Daiichi Sankyo says it is voluntarily recalling 13 lots of the ActHIB pediatric vaccine after it found an unidentified substance in two syringes. The vaccine is manufactured and marketed by Sanofi Pasteur and distributed by Daiichi in Japan.
"As a result of analysis of information by Sanofi Pasteur up to the present time, it has been confirmed that the foreign matter was aseptic (nonbacterial)," Daiichi says in a statement. "However, in order to eliminate every possible risk, it was decided to voluntarily recall the ActHIB products which were manufactured in the same manufacturing process as the syringes in which the foreign matter was confirmed starting today."
Daiichi told the AFP that most of the 1.3 million dose shipment had already been used and only a small percentage remained. A Sanofi Pasteur representative told the news agency that the vaccines were delivered between September 2010 and late January 2011 but were produced about six months prior.
The move comes after the Japanese government suspended Pfizer's meningitis/pneumonia vaccine Prevnar and Sanofi's ActHIB while regulators investigated the deaths of four children. The infants had been vaccinated with several childhood shots simultaneously.
After reviewing the data, the experts determined the deaths were most likely a coincidence, and no issues were found in the lots of the vaccines used for the children. But Prevenar and ActHIB will remain suspended until more data can be examined. In the U.S., the CDC says it's aware of the deaths, but health agencies "have not detected new safety concerns or unusual reporting patterns," according to a spokesperson.