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TEMPORARY SUSPENSION of SHIPMENT of Quinvaxem (DTwP-hepatitis B-Hib) vaccine
8 November 2010
On 28 October, Crucell Korea announced a temporary hold on all shipments of its fully liquid pentavalent vaccine Quinvaxem (a WHO-prequalified vaccine) and its hepatitis B vaccine Hepavax-Gene (thiomersal-free, not prequalified by WHO). The reason is that the STERILITY of its SHINGAL FACILITY in the Republic of Korea MAY have been compromised during the manufacture of recently-produced batches of these vaccines.
The POTENTIALLY-AFFECTED batches HAVE NOT BEEN distributed to countries. The risk assessment performed by Crucell and submitted to WHO regarding the quality, safety and efficacy of other BATCHES THAT HAVE ALREADY BEEN DISTRIBUTED through UN procuring agencies/direct supply shows that there were NO DEVIATIONS from the standard manufacturing process for these batches and that THEY MEET WHO REQUIREMENTS.
Given the above, WHO believes ALL BATCHES of Quinvaxem and Hepavax-Gen...