(Reuters) -The European Union’s health regulator said on Wednesday it was reviewing French drugmaker Valneva’s chikungunya vaccine after reports of serious side effects in older adults.
The European Medicines Agency’s (EMA) safety committee has temporarily suspended the use of the vaccine, branded as Ixchiq, in adults aged 65 years and older.
The company said it will continue to monitor the reported events and cooperate with health authorities, while actively exploring a potential update to the vaccine’s indication.
Ixchiq — the first preventive shot against chikungunya virus to be authorized in the Europe as well as the U.S. — contains a weakened strain of the virus that triggers the immune system to make antibodies.
The vaccine carries the risk of causing severe chikungunya-like adverse reactions, the EMA said in a statement.
Chikungunya is a mosquito-borne disease caused by the chikungunya virus. The most common symptoms of the infection are fever and joint pain.
About 17 serious adverse events, including two deaths, have been reported so far globally in people aged between 62 and 89 years who had received the vaccine, the agency said.
Two men aged 84 years and 77 years who had received the vaccine died in the French overseas territory of La Reunion, where a recent chikungunya outbreak has been reported.
The exact cause of the adverse events and their relationship with the vaccine have not yet been determined, the agency said, adding that the affected individuals also had other health conditions.
The French government suspended the use of the vaccine in persons aged 65 years and older last month pending investigation.
Advisers to the U.S. Centers for Disease Control and Prevention had recommended the vaccine last month for adults traveling to a country or territory where there is a chikungunya outbreak. The recommendation is yet to be signed off by the CDC.
(Reporting by Mariam Sunny in Bengaluru; Editing by Tasim Zahid and Shinjini Ganguli)
