Report inaccurate about vaccine effects: NGO
Two days after the Parliamentary Standing Committee came out with a damning report on Human Papilloma Virus (HPV) vaccine trials suggesting that girls “probably” died due to the adverse effects of vaccine in 2010, PATH, an international NGO that conducted the trials said that they were troubled by the report’s “inaccurate” characterisation of the “important work”.
Noting gross violations on part of administrator of the vaccine, PATH, the expert committee had recommended the government to report the violation to the US government so as to ensure appropriate action against PATH under the laws of its country of origin. The trial of the HPV vaccine, used to prevent cervical cancer, was started in Andhra Pradesh and Gujarat from 2009-2010. The administration of the vaccine, Gardasil, reportedly led to death of four girls in Khammam district of Andhra Pradesh.
However, according to PATH the demonstration project in India was part of a four-country project to explore suitable vaccine delivery strategies and help provide evidence for national health authorities to make informed decisions about the potential benefits and challenges of introducing vaccines against HPV, the primary cause of cervical cancer.
As per the statement issued by PATH, the government agencies, state government were in know how of the project and had approved before it was implemented. “At the time of its review, the ICMR determined the project was a post-licensure observational study and not a clinical trial. The project did not seek to evaluate the efficacy or long-term safety of the vaccines, which had already undergone clinical evaluation in India and had been licensed and approved by the Drugs Controller General of India,” it said. Adding that, “PATH designed the project protocols in compliance with the ICMR’s instructions and fully complied with the ICMR’s requirements regarding the necessary approval processes and the requirements of state governments regarding consent processes”. It also said that an essential goal of the project was to understand the challenges of equitable introduction of HPV vaccines in routine public-sector immunisation services.
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