TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
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The introduction of HPV vaccination is facing many challenges. The article published by Pollack et al. in the January issue of the Bulletin of the World Health Organization, besides providing useful information about the disease and the vaccine, discusses these challenges. Possible integration into EPI is also analyzed. The abstract is reproduced here below and access to the full text is at : http://www.who.int/bulletin/volumes/85/1/06-034397.pdf Some countries are already planning for vaccine introduction. Through a broad partnetship PATH Cervical Cancer Project is already helping four countries, India, Peru, Uganda and Vietnam, to conduct clinical and operations research. Studies will look at a variety of vaccine introduction questions. The following two-page fact sheet from PATH CCV Project provides further details: http://www.technet21.org/pdf_file/PATH-CCVProjectFactSheet.pdf Finally, in "The Ethics and Politics of Compulsory HPV Vaccination" published in the New England Journal of Medicine, James Colgrove examines political and ethical questions surrounding the proposed compulsory vaccination of 11- and 12-year-old schoolgirls in the US. He states that "A critical question is whether achieving a higher level of coverage justifies the infringement on parental autonomy that compulsory vaccination inevitably entails." The article can be downloaded from: http://www.technet21.org/pdf_file/HPV-IntroEthics.pdf This issue may be considered less relevant to many developing countries at this point but may likely catch up with them rapidly under a different disguise....remember the OPV issues. Thanks to Robert Davis and Evelyn Chege for this information. ________________________________ "Ensuring access to HPV vaccines through integrated services: a reproductive health perspective" by Amy E Pollack, Miranda Balkin, Lindsay Edouard, Felicity Cutts, Nathalie Broutet In 2006, a quadrivalent human papillomavirus (HPV) vaccine was licensed, and another vaccine may be licensed soon. Little is known about the practical considerations involved in designing and implementing cervical cancer prevention programmes that include vaccination as a primary means of prevention. Although the vaccine may ultimately be indicated for both males and females, young girls, or girls and women aged 9–25 years, will be the initial candidates for the vaccine. This paper describes avenues for service delivery of HPV vaccines and critical information gaps that must be bridged in order to inform future sexual and reproductive health programming. It proposes the role that the sexual and reproductive health community, together with immunization and cancer control programmes, could have in supporting the introduction of HPV vaccines within the context of current health systems. ______
prabirkc Accepted Answer
The Committee looking into the HPV post licensure study in India said that considerable time and effort had been invested in getting all the approvals, but the same could not be said for its actual implementation. A collective effort was required to raise the standards of clinical research — first, in the arena of implementation of bioethical guidelines and second, in the monitoring and investigating adverse events following immunisation to raise public confidence. The ‘Post-licensure observation study of HPV vaccination: demonstration project,' carried out by PATH in collaboration with the Indian Council of Medical Research (ICMR) in Andhra Pradesh and Gujarat since 2007, was suspended in April last year following reports of deaths and violation of ethics. The project is funded by a grant from the Bill and Melinda Gates Foundation and donation from HPV vaccine manufacturers — GSK and MSD. While recommending that the third and final phase of the project should be allowed to continue as it would “provide the most useful information and did not involve any further vaccination,” the interim report suggested that other studies which were already under way or planned to be carried out using HPV vaccine be stopped, and resumed only after conducting reviews. It ruled out a blanket ban on or approval of such studies in future. The report, however, warned that HPV vaccination was not to replace the cervical cancer screening programme, but to supplement it. Since the vaccine was expensive, an element of cost-effectiveness and determination of competing health immunisation priorities should have been addressed by the study. “The fact that the vaccine for the study was provided by the manufacturers free-of-cost does raise the concern about undeclared conflict of interest, since the results of the study may be used to influence the decision by the government.” S.S. Agarwal, the former Director, Sanjay Gandhi PGI of Medical Sciences; Lucknow; S.P.Agarwal, former Director-General of Health Services; and Suneeta Mittal, All-India Institute of Medical Sciences were members of the committee. The