Jan 19 (Reuters) – French drugmaker Valneva said on Monday it has voluntarily withdrawn its application seeking standard approval of its chikungunya vaccine in the United States after the FDA suspended the shot’s license in August, citing safety concerns.
The specialty vaccine-maker said it was also informed by the U.S. Food and Drug Administration that the agency was placing its application for further clinical trials of the vaccine, Ixchiq, on hold pending investigation of a newly reported serious adverse event.
The company, which said it had been waiting for further information on its formal response to the vaccine license suspension, added that there are currently no clinical studies involving Ixchiq that are actively vaccinating participants.
The vaccine had been awarded an accelerated U.S. approval, which typically requires further confirmatory trials to gain standard approval.
Valneva said it intends to move forward with planned post-marketing clinical activities, subject to further discussions with relevant regulatory authorities.
It said the serious adverse event happened outside the U.S. and that the case may be plausibly related to Ixchiq vaccination, but causality has not been determined. Valneva said it is actively seeking additional information to further characterize the case.
Chikungunya, a viral disease transmitted to humans by mosquitoes infected with the virus, causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash.
(Reporting by Anshuman Tripathy and Puyaan Singh in Bengaluru; Editing by Bill Berkrot)
