Valneva reported that its Phase 2 study VLA1553‑221, which enrolled 304 children aged 1‑11 years, has completed a 12‑month follow‑up and achieved a 94.7 % seroresponse rate at Day 360 with the full licensed dose. The half‑dose group showed a lower response, and the full‑dose response is comparable to the adult and adolescent data published earlier in the year.
The durability of the immune response and the absence of new serious adverse events reinforce the safety profile of IXCHIQ® in a younger population and support the company’s plan to pursue a pediatric Phase 3 trial. Valneva’s Chief Medical Officer, Dr. Juan Carlos Jaramillo, emphasized that the 12‑month persistence data confirm the vaccine’s long‑term protection potential and justify continued focus on the full dose for all age groups.
However, the positive pediatric data come against a backdrop of regulatory challenges. In August 2025, the U.S. Food and Drug Administration suspended IXCHIQ®’s license in the United States after a benefit‑risk assessment concluded that serious safety concerns—including hospitalizations and deaths—outweighed the benefits for most patients. The suspension limits the vaccine’s commercial reach in the largest market for chikungunya vaccines and has prompted scrutiny of Valneva’s safety monitoring processes.
The competitive landscape has also shifted. Bavarian Nordic’s chikungunya vaccine Vimkunya received FDA approval and is gaining traction as a potentially safer alternative. Valneva is therefore focusing on other pipeline assets, notably its Lyme disease vaccine candidate VLA15, to diversify its product portfolio and mitigate the impact of the IXCHIQ® setback.
The positive pediatric results could expand IXCHIQ®’s label and increase its addressable market, but the U.S. suspension and the emergence of a competitor mean that Valneva’s revenue prospects remain uncertain. Management remains cautious, emphasizing rigorous safety oversight and a phased regulatory strategy while exploring opportunities in other indications.
Dr. Jaramillo added, “The 12‑month persistence data confirm the vaccine’s long‑term protection potential and justify the continued focus on the full dose for all age groups.”
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