WHO grants prequalification to Crucell's Quinvaxem vaccine

By E. Janene Geiss

Philadelphia, Sept. 26 - Crucell NV said Tuesday that Quinvaxem, its fully liquid pentavalent vaccine co-developed with Novartis Vaccines and Diagnostics, has been granted "prequalification" by the World Health Organization.

Following the awarding of licensure by Korea's Food and Drug Administration in March 2006, the World Health Organization prequalification is a final prerequisite for the combination vaccine to be made available to supranational purchasing organizations. Supranational organizations are major customers for combination vaccines, which are used in mass vaccination programs in developing countries, according to a news release from the biotechnology company.

Crucell, which is based in Leiden, the Netherlands, said it began production of Quinvaxem at the facility of its Korean subsidiary immediately following the vaccine's licensure. First batches of the product recently have been released and are available for sale. Crucell now is able to offer the product to the supranational organizations Unicef and PAHO.

Crucell said it expects Quinvaxem to become an important contributor to the company's 2006 revenue forecast and its objective to achieve cash break-even in 2007.

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