Valneva suspended from marketing chikungunya shot in U.S. over safety concerns

[US Food and Drug Administration (FDA)]

The U.S. Food and Drug Administration (FDA) late Friday announced that it has suspended the marketing application granted for French biotech Valneva’s (NASDAQ:VALN [https://seekingalpha.com/symbol/VALN]) chikungunya vaccine Ixchiq due to safety concerns, including several deaths.

The FDA initially cleared the shot in November 2023 under its accelerated approval pathway to prevent chikungunya, a mosquito-borne viral disease, in individuals aged 18 years and older who are at an increased risk of contracting the virus.

The decision to suspend its marketing application was “based on serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness in vaccine recipients,” the regulator said.

The FDA has recorded one mortality directly linked to Ixchiq and more than 20 serious adverse events similar to chikungunya-like illness in those who received the live-attenuated vaccine.

Overall, there have been 21 hospitalizations and three deaths, the agency noted, adding that Ixchiq’s clinical benefit has not yet been proven in confirmatory trials and the vaccine’s benefits do not outweigh its risks according to a benefit-risk analysis conducted by the FDA’s biologics division.

“For these reasons, CBER believes this vaccine is not [https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-update-safety-ixchiq-chikungunya-vaccine-live] safe and that continued administration to the public would pose a danger to health,” the regulator added.

The decision comes in the same month that the FDA and CDC removed a recommended pause in the use of Ixchiq in those aged 60 years and older, after requiring labeling changes to the shot following an investigation into serious adverse events linked to the vaccine. [https://seekingalpha.com/news/4481386-fda-lifts-pause-on-valnevas-chikungunya-vaccine-in-elderly]

Other operators in the U.S. chikungunya vaccine market include Danish biotech Bavarian Nordic (BAVN [https://seekingalpha.com/symbol/BAVN]) (OTCPK:BVNRY [https://seekingalpha.com/symbol/BVNRY]) (OTCPK:BVNKF [https://seekingalpha.com/symbol/BVNKF]).

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