French vaccine major Sanofi-Aventis is expected to relaunch the pentavalent Shan5 vaccine produced by its Indian subsidiary, Shantha Biotech, only in 2013. It does not want to take further chances after the World Health Organisation (WHO) removed the vaccine from its prequalification list in July last year.
“We first thought it would be ready for undergoing the inspection process in January next year. However, the company is conducting more stability studies on the vaccine. Therefore, it may take a longer time before it goes through the usual approval process,” a senior official in the Central Drugs Standard Control Organization told Business Standard.
Sanofi had completely stopped producing Shan5 after the WHO delisted the vaccine from prequalification, based on complaints that a white sediment was found sticking to the vials. However, WHO stated there were no side-effects reported from this aberration.
With the stoppage of production, Shantha Biotech’s annual revenue had come down to around Rs 70 crore from the Rs 500 crore when the vaccine was in the market across the world, according to a senior company official who did not wish to be named.
“The company undertook extended studies on the vaccine, though Shan5 is absolutely ready for relaunch, only because the Sanofi management was very particular about its global reputation. Since we began the process of trials from the start as if it’s a new vaccine, it may be out in the market only in 2013,” the official told Business Standard.
Delay in restart of production of this five-in-one vaccine would extend the revenue loss to Sanofi’s Indian subsidiary into next year as well. It had bagged a $340-million procurement contract from WHO for the vaccine, which offers protection against diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B in children, in September 2009 for a period of three years starting 2010.
Referring to WHO’s move on this vaccine, Sanofi CEO Christopher A Viehbacher had, in October this year, said there would be no compromise on quality and safety, as all manufacturing facilities were of global standard, irrespective of location. “We have implemented all the corrective measures and will be participating in global tenders once the pre-qualification process is complete for low-cost and high-quality vaccines,” he said during his Hyderabad visit.
Hyderabad emerged as the capital of low-cost vaccines after city-based Shantha and Bharat Biotech had, in the early 90s, successfully developed and produced recombinant human vaccines at a price 15 times lower than that of the same products marketed by global pharma companies.
However, instances of rejection of vaccines on quality concerns — first in the case of Shan5 and then with regard to Bharat Biotech’s hepatitis B product, Revac-B, last month by WHO — are expected to have serious implications on the reputation of India’s ability to deliver high-quality vaccines at a low price, say analysts.