Pentavalent & other new combination vaccines: solutions in search of problems.
Subject: Vaccines (Economic aspects)
Vaccines (Laws, regulations and rules)
Authors: Madhavi, Y.
Raghuram, N.
Pub Date: 10/01/2010
Publication: Name: Indian Journal of Medical Research Publisher: Indian Council of Medical Research Audience: Academic Format: Magazine/Journal Subject: Biological sciences; Health Copyright: COPYRIGHT 2010 Indian Council of Medical Research ISSN: 0971-5916
Issue: Date: Oct, 2010 Source Volume: 132 Source Issue: 4
Topic: Event Code: 930 Government regulation; 940 Government regulation (cont); 980 Legal issues & crime Advertising Code: 94 Legal/Government Regulation Computer Subject: Government regulation
Product: SIC Code: 2836 Biological products exc. diagnostic
Geographic: Geographic Scope: India Geographic Code: 9INDI India
Accession Number: 242958372
Full Text: Sir,

The pentavalent vaccine and many other combination vaccines waiting to enter Universal Immunization Programme (UIP) have brought into sharp focus the gaping gap between lofty slogans of 'evidence based medicine' and the actual dynamics that drive policy on the ground (1-4). Notwithstanding the theatrics of the 'experts' of the World Health Organization (WHO) and the Global Alliance for Vaccines and Immunization (GAVI) globally and National Technical Advisory Group on Immunization (NTAGI) in India, it is becoming increasingly obvious that the pentavalent vaccine, like many other recent combination vaccines, is a solution searching for problems.

There is no scientifically valid evidence of a high enough disease burden due to Haemophilus influenzae type b (Hib) or Hepatitis-B (HepB) that justifies universal vaccination in India (5-7). Indeed, every attempt to find such evidence for HiB in India and elsewhere in Asia has failed (4). In the absence of evidence for individual vaccines, it defies logic how one can justify combining them into a pentavalent vaccine. It seems that there was a need only for 'expert' recommendations behind closed doors which were unquestioningly accepted. Unfortunately, increasing awareness and rising dissent against medicines-sans-evidence is forcing the policy makers to find post-facto evidence that is becoming increasingly difficult to manufacture. By now it is obvious that except to the determined 'experts' who drive our immunization policies, that there has never really been a real public health demand for many of these new vaccines, let alone their combinations.

Indeed, combination vaccines were invented precisely to overcome the poor penetration of the individual vaccines in the global market, as well as to overcome the expiry of their patents and establish eternal market monopolies. Scientific evidences indicate that combination vaccines bring no new health benefit to the immunized people (8-11), except the convenience of not having to take each vaccine separately, provided all those vaccines are actually needed. The issue of safety and efficacy of combination vaccines was often a cause for concern (12). For instance, MMR in combination with Varicella vaccine reported to have enhanced fibrile seizures in children (13-14), and Hepatitis A vaccine is not protective enough when combined with typhoid vaccine (15). It is a mere marketing trick. Every dubious new vaccine needs a piggyback ride on a diphtheria tetanus pertussis (DTP), measles or some other essential vaccine to get a back door entry into the UIP (16). Pushing Hib, Hep-B, mumps measles rubella (MMR), rotaviral, human papilloma virus (HPV), etc., through combination vaccines among people who do not need them in this manner also amounts to siphoning public money to benefit industry.

Why is it that 'equity' argument is often given only when it comes to government spending on vaccines? Why not for all other health care services or other basic amenities such as food, shelter, water and clean environment, which are ruled by market forces? Why are health concerns so muted when it comes to OPV induced paralytic cases? Is the government or NTAGI willing to take responsibility and compensate for vaccine induced paralytic cases? Why do we not have proper vaccine injury compensation in this country? Why should our immunization experts enjoy so much immunity from the unhealthy consequences of their advice for health? In any case, the hollowness of the 'equity' argument becomes obvious when we consider that the total coverage of 'universal' immunization is below 50 per cent of the children in India, even for the most essential and affordable vaccines.

