Seasonal update effectiveness questioned by FDA advisors

A person in Los Angeles, California receives a COVID-19 vaccination dose at Union Station during a free distribution event for those who have received vaccination shots or booster shots. The U.S. Food and Drug Administration’s panel of advisors has expressed doubts about the need for periodic updates to COVID vaccines, as it is uncertain if the virus follows a seasonal pattern like the flu.

During a meeting, advisors unanimously voted that new vaccines for the fall should be monovalent, targeting one variant of COVID, specifically one of the omicron XBB strains, which are currently dominant nationwide. However, concerns were raised about the language used in the original voting question, which suggested a “periodic update” to COVID shots.

Dr. Peter Marks, head of the FDA’s vaccine division, addressed the concerns by asking the panel’s chair to remove the wording from the question. Dr. Arthur Reingold, a professor of epidemiology at the University of California, Berkeley, stated that the question was unclear and did not provide a clear consensus on the need for regular updates to the vaccines.

These concerns raised by the panel reflect the uncertainty surrounding the future of the COVID pandemic, even as cases and deaths decrease across the country. This hesitation also highlights the opposition to the FDA’s proposed shift to annual COVID shots, which would involve yearly updates to the vaccines, similar to the administration of flu vaccines.

Several advisors cautioned against labeling COVID as a seasonal virus like the flu. They emphasized that the virus’s unpredictable spread and constant mutation into new variants prevent it from following a predictable seasonal pattern. Calling it “seasonal” could confuse the public about when and where they should get vaccinated.

In response to the advisors, Dr. Marks reiterated that COVID shots will likely require future updates. He emphasized that the current formulation of the vaccines will not be the final version and that future updates will be necessary.

Dr. Ashish Jha and Dr. Anthony Fauci, former White House health officials, support the idea of an annually updated COVID vaccine, drawing a parallel with the flu shot. Each year, researchers assess the flu strains in circulation and update the flu vaccines accordingly. They believe that if people view the COVID vaccine as an annual routine similar to the flu shot, it would make a significant difference in vaccine uptake.

Recent polling indicates that the public is open to the idea of an annual COVID vaccine. More than half of the surveyed adults in the United States expressed their likelihood to receive an annual COVID vaccine if it were offered similar to the flu shot. The survey also showed that 32% of respondents were “very likely” to do so.

The uptake of the most recent bivalent boosters, targeting the original COVID strain and omicron variants BA.4 and BA.5, has been slow. Only about 17% of the U.S. population, approximately 56 million people, have received Pfizer and Moderna’s boosters since their approval in September.

Pfizer, a leading COVID vaccine manufacturer, believes that transitioning to an annual COVID vaccine schedule could increase vaccination rates. Dr. Mikael Dolsten, Pfizer’s chief scientific officer, states that this shift would help people see COVID shots as a natural part of protecting their health. Pfizer is already developing “next-generation” versions of its shot, aiming to provide broader and extended protection against the virus for a full year.

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