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Spotlight Back On Indian Rotavirus Vaccine Controversy

 
• By Anju Ghangurde

A public interest litigation has sought to revive efforts to access segregated trial data from a locally developed oral rotavirus vaccine in India, amid concerns that it might be associated with a higher risk of intussusception in certain pockets of the country. In a further dimension, an expert panel recently brought up a "representation" on the inclusion of intussusception in the vaccine's package insert.

A public interest litigation (PIL) filed in the Supreme Court of India is believed to be seeking segregated data of a trial site for a domestically developed oral rotavirus vaccine in Vellore in southern India, to determine if certain sections of the population are potentially more susceptible to the vaccine's potential adverse effects.

The larger point being made, though, appears to be that any clinical trial on which a major public policy decision is taken should be ideally put

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