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J Glob Infect Dis. 2011 Oct-Dec; 3(4): 406–407.
PMCID: PMC3250003

“To Use or Not to Use”- Dilemma of Developing Countries in Introducing New Vaccines

Sir,

In recent years, developing countries have exhibited great market potential for introduction of newer vaccines. Anti-vaccine lobbyists argue that private vaccine manufacturers are trying their best to capture the multibillion-dollar market in emerging economies. Many vaccine manufacturers are based in developing countries. Despite this, Governments are blamed that they yield to pressure and concede to requests of introduction of newer vaccines by international organizations and private manufacturers. Governments can make decisions for the need for newer vaccines, based on evidence-based research, if it is available with them. In the absence of such evidence, Governments will have to decide based on either lobbying from private manufacturers or seek guidance from international organizations vis-à-vis advice given by self proclaimed experts, (which can be subjective and biased depending on the personal preferences).[1] It is imperative that professionals undertake critical appraisals for the successful development of important public health initiatives in developing countries.[2]

As an analogy, we cite the introduction of Haemophilus influenzae type b (Hib) vaccine through the free Universal Immunization program for children (UIP). This has been delayed by the Government of India due to a campaign launched by some professionals.[3] The Government's decision was based predominately on the relative higher cost of the newer pentavalent vaccine (300 Rupees) compared to the existing diptheria pertusis and tetanus (DPT) vaccine (around 3 INR). On the other hand, scientific evidence shows that the incidence of Hib in India is 7.1/100,000 in under-five old children, (32/100,000 in children less than 11 months old), a scenario which was present in Europe during the pre Hib vaccine era.[4] Every year, India reports the highest number of deaths (72,000) due to Hib disease, and the country ranks among the top ten countries with greatest number of deaths on this account.[5] An additional challenge faced is that surveillance systems in India, generally underestimate Hib disease burden. This is because the bacterium is fragile and hence extremely sensitive to the external environment, and this coupled with lack of adequate laboratory infrastructure and the additional clinical challenge of performing lumbar puncture, leads to further delays in specimen transport. The finding of high rates of clinical meningitis prevented by Hib vaccination in the face of low rates of laboratory confirmed cases of Hib meningitis indicate that, in some parts of the world, diagnostic methods currently available may significantly underestimate the burden of Hib disease.

Public health intelligence and use of evidence-based public health practice in formulating Government policies is necessary, but available evidence shows that this is not the case in most developing countries. Few initiatives from organizations like World Health Organization (WHO) or Governments of developing countries are currently available which encourage and implement evidence-based public practice in developing countries. Supporting public health professionals working in developing countries through allocation of technology, platform and research grants can help in providing necessary evidence for Governments to either accept or reject any new vaccines. Very few such studies estimating vaccine efficacy and effectiveness based on contextual conditions in developing countries are currently available. For example, for centuries’ malaria and tuberculosis (TB) are plaguing developing countries and by far are the worst killers en masse with TB itself accounting for more than 1000 deaths per day in India.[6] However, except for the Guindy trial,[79] India has not been able to develop its own vaccines against killer diseases. In the absence of efforts by the Government to either generate data about disease burden or produce their own vaccines, international agencies such as WHO will need to take the lead in advocating vaccines based on evidence available from other countries.

It is a matter of grave concern that some researchers who can influence policy, have advocated against the use of available technology due to perceived risks often without scientific evidence. Such criticism and apprehension regarding vaccine effectiveness and safety was seen earlier regarding use of monovalent oral polio vaccine, type 1 (mOPV1) in India. To allay these fears, National Polio Surveillance Project (NPSP) monitors all incidents of Vaccine Associated Paralytic Poliomyelitis (VAPP) and maintains a qualitative database comparable to the best in the world. These critics have been silenced due to the success of mOPV1, which has enabled the country to report the lowest burden of P1 type of polioviruses in the history of polio transmission. This can be true for most other vaccination programs also. Only standard surveillance systems and research conducted by public health researchers can provide appropriate evidence for decision-making.

