FDA Suspends License for Valneva's IXCHIQ Vaccine in the US Citing Four Severe Adverse Events

Valneva's chikungunya vaccine, IXCHIQ, has been suspended by the FDA in the US due to four new cases of severe adverse events similar to the disease. The suspension will impact the distribution and sale of the vaccine in the US. Valneva is analyzing the cases and will consider legal action if necessary. The company remains committed to maintaining access to the vaccine globally and will continue to provide it to countries where it is authorized. The FDA previously lifted a temporary halt of the vaccine's use in people over 60.

The US Food and Drug Administration (FDA) has recommended a temporary pause in the use of Valneva's chikungunya vaccine, IXCHIQ, in individuals aged 60 and older following the reporting of four severe adverse events similar to the disease. The suspension, which will impact the distribution and sale of the vaccine in the US, comes after the FDA and the Centers for Disease Control and Prevention (CDC) investigated severe adverse events, including neurologic and cardiac issues, in vaccine recipients aged 62 to 89 years [1].

The FDA's decision follows a CDC alert in early March that investigated five hospitalizations in people aged 65 and older who had received the vaccine. In late April, French drug regulators updated their recommendations for IXCHIQ after reports of adverse reactions in older people with underlying health conditions who were prioritized to receive the vaccine in a large ongoing outbreak in La Reunion and Mayotte. On May 7, the European Medicines Agency announced that its safety committee had launched a review of IXCHIQ in older people and said the vaccine must not be used in people aged 65 and older [1].

Valneva is currently analyzing the cases and has stated that it will consider legal action if necessary. The company remains committed to maintaining access to the vaccine globally and will continue to provide it to countries where it is authorized. The FDA previously lifted a temporary halt of the vaccine's use in people over 60.

The FDA approved the vaccine in November 2023 for use in people aged 18 and older at increased risk for the mosquito-borne disease. At its meeting in April, CDC vaccine advisors recommended including a precaution about the vaccine’s use in people aged 65 and older. The FDA and CDC said about 80,000 doses have been given globally. IXCHIQ contains a weakened form of the virus, which may cause symptoms of chikungunya. Federal officials said some of the severe adverse events reported are similar to severe complications from the disease [1].

References:

[1] https://www.cidrap.umn.edu/chikungunya/fda-cdc-recommend-pause-valneva-chikungunya-vaccine-older-adults