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Investing.com -- Moderna (NASDAQ:MRNA) shares dropped 13% pre-open on Monday as investors reacted to the weekend news that the U.S. Food and Drug Administration’s (FDA) top vaccine official, Dr. Peter Marks, was ousted. Shares of BioNTech (NASDAQ:BNTX) also declined, falling 5.75%
Dr. Marks, known for his pivotal role in Operation Warp Speed and his support for vaccine development during the Covid-19 pandemic, resigned following a clash with Health and Human Services Secretary Robert F. Kennedy Jr. over vaccine misinformation, according to the Wall Street Journal.
The shakeup comes at a time when the FDA’s Center for Biologics Evaluation and Research (CBER), which Dr. Marks has led since 2016, is critical in ensuring the safety and efficacy of vaccines. Dr. Marks expressed in his resignation letter that he could not support Kennedy’s stance, which has been characterized by skepticism towards immunizations—a position that directly conflicts with the scientific community’s consensus on vaccines.
Truist analyst Joon Lee weighed in on the situation, stating, "We expect some volatility on companies exposed to CBER on news of resignation of Dr. Marks, who has been a champion of therapeutic development for rare genetic diseases and also led the agency through Covid. However, his resignation appears to be more specific to disagreements around vaccines with minimal read-through to his (and CBER’s) approaches to reviewing and approving therapeutics for rare genetic diseases. We don’t expect material impacts to our BUY rated genetic medicine companies with exposures to CBER. Also affected could be vaccine developers including Pfizer (NYSE:PFE, NR), GSK (GSK, NR), Biontech (BNTX, BUY) and Moderna (MRNA, NR). However, impact to vaccines may be harder to handicap at this juncture."
Investors are likely concerned about the potential implications of Dr. Marks’ departure on Moderna’s vaccine business, given his influential role in the regulatory process. His exit is set to take effect on April 5, according to his resignation letter addressed to acting FDA Commissioner Sara Brenner. The unexpected change in leadership within the FDA’s vaccine division could introduce uncertainty for vaccine developers, including Moderna, at a time when vaccine safety and development remain a global priority.
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