The HPV vaccine: Science, ethics and regulation

Economic and Political Weekly

Volumn 45, Issue 48, 2010, Pages 27-34

  Sarojini, N B ^a   Srinivasan, Sandhya ^b   Madhavi, Y ^c   Srinivasan, S ^d   Shenoi, Anjali ^a  

^a Sama Resource Group for Women and Health   (India)

^b National Institute of Science Technology and Development Studies ^*

^c National Institute of Science Technology and Development Studies India   (India)

^d LOCOST   (India)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84859308274     PISSN: 00129976     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (27)

1. Aneja, H and J Puliyel (2009): "Selling Vaccines: Deciding on Who Can Afford HPV," Indian Pediatrics, 46:647, http://indianpediatrics.net/ july2009/647.pdf
2. Bhatla, N and N Moda (2009): "The Clinical Utility of HPV DNA Testing in Cervical Cancer Screening Strategies", Indian Journal of Medical Research 130(3):261-65.
3. Basu, M (2006): "The Relevance of Cervical Cancer Screening and the Future of Cervical Cancer Control in India in the Light of the Approval of the Vaccine against Cervical Cancer", Indian Journal of Cancer, 43(3):139. (Pubitemid 44701610)
4. Basu, P and D Chowdhury (2009): "Cervical Cancer Screening and HPV Vaccination: A Comprehensive Approach to Cervical Cancer Control", Indian Journal of Medical Research, 130:241-46.
5. CDSCO (undated): "Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy", Central Drugs Standard Control Organisation, Ministry of Health, Government of India, viewed on 30 July 2010 (http://cdsco.nic.in/CDSCO-GuidanceForlndustry.pdf).
6. Dabade, G et al (2010): "Concerns Around the Human Papilloma Virus (HPV) Vaccine", Memorandum, Indian Journal of Medical Ethics, 7(1):38-41.
7. Dhar, A (2010a): "Centre Halts HPV Vaccine Project", The Hindu, 7 April, viewed on 30 July 2010 (http://beta.thehindu.com/news/national/ article391024.ece).
8. - (2010b): "RTI Act Not Applicable to HPV Vaccine Project", The Hindu, 9 August, viewed on 9 August 2010 (http://www.thehindu.com/news/ article559462.ece).
9. Haug, C J (2008): "Human Papillomavirus Vaccination - Reasons for Caution", New England Journal of Medicine, 359:861-68.
10. ICMR (2006a): Annual Report 2005-2006 (New Delhi: Indian Council of Medical Research), viewed on 30 July 2010 (http://www.icmrnic.in/annual/2005-06/ hqds/overview.pdf).
11. - (2006b): Ethical Guidelines for Biomedical Research on Human Participants (New Delhi: ICMR), viewed on 30 July 2010 (http://icmr.nic. in/ethical-guidelines.pdf).
12. Jan Swasthya Abhiyan et al (2010): "Memorandum to the Health Minister on World Health Day Opposing HPV Vaccinations", 7 April, viewed on 30 July 2010 (http://samawomenshealth. wordpress.com/2010/04/08/memorandum- tothe-health-minister-on-world-health-dayopposing-hpv-vaccinations/).
13. Lippman, A, R Melnychuk, C Shimmin and M Boscoe (2007): "Human Papillomavirus, Vaccines and Women's Health: Questions and Cautions", Canadian Medical Association Journal, 177(5):484-87. (Pubitemid 47359772)
14. Madhavi, Y and N Raghuram (2010): "Crisis of Speculation: Donors Should Fund Only Locally Proven Vaccine Needs and Local Capacity Building", Rapid Response to P Moszynski (2010): "Drive to Vaccinate Children in Developing Countries Faces 'Acute Crisis' Because of High Costs", BMJ, 340: c2576.
15. MOHFW (2005): "The Drugs and Cosmetics Act and Rules, as Amended up to the 30th of June 2005", Ministry of Health and Family Welfare, viewed on 30 July 2010 (http://cdsco.nic.in/html/Drugs&CosmeticAct.pdf).
16. NIMS/ICMR: National Institute of Medical Statistics, Indian Council of Medical Research, "Clinical Trials Registry-India", http://www.ctri.in/Clinicaltrials/index.jsp
17. Parliament Proceedings (2010): "Calling Attention to a Matter of Urgent Public Importance: HPV Vaccine Programme by PATH in Certain States of India", Rajya Sabha Synopsis of Debate, 22 April, viewed on 30 July 2010 (http://164.100.47.5/newsynopsisi/Englishsessionno/219/Syn-%20 Eng-%20Dated%2022-04-2010.pdf).
18. PATH (2010): "Update: PATH'S HPV Vaccination Project in India", Program for Appropriate Technology in Health, press release 27 April, viewed on 30 July 2010 (http://www.path.org/news/an100422-hpv-india.php).
19. - (undated): "Shaping Strategies to Introduce HPV Vaccines in India; Formative Research Results from the HPV Vaccines: Evidence for Impact Project", viewed on 30 July 2010 (http://www.rho.org/files/PATH-FRTS- execsumm-India.pdf).
20. Sarojini, N B, Anjali, S and S Ashalata (2010): "Preliminary Findings of Visit to Bhadrachalam: HPV Vaccine 'Demonstration Project' Site in Andhra Pradesh" (New Delhi: Sama).
21. Special Correspondent (2009): "Pilot Programme for Vaccination against Cervical Cancer Launched", The Hindu, 10 July, viewed on 30 July 2010 (http://www.hindu.com/2009/07/10/stories/2009071059770500.htm).
22. Thacker, T (2010): "Ministry Admits Lapses in HPV Vaccine Trial", The Indian Express, 29 April, viewed on 30 July 2010 (http://www.indianexpress.com/news/ministry-admitslapses-in-hpv-vaccine-trial/ 612823/).
23. USFDA (2006): "FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus: Rapid Approval Marks Major Advancement in Public Health", press release, 8 June, viewed 30 July 2010 (http://www.fda.gov/NewsEvents/Newsroom/Press Announcements/2006/ucm108666.htm).
24. - (2009a): Vaccines and Related Biological Products Advisory Committee (VRBPAC) Briefing Document Cervarix, Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, 9 September, viewed on 30 July 2010 (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ BloodVaccinesandOtherBiologics/VaccinesandRelatedBiological- ProductsAdvisoryCommittee/UCM181371.pdf).
25. - (2009b): "FDA Approves New Vaccine for Prevention of Cervical Cancer", press release 16 October, viewed 30 July 2010 (http://www.fda.gov/ News-Events/Newsroom/PressAnnouncements/ucm187048.htm).
26. - (2010): Vaccines, Blood and Biologics, Vaccines, Approved Products, Gardasil, last updated 9 July 2010, viewed on 30 July 2010 (http://www.fda.gov/ BiologicsBloodVaccines/Vaccines/Approved-Products/ucmo94042.htm).
27. USNIH (United States National Institutes of Health) www.clinicaltrials. gov