ARTICLE | Clinical News

Ixiaro regulatory update

August 22, 2011 7:00 AM UTC

Intercell said in its 2Q11 earnings that it began a comprehensive investigation and root cause analysis of a May voluntary recall of a single batch of its Ixiaro Japanese encephalitis (JE) vaccine to prevent recurrence. EMA's CHMP warned that the recalled batch, JEV09L37, may be less potent than expected and may not induce a full protective immune response in subjects. Intercell is working with EMA to investigate the root cause, determine clinical implications of vaccination with a sub-potent lot and develop action plans and preventative measures, which it plans to finalize by year end (see BioCentury, June 6). ...