Immunization standards

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-Gene already in countries to be of assured quality and recommends continued use of the batches of Quinvaxem already supplied to countries. The vaccine remains on the list of WHO prequalified vaccines.

The problem was detected during quality control tests that are routinely performed during the production process. The action to put a temporary hold on all shipments has been taken as a precautionary measure pending the outcome of a thorough review of the manufacturing process by both the manufacturer and the Korean FDA and identification of the root cause(s) of the problem. The investigations are expected to last until end November 2010. WHO is following up closely with both the manufacturer and the Korean FDA as and when relevant information becomes available.