Vaccine 33S (2015) A4–A5
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Commentary
Gavi’s balancing act: Accelerating access to vaccines while ensuring robust national decision-making for sustainable programmes Stephen Sosler ∗ , Judith Kallenberg, Hope L. Johnson Gavi, the Vaccine Alliance, Geneva, Switzerland
Since its creation in 2000, Gavi, the Vaccine Alliance has leveraged its public–private structure – bringing together governments, UN agencies, private sector and civil society – to make new and underused vaccines more affordable and accessible to people in lower-income countries. Prior to the creation of Gavi, the world’s lowest-income countries endured the greatest burden of vaccine preventable diseases yet had limited access to new vaccines readily available in wealthier countries. For example, in 2000, over 60% of high-income countries were providing Hepatitis B vaccine in their national immunisation programmes. In the same year among lowincome countries, where the burden of hepatitis B was highest, less than 10% had introduced this vaccine. Gavi has an ambitious mission to significantly expand access to a range of new and under-used vaccines over a relatively short period of time. With cost barriers largely removed, lowerincome countries have embraced the opportunity to seek support for the introduction of life-saving vaccines. Since the initial Gavisupported introductions of monovalent Hepatitis B vaccine in 2001, the picture has evolved significantly. Gavi currently offers support for 11 vaccine programmes including human papillomavirus, inactivated polio vaccines, Japanese encephalitis, measles, meningitis A, oral cholera vaccine, pentavalent, pneumococcal conjugate, rubella, rotavirus, and yellow fever. Applications for vaccine support have surged and it is expected there will be more than 280 Gavi-supported vaccine programmes in 71 countries by the end of 2015. However, beyond the “quick win” of successfully launching a new, heavily subsidised vaccine, effective scale-up and sustained programme implementation require strong political will and longterm investments [1]. Gavi thus has an important responsibility to ensure that decisions to adopt new vaccines are locally owned and rooted in strong commitment that will last beyond the duration of its financial support. A challenge of Gavi’s mission is balancing the urgent need to address preventable death and disease with lifesaving vaccines that are available today with the need to ensure a robust decision-making process. In this commentary, we reflect on the evidence-informed globallevel process that Gavi uses to select vaccines that meet the public
∗ Corresponding author. Tel.: +41 22 909 6591. E-mail address: [email protected] (S. Sosler). http://dx.doi.org/10.1016/j.vaccine.2014.12.051 0264-410X/© 2015 Published by Elsevier Ltd.
health needs of low income countries, as well as translation of these globally-identified priorities into sustainable programmes rooted in locally-owned introduction decisions. Gavi uses a demand-driven funding model and offers support for a variety of vaccines. Support is awarded in response to countries’ requests through a centrally managed application process. Before countries are invited to apply for vaccine support, Gavi determines which vaccines to make available through the development of a Vaccine Investment Strategy (VIS). This global strategy is renewed every five years to identify new priority vaccines for inclusion in Gavi’s portfolio. The first VIS was produced in 2008 and the second in 2013. The VIS process brings together disease experts, implementing country representatives, manufacturers and other Vaccine Alliance partners to inform a comprehensive comparative analysis of potential vaccine opportunities for countries meeting Gavi’s eligibility requirements.1 A key consideration is whether Gavi has a comparative advantage in helping to overcome barriers to accessing a vaccine of public health importance. All Gavi countries share a limited ability to pay for vaccines as they have relatively low gross national incomes per capita (GNI p.c.) and therefore limited resources available for immunisation expenditures. Beyond this common barrier, Gavi countries have diverse needs. The VIS aims to identify vaccine investments with significant benefits for a significant number of countries (e.g. pneumococcal conjugate and rotavirus vaccines), or for which Gavi’s support fills a unique gap (e.g. support for the oral cholera vaccine stockpile in part to incentivize global supply). It excludes vaccines with lower value-for-money based on the projected health impact and cost of the vaccine, and considers local implementation feasibility as well as global factors such as Gavi’s ability to influence pricing. The 2008 VIS identified human papilloma virus (HPV), rubella, Japanese encephalitis and typhoid vaccines to be added to the portfolio of Gavi supported vaccines. The 2013 VIS identified expanded support for yellow fever mass preventive campaigns and investment in the global stockpile of cholera vaccines as new priorities. The Gavi Board deferred a decision on a malaria vaccine which was still undergoing clinical trials and will consider the case for this vaccine
1 Gavi’s current (2014) eligibility threshold is set at a Gross National Income level of $1580 this is from 2015per capita (according to World Bank data for the latest available year.
