Boston, MA 05/06/2014 (wallstreetpr) – After four years of disqualification, Sanofi SA (ADR) (NYSE:SNY)‘s five-in-one vaccine, dubbed Shan5, for children is granted prequalification status by the World Health Organization (WHO).
Re-Opens Door For UN Agencies
The prequalification status will open up the sale of the vaccine to the United Nations agencies like UNICEF and will also make it entitled to receive financing from the Global Alliance for Vaccines and Immunization (GAVI), which is a public-private partnership group and works toward extending immunization for children in developing nations.
Earlier in 2010, the prequalification status by WHO was withdrawn for Shan5, manufactured by Sanofi SA (ADR) (NYSE:SNY)’s affiliate Shantha Biotechnics Ltd in Hyderabad, India, after several complaints poured in from Comoros, Nepal and Columbia. The complaints raised concerns over presence of white sediment that was found stuck to glass vials consisting the vaccine. However, the company has earned back the status after a careful review by the WHO, which included a site inspection of Shantha’s facilities.
The 5-in-1 shot provides an effective protection against tetanus, diphtheria, Hib, pertussis and hepatitis B in Children. Therefore, the grant of approval will allow 50 developed countries to get access to the vaccine, and at the same time Sanofi will also benefit by unlocking hidden potential in the emerging markets. According to Shantha’s CEO, Harish Iyer, the vaccine could fetch Rs.500 revenue to Sanofi SA (ADR) (NYSE:SNY) within a time frame of next five years. Iyer said that the company will start supplying the vaccine this year and would price it competitively. Shan5 had already been granted approval to market the vaccine in India in March from the Drug Controller General of India.
As per WHO, the annual demand of pentavalent vaccine is 200 doses. These vaccines are available at an average price of $2.17 per dose to GAVI. Currently, Serum Institute of India Ltd based out in Pune and Biological E Ltd of Hyderabad are the other two pentavalent vaccine suppliers that are WHO pre-qualified.
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