The price of Rotavac India’s first indigenously developed Rotavirus Vaccine which will be sold to global public markets including UN procurement agencies has been fixed at US$ 1 by the company Bharat Biotech. The company hopes the new vaccine will help prevent part of the 500,000 child deaths each year caused due to rotavirus diarrhoea and improve access to better, affordable rotavirus vaccines.

Rotavac expects India licensure during 2014 and WHO Pre-qualification 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 trials ever conducted in India. According to CDC estimates, rotavirus causes approximately 352,000–592,000 deaths each year (median, 440,000 deaths) in children below 5 years of age.

Dr Krishna Ella, chairman and managing director, Bharat Biotech said that  offering rotavirus vaccines at US$ 1 price is a re-affirmation of our commitment to make vaccines affordable globally. It is a great effort, by the Bharat Biotech team which made this a possibility. 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 honour that commitment,” he added.

The company’s rotavirus vaccine development project is a public-private partnership project between the company and the Dept of Biotechnology Govt of India, Gates Foundation, Programme for Appropriate Technologies in Health, Centres 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. It has an installed capacity of 300 million doses and is well positioned to manufacture and supply Rotavac to UNICEF, PAHO, and for national immunization programmes.

The company 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 pre-qualification to enable supplies to UN Agencies. Bharat Biotech has also submitted a dossier for its pentavalent vaccine for WHO Pre-qualification.

“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.