FDA Vaccine Suspensions: Outliers or the New Normal

James Boiani, Amy Dow, Richard Hughes IV, Members of the Firm, and William Walters, Associate, in firm’s Health Care & Life Sciences practice, co-authored “FDA Vaccine Suspensions: Outliers or the New Normal” in Health Affairs.

Following is an excerpt:

On August 22, 2025, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) suspended the biologics license for IXCHIQ, a live-attenuated chikungunya vaccine, citing “serious safety concerns.” Manufactured by Valneva Austria GmbH, the vaccine was initially approved by the FDA in November 2023 via the accelerated approval program for therapies addressing serious conditions that can fill an unmet medical need based on a surrogate endpoint (i.e., a measure thought to predict clinical benefit) …

FDA’s IXCHIQ suspension notice states that “Continuous monitoring and assessment of the safety of all vaccines remains an FDA priority.” Yet it comes amid a telling shift in vaccine policy, with aggressive moves on COVID-19 vaccines, and suggests a possible shift in FDA’s posture toward suspension and revocation. Viewed within the context of a HHS Secretary with a long history of anti-vaccine views and actions, even incredibly rare adverse events may now affect the licensure of vaccines.

The FDA appears poised to use the suspension and revocation pathways more aggressively than in the past, particularly with respect to biologics. This approach is not the natural swinging of the philosophical pendulum from one administration to the next; it has the potential to be enormously disruptive. By creating significant uncertainties for manufacturers and investors alike, we could very well see a decline in investment, a trend that could restrict patients’ access to innovative new products.

Nor does this appear to be a one-off case; the whipsaw regulatory actions described above, echo other rapid changes, such as recent actions the agency has taken with respect to Sarepta’s ELEVIDYS.

These actions may prove to be the first test cases in a broader reorientation of U.S. vaccine regulation (and, perhaps, biotech and pharmaceutical products more broadly). Whether it remains an anomaly or sets precedent will shape the future of immunization policy, industry innovation, and public confidence in science itself. If it becomes a trend of regulatory unpredictability, it could erode public trust, chill investment, and weaken America’s vaccine ecosystem. …