Come September and the ambitious phase III clinical trial for an indigenous vaccine against rotavirus,which kills more than 1 lakh children below the age of five in India every year,is likely to get the nod from the health ministrys screening committee. More than a year after the first two phases of the clinical trial were completed,the panel is set to give its approval for the trial to be conducted by Serum Institute of India.
Dr Rajiv Dhere,Executive Director,Serum Institute of India Limited,said the waiting period has been quite long since the earlier trials were conducted. As many as 200 children and adults were tested at KEM Hospital last year. The phase III trial to be conducted at five centres Wardha,Ahmedabad,Jammu,Kolkata and Manipal is expected to enroll over 7,000 infants.
He said among the two groups,one will receive the vaccine Rotavac and over a period of a year,researchers will record the difference in the cases of diarrhea in each group.
We have tested the safety of the vaccine in a small group. Now,we want to test it in a larger group which mainly involves infants. The trial is community-based and will evaluate the acceptability of the vaccine,said Dhere. Rotavirus is one of the most common causes of diarrhea and severe infection (rotavirus gastroenteritis) is the leading cause of dehydrating diarrhea in infants and young children.
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A recent review of the burden of rotavirus disease-associated morbidity and mortality estimated that 4,40,000 deaths among children could be attributed to rotavirus infection. Around 82 per cent of such deaths occurred in developing countries. Because of this disease burden,several vaccines against rota virus have been developed in countries such as India,which are most likely to benefit from the introduction of vaccines and where mortality rate is high.
The Bill and Melinda Gates Foundation is backing two Indian firms,including Pune based Serum Institute of India,to develop vaccines for pneumonia and diarrhea.
Dr Lalit Kant,Deputy Director,Vaccines and Immunization,Bill & Melinda Gates Foundation said,The development of Rotavac is an important scientific breakthrough against rotavirus diarrhea in India. More than 1 lakh children below the age of five die of severe rotavirus diarrhea every year in India. Once licenced this indigenous and affordable vaccine has the potential to significantly reduce the burden of severe rotavirus disease in India. In the Year of the Intensification of Routine Immunization,the country is launching new initiatives to reach out to children who need it the most, said Kant.
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