Introducing Vaccines: Beyond the Rhetoric

Image: “Syringe and Vaccine” by PATH Global Health / CC 2.0

Introducing vaccines in low and middle income countries (LMICs) is a significant challenge. Besides the obstacle posed by the costs of procuring new vaccines, there are the logistical challenges of prepping existing infrastructure and prioritizing interventions to make the best of limited resources. Hence, the process needs to be well thought out and highly evidence-based. The introduction of the Hib-pentavalent vaccine in 2009 in Bangladesh highlights how this can be done. This was a massive accomplishment for the Expanded Programme on Immunization (EPI) in Bangladesh – not only because the vaccine was effective, but also because it was the first introduction based on country-specific disease burden data.

The standard vaccines that make up immunization programs in LMICs include DTP (diphtheria-tetanus-pertusis), BCG (against tuberculosis), oral polio and measles vaccines. Their prices have decreased over time to affordable levels, and many countries, including Bangladesh, have achieved high coverage with these¹. With a robust infrastructure in place due to long-term investment in delivery infrastructure, such countries are in a position to introduce newer, underused vaccines. These, like the Hib pentavalent, pneumococcal and rotaviral vaccines, are too expensive to be obtained directly from producers at “market-price”. Hence, organizations like the Global Alliance for Vaccines and Immunization (GAVI) have stepped in to reduce the delay between vaccine introduction and use in low-income countries. By ensuring a large, long-term market, and subsidizing vaccines in the short-term, they have been able to get manufacturers to commit to lower prices in countries willing to introduce these vaccines into their national immunization systems². However, even with these new bartering systems in place, it is hard for LMICs to decide which vaccines to include in their national systems.

One limitation for vaccine introduction is the cost of infrastructure development. Among these, the most critical is the expansion of cold storage facilities like refrigerators and insulated boxes used for taking vaccines into the community. While such details are often overlooked when discussing vaccines and their roles in society, they play as integral a role in the decision-making process as vaccine development itself. A second limitation is choosing which vaccine to introduce – with multiple vaccines available for introduction, it falls upon policy makers to decide which ones to focus on³. Ideally, the chosen vaccines are the proverbial “low-hanging-fruits” – vaccines that provide the most “bang for the buck”. However, to gauge which vaccines best fit these criteria, there needs to be ample evidence about disease burden – evidence that is usually lacking.

Although Haemophilus influenzae type B (Hib) causes 8 million cases of serious disease around the world among children every year and can cause baceterimia, pneumonia and meningitis4, vaccine introduction warrants country-specific data. To this end, research undertaken in Bangladesh showed that around a quarter of the people who contract Hib-meningitis die, while another quarter are left with various long-term disabilities⁵. A study in 1997 showed that a significant proportion of meningitis cases were caused by Hib⁶. Another study in 2004 showed that a fifth to a half of the strains responsible for disease were resistant to various antibiotics⁵. This bode ill for treatment, and emboldened the case for prevention. With the GAVI aggressively supporting Hib introduction and the WHO recommending its incorporation into the EPI in 2006, the situation was ripe for its introduction in Bangladesh. This resulted in its introduction in 2009, and evidence collected continued to showcase the benefits of the vaccine⁷. These results are important not just to convince policy makers of continued investment and support, but also to convince other developing countries to incorporate this vaccine into their health systems.

The decision-making process is shaped by numerous stakeholders. In Bangladesh, the government makes the final decision on GAVI applications, but this is influenced by various players. Often, researchers and academics, besides generating evidence about disease burden, raise awareness about their findings to emphasize the importance of vaccine introduction. Development partners like the WHO, UNICEF and GAVI also provide technical support, assessing infrastructure to gauge feasibility of introduction. While all these actors continue to influence the decision-making process, the governmental process goes through several committees of the Expanded Program on Immunization in Bangladesh until the vaccine is approved and donor funding is secured⁸.

In an ideal world, vaccines would be available all across the world at the same time. However, given the limitations of pricing and scarce resources, LMICs face hard choices when picking which vaccines to introduce into national systems. While the debate continues on vaccine pricing and availability, and organizations like GAVI aim to reduce the gap between the two “worlds”, it is important to understand how countries make these decisions. There needs to be a constant push to allocate resources towards prevention in the most cost-effective manner based on country-specific data. While some high income countries talk about personalized medicine at the individual level, it is only proper that low and middle income countries talk about “personalized interventions” at the national level as well.

References

1. Uddin, M. J. et al. Child Immunization Coverage in Rural Hard-to-Reach Haor Areas of Bangladesh: Possible Alternative Strategies. Asia. Pac. J. Public Health 21, 8–18 (2009).

2. Making vaccines affordable – GAVI. (2014). at <http://www.gavialliance.org/about/gavis-business-model/making-vaccines-affordable/&gt;

3. New and underused vaccines support – GAVI. (2014). at <http://www.gavialliance.org/support/nvs/&gt;

4. Watt, J. P. et al. Burden of disease caused by Haemophilus influenzae type b in children younger than 5 years: global estimates. The Lancet 374, 903–911 (2009).

5. Saha, S. K. et al. Invasive Haemophilus influenzae type b diseases in Bangladesh, with increased resistance to antibiotics. J. Pediatr. 146, 227–233 (2005).

6. Saha, S. K. et al. The increasing burden of disease in Bangladeshi children due to Haemophilus influenzae type b meningitis. Ann. Trop. Paediatr. 17, 5–8 (1997).

7. Baqui, A. H. et al. Effectiveness of Haemophilus influenzae Type B Conjugate Vaccine on Prevention of Pneumonia and Meningitis in Bangladeshi Children: A Case-Control Study. Pediatr. Infect. Dis. J. 26, 565–571 (2007).

8. Uddin, J., Sarma, H., Bari, T. I. & Koehlmoos, T. P. Introduction of new vaccines: decision-making process in Bangladesh. J. Health Popul. Nutr. 31, 211–217 (2013).