Bharat Biotech today announced the price of ROTAVAC India’s first indigenously developed Rotavirus Vaccine. The vaccine will be sold to global public markets, Governments worldwide including UN procurement agencies at a price of US $ 1.0. Bharat Biotech hopes its new vaccine will help prevent part of the ~ 500,000 child deaths each year caused due to rotavirus diarrhea and improve access to better, affordable rotavirus vaccines.
ROTAVAC® expects India licensure during 2014 and WHO Prequalification in 2015 for supply to UN agencies. The Vaccine is currently undergoing Phase III clinical development for safety and efficacy in 8000 subjects, one of the largest such clinical trial ever conducted in India. According to CDC estimates, rotavirus causes approximately 352,000–592,000 deaths each year (median, 440,000 deaths) in children <5 years of age.
Making the announcement Dr. Krishna Ella, Chairman and Managing Director Bharat Biotech said “Offering rotavirus vaccines at US $1 price is a reaffirmation of our commitment to make vaccines affordable globally. It is a great effort, by the Bharat Biotech team which made this a possibility. I am thankful to our technical and commercial teams for a decade of diligent efforts in delivering a world class product. The key to our success of bringing down cost of vaccine is our novel concepts in vaccine development and innovative manufacturing processes with Public Health in mind.”
“Bharat Biotech strongly backs the initiative by GAVI to make vaccines affordable and available for countries worldwide. In 2001 I made a commitment to the Gates Foundation to develop and supply a novel rotavirus vaccine at US$ 1 a dose. We are extremely happy to honor that commitment.” Dr. Ella added.
Bharat Biotech’s rotavirus vaccine development project is a public-private partnership project between the company and the Dept of Biotechnology Govt of India, Gates Foundation, Program for Appropriate Technologies in Health, Centers for Disease Control, USA, National Institutes of Health NIAID USA, Society for Applied Studies, Translational Health Sciences Technology Institute, Indian Institute of Science, All India Institute of Medical Sciences, and Stanford University. Bharat Biotech has an installed capacity of 300 million doses and is well positioned to manufacture and supply ROTAVAC® to UNICEF, PAHO, and for national immunization programs.
Bharat Biotech is a pioneer in developing novel vaccines catering to the needs of the 5.8 billion emerging market populace. It has a strong pipeline of Vaccines under development such as Typhoid conjugate vaccine (TCV), Japanese Encephalitis and Chikungunya. Vaccines for Rabies, Polio, and Typhoid are undergoing WHO prequalification to enable supplies to UN Agencies. Bharat Biotech has also submitted a dossier for its pentavalent vaccine for WHO Prequalification.
“Our commitment to global public health has been reinforced through delivery of Oral Polio and Hepatitis-b vaccines to the Govt of India and Governments worldwide. We are fully committed to Polio eradication. With more than a 1.5 billion doses supplied so far, Bharat Biotech has become a premier manufacturer of vaccines globally. Bharat Biotech greatly acknowledges the continued support and guidance accorded by the Government of India, WHO, UNICEF, GAVI and PAHO” Dr. Ella said.
Bharat Biotech International Limited, Hyderabad, India, is a multidimensional biotechnology company specializing in product-oriented research, development, manufacturing of vaccines and bio-therapeutics. Bharat Biotech was established in the year 1996 in Hyderabad, India, & has continuously raised the bar in setting new standards for research, development & commercialization of path breaking technologies through innovation and collaborative research.
Bharat Biotech is one of the first bio-pharma facilities in India to be audited and approved by Korean Food & Drugs Administration (KFDA). Bharat Biotech is also a WHO prequalified manufacturer of Hepatitis-B vaccines for supply to UNICEF and global procurement agencies. Bharat Biotech is one of the largest manufacturers of anti-rabies vaccines. INDIRAB is a market leader in India and several countries globally. Bharat Biotech has also pioneered preservative free vaccines for Hepatitis-b and Haemophilus Influenza-b. Bharat Biotech also manufactures vaccines for typhoid, polio, and pentavalent combination vaccines.
Bharat Biotech is ahead in the discovery of new molecules in the areas cardiology, anti infectives, and infectious diseases. Bharat Biotech is a market leader in wound healing segment with its REGEN-D, epidermal growth factor for diabetic foot ulcers, burns and wound healing.