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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
Japan has suspended the use of two pediatric vaccines made by Pfizer and sanofi following the deaths of four children in three days.
Japan suspended the use of two pediatric vaccines, one made by Pfizer and one by sanofi, following the deaths of four children in three days. The deaths occurred shortly after vaccination with Pfizer’s Prevenar vaccine (known as Prevnar in the United States) and sanofi’s ActHIB vaccine. Although a panel of experts at Japan’s Health Ministry have found no link between the deaths and vaccination, the suspension will remain in place while further studies are conducted.
Other national regulatory agencies are aware of the situation. In Hong Kong, the Department of Health said in a statement that it has “no record of untoward event report[s] associated with Prevenar, but we will inform all medical practitioners of the Japanese incident and request them to bring up any anomaly detected." sanofi’s vaccine is not used in Hong Kong, but both are widely used in the US. According to Reuters, FDA is monitoring the safety of both vaccines, but has not observed any safety concenrs in the US.
This is not the first time that Prevenar has faced safety suspicions. In 2009, a batch of Prevenar was pulled from the market in the Netherlands following the deaths of three infants after vaccination. In February 2010, however, it was announced that there was no link between the deaths and vaccination.