S. Sosler et al. / Vaccine 33S (2015) A4–A5
if and when the lead candidate is licensed and recommended for use by WHO in late 2015. Gavi’s VIS approach serves as an initial global filter to prioritise vaccines for Gavi support. However, national governments still have to decide whether and when introduction of a vaccine from the Gavi ‘menu’ is justified. Essential to Gavi’s operational model is a country-driven approach, whereby national governments make decisions to introduce a vaccine and then request support from Gavi. Gavi supports partners to develop normative guidance and provide technical assistance to countries on evidence generation and synthesis, including economic evidence, to help inform national decisions on new vaccine introduction. For example, Gavi’s Hib Initiative supported the Hib-Rota-PCV decision support model ‘TRIVAC’, utilised in the cost effectiveness studies reported in this issue [2,3] as well as studies published elsewhere [4,5]. Gavi also recognises the need to strengthen local institutions at the heart of the decision-making process and supports Vaccine Alliance partners and SIVAC (Supporting National Independent Immunization and Vaccine Advisory Committees) to provide technical and coordination assistance to national structures, such as Inter-Agency Coordinating Committees (ICCs) and National Immunization Technical Advisory Groups (NITAGs),2 to inform and facilitate government decisions and policy making related to national immunisation programmes. In addition, Gavi’s application process aims to reinforce principles of transparent, government driven and partner supported decision-making for new vaccine adoption. For example, new vaccine applications must be aligned with comprehensive Multi-Year Plans for immunisation (cMYPs), demonstrate the government’s commitment to meet mandatory co-financing requirements and be rooted in Health Sector Strategic Plans. Countries with a NITAG or other relevant technical advisory body are required to report on their decision-making process and recommendation for the new vaccine introduction. Finally, all applications submitted to Gavi must be approved by an ICC or Health Sector Coordinating Committee (where relevant), signifying agreement by in-country partners and be signed by the national ministers of health and finance. The Gavi model requires governments to share in the cost of Gavi-supported vaccines with the aim of fostering greater programme ownership and financial sustainability. From the time of introduction, governments are required to co-finance a small portion of the vaccine cost. As countries reach higher income levels this share goes up while Gavi’s support decreases. Upon crossing the eligibility threshold, governments enter a five-year transition during which they rapidly scale up their contributions to take on the full financing of Gavi supported vaccines. As countries expand their national immunisation programmes by adding more vaccines, governments need to consider the increasing budgetary impact of cumulative co-financing obligations and the anticipated cost of vaccines when they are no longer subsidised by Gavi. In addition, a clear understanding of the non-vaccine operational costs at various levels of immunisation programmes – particularly the facility level – is required. Several studies in this issue provide insight to improve the knowledge base of comprehensive immunisation programme costing while highlighting the importance of more precise estimates for accurate budgeting and resource mobilisation [6–9]. To inform considerations of the future cost of vaccines, Gavi is scaling up efforts to increase country awareness of the varying
2
National Immunisation Technical Advisory Group.
A5
market prices and cost profiles of Gavi-supported vaccines, both at the time of new vaccine applications and as countries approach the transition to self-financing. Likewise, additional support to create and strengthen national advisory bodies such as NITAGs is being provided. While all of these efforts are important to ensure that vaccine introduction decisions are evidence-based and country-owned, Gavi recognises that more needs to be done to engage local stakeholders and strengthen capacity for decision-making in the context of rapidly expanding immunisation programmes. The Pan American Health Organization’s (PAHO) ProVac initiative has played a path-finding role to improve local capacity to carry out economic evaluations and Gavi welcomes efforts to leverage lessons and expertise of institutions such as Agence de Medicine Preventive, PATH, the Sabin Vaccine Institute and the US Centers for Disease Control and Prevention for expanded support to other regions of the world. Lessons from middle and lower-middle income countries on the use of health technology assessments to prioritise health investments will also help to inform areas of potential future collaboration and South-to-South exchanges of experiences. Strengthened country capacity to access and evaluate evidence and to independently decide to introduce a vaccine – or not – is paramount to country-owned immunisation programmes. With ever-increasing competing priorities in the health