BackSanofi says Shan5 vaccine approved for purchase by UN agencies
WHO withdrew Shan5 after it received quality complaints from Colombia, Comoros and Nepal about the presence of white sediment sticking to glass vials
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A five-in-one vaccine for children made by Sanofi Pasteur Holding Ltd, the vaccines division of France’s Sanofi SA, is back on the approved list of the World Health Organization (WHO) after four years of disqualification.
The so-called prequalification status by the global health body qualifies the Shan5 vaccine for purchase by United Nations agencies and makes it eligible to receive funding from Global Alliance for Vaccines and Immunization (GAVI), a public-private partnership that focuses on saving children’s lives by increasing access to immunization in developing nations.
WHO withdrew the prequalification status to Shan5, made at Hyderabad’s Shantha Biotechnics Ltd, an affiliate of Sanofi, in 2010, after it received quality complaints from Colombia, Comoros and Nepal about the presence of white sediment sticking to glass vials containing the Shan5 vaccine.
Shantha expects revenues of over ₹ 500 crore from Shan5 in the next five years from sales in the developing world, chief executive officer Harish Iyer said on Monday. “We will start supplying Shan5 vaccine from this year onwards, and it will be competitively priced," Iyer said.
The demand for pentavalent vaccine is 200 million doses a year, according to WHO. Pune-based Serum Institute of India Ltd and Hyderbad-based Biological E Ltd are the other two WHO prequalified pentavalent vaccine suppliers.
Shan5 is a liquid paediatric combination vaccine that protects against diphtheria, tetanus, whooping cough, hepatitis B and haemophilus influenzae type B (Hib). The three-dose vaccine can be given for children starting from six weeks with a gap of four weeks up to 14 weeks age.
Shan5 in March received approval from Drug Controller General of India to market the vaccine in India.
Pentavalent vaccines are supplied at average price of $2.17 per dose to GAVI. Biological E has offered to cut down the prices further to $1.19 per dose, helping GAVI to save $150 million on vaccine procurement, according to GAVI.
“There is a significant supply shortage of pentavalent vaccine globally and we will be ramping our capacities to be able to meet some of that demand," Shantha’s Iyer said.
Shan5 was the first pentavalent vaccine from India to be prequalified by WHO in 2008.
Sanofi acquired Shantha Biotechnics for €440 million from another French company, Mérieux Alliance, in July 2009, largely in view of Shan5. Within a year of Sanofi’s acquisition, WHO withdrew prequalification status to Shan5, hitting Sanofi sales to the tune of $340 million.
Studies traced the sediments to the manufacture of the pertussis component, also known as whooping cough, which is a highly contagious bacterial disease.
As part of the corrective process, Sanofi invested around ₹ 1,000 crore to make changes to the manufacturing process, and conduct clinical trials from scratch, a costly and time-consuming process, to establish the safety and efficacy of the vaccine.
Shantha said the clinical trials were conducted on 1,100 infants across 11 hospitals across India, meeting global standards of quality, safety and efficacy.
Sanofi helped Shantha with the pertussis component of vaccine which was the root cause of Shan5’s disqualification.
“Shan5 is the first product that puts together the best of Shantha and Sanofi Pasteur’s assets and talents," Olivier Charmeil, president and chief executive of of Sanofi Pasteur, said in a statement on Monday.
Inexpensive vaccine supplies from India are integral to the success of global immunization programmes. Vaccine sales by Indian companies are estimated by the industry organization Pharmexcil to be worth $900-$1000 million and are growing at an annual average growth rate of 20%. The country accounts for almost 43% of total vaccines exported globally by volume.
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