Bharat Biotech announced the commercial roll-out of ROTAVAC 5D-Lowest dose volume rotavirus vaccine in the world.

M Venkaiah Naidu, Vice President of India launched the vaccine in New Delhi. The first generation, rotavirus vaccine, ROTAVAC was developed under a Public-Private Partnership with the Department of Biotechnology and other international partners.

Congratulating Bharat Biotech about its milestone achievement in delivering 100 Million doses of ROTAVAC vaccine and launching the new generation ROTAVAC 5D, in his address the vice-president urged the media and medical professionals to create awareness about various health problems.

He said, “There is a need for vaccination at the right time, while the government is doing its best, it is a greater social responsibility which every medical professional should take upon themselves, remove apprehension about vaccination, for prevention of disease and to better the health of the nation and its people.”

Developed by Bharat Biotech, oral rotavirus vaccine ROTAVAC 5D is safe and effective in the prevention of rotavirus diarrhea. ROTAVAC 5D can be stored at 2-8 degree, administered in 5 drops. ROTAVAC 5D is available in single-dose, multi-dose vials and pre-filled syringes. The company received commercial licensure and the vaccine is available for sale.

Speaking on the launch, Dr Krishna Ella, Chairman & MD, Bharat Biotech said, “We are proud to announce the milestone of 100 million doses of ROTAVAC supplies, the fastest among rotavirus vaccines in the world. Building on this success, we are pleased to announce the introduction of ROTAVAC 5D the lowest dose volume rotavirus vaccine in the world.”

Dr Ella added, “We have designed and developed a vaccine that is cost-effective due to its efficacy and low cold chain footprint. ROTAVAC 5D presented in multi dose vials, results in savings of app. $0.30/dose in supply chain and delivery costs.”

ROTAVAC 5D has been evaluated in clinical trials in India and other countries. This vaccine is safe, effective and affordable, besides being cross-protective against a variety of rotavirus strains. Its efficacy compares favorably with the efficacy of the currently licensed rotavirus vaccines in low-resource countries. The study results showed clear evidence of protection across different rotavirus strains and continued efficacy in the second year of life. Currently, over 25 countries have granted patents for ROTAVAC 5D.

Dr Ella also revealed, “Bharat Biotech has invested approx. 20 million to develop new manufacturing facilities and supporting infrastructure in its Genome Valley plant in Hyderabad, with an installed manufacturing capacity of app 200 million doses/year. The project was supported in part by the Bill & Melinda Gates Foundation.”

Dr Seth Berkley, CEO of Gavi, the vaccine Alliance said, “The introduction of this rotavirus vaccine has helped protect millions against the leading cause of deadly diarrhea in children worldwide and has been critical in ensuring better supply availability as well as diversity of product profiles. Bharat Biotech has been a key partner for Gavi, and I commend the company and its employees for reaching this milestone so quickly.”

Steve Davis, President & CEO of the PATH said, “Rotavirus continues to cause severe diarrheal disease and deaths, mostly among the most vulnerable children in the world. We are proud of PATH’s partnership with Bharat Biotech and other international researchers in the development of ROTAVAC and ROTAVAC 5D, and we are pleased to see them helping to improve the supply of affordable rotavirus vaccines as they are rolled out in public health programs in India and around the world.”

Globally rotavirus disease burden is estimated at approx. 200,000 deaths and approx. 2.0 million hospitalizations annually, mostly in low income countries. Prevention of rotavirus infections would lead to a significant reduction in infant mortality rates and reduce economic impact of hospitalizations to national governments across the globe.