The Access to Vaccines Index tracks how vaccine companies influence access to vaccines for children in low- and middle-income countries. The 2015 Methodology is designed to reveal an initial baseline of industry activity, while identifying new opportunities for stakeholders and companies to break down access barriers. It reflects stakeholders’ views on how vaccine companies are increasing access to vaccines, for which priority diseases, and on how and where these companies can contribute to global immunisation targets.
What the Index measures
At the core of the methodology are the first metrics for mapping how vaccine developers and manufacturers are addressing access to vaccines. These metrics cover three Research Areas: Research & Development, Affordability, and Manufacturing & Supply.
The Access to Vaccines Index will map how companies are responding to vaccine R&D priorities. The aim is to enable companies and other organisations working in the field to identify persistent product gaps and stimulate further R&D where it is most needed.
Indicators and rationales
Metrics in this area focus on mapping companies’ vaccine pipelines, including new, adapted and improved vaccines, as well as vaccine technologies.
A.1 R&D investments
Proportion of financial R&D investments dedicated to vaccine development for diseases relevant to the Index out of the company’s total vaccines revenue.
This metric will examine how companies allocate resources to vaccines R&D. With sufficient resources, companies can help ensure that vaccine candidates travel successfully through the pipeline. The Index will view the amounts companies allocate as a proxy for their commitment to bringing new vaccines to the market.
A.2 R&D projects – vaccines
Number of investigational vaccines that the company is developing for vaccine-preventable diseases in scope of the Index, including innovative and adaptive vaccines (developed in-house or through collaborative R&D).
This metric will lead to the most comprehensive review to date of the industry’s vaccine pipeline, comprising an overview of high-level project profiles, including which partners are involved. This will reveal where needs and priorities are already being addressed, by whom, and where gaps and opportunities remain for companies and other research organisations to address.
A.3 R&D projects – technologies
Number of projects the company is engaged in to develop technologies for vaccine packaging and delivery in order to overcome barriers* to vaccines in countries relevant to the Index (developed in-house or through collaborative R&D).
This metric will reveal where companies are improving or developing vaccine packaging and delivery technologies, for example to reduce unit sizes and improve supply chains, or to introduce needle-free technologies that are easier to administer and better tolerated. Such information will provide governments and global technical agencies with valuable insights into where new adaptations are emerging, and provide companies with feedback on where to focus attention and investments.
A.4 Facilitating access
Number of late-stage vaccine R&D projects for which the company provided evidence of having access provisions in place, with the aim of ensuring future availability, affordability, and/or accessibility in Index Countries (for both in-house and collaborative R&D).
This metric will map whether companies are taking steps (called access provisions), during the R&D process, to ensure successful vaccine candidates are rapidly made available, accessible and affordable. By putting access provisions in place while vaccines are under development, companies can significantly accelerate the speed at which they become available at an affordable price and at sufficient volumes. Access provisions can include pricing commitments, supply commitments or licensing agreements.
The Access to Vaccines Index will benchmark how companies consider affordability when pricing their vaccines. The aim is to understand companies’ strategic thinking and to stimulate more open discussions on what sustainable vaccine pricing looks like.
Indicators and rationales
Metrics in this area focus on examining companies’ pricing strategies and whether they are transparent about them, whether they propagate price transparency, and whether they file for registration in low- and middle- income countries.
B.1 Pricing strategy
The company has a pricing strategy that takes into account income and other socio-economic criteria* when selling products to governments and through pooled procurement.
This metric will assess the various factors companies consider when constructing pricing strategies. It will look at whether companies consider demand- and supply-side and other socio-economic factors, in order to ensure vaccines are priced affordably.
B.2 Pricing policy transparency
The company publicly discloses its pricing policy for vaccines and provides evidence that it does not prevent governments from making publicly available manufacturer prices.
This metric will examine whether the factors companies consider in their pricing strategies are publicly available so that governments and other procurers can understand the criteria for negotiating lower prices. It will also assess whether companies limit vaccine-price transparency by influencing governments’ ability to disclose prices.
