COVID-19 booster debate rages days before target rollout date

Emily Kopp, CQ-Roll Call on

Published in Political News

The Lancet review of 93 studies co-authored by two top FDA vaccine regulators — Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and Phil Krause, the office’s deputy director — pointed to enduring vaccine efficacy and highlighted some randomness in the data from Israel that has been released so far.

“Reported effectiveness against severe disease in Israel was lower among people vaccinated either in January or April than in those vaccinated in February or March, exemplifying the difficulty of interpreting such data,” they wrote in the article, which was co-authored with top global health officials at the WHO.

Gruber and Krause recently announced they would leave the agency later this year, reportedly in response to the president’s push on boosters.

“To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease,” they wrote.

They argue shots could make a bigger impact abroad.

“Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the authors wrote.


It’s not clear whether the FDA’s vaccine advisers will consider the questions raised by the WHO and these FDA officials. Gruber and Krause have typically been on hand to answer questions and offer input during prior advisory group meetings on COVID-19 vaccines.

Advisory meeting outlook

Archana Chatterjee, a member of the VRBPAC and dean of Chicago Medical School, said in a brief email that she was not sure about the scope of the committee’s discussions and whether they would include The Lancet article or the issue of global supply.

“I would like to review the briefing documents and hear the presentations and discussions before making up my mind,” she said.


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