WHO provided prequalification for the world’s first rotavirus vaccine

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Bharat Biotech, an Indian biopharmaceutical company with one of the largest pharmaceutical manufacturing plants of its kind in Asia-Pacific, announced that the World Health Organization (WHO Geneva) has awarded prequalification to the developing world’s first rotavirus vaccine, ROTAVAC®.

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.

Rotavirus is the leading cause of severe diarrhea among children less than five years of age around the world, resulting in ~215,000 deaths and 2 million hospitalizations. Vaccinations are an important part of global public health efforts to meet the Sustainable Developmental Goals of UNDP.

“We are highly 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.

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. The ROTAVAC® partnership has resulted in more than 15 international publications, including the pivotal phase III publication in Lancet in 2014.

WHO prequalification for ROTAVAC® is the result of a rigorous regulatory process. ROTAVAC® has been under development since the year 2000 necessitating investments of around $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.