The UK's medicine regulator has temporarily restricted the use of French vaccine maker Valneva's shot to treat chikungunya, a virus transmitted by mosquitoes, in people aged 65 and above as a precautionary measure.
The vaccine, IXCHIQ, was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in February to protect people aged 18 years and above against chikungunya, but is not yet available in the UK market, the regulator said on Monday.
“The decision to restrict the licence until further review is based on global data which has highlighted 23 cases of serious adverse reactions, including two cases reporting a fatal outcome, in people aged from 62 to 89 years of age who received the vaccine.”
The adverse events were reported in the French overseas territory of La Reunion, where a chikungunya outbreak was reported earlier this year.
The MHRA's decision comes after the European Medicines Agency, the US Food and Drug Administration and the Centres for Disease Control and Prevention in May suspended the use of the vaccine in the age group.
The French government was the first to take the step in April.
Reuters
UK's MHRA suspends Valneva's chikungunya vaccine for elderly
Image: AKOS STILLER/BLOMBERG
The UK's medicine regulator has temporarily restricted the use of French vaccine maker Valneva's shot to treat chikungunya, a virus transmitted by mosquitoes, in people aged 65 and above as a precautionary measure.
The vaccine, IXCHIQ, was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in February to protect people aged 18 years and above against chikungunya, but is not yet available in the UK market, the regulator said on Monday.
“The decision to restrict the licence until further review is based on global data which has highlighted 23 cases of serious adverse reactions, including two cases reporting a fatal outcome, in people aged from 62 to 89 years of age who received the vaccine.”
The adverse events were reported in the French overseas territory of La Reunion, where a chikungunya outbreak was reported earlier this year.
The MHRA's decision comes after the European Medicines Agency, the US Food and Drug Administration and the Centres for Disease Control and Prevention in May suspended the use of the vaccine in the age group.
The French government was the first to take the step in April.
Reuters
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