FDA plans a rapid review process for COVID-19 vaccine booster shots to combat variants

New variants of the coronavirus are jeopardizing hopes of quashing the COVID-19 pandemic by the fall. But acting Food and Drug Administration head Dr. Janet Woodcock said Thursday evening that the U.S. is planning a rapid review process for booster shots that would target the new strains, among other strategies to beat back the quickly spreading variants and prepare for new ones that might render the current vaccines ineffective.

"With current vaccines, we feel that, against any variants we have seen we have a fair amount of confidence they will provide good protection," Woodcock said. However, "the situation could change" quickly, and "if variants emerge that the vaccines have poor efficacy against, we will need to go through these quickly," she added. "If the virus changes, we are getting prepared for that."

Full clinical trials of booster shots would take too long and face other impracticalities, Woodcock said, but they would still need to be evaluated for safety and efficacy by an independent expert advisory panel, preferably in a public hearing. The FDA expects to propose written guidelines in two to three weeks.

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Woodcock did not speculate the point at which booster shots might be necessary. But Paul Offit, a University of Pennsylvania vaccine expert who sits on an FDA vaccine advisory board, told Politico that line will be "crossed when people who have been fully vaccinated with two doses of one of these [authorized] vaccines are nonetheless hospitalized with one of these variant strains." Offit and other vaccine experts suggest the U.S. gear up to fight COVID-19 like it does with the yearly flu, altering the foundational vaccine to tackle new mutations.

Several vaccine makers, including Moderna, are already preparing trials for COVID-19 booster shots.