Outgoing FDA Officials Attack Biden’s Vaccine Booster Plan

Two outgoing members of the Food and Drug Administration’s Office of Vaccines Research and Review were among the authors of an academic paper criticizing President Joe Biden’s plan for increased COVID-19 booster vaccines.

Director Marion Gruber and Deputy Director Phil Krause announced their resignations from the FDA on Aug. 31 and are set to leave this fall. Current administration sources told Politico that the pair resigned due to disagreements between the Biden administration and the agency over the efficacy of booster shots for the coronavirus vaccines.

Gruber and Krause were among 18 scientists who penned a Sept. 13 article in medical journal Lancet calling for vaccines to be dispensed to the unvaccinated rather than provided as boosters for those who have already received a full dose. Krause was listed as the primary author.

“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics,” the paper said. “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 paper argues that the evidence does not point toward a need for boosters “in the general population, in which efficacy against severe disease remains high.” It also warns that boosters “could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination.”

“The limited supply of these vaccines will save the most lives if made available to people who are at appreciable risk of serious disease and have not yet received any vaccine,” the paper concludes. “Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated.”

The Lancet paper is a rebuttal of the Biden administration’s plan to make a third shot of the Pfizer and Moderna vaccines available to all adults beginning Sept. 20.

The push resulted in heightened tensions between the administration, the FDA, and the Centers for Disease Control and Prevention, and it is unclear if the deadline will be met, as the agencies continue to deliberate this week.

Author: Virginia Aabram

Source: Washington Examiner: Outgoing FDA officials attack Biden’s vaccine booster plan

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