WHO delists Sanofi-Aventis combo vaccine
pharmafile | August 10, 2010 | News story | Manufacturing and Production, Sales and Marketing |Â Â Sanofi-Aventis, WHO, vaccinesÂ
The World Health Organization has dropped a combination vaccine made by Sanofi-Aventis’ subsidiary Shantha Biologics from its list of prequalified medicines, scuppering a $340 million supply contract.
In March the WHO said it had temporarily called a halt to purchasing and use of the Shan5 vaccine – used to protect against diphtheria, tetanus and pertussis (DTP), plus hepatitis B and Haemophilus influenza type B (Hib) – following reports of white sediment inside the product vials.
At the time it said the temporary suspension was a precaution and there was no evidence of any safety issues, although the sediment indicated an underlying quality issue which needed to be resolved.
The WHO’s prequalified medicines programme is a United Nations-sponsored initiative which aims to make priority medicines available for distribution via UN agencies such as UNAIDS and UNICEF.
It is also widely used by national health agencies to guide their own procurement programmes, however, so the delisting of Shan5 will likely have a deep impact on the use of the vaccine.
At the time the temporary block on Shan5 was announced in March it was estimated that around 24 million doses had been distributed by UN agencies and governments since the vaccine was included on the list.
Sanofi-Aventis acquired an 80% stake in Shantha Biotechnics in July 2009 in a deal which valued the Indian firm at 550 million euros. It announced the three-year (2010-2012) contract for Shan5 with the UN Children’s Fund the following September.
Shan5 is thought to be Shantha’s biggest product by sales, accounting for around three quarters of its annual sales of approximately 90 million euros.
The WHO said it was unable to accept Shantha’s corrective action plan to resolve the sediment issue and has also delisted its tetravalent vaccine Shantetra, which protects against DTP plus hepatitis B.
A prequalification assessment for DTP vaccine Shantrip has also been called to a halt, although Shantha’s hepatitis B vaccine Shanvac-B and tetanus toxoid vaccine ShanTT remain on the prequalified medicines list.
The company remains adamant that it will be able to get the vaccine back on the list in due course, but in the meantime could lose out to rival combination vaccine products from the likes of Novartis, Serum Insititute and Panacea Biotec, according to a report in the Economic Times.
Phil Taylor
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