Moderna (NASDAQ:MRNA) shares tumbled 13% pre-market on Monday following news that Dr. Peter Marks, the FDA’s leading vaccine official, was ousted over the weekend. BioNTech (NASDAQ:BNTX) shares also declined by 5.75%.
Dr. Marks, recognized for his significant role in Operation Warp Speed and advocacy for vaccine development during the COVID-19 pandemic, resigned after a disagreement with Health and Human Services Secretary Robert F. Kennedy Jr. concerning vaccine misinformation, according to The Wall Street Journal.
The departure of Dr. Marks comes at a critical time for the FDA’s Center for Biologics Evaluation and Research (CBER), which he has led since 2016. CBER plays a vital role in ensuring vaccine safety and effectiveness. In his resignation letter, Dr. Marks stated that he could not align with Kennedy’s views, which are often seen as opposing mainstream scientific consensus on vaccines.
Truist analyst Joon Lee commented on the situation, noting that companies associated with CBER could experience volatility following Dr. Marks’ resignation. However, he emphasized that the resignation appears related specifically to vaccine-related disagreements and is unlikely to impact CBER’s approach to reviewing therapeutics for rare genetic diseases. He maintained a positive outlook on genetic medicine companies under CBER’s purview.
Lee also mentioned that vaccine developers such as Pfizer (NYSE:PFE), GSK (GSK), BioNTech (BNTX), and Moderna (MRNA) could be affected by the leadership change, though the potential impact on vaccines remains uncertain.
Investors are particularly concerned about how Dr. Marks’ exit, effective April 5, could influence Moderna’s vaccine business, given his pivotal role in the regulatory landscape. The leadership transition within the FDA’s vaccine division introduces uncertainty for developers like Moderna, especially as vaccine safety and innovation remain global priorities.
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