Vaccines are one of the most powerful and cost-effective health interventions available. Yet WHO states that an estimated 19.4 million infants worldwide are still missing out on basic vaccines.
“There is a world to be won by increasing access to vaccines,” says Jayasree K. Iyer, Executive Director, Access to Medicine Foundation. “As a global community, we all share the responsibility of ensuring everyone can benefit from immunisation. The companies that develop and manufacture vaccines clearly also have a role to play. This Index has mapped what vaccine companies are doing, and what prompts them to take action – it is a critical step in the effort to make vaccine markets more inclusive.”
An infant is vaccinated against polio following the introduction of Sanofi’s inactivated polio vaccine in Nepal. Photo: Sanofi Pasteur/Gautham Dhimal
The independent Index, published Monday, analysed companies’ R&D pipelines, identifying nearly 90 vaccine projects for high-priority diseases. This includes dozens of first-ever vaccines, for diseases such as Ebola and a range of deadly bacterial infections. If successful, such vaccines could prove critical for tackling anti-microbial resistance (AMR). The Index also finds that companies are taking steps to prevent vaccine shortages and that, when setting prices, most take affordability into account to a degree. All companies consider a country’s eligibility for support from Gavi, a public-private partnership that funds vaccine purchases for lower-income countries.
Portfolios and pipelines follow the markets
In their vaccine portfolios and pipelines, the eight companies in scope concentrate on diseases with larger global markets: for example, the diseases with the most vaccines on the market are meningococcal disease, polio, seasonal influenza and hepatitis (A and B); the top five diseases targeted by R&D projects are pneumococcal disease, seasonal influenza, meningococcal disease, respiratory syncytial virus and human papillomavirus, which causes cervical cancer.
Figure 8. Vaccine adaptations account for half of R&D projects; individual company pipelines vary
Research & development: companies at work on innovation
Vaccine companies are working on 89 vaccine R&D projects for 35 diseases. The most attention is given to pneumococcal disease, human papillomavirus and seasonal influenza. This focus largely corresponds to the presence of commercial incentives. A third of the projects in company pipelines target one of the 12 diseases relevant to the Index for which no vaccine yet exists, including Ebola and HIV, as well as E. coli, C. difficile, and bacteria from the streptococcus and staphylococcus families.
Once a vaccine has been rolled out in real-world settings, it becomes clear whether further R&D is required to improve or adapt it. Adaptations account for almost half of the industry’s vaccine R&D pipeline. The most common adaptation is to expand the range of diseases (or strains) that a vaccine provides protection from. Also common are projects that aim to make vaccines more resilient to temperature fluctuations – an important characteristic for countries where refrigeration is not always an option.
For many diseases in scope, vaccines do not promise significant profits – particularly for diseases such as leprosy or human monkeypox that predominantly affect populations in low- and middle-income countries. “For these diseases, our research tells us that alternative incentives are likely necessary to encourage companies to develop new vaccines – such as public-private partnerships for vaccine R&D, or commitments to purchase new vaccines in bulk,” says Jayasree K. Iyer.
Pricing & registration: companies consider affordability to a degree
Immunisation programmes involve considerable costs, with vaccine prices accounting for a significant proportion. Vaccine companies have a responsibility to ensure vaccines are affordable for governments with limited resources. The Index has evaluated how companies take affordability into account when setting prices, as well as their efforts to make them available, by registering them for use in low- and middle-income countries.
When setting vaccine prices, most companies consider affordability to a degree and a country’s market conditions. Vaccine prices are also informed by cost, including investments in clinical development, and by the public health value of the vaccine. The only factor considered by all six companies evaluated is a country’s eligibility for support from Gavi. Companies generally offer their lowest prices to Gavi-eligible countries.
Many middle-income countries (MICs) are not eligible for Gavi support, and yet face healthcare budget constraints. When setting vaccine prices in MICs, the Index does not find clear evidence that companies systematically consider countries’ ability to pay. Looking ahead, the Index concludes that companies need a systematic approach to affordability, especially for countries that receive no support from Gavi and do not participate in pooled procurement via PAHO and UNICEF.
Manufacturing & supply: companies take action to prevent shortages
Vaccine demand can outstrip supply for a range of reasons, including outbreaks, inaccurate demand forecasting and manufacturing interruptions. All vaccine companies evaluated by the Index in this area are taking action to align global supply and demand, suggesting that vaccine shortages are, in some cases, being detected, mitigated and/or prevented. Four companies take comparatively strong action: GSK, Johnson & Johnson, Merck & Co. Inc. and Sanofi. Compared to other companies, these four take more actions that are key to improving supply. This includes having processes in place for scaling up production when needed and regularly reviewing whether supply matches projected demand. These four companies have also committed to staying in vaccine markets where there are few or no other suppliers, and/or notifying market stakeholders in advance when reducing supply.
“Disease outbreaks will continue to occur,” says Jayasree Iyer. “It is especially important that vaccine companies continue to improve approaches for preventing shortages. Companies need to be at the table as governments and others work to build resilient health systems.”
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Media materials: Graphs & figures from the Key Findings and other figures in the report are available upon request.
About the Access to Vaccines Index: The 2017 Access to Vaccines Index provides an initial baseline of industry activity to improve access to vaccines. It examines where and how companies are already taking action to improve immunization coverage, and brings good practices to the attention of other companies and stakeholders working in the vaccines space. These organisations will be able to use the Index to inform priorities and strategies, and to clarify where new incentives are needed to spur greater positive change. The methodology for the Index has been developed with reference to experts working in the field and industry. The research was reviewed prior to publication by a group of Expert Advisors: including from Clinton Health Access Initiative (CHAI) and Gavi the Vaccine Alliance. The Access to Vaccines Index has been developed by the Access to Medicine Foundation, an independent non-profit organisation based in the Netherlands. The Access to Vaccines Index is funded by the Dutch National Postcode Lottery (De Postcode Loterij).
About the Access to Medicine Foundation
The Access to Medicine Foundation is an independent, nonprofit organisation based in the Netherlands. It aims to advance access to medicine in low- and middle-income countries by stimulating and guiding the pharmaceutical industry to play a greater role in improving access to medicine. The Foundation is funded by the Bill & Melinda Gates Foundation, the Dutch Ministry of Foreign Affairs and the UK Department for International Development. For ten years, the Foundation has been building consensus on the role for the pharmaceutical industry in improving access to medicine and vaccines. It published its first benchmark of industry activity in this area in 2008, in the first Access to Medicine Index. The fifth Access to Medicine Index was published in November 2016. In 2017, the Foundation published the first Access to Vaccines Index, funded by the Dutch National Postcode Lottery. The first Antimicrobial Resistance Benchmark (AMR Benchmark) will be published in 2018.