Indian Journal of Medical ethics recently published a letter addressed to Mr Ghulam Nabi Azad, Honourable Union Minister for Health and Family welfare rising serious questions about the safety of gardasil vaccine in young women in India.
This letter was initially framed in October 2009 by a core group of public health organisations from India comprising of health networks, women’s groups and medical professionals. They wrote to express their serious concern about the introduction of Human Papilloma(HPV) Vaccine to young girls in the country.
Gardasil vaccine is currently manufactured and being marketed in the country by Merck Sharp and Dohme Indian pharmaceuticals limited. It is an Indian subsidiary of Merck & Co which is primarily an American company based in New Jersey State.
Zur Hausen, the winner of the Nobel Prize in Physiology or Medicine in 2008, discovered that oncogenic HPV causes cervical cancer. His discovery led to characterization of the natural history of HPV infection, an understanding of mechanisms of HPV-induced carcinogenesis, and eventually to the development of prophylactic vaccines against HPV infection.
Human Papilloma Virus(HPV) is the most common sexually transmitted infection in young age group individuals. The working hypothesis behind the production of vaccine is that if the HPV infection is prevented then the cancer will not occur.
There are more than 50 subtypes of HPV and about 15 of them are proven to be oncogenic. The current vaccine only confers protection against only 2 oncogenic strains, HPV 16 and HPV 18.
Clearly there is no evidence on what effect, the HPV vaccination will have on the incidence of cervical cancer in 20 years time among the young women who currently received vaccine. There is lot of need for research and further clinical trials on the safety and the long term effects of vaccine.
The letter addressed to the Union Health Minister posed some serious questions on the level of involvement of Indian Government in promoting the vaccination among Indian girls.
Two other state governments in India, Andhra Pradesh and Gujarat also approved the pilot vaccination programme sponsored by Belida Gates foundation in July-August 2009.These projects involved up to 16,000 tribal girls in each state.
Three tribal girls living in a common welfare hostel in Andhra state are reported to have died this month from the complications of the administration of HPV vaccine allegedly. This report is yet to be validated as the treating physician labels the cause of deaths as suicide rather than complications of vaccine.
But certainly these deaths have highlighted the lapses and irregularities in the approval process of the current gardasil vaccination project.Still there are many answered questions on this matter.
Government sources in Indian health Ministry believe that there is very little chance that this vaccine would become a part of the national immunisation programme. No official inquiry reports have been released to explain the cause of death of the three young girls who received gardasil vaccine.
There are up to 100 reported deaths related to the administration of gardasil vaccine all over the world. The trial vaccination projects being held in India should be withheld temporarily until the complete safety profile of gardasil vaccine is clarified further through trials.