Another side of the equity argument is that manufacturing these combination vaccines in public sector units (PSUs) would bring down their prices and make these more affordable to all. This would have been a welcome move (lest we too be branded as antivaccine), provided the public health need for these new vaccines is firmly established. Unfortunately, even well meaning minds in the government committed to reviving the crucial role of PSUs in Indian vaccine security seem to be lost in supply side arguments without firmly establishing the demand for these vaccines based on disease burden. This is inspite of having all the human, financial and technological resources to document disease burden scientifically. This is the fundamental tragedy of medicine-sans-evidence policy that rules in Indian vaccines.

Y. Madhavi * & N. Raghuram

* National Institute of Science, Technology & Development Studies

(Council of Scientific & Industrial Research), K.S. Krishnan Marg

New Delhi 110 012 & School of Biotechnology,

Indraprastha University

Delhi 110 006, India

* For correspondence:

madhavi@nistads.res.iny_madhavi01@hotmail.com

References

(1.) Kimman TG, Boot HJ, Berbers Guy AM, Vermeer-de Bondt PE, Ardine de Wit G, MelKer de HE. Developing a vaccination evaluation model to support evidence-based decision making on national immunization programs. Vaccine 2006; 24 : 4769-78.

(2.) Madhavi Y, Puliyel JM, Mathew JL, Raghuram N, Phadke A, Shiva M, et al. Evidence-based national vaccine policy. Indian J Med Res 2010; 131 : 617-28.

(3.) Mudur G. Antivaccine lobby resists introduction of Hib vaccine in India. BMJ2010; 340 : c3508.

(4.) Lone Z, Puliyel J. Introducing pentavalent vaccines in the EPI in India: A counsel for caution. Indian J Med Res 2010; 132 : 1-3.

(5.) Gupta N, Puliyel J. Vaccine Introduction where incidence of Hib meningitis is 0.007%. Decision-making based on heath economics or ideology. Indian J Med Res 2009; 129 : 339-40.

(6.) Beri RS, Ojha RK. Is Hib vaccination required at all in India? Indian Pediatr 2002; 39 : 1067-8.

(7.) Madhavi Y. The manufacture of consent? Hepatitis B vaccination. Economic Political Wkly 2003; 38 : 2417-24.

(8.) Food and Drug Administration (FDA). Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies. Washington DC: US Dept of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, April 1997, Docket No. 97N-0029.

(9.) American Academy of Pediatrics (AAP), Combination Vaccines for Childhood Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) Committee on Infectious Diseases, 1998-1999. Pediatrics 1999; 103 : 1064-77.

(10.) Bar-On ES, Goldberg E, Fraser A, Vidal L, Hellmann S, Leibovici L. Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae B (HIB). The Cochrane Library 2009, Issue 3, p.1-57.

(11.) Buttery JP, Anna R, McVernon J, Chantler T, Lane L, Jane Bowen-Morris J, et al. Immunogenicity and safety of a combination pneumococcal-meningococcal vaccine in infants. JAMA 2005; 293 : 1751-8.

(12.) Chen RT, Vitali Pool V, Takahashi H, Weniger BG, Patel B. Combination vaccines: post licensuer safety evaluation. Clin Infect Dis 2001; 33 : s327-33.

(13.) Jo White C, Stinson D, Staehle B, Cho Iksung, Matthews H, Ngai A, et al; and The MMRV Vaccine Study Group. Measles, mumps, rubella, and varicella combination vaccine: safety and immunogenecity alone and in combination with other vaccines given to children. Clin Infect Dis J 1997; 24 : 925-31.

(14.) Klein NP, Fireman B, Yih KW, Lewis E, Kulldorff M, Ray P, et al. Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics 2010; 126 : e1-8.

(15.) Beeching NJ, Clarke PD, Kitchin NRE, Pirmohamed J, Veitch K, Weber F. Comparison of two combined vaccines against typhoid fever and hepatitis A in healthy adults. Vaccine 2004; 23 : 29-35.

(16.) Madhavi Y. New combination vaccines: Backdoor entry into India's Universal Immunization Programme? Cur Sci 2006; 90 : 1465-9.
Gale Copyright: Copyright 2010 Gale, Cengage Learning. All rights reserved.