But if it hadn’t been for an experimental partnership between the World Health Organization and the not-for-profit health organisation, PATH – working without the involvement of multinational pharmaceutical companies – the vaccine might never even have been developed.
Outbreak season in the so-called meningitis belt across the Sahel starts annually in late December. Every 10 or 15 years, conditions come together to set off a major epidemic. In 1996-7, there were more than 250,000 reported cases; more than 25,000 people died, and many more were left with permanent disabilities.
After that epidemic, African governments came together and demanded that something be done. More specifically they wanted an effective, affordable vaccine that could be rolled out across the region.
The problem: there wasn’t one. The only vaccines available were tailored to the strains common in Europe and North America, not to Meningitis A, which caused the epidemics in West Africa. They were also far too expensive for a mass campaign in the region. As ever, the problem was money. Meningitis A affected poor people in the poorest regions of some of the poorest countries in the world.
For global health specialists, this is a sadly familiar
problem. Mogha Kamal-Yanni, senior health advisor at Oxfam, says the situation
is typical. “Clearly the current model of research and development is not
working,” she told IRIN. “It's a broken model, failing public health. It's not
producing what we need, or else it's unaffordable.”
The unwillingness of pharmaceutical companies to invest
in a disease that affects the poor has been widely blamed for the lack of a
vaccine against Ebola, which seriously hampered the response to the recent
outbreak in West Africa.
But this time, in response to the appeal from African
governments, the WHO and PATH set up the Meningitis Vaccine Project with the
objective of getting a vaccine approved and into production. With $70 million
from the Bill and Melinda Gates Foundation to oil the wheels, they began by
approaching the big pharmaceutical companies. “That was the accepted approach
at that time,” says the project manager, Kathleen Tiffay. “And that was what
Negotiations, however, soon stalled. Two big companies
were interested, but finally, after 18 months of negotiations, they said they
couldn't bring the price down below $2 a dose; the project's target was 'under
50 cents'. Discussions with another company, which owned technology needed to
produce the vaccine, also collapsed, again over pricing. “There was just too
big a gap,” says Tiffay.
That – she told IRIN – was the low point. “We had hoped
we could have it set up and ready to go in a year or a year and half.
Everything was taking much longer than our estimates.” Finally, those behind
the Meningitis Vaccine Project decided to go ahead and do it themselves. “And
to be realistic,” says Tiffay, “we weren't any slower than Big Pharma; in fact
we were probably faster.”
They describe what they did as setting up a kind of virtual pharmaceutical company. While the big established companies could have done everything in-house, they had to put together a series of partnerships – to supply the ingredients, license the technology, do the clinical trials and get all necessary approvals, and to manufacture the vaccine. Some partners, like the manufacturer, the Serum Institute of India Ltd (SIIL), were commercial companies. Others were public bodies. The US Food and Drug Administration licensed a conjugation method at negligible cost and supported transfer of the technology to the Indian company. Britain's National Institute for Biological Standards and Control worked on the licensing. The clinical trials were done with national partners at eight study sites across Africa and India.
Photo: Control of epidemic meningococcal disease, WHO practical guidelines, World Health Organization, 1998
The African meningitis belt runs across the continent.
The final product, MenAfriVac, has proved effective, safe even for infants, thermostable without refrigeration, and is now being produced in India for just 40c a dose. Although, in the end, the big multinational drug companies weren't involved in producing the vaccine, they didn't try to stop it, and the big companies that make up part of the board of the Vaccine Alliance, GAVI, supported the use of GAVI funds to pay for the mass vaccination programme.
Another similar and even more ambitious project is in the
pipeline, again led by PATH and the WHO, using the same Indian manufacturer.
The plan is to produce a vaccine that will protect against five different
strains of meningitis – A, C, Y, W and X. This time the funder is the British
international development agency, DFID. Its Research for Development arm has
allocated more than 5.5 million US dollars to develop a vaccine against
multiple strains of meningitis and take it as far as Phase I trials. Clinical
trials will start in January.
Marie-Pierre Preziosi of the WHO, one of the directors of
the vaccine project told IRIN: “The initial phases were challenging because the
landscape was complicated by there being a lot of existing patents. We needed
to find unpatented technology for all the different strains.
“But in the end, if the clinical trials are successful,
the product will be very affordable and there will be a high demand from affected
So is this the way forward?
Not so fast, says Tiffay. “The whole way that vaccines
and drugs are being currently produced is very dynamic. It's evolved a lot
since we began the Meningitis Project and started transferring technology and
working with developing countries. But the next time would be different,
because the whole field has changed, and each disease and each vaccine is
Preziozi also says one size won't fit all. “In this
case,” she says, “there was a clear call from WHO member states, and an
identifiable solution existed, but no product was available. But if you want to
go with different types of vaccine where the technology is not available, then
you might need to go with a different approach.”
So can you do without the big companies? “No, no, no.
Always there will be a need for Big Pharma to be there,” she says. “Because
research and development is very costly.”
Oxfam's Kamal-Yanni agrees. She says multiple models are
needed, and where there is substantial research and development work to be
done, the big drug companies will be essential. “The key thing we need to do is
to delink the cost of R&D from the cost of the resulting product. So then
the issue becomes how to finance the R&D, and that could be by up-front
grants, for instance, or by research prizes awarded for progress at each stage
(Further reading on the Meningitis Vaccine Project)
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