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Rotavac divides experts’ opinion over effectiveness

The Rotavirus, named due to its wheel like structure, is the most common cause of diarrheal related deaths amongst children in developing countries. India is no exception to this, accounting for 22 percent of all rotavirus related deaths (~100,000 of the global 453,000). The disease can be lethal in children under the age of 5. Those older are still susceptible, but the symptoms are typically milder and there is a reduced chance of fatality.

The disease pathology occurs through damage to the villus cells of the small intestine (the lining of the small intestine, with protrusions to increase surface area, aiding absorption), invading through attachment to glycolipids and causing atrophy to the cells. This atrophy results in shortened villi, and a reduction in digestive enzymes. This causes a drop in absorption rates of carbohydrates, and produces the diarrhoea that is hallmark of the disease.

This year India has introduced Rotavac, an indigenously developed vaccine developed by Bharat Biotech for the purpose of combating the disease in a cost-effective way, with an aim to reducing child mortality. Rotavac is a landmark treatment as it has brought the potential for vaccination to poorer communities at a fraction of the cost. Rotavac consists of three treatments, much like the commonly used RotaTeq vaccine. The key difference is that a full course of treatment of Rotavac costs Rs. 162, as opposed to the Rs. 2700 required for the same treatment using RotaTeq.

Rotavac may seem like an ideal treatment, given its low cost. However, the vaccine is highly controversial. The vaccine has polarised experts, who have alleged that the vaccine was announced before any form of peer review. Suspicion has clouded its development ever since. Alongside this, the efficiency of the vaccination has also been called into question. During a phase III clinical trial, it registered an efficacy of just 56%. This value is far below the rates seen in other vaccines, for example phase III trials conducted in 70,000 children administered RotaTeq revealed a 74% efficacy. Many have dismissed Rotavac as a result.

Also of note is the target pathogen of each vaccine. Of the three major vaccines in use by India, RotaTeq, produced by Merck, Rotarix, produced by GSK, and the new Rotavac, it is RotaTeq that is unique in the sense that it is pentavalent. It comprises 5 different strains of the virus isolated from human and bovine hosts. Both Rotarix and Rotavac share the similarity of being monovalent, though this by no means ensures their efficacy is similar. Rotarix displayed an efficacy for both reduction of hospitalisation and prevention of severe rotavirus gastroenteritis each of over 90%. Worth mentioning is that the specificity of the strain of rotovirus differs between Rotavac and Rotavix, with G9P[11] and G1P[8] being their respective target strains, possibly accounting for at least some degree of the difference in success rate. This casts a great amount of doubt on the effectiveness of widespread usage of Rotavac.

Whilst the vaccine’s value is heavily disputed, one could argue that a 50% reduction in a disease which kills 100,000 children in India a year, for what equates to only $3 per person, it is worth the risk. For those in poor communities, the more expensive options may simply be out of the question. For this reason, many would say it is irresponsible to dismiss the vaccine out of hand, especially when for some there are no cheaper alternatives.

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