The importance of assessing the burden of many diseases makes it essential for innovative methods to be developed and used, to arrive at reliable estimates of the true burden in such regions.[7,10] Public health researchers in low and middle income countries (LMIC) should use such innovative methods in addition to available evidence from comparable neighboring countries/regions. Government should not delay the introduction of newer vaccines by merely quoting the lack of locally available data on disease burden. Rather, the Government should make an effort to create efficient surveillance systems.

Scientific platforms need to be provided to national researchers, program managers and policy-makers to generate, translate and further implement evidence-based public health in developing countries such as India.[8,11,12] It would be beneficial to the populations in LMIC if agencies such as WHO and United Nations Children's Fund (UNICEF) help researchers generate data regarding specific policy areas for introducing newer vaccines in developing countries.[6] Also, WHO supported mechanisms such as Acute Flaccid Paralysis (AFP) surveillance system can be expanded, at least in low polio burden states, to collect evidence on other diseases to help decision-making regarding newer vaccines.

FOOTNOTE

We declare that we do not have any conflict of interests in writing this communication. We also declare that articles quoted in this paper are for the purposes of illustration and we could have found other examples not cited here, to discuss the same concept.

REFERENCES

1. Parry V. Why fear of vaccination is spelling disaster in the developing world: Anti-vaccination scares are as old as vaccination itself - but now they are putting lives at risk in the developing world, Guardian. 2010. [Last accessed on 2011 Apr 19]. Available from: http://www.bit.ly/cdAnWa .
2. Puliyel JM, Madhavi Y. Vaccines: Policy for public good or private profit? Indian J Med Res. 2008;127:1–3. [PubMed]
3. Mudur G. Antivaccine lobby resists introduction of Hib vaccine in India. BMJ. 2010;340:c3508. [PubMed]
4. Minz S, Balraj V, Lalitha MK, Murali N, Cherian T, Manoharan G, et al. Incidence of Haemophilus influenzae type b meningitis in India. Indian J Med Res. 2008;128:57–64. [PubMed]
5. Watt JP, Wolfson LJ, O’Brien KL, Henkle E, Deloria-Knoll M, McCall N, et al. Burden of disease caused by Haemophilus influenzae type b in children younger than 5 years: Global estimates. Lancet. 2009;374:903–11. [PubMed]
6. Chadha VK, Krishnamurthy MS, Shashidhara AN, Jagannatha PS, Magesh V. Estimation of annual risk of tuberculosis infection among BCG vaccinated children. Indian J Tuberc. 1999;46:105.
7. Bhushan K. Trial on experimental batches of freeze-dried B.C.G vaccine produced at Guindy laboratory. Bulletin Devoted to the Prevention of the Tuberculosis. 1962;9:16–9. Proceedings of the XIXth Tuberculosis and Chest Diseases Workers’ Conference, Delhi, 138.
8. Narayanan PR, Garg R, Santha T, Kumaran PP. Shifting the focus of tuberculosis research in India. Tuberculosis (Edinb) 2003;83:135–42. [PubMed]
9. Milstien J, Cárdenas V, Cheyne J, Brooks A. WHO policy development processes for a new vaccine: Case study of malaria vaccines. Malar J. 2010;9:182. [PMC free article] [PubMed]
10. Babu GR, Olsen J, Jana S, Nandy S, Farid M, Sadhana VJ. Evaluation of immunization cards and parental recall against gold standard for evaluating immunization coverage. [Last accessed on 2011 May 28];Internet J Epidemiol. 2011 9:2. Available from: http://www.ispub.com/journal/the_internet_journal_of_epidemiology/volume_9_number_2_21/article/evaluation-of-immunization-cardsandparental-recall-against-gold-standard-for-evaluating-immunizationcoverage.html .
11. Babu GR. Comment on ‘From risk factors to explanation in public health’ J Public Health (Oxf) 2008;30:515–6. [PubMed]
12. 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. [PubMed]

Articles from Journal of Global Infectious Diseases are provided here courtesy of Medknow Publications