The World Health Organization has cancelled the pre-qualification to Shantha Biotechnics' combination vaccine Shan5 because of manufacturing defects found in samples produced at a plant in India. Sanofi-Aventis (NYSE: SNY) controls 80 percent of Shantha as a result of a deal forged last year.
Problems were noted earlier this year in Shantha's product when a mysterious white sediment was found inside vials of vaccine. Although the company is seeking remedies to the problem, the WHO says it has concluded the corrective action plan Shantha has proposed to dissolve the sediments would require a revised manufacturing procedure and hence new approvals, according to the Economic Times. As a result of the WHO's actions, Shantha will not be able to supply the five-vaccine combination that prevents diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B, despite large orders, Trading Markets reports. Other markets will also be unwilling to buy it until the company is again granted pre-qualification.
Some individual vaccines in the combination continue to retain their pre-qualification, but Sanofi will have to re-apply for qualifying the entire combination after rectifying the defects, Trading Markets notes. "Given the pre-qualification requirements, it could happen by 2013," a Sanofi spokesperson says.
"This is a vaccine version of Ranbaxy's regulatory problems in the U.S. Since Shantha's main revenue stream will be cut off, it may run into losses until it resumes sales of Shan5," a pharmaceutical industry expert says, as quoted by the Economic Times. The paper also notes that the news may help other drugmakers that make five-in-one vaccines that have already been qualified by the WHO, including Panacea Biotech, Serum Institute and Novartis.