US health authorities have suspended licence for Ixchiq vaccine against chikungunya virus following reports of “serious adverse events” drug’s French maker said Monday
Ixchiq is one of just 2 vaccines approved by US Food & Drug Administration for mosquito-spread virus, which mainly occurs in tropical & subtropical regions but has recently been discovered in countries worldwide.
French company Valneva obtained US approval for vaccine in 2023 but reports of side effects have prompted reviews in particular over its use in older patients including by European Medicines Agency this year
“Suspension of licence is effective immediately”
Valneva said of FDA order issued Friday, citing 4 additional cases of serious side effects, 3 of which involved people aged 70-82
“As we determine potential next steps & as clear threat of chikungunya continues to escalate globally, Valneva remains fully committed to maintaining access to our vaccine as a global health tool”
Chief executive Thomas Lingelbach said
Company said it was evaluating financial impact of suspension “but is not modifying its revenue guidance at this time”
It said Ixchiq generated sales of 7.5 million euros ($8.8 million) in 1st half of this year
Suspension prompted sell-off of Valneva’s shares on Paris stock exchange, falling over 26%
Public health experts say chikungunya could be potential future pandemic threat as climate change pushes mosquitoes that spread it into new regions
Chikungunya is rarely fatal, though there is increased risk of death for babies & elderly
In July, WHO warned of risks of major chikungunya epidemic, calling for urgent action
Agency said it was picking up same early warning signs as in major outbreak 2 decades ago, which swept across Indian Ocean before spreading globally & affecting almost half a million people
So far this year, Europe has seen 27 chikungunya outbreaks, new record for continent, European Centre for Disease Prevention and Control (ECDC) said this month
