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WHO grants Prequalification to DBT funded rotavirus vaccine, ROTAVAC®

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ROTAVAC® has the potential of accessibility and affordability for countries with highest burden of disease

New Delhi India, 25th January 2018: Bharat Biotech yesterday announced that the World Health Organization (WHO Geneva) has awarded prequalification to the developing world’s first rotavirus vaccine, ROTAVAC®. This vaccine to prevent infant deaths and hospitalizations due to rotavirus diarrhea was launched by the Hon’ble Prime Minister of India, Shri Narendra Modi in New Delhi in March 2015 and is one of the first novel vaccines to be developed completely from a developing world country.

WHO Prequalification is necessary for UN agencies and Gavi, the Vaccine Alliance to purchase the vaccine in partnership with developing countries and will help accelerate availability of the ROTAVAC® to the developing countries with the highest burden of disease. India has introduced ROTAVAC® into its national immunization program during 2016, with ~ 35 million doses delivered till date.

Dr. M.K. Bhan, Ex Secretary Department of Biotechnology, who isolated the ROTAVAC® 116E strain, said “Core funding for the development of ROTAVAC® was received from the Gates Foundation, PATH and BIRAC – Department of Biotechnology Government of India, since the year 2000. Additional funding from agencies such as the Research Council of Norway and UK Department for International Development have made this project a success.”

Bharat Biotech acknowledges the steadfast support of its partners from around the world who recognized the importance of rotavirus diarrhoea early on and committed support for this project from the beginning of its development through licensure. The partnership spanned all aspects of product development, licensure, and WHO prequalification, and represents a true reflection of “Clone to Clinic to Global Access”, resulting in a lifesaving product for global populations.

Dr. T.S. Rao former Senior Adviser (Additional Secretary Rank) in the Department of Biotechnology (DBT), Ministry of Science and Technology, Govt. of India said that “the program was initiated with 6 people and later it became 200 people team working with mutual cooperation to develop a rotavirus vaccine. Today we are celebrating the WHO Prequalification success just because of the hard work of the entire team.”

“We are honored and delighted to become the first rotavirus vaccine from the developing world and India to be WHO Prequalified. We feel proud to dedicate this innovated in India and Made in India vaccine to the world. The true impact of vaccines can be seen, when vaccinations are carried out in affected populations. The Government of India has given a big boost by making ROTAVAC® available to millions in India already.” said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech.

“Bharat Biotech’s track record of life saving vaccines is a testimony to the company’s long-standing commitment to make affordable vaccines for the developing world. ROTAVAC® has been supplied to low income countries at $ 1.0 / dose, with the feasibility for further ~30% price reductions, based on the procurement of around 100 million doses for these countries” Dr. Krishna Ella added.

ROTAVAC® was developed as a result of a multi country multi partner collaborative model of Team science for over 2 decades. This large public private social innovation partnership included the Government of India’s Department of Biotechnology (DBT), the Indian Council of Medical Research, the Indian Institute of Science (IISC), the All India Institute of Medical Sciences (AIIMS), the Translational Health Sciences and Technology Institute (THSTI), the Society for Applied Studies (SAS), Christian Medical College (CMC) Vellore, King Edwards Memorial Hospital (KEM) Pune, Stanford University School of Medicine, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Johns Hopkins University and PATH.

WHO prequalification for ROTAVAC® is the result of a rigorous regulatory process, which started in 2016. ROTAVAC® has been under development since the year 2000 necessitating investments of around USD 200 million towards product development and dedicated manufacturing infrastructure. The Genome valley facility has an installed manufacturing capacity of up to 200 million doses / year, is a scalable model ready to meet global demand.

“PATH enthusiastically welcomes Bharat Biotech’s news about reaching this exciting and important milestone for ROTAVAC. As a longstanding partner in the development of the vaccine since 2001, we know that achieving WHO prequalification of ROTAVAC brings us even closer to meeting the critical public health goal of improving the supply of affordable rotavirus vaccines worldwide,” said Mr. Neeraj Jain of PATH.

Rotavirus is the leading cause of severe diarrhea and death among children less than five years of age around the world. According to a recent study, 37 percent of the 578,000 childhood diarrheal deaths in 2013 were due to rotavirus, for a total of 215,000 rotavirus death globally. Vaccinations are an important part of global public health efforts to meet the Sustainable Developmental Goals of UNDP.

“India’s leadership in developing and introducing its own rotavirus vaccine is commendable and emphasizes a national commitment to improving the health of its children,” said Duncan Steele, deputy director on the Enteric Diarrheal Diseases team at the Bill & Melinda Gates Foundation. “The advent of a locally manufactured, WHO prequalified rotavirus vaccine offers promise to protect children in India, Africa, the Americas and the rest of Asia from this debilitating disease.”

The project to develop ROTAVAC® has resulted in more than 15 international publications in peer reviewed journals, including the pivotal phase III publication in Lancet in 2014 proving its comparable efficacy in the developing world. ROTAVAC® has 5 global patents, granted in countries such as India, USA, UK, South Africa, China, Nigeria, among several others. Product registrations for ROTAVAC® are in process in more than 30 countries globally.

The Government of India has introduced Rotavirus Vaccines into the universal immunization programme, where the vaccine is provided free of charge to the entire birth cohort. However, this introduction is limited to 9 states namely Odisha, Andhra Pradesh, Haryana, Himachal Pradesh, Assam, Tripura, Tamil Nadu, Madhya Pradesh, and Rajasthan. Diarrheal deaths and hospitalizations due to rotavirus infections are highly prevalent in all parts of India. Further expansion of the Universal Immunization Programme to the entire country will result in significant reductions in infant mortality rates and hospitalization costs for governments and private citizens alike.