The company makes efforts to ensure vaccines are available in low- and middle-income countries by filing for registration there.
This metric will examine whether companies register their vaccines for sale in the countries that need them most, rather than focusing solely on the most lucrative markets. Registration is widely seen as the gateway to greater access to vaccines.
The Access to Vaccines Index will assess companies’ policies and processes for providing reliable supplies of vaccines. The aim is to identify information gaps and opportunities for market actors to work together to align supply and demand.
Indicators and rationales
Metrics in this area focus on the strategies and processes companies put in place to ensure a reliable supply of vaccines. Additionally, this area will measure whether companies engage with local vaccine manufacturers, as this can increase local production capacities and ensure production of quality vaccines. Lastly, this measurement area will look at whether companies adapt brochures and/or packaging or other delivery technologies to overcome barriers to vaccines in developing countries.
C.1 Overcoming local barriers
The company is implementing vaccine packaging and delivery technologies* in order to overcome barriers to access to vaccines in Index countries (e.g., stock-outs, imperfect supply chains, manufacturing costs, lack of trained health care professionals) and ensure these vaccines are non-inferior to the standard vaccine in terms of quality.
This metric will assess whether companies help to overcome local barriers to access to vaccines by either adapting vaccine packaging or implementing new delivery technologies.
C.2 Ensuring rational use
The company adapts package inserts/packaging to ensure rational use of the vaccine at the point of delivery, i.e., that the vaccine is administered appropriately.
This metric will look at whether companies provide clear instructions in the packaging materials on how to administer a vaccine, which minimise the risk of vaccines being given incorrectly.
C.3 Responding to shortages
The company has a strategy in place to help ensure sufficient or additional supplies of vaccines are made available** in case of global, regional or local shortages (both for vaccines that are part of routine immunisation as well as those needed in emergency situations, such as outbreaks, natural disasters, etc.).
This metric will reveal the strategies and procedures companies have in place to quickly avert potential vaccine shortages. The aim is to provide insight into the best actions companies can take to prevent shortages from developing, and into opportunities for other actors to trigger a timely response from companies.
C.4 Collaboration to align supply and demand
The company has a mechanism in place to engage with vaccine purchasers and partners on a regular basis to align supply and demand of its vaccines in order to identify, prevent or bridge periods of global, regional or local stockouts, for example due to supply delays, due to the company exiting a specific vaccine market or in response to urgent, unplanned or accelerated demand.
This metric will assess the mechanisms companies have put in place to ensure they regularly engage with other stakeholders to align supply and demand (for example, with governments, UNICEF, Gavi and PAHO). The aim is to identify gaps in information sharing and highlight opportunities for closer collaboration.
C.5 Supporting vaccine security
The company has a strategy in place that takes into account global health needs for vaccines, including a commitment to continue vaccine production for its vaccines which have either few or no other suppliers AND a commitment to proactively and clearly communicate any intentions on altering supply plans, manufacturing capacity and/or exiting a specific vaccine market, and to work with stakeholders to bridge the period when supplies would diminish or cease.
This metric aims to identify whether companies take public health into account when making strategic and business decisions. This analysis will help understand how companies balance business priorities with public health needs.
C.6 Increasing global manufacturing capacity
The company has engaged in partnerships, training and/or technology transfer that support the growth of manufacturing capabilities with the aim of increasing vaccine supply and innovation in manufacturing.
This metric will assess companies’ efforts to increase global vaccine manufacturing capacity, e.g., through partnerships, training exercises or technology transfers with other manufacturers; or by sharing manufacturing innovations. The aim is to share practices that could be applied for different vaccines, and to identify where manufacturing capacity is potentially not being strengthened sufficiently.
Scope of the Index
The Access to Vaccines Index evaluates how 8 major vaccine companies are improving access to preventive vaccines for 69 priority diseases in 107 high-need countries. In addition to the vaccines themselves, the Index will also look at whether companies are developing and implementing platform technologies that can be used for different vaccines and vaccine types, and that make vaccines more suitable for use in resource-limited settings.
