09-17-2021, 10:57 AM
President Biden’s administration’s plan calls for a third dose of the Pfizer or
Moderna vaccine eight months after recipients’ second jab.
The two officials are allegedly leaving their positions because they are frustrated with White House pressures to move forward with booster vaccines without FDA approval, as well as with the CDC’s involvement in the vaccine approval process.
Indeed, the FDA has only approved booster vaccines for those who are immunocompromised, but the Biden Administration announced it is expected to have booster shots for most Americans beginning around September 20.
Link
Two senior officials have resigned from their positions within the US Food and Drug Administration over frustrations with the Biden administration’s plans to move forward with recommending COVID-19 booster shots without their prior approval, according to a report.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause are set to leave the agency this fall, with sources telling Politico that the two officials were at odds with the FDA’s top vaccine official, Peter Marks, and were discontented over the roles of the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices in decisions that they believed should be handled by the FDA.
According to trade publication Endpoints, the officials felt they were sidelined on major decisions, that the administration’s plan for boosters was jumping the gun, and that Marks should have pushed for the FDA to have more autonomy on the matter.
Marks played a leading role in helping the administration craft its August announcement of calls for an additional vaccine for most adults after eight months.
Marks announced the resignations in a letter to colleagues obtained by Endpoints.
“The administration’s booster plan; it wasn’t the FDA’s booster plan,” University of Pennsylvania infectious disease expert Paul Offit, who serves on the FDA’s vaccine advisory committee, told Politico. “The administration has kind of backed themselves up against the wall a little bit here.”
Acting FDA Commissioner Janet Woodcock sent a memo to regulators Tuesday standing by the booster timeline, stating, “The issues are complex and the days are long, but please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put Covid-19 behind us and better prepare us for future challenges.”
Jeff Zients, the Biden administration’s coronavirus czar, also defended the booster timeline.
Acting FDA Commissioner Janet Woodcock sent a memo to regulators Tuesday standing by the booster timeline, stating, “The issues are complex and the days are long, but please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put Covid-19 behind us and better prepare us for future challenges.”
Jeff Zients, the Biden administration’s coronavirus czar, also defended the booster timeline.