BioNTech SE (BNTX) shares tumbled 6.71% in pre-market trading on Monday, as investors reacted to the sudden resignation of Dr. Peter Marks, a top Food and Drug Administration (FDA) official. The departure of this influential figure has sent shockwaves through the biotech sector, particularly affecting vaccine manufacturers.

Dr. Marks, who led the FDA's Center for Biologics Evaluation and Research (CBER), stepped down on Friday night due to disputes with Robert F. Kennedy Jr., the new Secretary of the U.S. Department of Health and Human Services (HHS). The resignation letter, published by the New York Times, revealed tensions over vaccine safety concerns. As the director of CBER, Dr. Marks played a crucial role in approving new vaccines, gene therapies, and other cutting-edge medicines, including the rapid development and approval of COVID-19 vaccines during Operation Warp Speed.

The resignation has raised concerns about the future of vaccine approvals and regulations, particularly impacting companies like BioNTech, which partnered with Pfizer on a COVID-19 vaccine. Analysts warn that Dr. Marks' departure creates significant uncertainty in the biotech space, especially for vaccine, gene therapy, and cell therapy developers. As vaccine skepticism mounts at high government levels, investors fear potential challenges in the regulatory environment for vaccine makers, contributing to the sharp decline in BioNTech's stock price.