sector, value-formoney considerations to inform vaccine introduction decisions are more important than ever. This need will likely be accentuated with vaccines in the pipeline targeting more localised disease burden or with lower vaccine effectiveness, for example future vaccines against malaria and dengue. The unprecedented increase in access to new vaccines in lower-income countries over the past decade necessitates increased support for national-level decision-making processes to better ensure sustainability of expanding immunisation programmes. This will be a major focus of Gavi’s next strategic period 2016-2020. Conflict of interest The authors have no conflict of interest. The content of this article represents the personal views of the authors and so does not reflect the official position of the GAVI Alliance. References [1] Orin SL, Hajjeh R, Wecker J, Cherian T, O’Brien KL, Deloria Knoll M, et al. A policy framework for accelerating adoption of new vaccines. Hum Vaccines 2010;6(12):1021–4. [2] Sigei CK, Odaga S, Madrid Y, Clark A, Mvundura M. Cost effectiveness of rotavirus vaccination in Kenya and Uganda. Vaccines 2014. [3] Diop A, Atherly D, Faye A, Sall FL, Nadiel L, Yade B, et al. Estimated impact and cost-effectiveness of rotavirus vaccination in Senegal: a country-led analysis. Vaccines 2014. [4] Clark AD, Griffiths UK, Abbas SS, Rao KD, Privor-Dumm L, Hajjeh R, et al. Impact and cost-effectiveness of Haemophilus influenzae type b conjugate vaccination in India. J Pediatr 2013;163(1 Suppl):S60–72. [5] Griffiths UK, Clark A, Shimanovich V, Glinskaya I, Tursunova D, Kim L, Mosina L, Hajjeh R, Edmond K, et al. Comparative economic evaluation of Haemophilus influenzae type b vaccination in Belarus and Uzbekistan. PLoS ONE 2011;6(6):e21472. [6] Ahanhanzo CD, Huang Xiao Xian, Le Gargasson J-B, Sossou J, Nyonator F, Colombini A, et al. Determinants of routine immunization costing in Benin and Ghana in 2011. Vaccines 2014. [7] Le Gargasson J-B, Nyonator FK, Adibo M, Gessner BD, Colombini A. Costs of routine immunization, and the introduction of new and under-utilized vaccines in Ghana. Vaccines 2014. [8] Schutte C, et al. Cost analysis of routine immunisation in Zambia. Vaccines 2014. ˜ [9] Janusz CB, Castaneda-Orjuela C, Berenice IM, Felix G, Mendoza L, Díaz IY, et al. Examining the cost of delivering routine immunization in Honduras. Vaccines 2014.
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Commentary
Gavi’s balancing act: Accelerating access to vaccines while ensuring robust national decision-making for sustainable programmes Stephen Sosler ∗ , Judith Kallenberg, Hope L. Johnson Gavi, the Vaccine Alliance, Geneva, Switzerland
Since its creation in 2000, Gavi, the Vaccine Alliance has leveraged its public–private structure – bringing together governments, UN agencies, private sector and civil society – to make new and underused vaccines more affordable and accessible to people in lower-income countries. Prior to the creation of Gavi, the world’s lowest-income countries endured the greatest burden of vaccine preventable diseases yet had limited access to new vaccines readily available in wealthier countries. For example, in 2000, over 60% of high-income countries were providing Hepatitis B vaccine in their national immunisation programmes. In the same year among lowincome countries, where the burden of hepatitis B was highest, less than 10% had introduced this vaccine. Gavi has an ambitious mission to significantly expand access to a range of new and under-used vaccines over a relatively short period of time. With cost barriers largely removed, lowerincome countries have embraced the opportunity to seek support for the introduction of life-saving vaccines. Since the initial Gavisupported introductions of monovalent Hepatitis B vaccine in 2001, the picture has evolved significantly. Gavi currently offers support for 11 vaccine programmes including human papillomavirus, inactivated polio vaccines, Japanese encephalitis, measles, meningitis A, oral cholera vaccine, pentavalent, pneumococcal conjugate, rubella, rotavirus, and yellow fever. Applications for vaccine support have surged and it is expected there will be more than 280 Gavi-supported vaccine programmes in 71 countries by the end of 2015. However, beyond the “quick win” of successfully launching a new, heavily subsidised vaccine, effective scale-up and sustained programme implementation require strong political will and longterm investments [1]. Gavi thus has an important responsibility to ensure that decisions to adopt new vaccines are locally owned and rooted in strong commitment that will last beyond the duration of its financial support. A challenge of Gavi’s mission is balancing the urgent need to address preventable death and disease with lifesaving vaccines that are available today with the need to ensure a robust decision-making process. In this commentary, we reflect on the evidence-informed globallevel process that Gavi uses to select vaccines that meet the public
∗ Corresponding author. Tel.: +41 22 909 6591. E-mail address: [email protected] (S. Sosler). http://dx.doi.org/10.1016/j.vaccine.2014.12.051 0264-410X/© 2015 Published by Elsevier Ltd.
