FDA officials say annual Covid-19 shots may be needed in the future

The United States might need to update its Covid-19 vaccines each year, according to a trio of top US Food and Drug Administration officials, and “a new normal” may include an annual Covid-19 vaccine alongside a seasonal flu shot.

“Widespread vaccine- and infection-induced immunity, combined with the availability of effective therapeutics, could blunt the effects of future outbreaks. Nonetheless, it is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal. It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza. And it likely will require similar annual consideration for vaccine composition updates,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research; Principal Deputy Commissioner Dr. Janet Woodcock; and new FDA Commissioner Dr. Robert Califf wrote in a paper published in the medical journal JAMA on Monday.

A patient receives a booster dose of the Pfizer-BioNTech coronavirus vaccine in Southfield, Michigan, in August 2021.

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“During the 2022-2023 COVID-19 vaccine planning and selection process, it is important to recognize that the fall season will present a major opportunity to improve COVID-19 vaccination coverage with the goal of minimizing future societal disruption and saving lives,” they wrote. “With the plan for implementation of this year’s vaccine selection process, society is moving toward a new normal that may well include annual COVID-19 vaccination alongside seasonal influenza vaccination.”

June could be when FDA officials make a decision on the composition of Covid-19 vaccines for the fall and winter seasons – and what the vaccination plans might be.

By this summer, “decisions will need to be made” on who should be eligible for additional Covid-19 shots in the fall, and by June, the composition of the vaccines will need to be determined, Marks, Woodcock and Califf wrote.

LANDOVER, MARYLAND - MARCH 18: Pharmacist Fedelis Onyimba injects the Moderna COVID-19 vaccine into one of about 200 people who got their shots at First Baptist Church of Highland Park March 18, 2021 in Landover, Maryland. The vaccination site is part of the Maryland Vaccine Equity Task Force's effort to partners with all 24 of Maryland's local health departments to focus coronavirus vaccination efforts on "underserved, vulnerable, and hard-to-reach populations to ensure the equitable delivery of vaccines." (Photo by Chip Somodevilla/Getty Images)

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Last week, the FDA announced plans to convene its Vaccines and Related Biological Products Advisory Committee on June 28 to discuss whether the composition of current Covid-19 vaccines should be modified, and if so, what updates should be selected for the fall.

“In terms of practical considerations, at the recent meeting of the VRBPAC, there was relatively uniform agreement that a single vaccine composition used by all manufacturers was desirable and that data would be needed to inform and drive the selection of a monovalent, bivalent, or multivalent COVID-19 vaccine,” Marks, Woodcock and Califf wrote. “There was also general agreement that, should a new vaccine composition be recommended based on the totality of the available clinical and epidemiologic evidence, optimally it could be used for both primary vaccination as well as booster administration.”

VRBPAC members met in April to discuss how the composition of Covid-19 vaccines could change to target any new and emerging coronavirus variants. The committee agreed that there needs to be a framework for how and when such changes take place. The advisers plan to continue their conversation in the coming months.

Children 12-15 years old receive a Pfizer-BioNTech Covid-19 vaccine booster at Hartford Hospital in Hartford, Connecticut on January 6, 2022.

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“By summer, decisions will need to be made for the 2022-2023 season about who should be eligible for vaccination with additional boosters and regarding vaccine composition. Administering additional COVID-19 vaccine doses to appropriate individuals this fall around the time of the usual influenza vaccine campaign has the potential to protect susceptible individuals against hospitalization and death, and therefore will be a topic for FDA consideration,” Marks, Woodcock and Califf wrote.

Certain immunocompromised people and adults 50 and older are eligible for additional booster doses of Covid-19 vaccine in the United States. The FDA officials added that for those who have yet to get vaccinated or boosted, getting a vaccine dose now will not have adverse effects that preempt getting an additional dose in the fall.

The composition of the current vaccines could be updated to target circulating coronavirus variants. Marks, Woodcock and Califf wrote that this coming fall and winter, three factors may come together to place the nation at additional risk of Covid-19: waning immunity, seasonal waves of more coronavirus spread, and the further evolution of the coronavirus, leading to new variants.

“The timeframe to determine the composition of the COVID-19 vaccine for the 2022-2023 season, to use alongside the seasonal influenza vaccine for administration in the Northern Hemisphere beginning in about October, is compressed because of the time required for manufacturing the necessary doses,” the officials wrote. “A decision on composition will need to be made in the US by June 2022.”