Gardasil study: Death of 6 girls not due to vaccine failure, says Indian minister

Dance with Shadows

Saturday, April 17, 2010, 8:07

The alleged deaths of 6 children in AP and Gujarat states during cervical cancer vaccine trials were not from the vaccine failure but due to other reasons including viral fever, drowning, suicide, according to a communication from the ministry of health and family welfare, government of India.

Four deaths in the target of 14019 in Andhra and two in the target of 10,686 in Gujarat have been reported from among the children who were administered these vaccines, stated an official release quoting the information given by Minister of State for Health & Family Welfare, S. Gandhiselvan in written reply to a question raised in Lok Sabha.

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, States have been advised not to carry out any further vaccinations at present.

For assessing the health services needs and preparedness for introducing Human Papilloma Virus (HPV) vaccines into the health services in future, PATH, an international NGO, was given permission for a post licensure observational study of HPV vaccination in Khammam district (Andhra Pradresh) and Vadodara district ( Gujarat).

The study by PATH, was recommended by the Ethical Committee and Advisory Groups at State and Central level. Indian Council of Medical Research, an autonomous body under the Ministry has provided technical support for the development of protocols, and advised on ethical issues as per Govt. of India guidelines, the release stated.

Two imported brands of Human Papilloma Virus (HPV) vaccines namely Gardasil (imported by M/s MSD Pharmaceuticals, Gurgaon) and Cervarix (imported by M/s GSK Pharmaceuticals, Mumbai), were allowed to undergo clinical trial (Phase III) in India, before granting permission to import and Market Authorization.

Even though the cause of the 6 deaths has been determined as not due to the vaccine, based on the concerns on these deaths, States have been advised not to carry out any further vaccinations at present, the minister has stated.

Recently, Indian government has suspended Merck’s cervical cancer vaccine Gardasil study in two states following reports of deaths of 4 girls and several complications.

Gardasil was to be tested for its “acceptability and service delivery issues” in about 32,000 girls aged 10-14 in the southern Indian state of Andhra Pradesh and Western state of Gujarat.

Gardasil vaccination programme is being conducted jointly with PATH, a Seattle-based NGO, the Indian Council of Medical Research (ICMR) and the two state governments. The vaccination drive is funded by the Bill and Melinda Gates Foundation

PATH-International, which is conducting the study for the maker of Gardasil Merck, an American pharmaceutical company since July 2009, has described the study as a “demonstration project.”

The human papilloma virus (HP) vaccine HPV vaccine Gardasil, meant to prevent cervical cancer among women, has been alleged to have led to the death of the four girls who were administered the dose in Khammam district of Andhra Pradesh.

Besides the death, more than 120 girls, who were given the vaccination, have complained severe adverse reactions of stomach disorders, epilepsy, headaches and early menarche.

The cervical cancer vaccination study is not part of the universal immunisation programme of the country and PATH had claimed it was a promotional programme for the vaccine in India. ICMR had clarified that it was, indeed, a clinical trial, human rights NGOs alleged.

Villagers in these states were told that Garadasil was an expensive vaccine and that they would not be able to afford it once the company’s project was over, hence they should get their daughters vaccinated, they alleged.

MSD Pharmaceuticals (India), the local affiliate of Merck & Co., Inc USA launched Gardasil a quadrivalent human papillomavirus vaccine. Gardasil is the only vaccine that helps protect against 4 types – types 6, 11, 16, 18 – of HPV. The vaccine helps prevent diseases such as cervical cancer; abnormal and precancerous cervical lesions, vaginal lesions, vulvar lesions; and genital warts, caused by these types of HPV, MSD said while announcing the launch.

Gardasil is recommended to be given to females aged between 9 to 26 years.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.