Rotavirus vaccine Rotarix

The company notified the TGA following the identification of DNA fragments of a virus that does not cause disease or replicate in humans. There is no evidence that the virus, or DNA fragments from it, have any adverse effects in humans. The European Medicines Agency has not identified a public health risk associated with the vaccine, and has taken no regulatory action, but is continuing to gather information. The USA FDA has not taken any regulatory action, but has requested USA medical practitioners not to use Rotarix for the next 4-6 weeks while the matter is further investigated. The TGA is working closely with its international regulatory counterparts and GSK to ensure the continued safety of this vaccine, and is convening an expert committee to provide further advice on the matter. The TGA will provide advice regarding its careful scientific risk assessment as soon as it is completed. Visit www.racgp.org.au/ff/15 .

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