New Access to Vaccines Index Reveals First Landscape of Vaccine Company Actions to Improve Immunisation Coverage

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Vaccines are one of the most powerful health interventions available. Yet WHO estimates that 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 responsibility of ensuring everyone benefits 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 -a critical step to making vaccine markets more inclusive."

The independent Index, published Monday, analysed companies' R&D pipelines, identifying 89 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 companies are taking steps to prevent shortages and that, when setting prices, they 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.

A growing market 

The global vaccine market is growing: between 2000 and 2014, it expanded from USD 6 bn to USD 33 bn, with sales to richer countries accounting for around 65% of the total. Governments are spending more on vaccines, including poorer countries. Many lower income countries procure vaccines with financial support from Gavi and through organisations such as UNICEF: UNICEF doubled its vaccine spend between 2010 and 2014, to USD 1.5 bn.

The Index has mapped the actions of eight key vaccine companies, including the largest companies in terms of revenue. Often termed "the big four", GSK, Merck & Co., Inc., Pfizer and Sanofi represent around 80% of global vaccine revenues. Serum Institute of India is also in scope. It is of major importance for global public health, with a wide geographic reach and selling almost 1.4 billion vaccine doses each year. In addition to these five, the Index evaluates three further companies with significant potential for improving access to vaccines: Daiichi Sankyo, Johnson & Johnson and Takeda.

The Access to Vaccines Index measures company activity across defined sets of diseases and countries. The disease scope comprises 69 diseases with the highest priority for improving access to immunisation: 44 diseases where no vaccines exist on the market, and 25 diseases where vaccines exist but with issues surrounding accessibility. The geographic scope comprises 107 countries with the highest perceived need for access to vaccines.

The Index has examined company behaviour in three areas: research & development; pricing & registration; and manufacturing & supply. All eight were evaluated in research & development: here GSK leads, followed closely by Johnson & Johnson. Six (Daiichi Sankyo and Takeda are the exceptions) have vaccines on the market for diseases in scope and sales in countries in scope. These six companies were therefore suitable for evaluation in pricing and registration, and in manufacturing and supply. Across all three areas, GSK performs the best with Sanofi also performing well across the board.

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.

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 commercial incentives. A third of the projects in pipelines target one of 12 diseases relevant to the Index for which no vaccine yet exists, including Ebola, 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 - important 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 register 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. "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."

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.

Contact:
Suzanne Wolf
+31-23-533-91-87
[email protected]

SOURCE Access to Medicine Foundation