WHO grants prequalification to Bharat Biotech's 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 the 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 to date.

Rotavirus is the leading cause of severe diarrhoea 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 honoured 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 ~ 100 million doses to these countries”, Dr Krishna Ella added.

ROTAVAC^® was developed as a result of a multi-country - the 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.

“The novel team science partnership that developed this vaccine serves as a useful model for others to follow”, said Dr Roger I. Glass, Director of the Fogarty International Center at the U.S. National Institutes of Health, who helped shepherd the process. “The result is an effective, yet economical, vaccine that has the potential to save thousands of children’s lives in Africa and elsewhere.” According to him, Rotavirus is responsible for an estimated 36% of hospitalizations for childhood diarrhoea around the world and for an estimated 200,000 deaths in low and middle-income countries.

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 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.

“India’s leadership in developing and introducing its own rotavirus vaccine is commendable and emphasizes a national commitment to improving the health of their 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.”

Bharat Biotech has successfully miniaturized the dose volume of ROTAVAC^®, to 0.5 ml/dose and is presented in a ready to use format, requiring no further reconstitution, similar to oral polio vaccines. The product profile of ROTAVAC^® has been optimally designed for the developing world by the developing world to aid ease of administration, reduced training requirements, and with the lowest cold chain footprint for an oral rotavirus vaccine in the world. The cold chain footprint has been reduced to ~3 cm

3/dose, resulting in significant savings in cold chain storage and distribution costs. The 0.5 ml dose volume also reduces the number of spit ups by infants when the vaccine is administered.