STORY AT-A-GLANCE

  • Two senior U.S. Food and Drug Administration officials have suddenly turned in their resignations; Marion Gruber is leaving her position as director of FDA’s Office of Vaccines Research & Review in October, and her deputy, Dr. Philip Krause, is leaving in November
  • Gruber and Krause reportedly said they don’t believe there’s sufficient data to support the rollout of COVID boosters in September 2021. They also objected to involvement by the U.S. Centers for Disease Control and Prevention and its advisory panel on immunizations in the decision making
  • August 12, 2021, health officials authorized a third booster shot for people with weakened immune systems who had initially received the Pfizer or Moderna injections. Since then, at least 955,000 COVID-19 boosters have been administered, though it’s unclear whether all were technically authorized
  • The rollout of booster shots for adults who got their second dose at least six months ago is expected to begin September 20, 2021
  • While Gruber and Krause appear to have resigned in protest because the Biden administration and CDC are moving ahead with boosters despite a lack of data, this data vacuum was enabled by the FDA itself from the start, as it opted to forgo stringent post-vaccination data collection and evaluation