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Investing.com -- Bernstein warned in a note Tuesday that “shock waves are expected at the ACIP meeting this week,” citing a series of unusual developments that could have implications for Merck, Pfizer and Moderna.
The meeting, held Dec. 4–5, features an agenda that Bernstein analyst Courtney Breen says includes “an array of ‘unusual’ factors,” with limited detail, “no speakers listed,” and “no declaration of anticipated vote language.”
Analysts added that the agenda “has also swapped days with the broader work groups,” a move that, combined with recent regulatory signals, suggests “Friday is likely to be a big day.”
Elevating the stakes is a memo from Dr. Vinay Prasad, head of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research.
Breen wrote that Prasad “alleged that COVID-19 vaccines caused at least 10 pediatric deaths based on an internal review of VAERS reports,” which it notes would mark “the first FDA acknowledgment of vaccine-linked fatalities in children.”
According to Bernstein, Prasad also “signaled a major regulatory shift,” indicating that the agency will “prioritize clinical endpoints over surrogate measures,” “reassess vaccine use in pregnancy,” and reevaluate frameworks such as the annual flu program.
Bernstein also highlights heavy public engagement: “There are ~3.8k public comments posted for the December 2025 ACIP meeting,” with sentiment appearing mixed.
Roughly “50% of comments expressed support for Hep-B birth dose, while 48% conveyed skepticism.”
The firm says it will watch for any signals on “changes to the relationship between vaccine access/coverage & ACIP recommendations,” as well as potential shifts to evidentiary standards.
Bernstein notes that MRK and GSK are key manufacturers in Hep-B, while MRK, PFE and MRNA are exposed to any changes across the broader childhood vaccine schedule.