 formulation.

The advisers reviewed data indicating that, as of late May, the KP variants accounted for roughly half of the coronavirus cases nationwide, suggesting they would continue to spread more broadly than JN.1. Representatives from Moderna and Pfizer stated that they could produce vaccines targeting either variant.

FDA studies have shown that vaccine efficacy improves when vaccines target the dominant variants more precisely.

On Wednesday, federal officials painted an optimistic picture of the nation’s battle against Covid-19. Natalie J. Thornburg, a CDC official, reported that case numbers were relatively low, and illnesses from JN.1 were not more severe than those caused by earlier variants. Covid-related deaths have also decreased significantly, with fewer than 400 deaths recorded per week recently, down from a peak of approximately 2,500 weekly deaths during the winter. However, older Americans remain a significant portion of those hospitalized with Covid-19.

The tepid reception of updated vaccines was also evident among nursing home residents, who are particularly vulnerable to severe illness, hospitalization, or death from Covid-19. CDC data from May showed that about 30 percent of nursing home residents were up-to-date on their Covid shots, a significant drop from 65 percent two years ago.

As the FDA moves forward with updating the Covid vaccine formula, the focus remains on adapting to the evolving virus to provide the best possible protection for the population.

David Faber
David Faber
I am a Business Journalist of The National Era
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