WHO withdraws pre-qualification of Sanofi-Aventis vaccine

The French drug manufacturer Sanofi-Aventis announced on August 3 that one of its subsidiaries in India, Shantha Biotechnics Ltd., had failed to meet quality standards for the World Health Organization with regards to its Shan5 combination vaccine.

As a result of losing what is known as “pre-qualification,” Shanta Biotechnics will not be allowed to supply Shan5 to the WHO, and therefore the United Nations, despite a having a large number of pending orders. The problem stems from manufacturing defects that were found in samples produced by a plant in Hyderabad, according to

Shan5 is a combination of five vaccines that prevents diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B. The problem, according to a statement by Sanofi, was linked to the manufacture of the pertussis vaccine.

Other markets are not expected to purchase Shan5 anymore as well until Shanta fixes the defect and regains its pre-qualification from the WHO. Until then, its $340 million contract from the U.N. Children’s Fund to supply the vaccine from 2010 to 2012 has been suspended, reports.

Individual vaccines in the Shan5 combination have retained their pre-qualification, but the entire vaccine will have to reapply to regain it after the defects are fixed. Sanofi does not expect this to happen before 2013.

Shanti has already distributed approximately 24 million doses of the vaccine worldwide, partially through the WHO.