BioNTech SE (BNTX) shares plummeted 7.73% in pre-market trading on Monday, as the biotech sector reeled from the shocking resignation of Dr. Peter Marks, a top Food and Drug Administration (FDA) official. Dr. Marks, who led the FDA's Center for Biologics Evaluation and Research (CBER), stepped down on Friday night over disputes with Health and Human Services Secretary Robert F. Kennedy Jr. regarding vaccine safety.

The resignation has sent shockwaves through the biotech industry, particularly affecting vaccine manufacturers like BioNTech, which partnered with Pfizer to develop a Covid-19 vaccine. Dr. Marks played a crucial role in Operation Warp Speed and was known for his support of rapid approvals for rare disease drugs and vaccines. His departure creates significant uncertainty in the biotech space, especially for vaccine, gene therapy, and cell therapy developers.

Analysts suggest that the impact of Dr. Marks' resignation will be felt until the industry gains a better understanding of how his legacy might continue under new leadership at the FDA. This uncertainty, coupled with concerns about potential changes in vaccine policy under Kennedy's influence, has prompted investors to reassess their positions in vaccine-related stocks. The news has also affected other major players in the vaccine industry, with Moderna and Pfizer experiencing significant pre-market declines as well.