health needs of low income countries, as well as translation of these globally-identified priorities into sustainable programmes rooted in locally-owned introduction decisions. Gavi uses a demand-driven funding model and offers support for a variety of vaccines. Support is awarded in response to countries’ requests through a centrally managed application process. Before countries are invited to apply for vaccine support, Gavi determines which vaccines to make available through the development of a Vaccine Investment Strategy (VIS). This global strategy is renewed every five years to identify new priority vaccines for inclusion in Gavi’s portfolio. The first VIS was produced in 2008 and the second in 2013. The VIS process brings together disease experts, implementing country representatives, manufacturers and other Vaccine Alliance partners to inform a comprehensive comparative analysis of potential vaccine opportunities for countries meeting Gavi’s eligibility requirements.1 A key consideration is whether Gavi has a comparative advantage in helping to overcome barriers to accessing a vaccine of public health importance. All Gavi countries share a limited ability to pay for vaccines as they have relatively low gross national incomes per capita (GNI p.c.) and therefore limited resources available for immunisation expenditures. Beyond this common barrier, Gavi countries have diverse needs. The VIS aims to identify vaccine investments with significant benefits for a significant number of countries (e.g. pneumococcal conjugate and rotavirus vaccines), or for which Gavi’s support fills a unique gap (e.g. support for the oral cholera vaccine stockpile in part to incentivize global supply). It excludes vaccines with lower value-for-money based on the projected health impact and cost of the vaccine, and considers local implementation feasibility as well as global factors such as Gavi’s ability to influence pricing. The 2008 VIS identified human papilloma virus (HPV), rubella, Japanese encephalitis and typhoid vaccines to be added to the portfolio of Gavi supported vaccines. The 2013 VIS identified expanded support for yellow fever mass preventive campaigns and investment in the global stockpile of cholera vaccines as new priorities. The Gavi Board deferred a decision on a malaria vaccine which was still undergoing clinical trials and will consider the case for this vaccine
1 Gavi’s current (2014) eligibility threshold is set at a Gross National Income level of $1580 this is from 2015per capita (according to World Bank data for the latest available year.
S. Sosler et al. / Vaccine 33S (2015) A4–A5
if and when the lead candidate is licensed and recommended for use by WHO in late 2015. Gavi’s VIS approach serves as an initial global filter to prioritise vaccines for Gavi support. However, national governments still have to decide whether and when introduction of a vaccine from the Gavi ‘menu’ is justified. Essential to Gavi’s operational model is a country-driven approach, whereby national governments make decisions to introduce a vaccine and then request support from Gavi. Gavi supports partners to develop normative guidance and provide technical assistance to countries on evidence generation and synthesis, including economic evidence, to help inform national decisions on new vaccine introduction. For example, Gavi’s Hib Initiative supported the Hib-Rota-PCV decision support model ‘TRIVAC’, utilised in the cost effectiveness studies reported in this issue [2,3] as well as studies published elsewhere [4,5]. Gavi also recognises the need to strengthen local institutions at the heart of the decision-making process and supports Vaccine Alliance partners and SIVAC (Supporting National Independent Immunization and Vaccine Advisory Committees) to provide technical and coordination assistance to national structures, such as Inter-Agency Coordinating Committees (ICCs) and National Immunization Technical Advisory Groups (NITAGs),2 to inform and facilitate government decisions and policy making related to national immunisation programmes. In addition, Gavi’s application process aims to reinforce principles of transparent, government driven and partner supported decision-making for new vaccine adoption. For example, new vaccine applications must be aligned with comprehensive Multi-Year Plans for immunisation (cMYPs), demonstrate the government’s commitment to meet mandatory co-financing requirements and be rooted in Health Sector Strategic Plans. Countries with a NITAG or other relevant technical advisory body are required to report on their decision-making process and recommendation for the new vaccine introduction. Finally, all applications submitted to Gavi must be approved by an ICC or Health Sector Coordinating Committee (where relevant), signifying agreement by in-country partners and be signed by the national ministers of health and finance. The Gavi model requires governments to share in the cost of Gavi-supported vaccines with the aim of fostering greater programme ownership and financial sustainability. From the time of introduction, governments are required to co-finance a small portion of the vaccine cost. As countries reach higher income levels this share goes up while Gavi’s support decreases. Upon crossing the eligibility threshold, governments enter a five-year transition during which they rapidly scale up their contributions to take on the full financing of Gavi supported vaccines. As countries expand their national immunisation programmes by adding more vaccines, governments need to consider the increasing budgetary impact of cumulative co-financing obligations and the anticipated cost of vaccines when they are no longer subsidised by Gavi. In addition, a clear understanding of the non-vaccine operational costs at various levels of immunisation programmes – particularly the facility level – is required. Several studies in this issue provide insight to improve the knowledge base of comprehensive immunisation programme costing while highlighting the importance of more precise estimates for accurate budgeting and resource mobilisation [6–9]. To inform considerations of the future cost of vaccines, Gavi is scaling up efforts to increase country awareness of the varying
2
National Immunisation Technical Advisory Group.
