Introducing new vaccines in low- and middle-income countries: challenges and approaches

Guignard, Adrienne; Praet, Nicolas; Jusot, Viviane; Bakker, Michael den; Baril, Laurence

doi:10.1080/14760584.2019.1574224

Cited by 77 publications

(64 citation statements)

References 90 publications

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“…New health technologies continue to be introduced in LICs. For example, since 2010 108 out of 138 LICs, introduced at least one new vaccine (13). The introduction of such new health technologies requires HTA in order to set priorities.…”

Section: Hta In Low Income Countriesmentioning

confidence: 99%

“…An additional constraint to implementing decisions made through systematic HTA processes such as EDPs in LICs relates to the fact that some LICs have accepted donated (especially diagnostic) technologies without assessment (13). Because some of the donated health technologies are not developed for use in the LIC contexts, they may require substantial financial and human resources for their operation and maintenance.…”

Section: Critical Reflections On the Applicability Of Edps In Low Incmentioning

confidence: 99%

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Implementing evidence-informed deliberative processes in health technology assessment: a low income country perspective

Kapiriri

Baltussen

Oortwijn

2020

Int J Technol Assess Health Care

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The purpose of this paper is to discuss the potential feasibility and utility of evidence-informed deliberative processes (EPDs) in low income country (LIC) contexts. EDPs are implemented in high and middle income countries and thought to improve the quality, consistency, and transparency of decisions informed by health technology assessment (HTA). Together these would ultimately improve the legitimacy of any decision making process. We argue—based on our previous work and in light of the priority setting literature—that EDPs are relevant and feasible within LICs. The extreme lack of resources necessitates making tough decisions which may mean depriving populations of potentially valuable health technologies. It is critical that the decisions and the decision making bodies are perceived as fair and legitimate by the people that are most affected by the decisions. EDPs are well aligned with the political infrastructure in some LICs, which encourages public participation in decision making. Furthermore, many countries are committed to evidence-informed decision making. However, the application of EDPs may be hampered by the limited availability of evidence of good quality, lack of interest in transparency and accountability (in some LICs), limited capacity to conduct HTA, as well as limited time and financial resources to invest in a deliberative process. While EDPs would potentially benefit many LICs, mitigating the identified potential barriers would strengthen their applicability. We believe that implementation studies in LICs, documenting the contextualized enablers and barriers will facilitate the development of context specific improvement strategies for EDPs.

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Section: Hta In Low Income Countriesmentioning

confidence: 99%

Section: Critical Reflections On the Applicability Of Edps In Low Incmentioning

confidence: 99%

Implementing evidence-informed deliberative processes in health technology assessment: a low income country perspective

Kapiriri

Baltussen

Oortwijn

2020

Int J Technol Assess Health Care

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“…This greatly enhanced the speed with which these vaccines could be introduced and reduced the financial burden on the public healthcare sector. More recently, whilst some vaccines have become rapidly available (for example, haemophilus influenzae type b and hepatitis B vaccines), others (such as pneumococcal conjugate and human papillomavirus vaccines) have faced delays in implementation in LMICs compared to more rapid introduction in high-income settings [13]. Furthermore, whilst supply constraints often occur [14], for most vaccines some level of manufacturing capacity is available due to the existence of markets in high-income countries.…”

Section: Introductionmentioning

confidence: 99%

Estimated impact of RTS,S/AS01 malaria vaccine allocation strategies in sub-Saharan Africa: A modelling study

