Sanofi Pasteur and partner Daiichi Sankyo have decided to voluntarily recall 13 lots of a paediatric vaccine in Japan, where its use is currently suspended.
The affected lots of ActHIB, which are manufactured and marketed by Sanofi and distributed by Daiichi Sankyo in Japan for haemophilus influenza type b, are being recalled due to an investigation which confirmed two cases of contamination inside syringes of diluent used to reconstitute the vaccine. Sanofi confirmed that the foreign matter was non-bacterial, but "in order to eliminate every possible risk", it was decided to voluntarily recall the ActHIB products manufactured in the same process as the affected syringes.
Last week, Japan's Ministry of Health, Labour and Welfare temporarily suspended ActHIB and Pfizer's Prevnar for protection against meningitis and pneumonia while it investigates the deaths of four children linked to the vaccines. A safety panel review found no link but ActHIB and Prevnar remain suspended for now as a precautionary measure; the ActHIB recall is not connected to the case.