FDA delays decision on Valneva’s chikungunya vaccine by three months for phase 4 negotiations

The FDA’s decision on Valneva’s chikungunya virus vaccine candidate, VLA1553, has been delayed. Initially, the agency was set to decide by the end of the month. Still, now, extending beyond the initial two-week grace period, the FDA has postponed its verdict for three additional months, with the new decision date now scheduled for the conclusion of November.

Valneva, a French biotech company, had eagerly anticipated the FDA’s decision. However, the company recently announced that the FDA had deferred its judgment date to November end. The rationale behind this extension, according to Valneva, is that the FDA requires more time for deliberation to come to an alignment and consensus regarding the phase 4 program, which is deemed necessary under the accelerated approval pathway. Significantly, the FDA has not requested further clinical data, indicating that the decision is based more on procedural aspects.

Dr. Juan Carlos Jaramillo, Valneva’s Chief Medical Officer stated that if VLA1553 gains authorization, it will mark a significant milestone, as it would be the pioneer vaccine candidate to be sanctioned through the accelerated approval pathway for an outbreak disease. He also emphasized that the subsequent phase 4 activities, if VLA1553 gets the green light, would establish a benchmark for future endeavors in this field. Dr. Jaramillo remained optimistic, stating that approval might potentially be obtained before the extended PDUFA (Prescription Drug User Fee Act) date.

Despite the setback, Valneva continues to hold the prospect of becoming the first company to secure approval for a chikungunya vaccine within the U.S. market. This achievement would come with an added benefit—a priority review voucher (PRV), which can expedite future FDA reviews or be sold for strategic gain. Although Valneva currently maintains its lead in the race for the PRV, the delay does impact the duration in which it has an exclusive market presence.

Earlier in the year, Merck & Co. withdrew from the PRV competition, leaving Valneva as the primary contender. However, Bavarian Nordic, a company that has recently reported consecutive successes in phase 3 trials, remains a contender, albeit slightly trailing Valneva’s progress. Bavarian Nordic’s standing has been strengthened by its acquisition of the candidate through a substantial $380 million deal. Their clinical data, while subject to the usual caution about comparing across trials, implies that their vaccine could offer similar protection to VLA1553, possibly acting faster.

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