EMA Recommends Revaccination for Travellers in Need of Protection with Ixiaro

Intercell AG is recalling batch JEV09L37 of vaccine Ixiaro throughout the EU. The CHMP recommends that revaccination with a different batch should be considered.

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) was informed that a specific batch of the Japanese encephalitis vaccine Ixiaro (batch JEV09L37) may be less potent than expected and may not induce a full protective immune response in vaccinees. Therefore, as a precautionary measure, Intercell AG is recalling batch JEV09L37 of Ixiaro throughout the EU.

For individuals who have already received one or two doses of Ixiaro from this batch and who are planning to travel soon to regions of exposure to Japanese encephalitis, the CHMP is recommending that revaccination with a different batch should be considered.

Within the EU, batch JEV09L37 manufactured by Intercell AG,  has been used in France, Italy, Spain