WHO approves Shantha Biotechnics’ inactivated polio vaccine

New Delhi: Sanofi Pasteur, the vaccines division of Sanofi, announced on 24th October that its standalone IPV (Inactivated Polio Vaccine) – ShanIPV, developed by its affiliate Shantha Biotechnics, has received prequalification status from the World Health Organization (WHO). This status qualifies ShanIPV vaccine for purchase by the United Nations’ agencies.

The WHO prequalification programme is a service provided to the United Nations’ procurement agencies. The goal of the programme is to ensure that the vaccines used in immunization programmes are safe and effective, the vaccine efficacy data and studies are relevant to the target population, and that the vaccine meets the specific needs of the programme, reflected by the tender specifications: i.e. potency, thermostability, presentation, labeling, shipping conditions, etc.

“WHO-prequalification of a vaccine is a stringent process wherein the WHO reviews the production process, quality control procedures, tests consistency of various batches and works closely with the responsible National Regulatory Authority in this process. The prequalification is testament to our commitment to provide high quality vaccines. ShanIPV plays a crucial part in keeping India polio-free and we are proud to have supplied more than 28 million doses of this vaccine to the Indian Government since 2015.” said Dr Mahesh Bhalgat, Executive Director and COO, Shantha Biotechnics, a Sanofi Pasteur company.

“Over the last two decades, Sanofi Pasteur has been serving the vaccination needs of India by making available the highest quality products. Today, the only 2 WHO-prequalified IPV containing vaccines that are available in India are both from Sanofi Pasteur (ShanIPV and Hexaxim). Through our partnership with the Government of India, I’m proud to share that every one-out-of-two babies born in the country is protected with an IPV from Sanofi Pasteur.” said Jean-Pierre Baylet, Country Head – Sanofi Pasteur, India & South Asia.

India is currently in its fifth year of being polio-free and its seventh, since the last reported polio case. According to the GPEI (Global Polio Eradication Initiative) Endgame Strategic Plan 2013-2018, introducing at least one dose of IPV in current polio eradication programs and completely switching from OPV to IPV in the next few years, is critical to ending polio transmission. As per the dashboard of India’s Ministry of Health & Family Welfare (April 2018), the coverage of IPV dose 1 is 62 percent and that of dose 2 is 52 percent.

Given India’s high birth cohort, Sanofi Pasteur has invested significantly over the years to ensure access to high-quality vaccination against polio for a large number of babies in India.

Shantha Biotechnics, which was acquired by Sanofi Pasteur Holding in 2009, is a biotechnology pioneer from the emerging countries, founded by Dr K I Varaprasad Reddy in 1993 in Hyderabad, India. Shantha is a fully integrated biotechnology company involved in R&D, manufacturing and marketing.