The US Food and Drug Administration (FDA) has seen a significant exodus of top vaccine regulators following the resignation of Dr. Peter Marks, the agency’s chief vaccine official. The departures have raised concerns about the agency’s ability to approve new vaccines and other drugs.
Experts warn that the loss of experienced staff will leave a void at a critical time when distrust in vaccines and health institutions is growing. Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Pennsylvania, described the departures as “hollowing out” the agency and said the loss of institutional memory would have significant consequences.
The FDA’s Center for Biologics Evaluation and Research (CBER) has been responsible for ensuring the safety and effectiveness of vaccines and gene therapies. The departures include Julia Tierney, Christopher Joneckis, Sheryl Lard-Whiteford, and Michelle Limoli, who had worked on various aspects of vaccine regulation.
The moves come as HHS Secretary Robert F. Kennedy Jr. works to reshape the public health infrastructure and has previously been critical of CBER’s decisions. The administration’s actions have left former officials describing a “complete s—show” and concerns about additional risk.
Approval of vaccines for cancer, particularly mRNA-based treatments, is now at risk due to the departures. Experts warn that the loss of top regulators will slow down the approval process, potentially leading to delays in life-saving vaccine development.
The FDA’s CBER is responsible for approving vaccines against diseases such as bird flu, which has already infected 998 dairy herds and killed one person. The agency’s ability to respond to public health threats is now uncertain.
Despite some top officials remaining at the agency, concerns about the impact of the departures on vaccine regulation and approval remain high.
Source: https://www.nbcnews.com/health/health-news/top-vaccine-regulators-fda-threatening-new-approvals-rcna198898