Two senior Food and Drug Administration officials have resigned after the Biden administration and the Centers for Disease Control pushed out recommendations for a third Wuhan coronavirus booster shot before the agency issued an official approval.
From CNBC:
Two senior Food and Drug Administration officials responsible for reviewing Covid-19 vaccine applications are leaving the federal agency this fall, an agency spokesperson confirmed Tuesday.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency in October and November, respectively, according to a letter shared with CNBC by FDA spokeswoman Stephanie Caccomo.
Their announced plans to depart come as the Biden administration prepares to begin offering Covid vaccine booster shots to the general public the week of Sept. 20. Some health experts saw the move as premature and political, especially because the FDA hasn’t finished reviewing data on boosters yet.
During a White House Wuhan Coronavirus task force briefing on Monday, Coronavirus Response Coordinator Jeffery Zients confirmed political officials like Dr. Anthony Fauci and CDC Director Rochelle Walensky made the decision to move forward without the FDA.
“The booster decision, which you referenced, is –we’ve talked about the decision — was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock, the FDA Acting Commissioner; Dr. Francis Collins; Dr. Kessler; and others,” Zients said. “And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot. We announced our approach in order to stay ahead of the virus, give states and pharmacies time to plan, and to be transparent with the American people as to the latest data and expert clinical judgments from the team to give them time to do their own planning.”
