PHARMA firm Wyeth has been given the goahead by the country's drug regulator to resume clinical trials for its Prevnar 13 vaccine in India seven months after it was suspended when a child suffering from a pre-existing caridac disorder died after being given the vaccine.
"The DCGI is satisfied with the systems and protocols in place for conduct of the trials as per good clinical practice (GCP) norms. The unfortunate death of an infant during clinical trials was reviewed by the study doctors and the ethics committee, which requested a review of the case by a team of physicians that included two independent doctors who were not part of the study. All of them found that the death was not associated with any of the vaccines the child received," a Wyeth spokesperson said. The trials, now in phase III, is part of global trials to judge the safety, tolerance and the ablilty of the vaccine to increase the production of antibodies once administered.
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