A vaccine against rotavirus infection, developed in India as a low-cost alternative to available vaccines, has shown positive results in Phase III clinical trials. Rotavirus is the most severe and lethal cause of childhood diarrhoea, and is responsible for the death of approximately 100,000 small children in India each year. The vaccine, Rotavac, developed as part of a public-private partnership endeavour, will cost about 50 times less than currently available vaccines.
Rotavac has been developed by the department of biotechnology (DBT) of the science ministry of the government of India and private sector company Bharat Biotech. The results of the Phase III clinical trials were announced Tuesday.
Rs 50 a dose
Bharat Biotech announced that each dose of Rotavac will be sold for Rs 50, and the company will file for registration for the vaccine in India soon. Once licensed by the Drug Controller General of India (DGCI), the vaccine will become available in the market as a much more affordable alternative to existing vaccines.
| Deadly virus
Rotavirus is the most common cause of severe diarrhoea and dehydration in infants and young children. The virus is found everywhere, and nearly every child in the world is at risk of infection
Each year, approximately 453,000 children under the age of five worldwide die from severe, dehydrating diarrhoea due to rotavirus infection—37 percent of all deaths attributable to diarrhoea. India suffers the highest mortality burden of rotavirus among all countries; the country alone accounts for 22 per cent of deaths caused by rotavirus, globally
Rotavirus kills approximately 100,000 children in India each year. The heaviest toll is on the youngest among them; approximately 50 per cent and 75 per cent of rotavirus-associated deaths in India occur between 1 and 2 years of age, respectively.
The toll from the illness caused by rotavirus is also significant. A study by the Indian Rotavirus Surveillance Network found that over a two-year period, from 2005 to 2007, rotavirus was responsible for approximately 39 per cent of diarrhoea-related inpatient hospital visits
Based on these and other data, it is estimated that rotavirus leads to 457,000-884,000 hospitalizations and two million outpatient clinic visits each year in India—healthcare costs, Rs 2 to 3.4 billion
Companies Merck & Co and GlaxoSmithKline (GSK) manufacture the vaccine at present, but their products cost at least Rs 7,500 for three doses, says former secretary of DBT, M K Bhan, who was closely associated with the trial. But the new vaccine will cost hardly Rs 150 for three doses, he adds.
This product is comparable in efficacy with other products available in the market, but the best thing is it will be affordable for everybody. Further, every detail will be monitored in post-marketing surveillance, so that its effect in open setting could be checked, says Bhan.
“This is an important scientific breakthrough against rotavirus infection. The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year,” says DBT secretary, K Vijayraghavan.
Rotovac and other vaccines
Phase III of the clinical trials of Rotavac began in March 2011. The trial was randomized, double-blind (only half of the patients get the treatment and other half act as control) and placebo-controlled, and monitored 6,799 infants aged between six to seven weeks at the time of enrollment.
The phase III clinical trial enrolled 6,799 infants in India 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 children were aged six to seven weeks at the time of enrollment. They received Rotavac and the vaccines under the universal immunization programme (UIP), including the oral polio vaccine (OPV). When their immune responses to OPV were tested, the results showed that infants receiving OPV at the same time as Rotavac generated a comparable immune response to all three polio serotypes as the infants receiving OPV without Rotavac. The results thus support the concurrent administration of OPV and Rotavac.
An independent group of experts served as the data safety monitoring board (DSMB) for the phase III study. At a meeting in February this year, DSMB determined that the trial met the highest standards for ethics. It also stated that the vaccine safety profile is excellent and that the efficacy data met pre-specified success criteria.
The clinical operation management unit, headed by Nita Bhandari from Society for Applied Studies, oversaw the day-to-day coordination and logistical complexities of this multi-site study and played a pivotal role in the conduct of the trial.
Talking to the media, Bhandari said that all the norms of Drugs Controller General of India (DCGI) were followed during the trial. All the families of subjects were given a cell phone so that they could contact in an emergency. Doctors were also available at all times for to attend to them.
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