Vaccine developer Intercell AG recently announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has released a positive opinion for the use of the vaccine IXIARO in children.
The European Commission is expected to issue a final decision on IXIARO, a vaccine to prevent Japanese Encephalitis, in February or March. Intercell submitted its application for the approval of a pediatric label extension in mid-2012 based on favorable data from two phase III clinical studies.
In both of the clinical trials, IXIARO was proven to be highly immunogenic in children aged two months to 18 years with a safety profile comparable to other pediatric vaccines already under license for other illnesses.
“We are very pleased about the positive CHMP opinion on the pediatric indication for our JE vaccine.” Intercell CEO Thomas Lingelbach said. “This will be the first time European travelers of all ages can be protected against this dreadful disease with a licensed vaccine.”
Lingelbach said that developing a vaccine to protect children from Japanese Encephalitis has been one of the major goals of the company following the approval and launch of the vaccine for adult use. IXIARO is the company’s first product on the market and has been licensed for use in 30 countries. It is a purified, inactivated vaccine.