Composition for COVID-19 Vaccine for 2022-2023 Season Must be Decided by June, Say Califf, Woodcock and Marks in JAMA Editorial

May 5, 2022

A decision on the composition of a COVID-19 vaccine to be administered to the American population beginning this fall will need to be made by June.

That’s according to an editorial in the Journal of the American Medical Association (JAMA) penned by FDA Commissioner Robert Califf, former Acting Commissioner Janet Woodcock, who now serves as FDA’s principal deputy commissioner, and Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER).

“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,” wrote the FDA heavyweights in the editorial.

Because of this timing, they said, the FDA, along with its Vaccines and Related Biological Products Advisory Committee (VRBPAC), will need to arrive at a recommendation for the future of the vaccine based on the available evidence and predictive modeling, “with the understanding that there will be some inherent residual uncertainty about the further evolution of SARS-CoV-2,” they said.

“To date, the original, or prototype, vaccine composition deployed has been reasonably good at protecting against severe outcomes from COVID-19,” wrote Califf, Woodcock and Marks. “However, a greater depth and duration of protection might be achieved with a vaccine covering currently circulating variants.”

The three said careful consideration will need to be given to the choice of the SARS-CoV-2 variant(s) to cover in the COVID-19 vaccines for the fall and winter because the variant(s) covered by the vaccine may have an important influence on both the extent and duration of protection against any future SARS-CoV-2 variants.

“Better alignment between the variant(s) covered by the vaccine and circulating variant(s) of SARS-CoV-2 might be expected to prevent a broader spectrum of disease, potentially for a longer time,” they wrote.

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, said Califf, Woodcock and Marks.

There was also general agreement at the recent meeting that, should a new vaccine composition be recommended based on the totality of the available clinical and epidemiologic evidence, it could be used for both primary vaccination as well as boosters, they wrote.

A yearly COVID-19 vaccine that becomes available in the fall will likely require similar annual consideration for vaccine composition updates in consultation with the FDA and VRBPAC, they added.

Thus far, only 45 percent of the U.S. population has received a third vaccine dose, including only about 68 percent of those older than 65 years. Robust observational data from Israel with a large sample size showed additional protection against hospitalization and death in that population from third and fourth boosters.

By summer, decisions will also need to be made for the 2022-2023 season about who should be eligible for vaccination with additional boosters, said Califf, Woodcock and Marks.

“It is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal,” they wrote, adding that it will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses, such as influenza.

Read the full JAMA editorial here: bit.ly/3FgC192. — Suz Redfearn