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Civil Society Activism Hinders Vaccine-introduction in India: Vote for autocracy?

Shearer and colleagues use sophisticated modeling techniques to try and explain why some countries take longer to adopt Haemophilus influenza type b (Hib) vaccine in their national immunization programs (1). A primary premise they make is that the vaccine is beneficial to society. Published evidence of strain shifts and side effects however contradict this assumption.

Data from Canada and elsewhere suggests that Hib vaccine has nearly eliminated Haemophilus influenza type b but there has been a proportional increase in non-Hib strains including non-serotypable strains causing invasive H influenza disease in the post Hib vaccine era (2-10). Studies from Finland have shown an increase in type 1 diabetes after introduction of the vaccine. The increase in incidence was 58/100000 (p=0.029) (11,12) where the pre-Hib vaccine incidence of Hib in Europe was 12 to 54/ 100000 (13)

We note that research by Shearer and colleagues did not model the results of local studies – only their existence (1). The authors state that knowing a study exists is not equivalent to knowing the implication of their findings or their dissemination to decision makers. Such patronization of decision makers does not serve the cause of objective discourse. In India as also in other countries, evidence of natural immunity to Hib, developed in infancy because of infection with other bacteria (with cross-reactive antigens) (14-17) have been quoted as the rationale negating need to vaccinate with Hib. The low incidence of Hib disease has had a direct bearing on the non-introduction of the vaccine in India.

A large multi-center study in India, funded by GAVI (18) found that the incidence of all-cause pneumonia deaths was fifty times less than what was projected previously (19, 20). The incidence of pneumonia was so low that even with 10% mortality; the deaths would not match the figures projected to make the vaccine appear cost-effective. This study argues against the need for both the Hib vaccine and the pneumococcal vaccine in India. Rather conveniently the data from this study was not included in the National Technical Advisory Group on Immunization (NTAGI) report recommending Hib (21). The data from the study was obtained under the Right to Information Act. The omission of this data from the recommendation of the NTAGI (to decision makers) became the focus of a public interest petition in the Delhi High Court and it has resulted in reevaluation of the NTAGI report by the Government of India (22). This suggests that attempts ‘not to disseminate findings to decision maker’ may not always serve the purpose.

Another premise the authors start with (1), is that ‘democracy’ results in early introduction of vaccines. A previous study (23) and their own results (not included in the abstract) (1) have actually proved the opposite - that autocracy favors vaccine introduction. The experience from India also suggests that a well informed and active civil-society movement sometimes stands in the way of the introduction of vaccines. It is not such bad news either.
One is left to speculate what lessons the GAVI will take from this finding. One hopes accelerated introduction of the other vaccines like human papillomavirus, pneumococcal and rotavirus vaccines will not be accompanied by an assault on democratic rights, institutions and systems like the Right to Information Act in India.

Prashant Tyagi MBBS
Department of Pediatrics
St Stephens Hospital
Delhi 110054 India

Mira Shiva MD
Initiative for Health , Equity and Society/Third World Network
All India Drug Action Network
A-60, Hauz Khas
New Delhi - 110 016
Tel: 91-11-26512385, Mob:91 9810582028

Jacob Puliyel MD MPhil
Department of Pediatrics
St Stephens Hospital
Delhi 110054 India