The Access to Vaccines Index measures 8 vaccine companies: eight large research-based pharmaceutical companies based in mature markets and one vaccine manufacturer based in an emerging market. These companies have been identified by the Index team and through stakeholder discussions as having the potential for improving access to existing and future vaccines. Stakeholders confirmed that the Index should focus on the largest global players in the vaccine market.
The Index evaluates each company in relevant research areas only. All eight companies were evaluated in research & development. Six companies have vaccines on the market for diseases in scope and sales in countries in scope: these six were therefore suitable for evaluation in pricing and registration, and in manufacturing and supply. Daiichi Sankyo and Takeda are the exceptions – they are evaluated in Research & Development only.
The 2017 Access to Vaccines Index includes: eight large research-based pharmaceutical companies with significant vaccine units, and one large vaccine manufacturer based in an emerging market. The companies are:
- Johnson & Johnson
- Merck & Co., Inc.
- Pfizer Inc.
- Serum Institute of India
Companies evaluated in R&D only:
- Daiichi Sankyo
- Takeda Pharmaceutical Co.
The disease scope of the Access to Vaccines Index consists of 69 diseases that are vaccine preventable, and have the highest priority when it comes to improving access to immunisation. The list comprises 44 diseases where no vaccines yet exist on the market, and 25 diseases where vaccines exist but with issues surrounding accessibility. The disease scope covers:
- Diseases recommended by the WHO for routine immunisation
- Diseases identified by the WHO as having a high need for further vaccine R&D
- Diseases suitable for prevention via maternal immunisation
- Emerging infectious diseases
- Diarrhoeal diseases
- Lower respiratory infections
- Neglected Tropical Diseases
Access to vaccines is needed equally in all countries in the world. Yet lower income countries face a tougher challenge when it comes to successfully immunising their populations. The Index covers countries with the highest perceived need for greater access to vaccines: namely, the poorest countries, the least developed countries, and countries with the highest levels of inequalities.
These categories were defined using three critera: (1) countries’ levels of income (gross national income [GNI] per capita), using World Bank data; (2) their levels of development according to the United Nations Development Programme (UNDP); and (3) the scope and scale of inequality in each country according to the United Nations Economic and Social Council (ECOSOC).
Building the methodology
The Index team built the methodology for the Access to Vaccines Index in four steps: feasibility & landscaping; establishing the founding principles; challenging the founding principles; finalising the metrics.
The Index team built the methodology for the Access to Vaccines Index in four steps:
The Index team established the broad parameters of the Access to Vaccines Index through an initial feasibility exercise, landscaping study and literature review. These studies used the priorities defined in the Global Vaccine Action Plan (GVAP) as a background framework, and drew on the Foundation’s ten years’ experience in engaging with stakeholders and tracking company behaviour.
Based on their conclusions, the team developed the founding principles of the Index:
The role for vaccine companies in improving access to vaccines rests primarily in the areas of Research & Development, Affordability and Manufacturing & Supply.
In Research & Development, companies are expected to continually address high-priority gaps for new and improved vaccines and delivery technologies.
In Affordability, companies are expected to actively address the affordability of their vaccines for governments with limited resources.
In Manufacturing & Supply, companies are expected to have strong policies and processes in place to ensure sufficient high-quality vaccines are available.
The Index team challenged these founding principles through consultations with the major players working to improve access to immunisation. Stakeholders also interrogated the parameters of the proposed methodology to see if other areas of company behaviour, such as managing intellectual property or donations, should also be included. The aim was to ensure that the Access to Vaccines Index complements the work of other organisations working in this space, and that all stakeholders can use the Index’s data and insights to inform future interventions.
In-depth feedback was provided by experts working in industry, governments, NGOs, procurers, philanthropic organisations and research organisations. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) provided consolidated feedback from companies with vaccine units, and the Index team held individual discussions with large research-based pharmaceutical companies as well as the largest manufacturers based in emerging markets. Essential strategic feedack was provided by a group of Expert Advisors, from Clinton Health Access Initiative (CHAI) , Gavi the Vaccine Alliance, UNICEF and the IFPMA.