A5
market prices and cost profiles of Gavi-supported vaccines, both at the time of new vaccine applications and as countries approach the transition to self-financing. Likewise, additional support to create and strengthen national advisory bodies such as NITAGs is being provided. While all of these efforts are important to ensure that vaccine introduction decisions are evidence-based and country-owned, Gavi recognises that more needs to be done to engage local stakeholders and strengthen capacity for decision-making in the context of rapidly expanding immunisation programmes. The Pan American Health Organization’s (PAHO) ProVac initiative has played a path-finding role to improve local capacity to carry out economic evaluations and Gavi welcomes efforts to leverage lessons and expertise of institutions such as Agence de Medicine Preventive, PATH, the Sabin Vaccine Institute and the US Centers for Disease Control and Prevention for expanded support to other regions of the world. Lessons from middle and lower-middle income countries on the use of health technology assessments to prioritise health investments will also help to inform areas of potential future collaboration and South-to-South exchanges of experiences. Strengthened country capacity to access and evaluate evidence and to independently decide to introduce a vaccine – or not – is paramount to country-owned immunisation programmes. With ever-increasing competing priorities in the health sector, value-formoney considerations to inform vaccine introduction decisions are more important than ever. This need will likely be accentuated with vaccines in the pipeline targeting more localised disease burden or with lower vaccine effectiveness, for example future vaccines against malaria and dengue. The unprecedented increase in access to new vaccines in lower-income countries over the past decade necessitates increased support for national-level decision-making processes to better ensure sustainability of expanding immunisation programmes. This will be a major focus of Gavi’s next strategic period 2016-2020. Conflict of interest The authors have no conflict of interest. The content of this article represents the personal views of the authors and so does not reflect the official position of the GAVI Alliance. References [1] Orin SL, Hajjeh R, Wecker J, Cherian T, O’Brien KL, Deloria Knoll M, et al. A policy framework for accelerating adoption of new vaccines. Hum Vaccines 2010;6(12):1021–4. [2] Sigei CK, Odaga S, Madrid Y, Clark A, Mvundura M. Cost effectiveness of rotavirus vaccination in Kenya and Uganda. Vaccines 2014. [3] Diop A, Atherly D, Faye A, Sall FL, Nadiel L, Yade B, et al. Estimated impact and cost-effectiveness of rotavirus vaccination in Senegal: a country-led analysis. Vaccines 2014. [4] Clark AD, Griffiths UK, Abbas SS, Rao KD, Privor-Dumm L, Hajjeh R, et al. Impact and cost-effectiveness of Haemophilus influenzae type b conjugate vaccination in India. J Pediatr 2013;163(1 Suppl):S60–72. [5] Griffiths UK, Clark A, Shimanovich V, Glinskaya I, Tursunova D, Kim L, Mosina L, Hajjeh R, Edmond K, et al. Comparative economic evaluation of Haemophilus influenzae type b vaccination in Belarus and Uzbekistan. PLoS ONE 2011;6(6):e21472. [6] Ahanhanzo CD, Huang Xiao Xian, Le Gargasson J-B, Sossou J, Nyonator F, Colombini A, et al. Determinants of routine immunization costing in Benin and Ghana in 2011. Vaccines 2014. [7] Le Gargasson J-B, Nyonator FK, Adibo M, Gessner BD, Colombini A. Costs of routine immunization, and the introduction of new and under-utilized vaccines in Ghana. Vaccines 2014. [8] Schutte C, et al. Cost analysis of routine immunisation in Zambia. Vaccines 2014. ˜ [9] Janusz CB, Castaneda-Orjuela C, Berenice IM, Felix G, Mendoza L, Díaz IY, et al. Examining the cost of delivering routine immunization in Honduras. Vaccines 2014.
