Earlier this month, a phase 3 clinical trial of a new vaccine began in India. Phase 3 trials begin around the world all of the time but to me this one is particularly important. This vaccine is from India, for Indians. It was discovered, developed and tested in India, specifically to protect Indian children from rotavirus.
Rotavirus is the most common cause of severe diarrheal disease in children worldwide and is responsible for the deaths of more than 527,000 children each year. One third of those deaths are in India. By comparison, around 20 children in the United States die each year from the disease.
Rotavirus is easily preventable with a simple, childhood vaccine. However, the vaccine that children in the developed world receive is too expensive – around U.S. $200 – for many families around the world to afford.
The solution seems simple: Indian babies need access to an affordable vaccine. But developing new vaccines that cost less can be very difficult.
The idea for the “India rotavirus vaccine” was sparked in the 1980s, when two groups of scientists working in India discovered unusual strains of rotavirus, which infected newborns in hospital nurseries without making them sick. The groups began as competitors but over the years began to work together to create a new vaccine. The plan was to use these naturally occurring, weakened strains of the virus to develop a vaccine for babies that would give them exposure and therefore protection, but without symptoms.
Many collaborators shared this spirit of discovery and were committed to the vision of making a new, lifesaving vaccine for rotavirus. Along the way, they brought a diverse set of partners into their quest, including the Government of India, the National Institutes of Health and Center for Disease Control (CDC), Bharat Biotech International in Hyderabad, India and PATH in Seattle, Washington. They were dedicated to moving the development of the vaccine along quickly to ensure that it would get to children as soon as possible.
Results from the last round of trials conducted between November 2006 and February 2008 in nearly 400 Indian infants were impressive. The vaccine was found to be safe and produced immunity in close to 90 percent of the babies after three doses.
The start of the phase 3 study this month is so exciting for me because I know that, if it’s successful, we will have overcome the last major barrier to getting approval for the vaccine. It means that we are one step closer to getting the vaccine to kids in India. The study will enroll 6,800 infants across three sites in India (New Delhi, Pune, and Vellore) over the next six to eight months. Successful results could lead to Indian licensure of this vaccine by late 2014 and WHO pre-qualification in 2015.
We hope, and expect, that this new, low-cost vaccine will have promising results for these children. Each day the introduction of the rotavirus vaccine is delayed is another day that children are needlessly dying from this preventable disease, not only in India, but across many countries in the developing world.
Source: Bill & Melinda Gates Foundation