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Vaccine Markets in Turmoil: Peter Marks Resigns Amidst Controversial Leadership Changes at HHS

Stock prices for major vaccine manufacturers declined Monday following the Friday resignation of Peter Marks, the Food and Drug
Administration’s leading vaccine official, who stepped down citing conflicts with newly appointed Health and Human Services Secretary Robert F. Kennedy Jr.

Marks, who had led the FDA’s Center for Biologics Evaluation and Research (CBER) since 2016, stated in his resignation letter that Kennedy was seeking “subservient confirmation of his misinformation and lies.” As CBER director, Marks played an instrumental role in Operation Warp Speed during the first Trump administration, helping expedite the development and authorization of COVID-19 vaccines.

The departure sparked concerns about potential changes to vaccine regulation under Kennedy, who has historically promoted vaccine skepticism. Major pharmaceutical companies like Pfizer and GSK saw their shares drop approximately 1%, while smaller biotechnology firms including Moderna, BioNTech, Vaxcyte, and Novavax experienced steeper declines.

Kennedy’s stance on vaccines emerged as a significant issue during his Senate confirmation process. As the founder and previous chairman of Children’s Health Defense, he has been criticized for spreading discredited theories about vaccine safety. His response to the ongoing measles outbreak, which has affected nearly 500 individuals across the United States, has drawn particular scrutiny.

In his resignation letter, Marks specifically referenced this outbreak, noting that it demonstrates the consequences of undermining established scientific consensus regarding public health measures. While the measles vaccine is proven to be 97% effective with two doses, Kennedy has characterized vaccination as a “personal decision” and promoted alternative treatments like vitamin A, which lack scientific support.

The transition has also affected vaccine advisory meetings, though a Centers for Disease Control and Prevention meeting has been
rescheduled for next month. This meeting will cover vaccines for multiple conditions including COVID, RSV, HPV, and measles.

Financial analysts have offered mixed perspectives on these
developments. David Risinger of Leerink Partners identified the upcoming CDC meeting as a crucial indicator for vaccine developers. Jefferies analysts acknowledged increased uncertainty following Marks’ departure but viewed the rescheduled meeting as a positive sign of commitment to established evaluation procedures.

Some observers see President Trump’s nomination of Susan Monarez for CDC director, replacing vaccine critic David Weldon’s withdrawn nomination, as an encouraging development. Monarez has been affiliated with the Advanced Research Projects Agency for Health since 2023.

The selection of Marks’ replacement is being watched closely by stakeholders. Senator Bill Cassidy, who provided the decisive vote for Kennedy’s confirmation, advocated on social media platform X for a successor with “similar stature and credibility amongst the scientific community, who will lead without bias.”

The authority to appoint Marks’ replacement typically falls to newly confirmed FDA Commissioner Martin Makary. The development occurs amid broader changes at HHS, including recently announced plans for significant staff reductions and organizational restructuring under Kennedy’s leadership.

Multiple requests for comment from major vaccine manufacturers including Moderna, BioNTech, and Novavax, as well as from HHS, remained unanswered. The situation continues to evolve as the healthcare and pharmaceutical sectors adjust to new leadership and potential policy shifts at key federal agencies.

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