Based on the concerns expressed on the death of six children who were administered the controversial Human Papilloma Virus (HPV) vaccines in Andhra Pradesh and Gujarat, the Central government has terminated the phase-3 trial of these vaccines, Gardasil by MSD Pharmaceuticals and Cervarix by GSK Pharmaceuticals.
Four deaths in the target of 14019 in Andhra Pradesh and two in the target of 10,686 in Gujarat have been reported from among the children who were administered these controversial vaccines. The cause of deaths was determined as viral fever, drowning, suicide, severe anaemia with malaria and suspected snake bite. Based on the concerns on these deaths, the states, Andhra Pradesh and Gujarat, have been advised not to carry out any further vaccinations at present, sources said.
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.
This is not the first time such suspected death occurs after the vaccination of HPV vaccine. More recently, the GSK was notified by the UK's Department of Health on September 28, 2009 about the death of a 14-year-old girl, Natalie Morton, who was vaccinated at a school in Coventry with GSK's cervical cancer vaccine, Cervarix, as part of the national HPV immunisation programme. After the incident, which caused an alarm in many parts of the world about the efficacy of the vaccine, the GSK recalled a particular batch of Cervarix.