WHO suspends use of Sanofi-Aventis vaccine
pharmafile | March 18, 2010 | News story | Manufacturing and Production | Sanofi-Aventis, Shantha Biotechnics, Vaccine
The World Health Organization has temporarily stopped procurement and use of a combination vaccine supplied by Sanofi-Aventis subsidiary Shantha Biotechnics following reports of white sediment inside the product vials.
Suspension of a few lots of the Shan5 vaccine was put in place last month, but since then additional cases have emerged and the decision taken to suspend all lots of the product.
Shan5 is used to protect against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B (Hib), a major cause of meningitis.
Almost 24 million doses of the product has been distributed by UN agencies and also via direct procurement by national governments since it was added to the WHO’s prequalified vaccine list.
If the sediment issues cannot be resolved quickly they could threaten a three-year, $340 million contract to supply the vaccine announced by Sanofi-Aventis last September.
Children’s charity UNICEF has also said it will suspend purchasing and distribution of the vaccine and is working to identify alternative products to allow vaccination programmes to resume.
“In this initial phase, the focus is on ensuring new vaccine deliveries to countries so vaccination can be resumed,” it said in a joint statement with the WHO.
Any national authorities that have received lots of the Shan5 vaccine should place the product in quarantine “until further direction is provided by WHO”, the statement continued, indicating the issue was first reported to the manufacturer in 2009.
Hyderabad, India-based Shantha says it is working with the WHO to review batch records for any deviations in the manufacturing process, including the raw materials used, as well as a review of the cold chain during transportation.
WHO received complaints about Shan5 from Colombia, Comoros, Congo and Nepal. For example, in Congo 15 of 24 lots were found to have the sediment when checked.
The WHO says there are no obvious safety issues associated with the vaccine and no adverse events with Shan5 have been reported. However, the presence of the sediment does indicate a quality problem with the product which needs to be investigated further, it said.
The agency stressed that the vaccine remains on its prequalified vaccine list, but it recommends that countries continue vaccination “using pentavalent vaccine from an alternative manufacturer or an alternate DTP-containing vaccine until further notice”.
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