2020

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Background The RTS,S/AS01 vaccine against Plasmodium falciparum malaria infection completed phase III trials in 2014 and demonstrated efficacy against clinical malaria of approximately 36% over 4 years for a 4-dose schedule in children aged 5–17 months. Pilot vaccine implementation has recently begun in 3 African countries. If the pilots demonstrate both a positive health impact and resolve remaining safety concerns, wider roll-out could be recommended from 2021 onwards. Vaccine demand may, however, outstrip initial supply. We sought to identify where vaccine introduction should be prioritised to maximise public health impact under a range of supply constraints using mathematical modelling. Methods and findings Using a mathematical model of P. falciparum malaria transmission and RTS,S vaccine impact, we estimated the clinical cases and deaths averted in children aged 0–5 years in sub-Saharan Africa under 2 scenarios for vaccine coverage (100% and realistic) and 2 scenarios for other interventions (current coverage and World Health Organization [WHO] Global Technical Strategy targets). We used a prioritisation algorithm to identify potential allocative efficiency gains from prioritising vaccine allocation among countries or administrative units to maximise cases or deaths averted. If malaria burden at introduction is similar to current levels—assuming realistic vaccine coverage and country-level prioritisation in areas with parasite prevalence >10%—we estimate that 4.3 million malaria cases (95% credible interval [CrI] 2.8–6.8 million) and 22,000 deaths (95% CrI 11,000–35,000) in children younger than 5 years could be averted annually at a dose constraint of 30 million. This decreases to 3.0 million cases (95% CrI 2.0–4.7 million) and 14,000 deaths (95% CrI 7,000–23,000) at a dose constraint of 20 million, and increases to 6.6 million cases (95% CrI 4.2–10.8 million) and 38,000 deaths (95% CrI 18,000–61,000) at a dose constraint of 60 million. At 100% vaccine coverage, these impact estimates increase to 5.2 million cases (95% CrI 3.5–8.2 million) and 27,000 deaths (95% CrI 14,000–43,000), 3.9 million cases (95% CrI 2.7–6.0 million) and 19,000 deaths (95% CrI 10,000–30,000), and 10.0 million cases (95% CrI 6.7–15.7 million) and 51,000 deaths (95% CrI 25,000–82,000), respectively. Under realistic vaccine coverage, if the vaccine is prioritised sub-nationally, 5.3 million cases (95% CrI 3.5–8.2 million) and 24,000 deaths (95% CrI 12,000–38,000) could be averted at a dose constraint of 30 million. Furthermore, sub-national prioritisation would allow introduction in almost double the number of countries compared to national prioritisation (21 versus 11). If vaccine introduction is prioritised in the 3 pilot countries (Ghana, Kenya, and Malawi), health impact would be reduced, but this effect becomes less substantial (change of <5%) if 50 million or more doses are available. We did not account for within-country variation in vaccine coverage, and the optimisation was based on a single outcome measure, therefore this study should be used to understand overall trends rather than guide country-specific allocation. Conclusions These results suggest that the impact of constraints in vaccine supply on the public health impact of the RTS,S malaria vaccine could be reduced by introducing the vaccine at the sub-national level and prioritising countries with the highest malaria incidence.

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“…Although the World Health Organization (WHO) Tailoring Immunizations Program provides a framework for improving coverage of vaccines already on the market or in the routine immunization schedule of a country, 3 it is not specifically designed for vaccines that have not yet been implemented. Guignard et al 4 provide a summary of challenges faced by LMICs in introducing new vaccines, including limited health care infrastructure. The summary from Guignard et al 4 also indicates that having a purposeful plan to introduce vaccines is necessary.…”

Section: Introductionmentioning

confidence: 99%

“…Guignard et al 4 provide a summary of challenges faced by LMICs in introducing new vaccines, including limited health care infrastructure. The summary from Guignard et al 4 also indicates that having a purposeful plan to introduce vaccines is necessary. The introduction of a vaccine into a country’s health care system is a sensitive time to attune the public to the significance of the disease and the benefits of the vaccine.…”

Section: Introductionmentioning

confidence: 99%

How Do Experts and Nonexperts Want to Promote Vaccines? Hepatitis E Vaccine as Example

Ren

Wagner

Xie

et al. 2019

Health�Serv�Insights

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Low- and middle-income countries receive limited guidance from external entities about how to introduce vaccines. This is especially true for the Hepatitis E (HepE) vaccine, which is currently only commercially available in China. The aims of this qualitative study are to identify which attributes of the HepE disease and vaccine are considered important, and to compare desired promotion methods between different stakeholders. Stakeholders included experts (Centers for Disease Control and Prevention staff, health care providers, and researchers), and nonexperts included members of high-risk populations, HepE cases, and vaccinees. Participants’ thoughts were coded and broadly summarized. We contacted 63 persons—35 experts and 28 nonexperts. Safety and effectiveness (but not price) of the vaccine, along with severity of disease and transmission route of infection, were all listed as important attributes. Emphasizing the importance of sharing stories from cases, relying on personal experiences, staying away from statistical explanations, and using the government as a source of promotion were other points repeatedly raised by the participants. Qualitative interviews with experts and nonexperts has revealed that focusing on attributes of disease severity and susceptibility to infection, as well as vaccine safety and effectiveness within stories of cases, are preferred ways to promote the vaccine.

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Introducing new vaccines in low- and middle-income countries: challenges and approaches

Cited by 77 publications

References 90 publications

Implementing evidence-informed deliberative processes in health technology assessment: a low income country perspective

Implementing evidence-informed deliberative processes in health technology assessment: a low income country perspective

Estimated impact of RTS,S/AS01 malaria vaccine allocation strategies in sub-Saharan Africa: A modelling study

How Do Experts and Nonexperts Want to Promote Vaccines? Hepatitis E Vaccine as Example

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