1. Shearer JC, Stack ML, Richmond MR, Bear AP, Hajjeh RA, et al. (2010) Accelerating Policy Decisions to Adopt Haemophilus influenzae Type b Vaccine: A Global, Multivariable Analysis. PLoS Med 7(3): e1000249. doi:10.1371/journal.pmed.1000249
2. Brown VM, Madden S, Kelly L, Jamieson FB, Tsang RS, Ulanova M. Invasive Haemophilus influenzae disease caused by non-type b strains in Northwestern Ontario, Canada, 2002-2008. Clin Infect Dis. 2009 15;49:1240-3.
3. Tsang RS, Sill ML, Skinner SJ, Law DK, Zhou J, Wylie J. Characterization of invasive Haemophilus influenzae disease in Manitoba, Canada, 2000-2006: invasive disease due to non-type b strains. Clin Infect Dis. 2007 15;44:1611-4.
4. Urwin G, Krohn JA, Deaver-Robinson K, Wenger JD, Farley MM. Invasive disease due to Haemophilus influenzae serotype f: clinical and epidemiologic characteristics in the H. influenzae serotype b vaccine era. The Haemophilus influenzae Study Group. Clin Infect Dis. 1996;22:1069-76.
5. Perdue DG, Bulkow LR, Gellin BG, Davidson M, Petersen KM, Singleton RJ, Parkinson AJ. Invasive Haemophilus influenzae disease in Alaskan residents aged 10 years and older before and after infant vaccination programs. JAMA. 2000;283:3089-94.
6. McConnell A, Tan B, Scheifele D, Halperin S, Vaudry W, Law B, Embree J; of The Canadian Immunization Monitoring Program, ACTive (IMPACT). Invasive infections caused by haemophilus influenzae serotypes in twelve Canadian IMPACT centers, 1996-2001. Pediatr Infect Dis J. 2007;26:1025-31.
7. Adderson EE, Byington CL, Spencer L, Kimball A, Hindiyeh M, Carroll K, Mottice S, Korgenski EK, Christenson JC, Pavia AT. Invasive serotype a Haemophilus influenzae infections with a virulence genotype resembling Haemophilus influenzae type b: emerging pathogen in the vaccine era? Pediatrics. 2001;108:E18.

9. [No authors listed] Invasive Haemophilus influenzae disease in Manitoba in the post-vaccination era suggests a changing epidemiology. Can Commun Dis Rep. 2006;32):125-30.
10. Kalies H, Siedler A, Gröndahl B, Grote V, Milde-Busch A, von Kries R. Invasive Haemophilus influenzae infections in Germany: impact of non-type b serotypes in the post-vaccine era. BMC Infect Dis. 2009;9:45.

11. Classen JB, Classen DC. Clustering of cases of insulin dependent diabetes (IDDM) occurring three years after hemophilus influenza B (HiB) immunization support causal relationship between immunization and IDDM. Autoimmunity. 2002 ;35:247-53.

12. J. B. Classen, D. C. Classen. Vaccines and the risk of insulin-dependent diabetes (IDDM): potential mechanism of action. Medical Hypotheses 2001;57, 532-538.
13. Watt JP, Levine OS, Santosham M. Global reduction of Hib disease: what are the next steps? Proceedings of the meeting: Scottsdale, Arizona, September 22-25, 2002. The Journal of Pediatrics 2003;143, S163-S187.

14. Puliyel JM, Agarwal KS, Abed Abass F. Natural immunity to Haemophilus influenza b in infancy in Indian children. Vaccine. 2001;19:4592-4.

15. Minz S, Balraj V, Lalitha MK, Murali N, Cherian T, Manoharan G, Kadirvan S, Joseph A, Steinhoff MC. Incidence of Haemophilus influenzae type b meningitis in India. Indian J Med Res. 2008;128:57-64
16. Tastan Y, Alikasifoglu M, Ílter O, Erginöz E, Arvas A, Yüksel D, Türkcü F,
Badur S. Natural Immunity to Haemophilus influenzae Type b Among Healthy Children in Istanbul, Turkey. Indian Pediatrics 2000;37: 414-417
17. Toraño Peraza G, Hernández Vadell I, Toledo Romaní ME, Baly Gil A, Tamargo Martínez I, Carmenate García A. Naturally acquired immunity to Haemophilus influenzae type B in healthy Cuban children. Mem Inst Oswaldo Cruz. 2004;99:687-9.
18. Final Report. India Hib vaccine probe study: Part A. accessed 17/3/10
19. WHO Estimating the local burden of Heamophilus influenza type b(Hib)disease preventable by vaccination accessed 17/1/10
20. Unicef. Pneumonia the forgotten killer of children. accessed 24/1/10

21. Kant L. NTAGI subcommittee recommendations on Haemophilus influenzae type B (Hib) vaccine introduction in India. Indian Pediatr. 2009;46:945-54 NTAGI.

22. Sexana KB and others in the High Court of Delhi. Writ Petition (Civil) No. 51 Of 2009 Public Interest Litigation. Delhi High Court New Delhi.

23. Gauri V, Khaleghian P. Immunization in developing countries: its political and organizational determinants. World Development 2002;30: 2109-2130.

No competing interests declared.

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