Bharat Biotech unveils oral rotavirus vaccine ROTAVAC 5D to protect against diarrhoea

Developed by Bharat Biotech, oral rotavirus vaccine ROTAVAC 5D is safe and effective in the prevention of rotavirus diarrhoea. ROTAVAC 5D can be stored at 2-8ºC, administered in 5 drops.

New Delhi: Hyderabad based Bharat Biotech recently announced the commercial roll-out of ROTAVAC 5D - Lowest dose-volume rotavirus vaccine in the world.

Vice President of India, M Venkaiah Naidu, launched the vaccine in New Delhi. The first generation, rotavirus vaccine, ROTAVAC was developed under a Public-Private Partnership with the Department of Biotechnology, Govt. of India 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 of India Shri. M Venkaiah Naidu 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 diseases 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 diarrhoea. ROTAVAC 5D can be stored at 2-8ºC, 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 of ROTAVAC 5D, Dr Krishna Ella the Chairman and Managing Director of 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 result in savings of ~ $ 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 favourably 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 ~ $ 20 million to develop new manufacturing facilities and supporting infrastructure in its Genome Valley plant in Hyderabad, with an installed manufacturing capacity of ~ 200 million doses/year. The project was supported in part by the Bill & Melinda Gates Foundation.”

ROTAVAC 5D is a miniaturized affordable rotavirus vaccine, delivering a potent product with a dose volume of 0.5ml. It enables complete delivery of the antigenic payload in 5 drops, avoiding spit-ups observed with larger dose volumes. ROTAVAC 5D is available in multidose vials with cold chain footprints of ~4 cm3/ dose, with the smallest cold chain footprint of rotavirus vaccines, and saving cold chain costs due to storage, distribution, administration, and disposal. ROTAVAC 5D can be stored at 2-8ºC for 24 months and is stable at 37ºC for 7 days. The vaccine stability combined with its small cold chain footprint enables its use in low resource settings and outreach programs.

The occasion also commemorates the achievement of ~100 million doses of worldwide supplies of ROTAVAC. This is a great achievement of manufacturing scaleup, within 2 years of WHO Prequalification, and Bharat Biotech’s ability to provide global access to this important vaccine. With supplies to national immunization programs, UNICEF and GAVI, ROTAVAC has become a truly global vaccine.

“The introduction of this rotavirus vaccine has helped protect millions against the leading cause of deadly diarrhoea in children worldwide,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, “and has been critical in ensuring better supply availability as well as the 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.”

The proactive approach by the Government of India to include rotavirus vaccines in the national immunization program and its efficient programmatic implementation presents a successful model for new vaccine introductions worldwide. A novel vaccine innovated in India, developed in India and to be made in India, which he said is a big boost to the “Make in India” initiative by the Government of India.

“Rotavirus continues to cause severe diarrheal disease and deaths, mostly among the most vulnerable children in the world,” said Steve Davis, President and CEO of the nonprofit global health organization PATH. “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 ~ 200,000 deaths and ~ 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 the economic impact of hospitalizations to national governments across the globe.

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