International Activity Report 2010 - Innovation in action: a tale of two vaccines

© Bruno De Cock

Both will undoubtedly save the lives of many people in the countries where the vaccines have been rolled out. But the story behind each also illuminates both the risks and rewards of working to open up access to lifesaving vaccines as widely as possible in the places where we work.

 Every year, during the dry months – the epidemic season – the fear among communities who live in Africa’s meningitis belt is palpable as they wait for this debilitating and often fatal disease to strike.

And every year, there are many fatalities; those who survive are often left with longterm mental and physical disabilities.

MSF has long been involved in fighting the disease across the region and regularly mounts large reactive vaccination campaigns to combat the disease. However, in 2010, MSF teams, supporting the national health authorities in Niger and Mali, helped roll out a new vaccine that could finally put an end to the shattering cycle of meningitis epidemics in this region once and for all.

“ A revolution and game-changer to end epidemics”

The new vaccine has many advantages over the older vaccines – it protects young children more effectively and lasts up to ten years. Most importantly, the vaccine will stop transmission of the bacteria that causes meningitis within the population by eliminating the carriage of the germ.

And this could mean an end to epidemics.

“This new vaccine opens up whole new possibilities. In 2009, MSF vaccinated more than seven million people for meningitis A.

We were confined to emergency response, trying to slow and stop epidemics.

The traditional vaccine conferred very short-term protection making true long-term preventionimpossible,” says Dr Cathy Hewison, medical advisor at MSF.

“This new vaccine gives four times greater protection and lasts ten years. It’s a revolution and a game changer to prevent epidemics in the future.”

But beyond the public health revolution, the way in which the vaccine was developed – tailored specifically to protect the target population in sub-Saharan Africa for an affordable price – is also groundbreaking.

Responding to urgent medical needs, not only the market

Effective meningitis vaccines already exist in high-income countries but, as with the overwhelming majority of vaccines, medicines and diagnostic tools, the pharmaceutical research and development agenda has been driven by wealthy markets and largely fails to address the needs of people who live in poorer countries. This means that drugs and other health tools are developed to respond primarily to diseases prevalent in rich countries, and are adapted to developing country contexts in a second stage. Diseases that mostly afflict developing countries either go unaddressed, or patients must wait far longer for new medical products to reach them.

 This project, in contrast, was launched directly in response to a call from African governments to tackle this merciless killer.

A clear brief set out the requirements: the vaccine should be targeted to protect people from meningitis A, the particular form of meningitis prevalent in sub-Saharan Africa. And an affordable target price was set at no higher that 50 US cents.

Following a period in which major pharmaceutical companies considered and then walked away from the brief, a consortium of academics and scientists from both developing and high-income countries came together to collaborate on the vaccine. The scientific know-how on the production of the vaccine was transferred from a US institution to the Serum Institute in India, linking top scientific capacity to low production costs.

Further collaboration took place as African scientists contributed to the design of the research and conducted the clinical trials.

Finally, the World Health Organization gave the vaccine its quality stamp of approval, providing assurance of the product’s safety and efficacy, and allowing the roll-out to begin.

With development costs a fraction of those usually incurred, the vaccine development has been greeted as a victory for public health and a shining example of what can be achieved outside the normal product development paradigms.

As Dr Tido Von Schoen-Angerer, director of the MSF Campaign for Access to Essential Medicines, says: “This is a complete revolution compared to the usual patentbased, profit-driven model. It’s a striking contrast to the blockbuster vaccines developed by the largest commercial developers for Western markets that fetch extremely high prices and aren’t produced with developing country needs in mind.”

A different approach: the pneumococcal vaccine Meanwhile, across the continent in Kenya, MSF and other healthcare providers have started using a new pneumococcal vaccine that again could save thousands of young lives. But a look at its development tells a very different story to that of the meningitis vaccine.

For more than a decade, infants in wealthy countries have benefited from a pneumococcal vaccine, and research has kept on delivering, with two improved versions introduced in Europe and the United States in 2009 and 2010. Now, finally, children in developing countries also stand to benefit.

The medical benefits of the vaccine are clear – pneumococcal diseases include some forms of meningitis and pneumonia, and the vaccine has the potential to prevent millions of bouts of illness and countless deaths – yet it has taken more than a decade for this vaccine to become available to children in developing countries. What’s more, the price tag is very high, and raises fears that the vaccine may prove unaffordable in the long run.

The devil is in the detail So what’s gone wrong here? In an effort to push this vaccine out more widely, an innovative financial mechanism was devised called the Advance Market Commitment.

Essentially this is an international subsidy that donors pay to pharmaceutical companies in exchange for them agreeing to sell the vaccines in developing countries at lower prices than those paid in wealthy markets. The idea is that the poorest countries get to access the vaccines at discounted rates, and sooner than otherwise would have been possible.

But the devil is in the detail and closer examination reveals a different picture.

In contrast to the meningitis vaccine, where affordability was established as a core objective, the final prices for the pneumococcal vaccine negotiated with the pharmaceutical companies are still high. In addition to the multi-million dollar subsidy received by each company, donors,

with small co-payments from developing countries, are paying US$ 10.50 for each child vaccinated. This is of great concern both to donors who are currently footing most of the bill, and for the developing countries that must eventually pay the full cost of the vaccines themselves. Securing long-term affordability is all the more crucial when you consider that the cost of this vaccine will have to be added to the cost of other routine vaccinations against measles and other common childhood diseases.

The big picture shows that the big pharmaceutical companies have received a vastly inflated and unwarranted subsidy for providing pneumococcal vaccine to developing countries – when they are already reaping blockbuster profits from the same vaccines in wealthy countries.

And, once donor support ends, those same developing countries may end up unable to afford the vaccine.

It’s likely that a considerably lower price could have been achieved if donors had granted more support to low-cost producers – similar vaccines in the pipeline could cost only US$ 6 per child vaccinated, but will not be available for several years. With a financial squeeze on all areas of global health funding, the exaggerated sum spent on this project could now mean a shortfall in the funding available for other important vaccines to protect young children in poor countries from killer diseases.

As Dr Nitya Uday Raj, medical coordinator for MSF in Kenya, says: “Pneumonia is a primary morbidity for young children in Dagahaley Camp, where we provide health services to Somali refugees and we are excited about adding this vaccine. During our conversations with the Ministry of Health about the roll out, they expressed concerns about how they would manage when they stop getting donor subsidies.”

MSF is committed to working with national authorities to boost and expand effective childhood vaccination programmes in the places where we work. But to ensure that those ambitions are sustainable over the long run, it’s essential not only for us to support and nurture new and creative approaches to the development of vaccines, but also to remain vigilant that the public health interest is prioritised above all else.

The tale of two vaccines is a cautionary one.

MSF’s Campaign for Access to Essential Medicines works to help our medical teams give quality care to the people we treat through promoting the development of new vaccines, medicines and tests, and challenging existing barriers to treatment – such as cost – for patients in poorer countries.

To learn more about the Access Campaign’s activities, visit www.msfaccess.org or follow @MSF_access on Twitter.