FDA's top vaccine chief resigns amid growing concerns over new HHS leadership

Source: CBER. ?Dr Peter Marks, the director of the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER).

In his resignation letter, Marks cited concerns over Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.'s approach to vaccine policies, stating that Kennedy prioritised "misinformation and lies" over scientific truth.

Marks played a pivotal role in the rapid development and approval of Covid-19 vaccines during Operation Warp Speed. His departure has raised concerns among health experts about the future direction of vaccine regulation under the current HHS leadership.

Dr Paul Offit, a vaccine expert at Children's Hospital of Philadelphia, remarked that Marks' resignation allows "the fox to guard the hen house," expressing apprehension about the implications for public health.

This resignation occurs amid broader restructuring within HHS, including significant layoffs and agency closures. Secretary Kennedy has initiated these changes, criticising the department as an inefficient "sprawling bureaucracy".

Furthermore, the FDA has recently delayed its decision on granting full approval to Novavax's Covid-19 vaccine, and missed the 1 April deadline. This delay follows Marks' departure and reflects the ongoing shifts within the agency.