New Rotavirus vaccine in India faces controversy

A new pediatric vaccine for rotavirus that apparently showed 56% efficacy in a phase III clinical trial has run into controversy, according to an expert who points to the need for more safety data and questions the rationale for including it in routine immunization.

…  “I think the fact that this [vaccine] was announced before peer review, [means] it will never be properly reviewed. That is the story that must come out,” Puliyel told CMAJ.

In fact, the government announcement came before the study was even officially completed. According to the clinical trials registry, the estimated study completion date is April 2014, with an estimated primary completion date of December 2013, both months away.

 Read the complete article exposing the flaws in the newly announced rotavirus vaccine in the article by Dr. Soumyadeep B at CMAJ



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