committee wanted a blurring of the distinction between routine, national immunisation programme and the research nature of the HPV vaccination study. “It is important that public-private partnership programmes be extra vigilant and ensure the authority of the State is not misrepresented.” It said the seven deaths (five in Andhra Pradesh and two in Gujarat) among those administered the vaccine were “most probably” unrelated to it, as there was no characteristic and uniform pattern of illness preceding the deaths, or temporal/spatial clustering, going by the FIR. Questioning the legality and morality of the circular issued by Andhra Pradesh, authorising hostel wardens and head masters to sign the consent on behalf of the minor girls included in the study, the report said everyone should desist from research on tribal population, except where it benefitted them. It made out a strong case for specific and separate legislation covering all aspects of biomedical and health research that involve human participants, and eliminating overlaps such as definition of clinical trial/clinical research that exist in Schedule Y of Drugs and Cosmetics Act Rules, and the ICMR guidelines. http://www.thehindu.com/health/policy-and-issues/article1165640.ece The three-member committee, set up to probe the alleged irregularities in conducting studies using human papillomavirus (HPV) vaccine by PATH in India, has identified several deficiencies in the planning and implementation of the project leading “to a crisis requiring suspension of the study,” but has fallen short of fixing responsibility on any individual or agency. The interim report submitted to the Ministry of Health and Family Welfare said that it was true that a lot of negative vibes had been generated against this project due to mishandling of the situation, but the committee had not been able to identify a single event, individual or agency which could be held entirely accountable for it. All the deficiencies were minor in nature, which should serve as a lesson for strengthening clinical research in future rather than starting any punitive or disciplinary proceedings.
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prabirkc Accepted Answer
Thanks Scott- the link is now working, one of the comments is given below- "The study population is representative of the population of the two states, including girls living in urban, rural, and tribal areas. Since the post-licensure observational study seeks to determine vaccine coverage achieved, feasibility, acceptability of HPV vaccination, and implementation costs associated with different vaccination strategies in a variety of socioeconomic settings, blocks (neighborhoods) were selected to represent diverse populations that would be eligible for HPV vaccination through a public health program, including those in urban, rural, and tribal settings." (http://www.path.org/news/an100422-hpv-india.php ) Strictly speaking this is a strange way to put it. 2 deaths in Andhra were of tribal girls. The article mentions a total of 6 deaths. Andhra and Gujarat do not have such large tribal populations. The health facilities available to tribal girls living in hostels (hardly "representative";) are poor- but not poor enough to explain the lopsidedly large ratio 1 tribal:3 deaths . PATH certainly has a responsibility which increases because individual Informed Consent was not taken from the tribal girls or their parents in a large number of cases. I think PATH would benefit from waiting for India to be satisfied with the approach to HPV before advertising the vaccine so forcefully. to the best of my knowledge the trials remain suspended.
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prabirkc Accepted Answer
The ethical question has certainly caught up. In a trial in India young tribal girls in hostel were given the vaccine without proper informed consent. Given that any vaccine needs to be given after providing proper information in USA this is amazing to say the least. More surprising is that the non-profit PATH was involved in this trial but forgot to vet it for ethical issues of this sort. Some deaths among the immunized girls led to the issue of Lack of Informed Consent being brought into the limelight and now the trial has been stopped.
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James Cheyne Accepted Answer
Part of the little know story of HPV vaccine introduction is the rapid addition of the vaccine to the PAHO Revolving Fund portfolio and implementation of pilot vaccination programs in nearly 20 developing countries only 3-4 years after introduction in the US and Europe. I think that must be a record! (Thanks to Scott Wittet (PATH) for this information) Both GlaxoSmithKline and Merck & Co,, Inc. have licensed their vaccines for use in over 100 countries so now need GAVI to negotiate a price for this vaccine that they can afford and a price that is also affordable for the countries to provide their 'co-payment'.
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