The Union Health Ministry has ordered a high level investigation into death of six children in Andhra Pradesh and Gujarat who were administered the controversial Human Papilloma Virus (HPV) vaccine. The ministry has formed a three-member committee under the chairmanship of well-known scientist and pharmacologist Dr Ranjith Roy Choudhury.
The ministry has asked the committee to submit a report to the government within one month about the real reasons that led to the death of six children after they were administered the HPV vaccine. Based on the concerns of the death of these six children, the central government had earlier terminated the trial of the HPV vaccines, being marketed by two multinational companies MSD Pharmaceuticals and GSK Pharmaceuticals. While the MSD Pharmaceuticals markets the drug under the brand name of Gardasil, GSK Pharmaceuticals sells the drug under the brand name of Cervarix.
Further continuation of the trial and the subsequent introduction of the vaccine into the national universal vaccination programme will depend on the outcome 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. The issue was also echoed in Parliament when the members expressed concern over the death of children.
Some time back, two imported brands of HPV vaccines, Gardasil and Cervarix, were allowed to undergo phase-III clinical trial in India, before granting permission to import and market authorization. For assessing the health services needs and preparedness for introducing HPV vaccines into the health services in future, an international NGO named PATH was given permission for a post licensure observational study of HPV vaccination in Khammam district in Andhra Pradresh and Vadodara district in Gujarat.
The study by PATH was recommended by the Ethical Committee and Advisory Groups at state and central government levels. The Indian Council of Medical Research (ICMR), an autonomous body under the union health ministry has been providing technical support for the development of protocols, and has been advising on ethical issues as per the government of India guidelines.