Investigation of Prevenar and deaths in children in Japan: what does it mean for Australia?

摘要

In response to the suspension of Prevenar and ActHIB in March 2011 in Japan due to a potential link with childhood deaths, the TGA conducted an investigation finding no safety signal for an association between Prevenar and death in Australia. As a result, the registration and recommendations for use of Prevenar are unchanged. This article describes the process used by the TGA to investigate this potential safety concern.