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.