Two Senior FDA Leaders Resign Amid Crucial Times in Vaccine Regulation.

    The United States Food and Drug Administration (FDA) will be losing two of its most senior vaccine leaders in the next few weeks. Their resignations can significantly derail efforts regarding the ongoing formulation of safe and efficient COVID-19 vaccines.

    The senior FDA leaders stepping down are Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and Phil Krause, deputy director of the Office of Vaccine Research and Review (OVRR).

    Gruber is a veteran of the federal agency for more than three decades and will be leaving in October, while Krause is deferring his position of more than ten years in November.

    The resignation of Gruber and Krause could not have come at a worse time because the agency is closely monitoring the development of children’s COVID-19 vaccines and booster shots at present. Their departure is also foreseen to hurt the expected release of the booster shots on or before September 20.

    According to a former senior FDA leader, Gruber and Krause are leaving because the Centers for Disease Control and Prevention (CDC) and their Advisory Committee on Immunization Practices (ACIP) are sidelining the agency’s major decisions.

    They are also upset with Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), for not establishing a proper barrier regarding decisions that should be made and kept inside the FDA.

    Moreover, the ex-senior FDA leader added that Gruber and Krause’s breaking point was when the Biden administration crossed the line on the closely monitored development of COVID-19 booster shots.

    Upon hearing the news of their resignation, former Biomedical Advanced Research and Development Authority (BARDA) director Rick Bright wrote:

    “These two are the true leaders of CBER” and “a huge global loss if they both leave.”

    Bright added that “Dr. Gruber is much more than the Director” and described her as a visionary who played a vital role in the global clinical, regulatory science for Sars-cov-2, Zika, Mers, Ebola, and flu, among others.

    The FDA’s former acting chief scientist, Luciana Borio, posted on social media:

    “The agency is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”

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