EMA reviews Ixiaro following recall, annuls potency concerns
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EMA reviews Ixiaro following recall, annuls potency concerns The EMA concludes that the lower potency of a particular batch of Ixiaro [IC-51] has had no impact on its overall effectiveness, and the benefits of the Japanese encephalitis vaccine continue to outweigh its risks. In 2011, the company the markets Ixiaro, Intercell AG, recalled a batch of the vaccine after tests revealed that the batch lacked potency against Japanese encephalitis virus, and there were concerns that it could fail to provide adequate protection. This sparked the EMA’s CHMP to conduct a review into the vaccine’s overall effectiveness and safety. The CHMP concluded that the root cause of the lower potency was an unusually high content of other metals in one specific lot of aluminium compound used to manufacture the vaccine. While other batches of Ixiaro were also made using the same lot of aluminium compound, these batches have since expired and are no longer in use. The CHMP has recommended measures that the company should implement to ensure that the vaccine continues to offer adequate protection in future, including a study to establish the acceptable content of other metals in the aluminium compound and adherence to more stringent potency requirements. EMA. Questions and answers on the review of Ixiaro (Japanese encephalitis vaccine). Internet Document : [2 pages], 15 Mar 2012. Available from: URL: http:/ 803068424 /www.ema.europa.eu
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Reactions 31 Mar 2012 No. 1395
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