The Government of India's Department of Biotechnology (DBT) and Bharat Biotech have announced positive results from a Phase III clinical trial of a rotavirus vaccine developed and manufactured in India.
Data from the trial, presented today at the International Symposium on Rotavirus Vaccines for India-The Evidence and the Promise, showed ROTAVAC to have an excellent safety and efficacy profile.
The clinical study demonstrates for the first time that the India-developed rotavirus vaccine ROTAVAC is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India. ROTAVAC significantly reduced severe rotavirus diarrhoea by more than half-56 percent during the first year of life, with protection continuing into the second year of life. Moreover, the vaccine also showed impact against severe diarrhoea of any cause.
"This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year," said DBT Secretary Dr. K. VijayRaghavan. "The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India."
The vaccine was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors.
The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86. Since then, partners have included DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and the nongovernmental organization, PATH. Dr. M.K. Bhan, who recently completed his service as DBT Secretary, was tireless in fostering the social innovation partnership and ensuring the highest standards for the vaccine.
The randomized, double-blind, placebo-controlled Phase III clinical trial enrolled 6,799 infants in India (aged six to seven weeks at the time of enrolment) at three sites-the Centre for Health Research and Development, Society for Applied Studies (SAS) in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre in Vadu, Pune; and Christian Medical College (CMC) in Vellore.
The Clinical Operations Management Unit headed by Dr Nita Bhandari at SAS oversaw the day-to-day coordination and logistical complexities of this multi-site study and played a pivotal role in the conduct of this trial. The Principal Investigators were Dr. Temsunaro Rongsen-Chandola at SAS, Dr. Ashish Bavdekar at KEM, and Dr. Gagandeep Kang at CMC.
The Data Safety Monitoring Board (DSMB), an independent group of experts established to protect.
The participating infants' rights and needs during the Phase III trial, determined that the trial met the highest standards for ethics and patient care and complied with international standards for good clinical practices.
Bharat Biotech previously announced a price of US$ 1.00/dose (or approximately INR 54/dose) for ROTAVAC(r) and will soon file for registration of the vaccine in India. If licensed by the Drugs Controller General of India (DCGI), the vaccine will be a more affordable alternative to the rotavirus vaccines already on the market.
"With its low price and strong efficacy, ROTAVAC(r) has the potential to significantly reduce the incidence of severe diarrhoea due to rotavirus among children in India," said Dr. M.K. Bhang, Advisor to the Indian Academy of Pediatrics and former DBT Secretary.
The vaccine 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.
Infants enrolled in the study received ROTAVAC(r) and the Universal Immunization Programme (UIP) vaccines, including oral polio vaccine (OPV). When the immune responses to OPV were tested, the result showed that infants receiving OPV at the same time as ROTAVAC(r) generated comparable immune responses to all three polio serotypes as the infants receiving OPV without ROTAVAC(r); this result supports the concurrent administration of OPV and ROTAVAC(r).
"Vaccines work to save and protect children from diseases like rotavirus for a lifetime," said Bill Gates, Co-Chair of the Bill and Melinda Gates Foundation. "This public-private partnership is an exemplary model of how to develop affordable technologies that save lives."
The vaccine development partnership was supported by DBT, the Bill and Melinda Gates Foundation, the Research Council of Norway, and the UK Department for International Development. Bharat Biotech invested important technical, manufacturing, and financial resources towards vaccine development. ROTAVAC(r) is an oral vaccine and is administered to infants in a three-dose course at the ages of 6, 10, and 14 weeks. It is given alongside routine immunizations in the UIP vaccines recommended at these ages.
