BioNTech SE (BNTX) shares tumbled 6.71% 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, stepped down 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 makers. BioNTech, which partnered with Pfizer to develop a Covid-19 vaccine, was among the hardest hit. 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.

Analysts suggest that Dr. Marks' departure creates significant uncertainty in the biotech space, especially for vaccine, gene therapy, and cell therapy developers. The impact is expected to be felt until the industry gains a better understanding of how Dr. Marks' 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 like BioNTech.