Following the government’s decision to conduct a feasibility study to introduce a vaccine for Human Papillomavirus (HPV), public health activists and women’s groups question the vaccine’s safety and efficacy
By Team FI
Health rights activists, women’s groups and representatives of public health networks have reacted with shock and concern over the Government of India’s recently announced plan to introduce human papillomavirus (HPV) vaccine in the Universal Immunization Programme (UIP).
In a memorandum sent to the Union Minister for Health and Family Welfare, the activists state their concerns over the Government’s decision to conduct a feasibility study in order for the vaccine to be used in the country in the next three months. “We are extremely concerned about the long-term safety and efficacy of the HPV vaccines—Gardasil and Cervarix—and strongly feel that it would lead to serious adverse effects for its recipients. The Supreme Court is hearing the writ petitions (Kalpana Mehta and others vs Union of India & Others; Writ Petition Sama and others vs Union of India & Others) that have raised important questions regarding the vaccine’s safety and efficacy as well as its relevance and priority as a public health measure in India,” states the memorandum.
The Memorandum pointed out the lack of “conclusive evidence” that the vaccine would ensure protection against HPV. “These vaccines have not been in use for long enough to know the level of protection they will offer to young women when they are actually exposed to the risk of HPV infection. The impact of the vaccines on the health of adolescents is also not known,” states the memorandum.
Following is the full text of the Memorandum :
Shri Jagat Prakash Nadda,
Union Minister for Health and Family Welfare,
Ministry of Health and Family Welfare,
Nirman Bhavan, Maulana Azad Road,
New Delhi 110 011.
Date: 5 August 2015
Sub: Memorandum regarding the introduction of human papillomavirus (HPV) Vaccines in the Universal Immunization Programme.
We, the concerned representatives of public health networks, women’s groups, health researchers, health and women’s rights activists and individuals are writing to you to convey our shock and concern over the Union Government’s plan (reported in Asian Age http://www.asianage.com/india/government-plans-reintroduce-hpv-vaccine-308) to introduce the human papillomavirus (HPV) vaccine in the Universal Immunization Programme (UIP). According to the newspaper report, the Government has asked the National Technical Advisory Group on Immunisation (NTAGI) to conduct a feasibility study in the next three months on the vaccine so that it can be introduced in the country. We are extremely concerned about the long-term safety and efficacy of the HPV vaccines—Gardasil and Cervarix—and strongly feel that it would lead to serious adverse effects for its recipients. The Supreme Court is hearing the writ petitions that have raised important questions regarding the vaccine’s safety and efficacy as well as its relevance and priority as a public health measure in India.
At the outset we would like to bring to your notice that the HPV will by itself not reduce the rate of cervical cancer in India. It is well documented that HPV infection is a necessary cause of cervical cancer; however, since every woman with HPV infection does not develop cervical cancer, it is not necessarily a sufficient cause. Other factors are necessary for progression from cervical HPV infection to cancer. Long-term use of hormonal contraceptives, high parity (number of times given birth), early initiation of sexual activity, multiple sex partners, tobacco smoking and co-infection with HIV have been identified as established factors; co-infection with Chlamydia trachomatis and herpes simplex virus type-2, immuno-suppression, low socioeconomic status, poor hygiene and diet low in antioxidants are other probable factors influencing the progression of cervical cancer. Genetic and immunological host factors and viral factors such as variants of type, viral load and viral integration are likely to be important, though they have not yet been clearly evaluated.
Further, there is a lot unknown about HPV vaccines even today, including whether a repeat dose is required and how long the vaccine might protect from HPV infection. There is no conclusive evidence which suggests that the vaccine will protect girls from acquiring HPV and developing cervical cancer later in their life. These vaccines have not been in use for long enough to know the level of protection they will offer to young women when they are actually exposed to the risk of HPV infection.
The impact of the vaccines on the health of adolescents is also not known. For instance, individual case reports of CRPS (Complex Regional Pain Syndrome) and POTs (Postural Orthostatic Tachycardia Syndrome) have been reported following HPV vaccinations from several countries including Australia, Germany, Japan, the US and Denmark. The Danish Health and Medicines Authority has drawn the attention of the European Medicines Agency (EMA) towards the vaccine’s safety and efficacy and the EMA is currently conducting a review of the vaccine’s safety profile.
There is little evidence of the safety and efficacy of the HPV vaccine in the Indian context. These vaccines were hurriedly licensed here, on the basis of grossly insufficient research; the Cervarix trial was restricted to women and Gardasil was introduced after a trial with only 110 girls and no adult women.
Government committees have criticised both scientific and ethical aspects of the vaccines’ introduction in India. The 41st Report of the Parliamentary Standing Committee had called for an enquiry into the licensing of the products. However, no enquiry was conducted. The 72nd Parliamentary Standing Committee found gross under-reporting of adverse events in the only large scale “demonstration” study of the two vaccines, on girls between 9 and 16, carried out in Gujarat and Telangana by the US-based NGO Programme for Appropriate Technology in Health (PATH) in collaboration with the Indian Council of Medical Research (ICMR).
A number of girls experienced side effects and at least 7 died post vaccination. The Parliamentary Standing Committee concluded that the girls’ deaths were not properly investigated and that they were instead summarily dismissed as being unrelated to the vaccine. The Committee also concluded that PATH’s demonstration study violated the rights of the vaccinated girls and called for an enquiry by the National Human Rights Commission (NHRC) and the National Commission for the Protection of Child Rights (NCPCR).
Further, money and resources that would be spent on this vaccine should be spent to strengthen health services including screening for cervical cancer. These include large-scale awareness programmes (including sex education for girls) on HPV, cervical cancer, methods of preventing transmission of sexually transmitted infections, and the need for screening. This will have a far greater impact in reducing the incidence of and mortality from cervical cancer. Indeed, the Planning Commission’s working group on Non-Communicable Diseases (NCD) for the 12th Five Year Plan recommended that “at this juncture emphasis on availability of HPV vaccine at district level may not be required as simple advice on personal hygiene and early symptoms of Cervix Cancer and training of Health worker in VIA techniques will help in prevention & early detection of cervix cancers”. (Proposal for the 12th five year plan, working group on NCDs, Planning Commission, GoI, pg 100).
Finally, you are well aware that the Supreme Court is still waiting to hear from the DCGI and the ICMR on its order of 12th August 2014, calling on them to produce the files relating to the licensing and collaboration with PATH before the court in the matter of Writ Petition (civil) 558/2012 Kalpana Mehta and others vs Union of India and others and Writ Petition (civil) No.921/2013 Sama and others vs UoI and others. It is unacceptable to ask NTAGI to look into the feasibility of the vaccine when the Health Ministry has failed to comply with the order with respect to licensing that deal with safety and effectiveness of these vaccines.
We sincerely urge you to call an immediate halt to any attempts to introduce the HPV vaccines in the Universal Immunization Programme in the larger interest of the health and well-being of the adolescent girls and women of this country.