Inquiry panel on HPV vaccine finds no violation in phase-4 trials in AP, Gujarat

Pharmabiz.com

October 18, 2010
Ramesh Shankar, Mumbai

The three-member inquiry committee, set up by the Union Health Ministry to investigate the death of six children in Andhra Pradesh and Gujarat who were administered the controversial Human Papilloma Virus (HPV) vaccine, has found no violation in the phase IV trials conducted in these states in which more than 24,000 children were administered the controversial vaccine, it is learnt.

According to sources, the committee, comprising Dr S P Aggarwal, former director general of Health Services (DGHS), Dr Suneeta Mittal, head of the department, Obstetrics and Gynaecology at AIIMS and Ranjit Roy Chaudhury, a leading clinical pharmacologist, has recently submitted its report to the ministry, almost five months after it was constituted to delve into the real reasons that led to the death of six children after they were administered the HPV vaccine. The committee, which was asked to go into the regulatory issues, did not find any violation in the study, sources said. However, the ministry did not so far reveal the contents of the report.

Though the authorities had earlier termed the cause of deaths of six children as viral fever, drowning, suicide, severe anaemia with malaria and suspected snake bite, there was outcry from the public as well as the scientific community in the country over the real reasons for the deaths, forcing the government to terminate the study, called the observational study, and to constitute a committee to find the real reasons for the death.

Earlier, an International NGO named PATH was given permission to carry out a post licensure study of HPV vaccination in three blocks each of Khammam district of Andhra Pradesh and Vadodara district of Gujarat, with the permission of state governments. The objectives of the study were to demonstrate the suitability of vaccine delivery strategies for HPV in the 10-14 year adolescent girls, to raise community awareness of HPV, cancer of cervix and its prevention, and gaining experience in HPV vaccination and to build evidence based vaccine delivery strategy for future introduction of HPV in the universal immunisation programme.

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