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WEST AFRICA: New Vaccine For Mass Campaign Against Meningitis

Brahima Ouédraogo and Terna Gyuse

OUAGADOUGOU and CAPE TOWN, Dec 8 2010 (IPS) - More than 20 million people will be vaccinated between now and the end of the year in Burkina Faso, Mali and Niger as a mass vaccination campaign using a new conjugate vaccine unfolds across West Africa. Manufactured in India, MenAfriVac offers health authorities a powerful weapon against a deadly disease.

Meningitis is an infection of the membrane that surrounds the brain and spinal column. It is most prevalent in a region known as “the meningitis belt”, which extends across sub-Saharan Africa from Senegal in the west to Ethiopia in the east.

Between 1995 and 1997, a severe meningitis epidemic infected 250,000 people in this region, killing 25,000. Five to ten percent of patients who catch the disease die within 24-48 hours after symptoms appear; 10 to 20 percent suffer serious neurological damage, including loss of hearing and learning difficulties.

According to the World Health Organization,14 African countries put in place stronger surveillance in 2009 which recorded a total of 78,416 suspected cases of meningitis, and 4,053 deaths – the highest number since the 1996 epidemic.

Mali, Niger and Burkina Faso are at the heart of the affected region, and all three countries are involved in the latest phase of the introduction of the new vaccine. Where the previous vaccine offered immunity for just three years, the MenAfriVac protects for ten years and can be given to people aged from one to 29 years of age.

Challenges to vaccine access

New vaccines are often prohibitively expensive, restricting their use in developing countries. There is also little incentive for pharmaceutical companies to research and develop drugs for diseases that are prevalent only in poor countries, meaning some diseases - malaria remains a stand-out example - still do not have vaccines.

More pharmaceutical producers based in the South have entered the market, but the most costly vaccines are still produced by a small number of powerful multinational companies: GSK, Merck, Novartis, Sanofi-Pasteur and Wyeth/Pfizer dominate.

There is some willingness by these five to provide vaccines at subsidised prices to the poorest countries, but the costs are still high; worse, middle-income countries do not qualify for the lower prices, and are unable to make the vaccines widely available.

The new producers in the South - include a mixture of private firms like India's Serum Institute, and state-owned company's like Indonesia's Biofarma and Brazil's BioManguinhos - could offer competition that would sharply reduce prices. But they will have to overcome obstacles of intellectual property, technological capacity to produce complex new vaccines, and stringent regulation.

“It’s a great victory to be to be able to launch this test. We are in the meningitis belt and this campaign will allow us to master meningitis epidemics which contribute enormously to [the deaths] of children under five as well as older ones,” said Hervé Periès, the representative of the United Nations Children’s Fund in Burkina Faso.

It’s a victory that has harnessed the capability of Indian pharmaceutical companies to produce advanced drugs at an affordable price.

According to Dr Prasad Kulkarni of the Serum Intitute of India Ltd, which manufactures MenAfriVac, the company was approached by the Meningitis Vaccine Project (MVP) in 2002 about developing a vaccine against group A meningitis for sub-Saharan Africa.

Kulkarni says several multinational pharmaceutical companies had already declined an invitation from the MVP, a partnership between WHO and the non-profit organisation PATH (Program for Appropriate Technology in Health), because with group A meningococcus essentially non-existent in industrialised countries, the cost of devoting resources to this project rather than something more lucrative was deemed to high.

“Serum Institute’s company policy is dedicated to making affordable vaccines available to the children of the world,” says Kulkarni. “Therefore developing a meningococcal conjugate vaccine fit into our business strategy and philanthropic philosophy, and we told MVP that we could manufacture the vaccine in volume at a cost that would not exceed US $0.50 per dose.”

The vaccine is produced at SIIL using technology developed at the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER). SIIL scaled up the process for commercial manufacturing.

“Transferring the conjugation technology from CBER to SIIL was probably the greatest challenge, but acquiring this know-how gave SIIL the opportunity to add a better product and replace a polysaccharide vaccine that does not work very well,” Kulkarni told IPS.

Dr Marie-Pierre Preziosi, who works with WHO’s Product Development and Research Team of the Immunization, Vaccines and Biologicals Department says MenAfriVac has many advantages over the previous vaccine, beginning with the longer protection it confers.

“It [also] confers “memory”, that is, if a person is immunised and meets with the bacteria or the agent of the disease again later on, the body will remember and will react better. And it works in younger children. All in all it’s a very good tool for prevention that we have in hand.”

The vaccine was approved by the Drugs Controller General of India in December 2009 – and MenAfriVac is a useful addition to India’s drug arsenal as well, as there have been outbreaks of group A meningitis in South Asia in the past 30 years. The vaccine was pre-qualified by the World Health Organization in June 2010.

“Transferring the technological expertise to make a conjugate vaccine to SIIL considerably reduced the production cost of the vaccine, and the model allowed for the opportunity to design a vaccine-based strategy [in line with] the actual vaccination needs in Africa,” Kulkarni says.

SIIL is now producing a meningococcal vaccine that will be used in 25 countries in Africa where 450 million people are at risk for meningitis.

SIIL will provide 25 million doses of MenAfriVac over the next ten years. According to the MVP, each dose will cost around 40 cents, compared to $10-20 cost of the vaccine elsewhere in the world or $100 for a tetravalent vaccine in the U.S.

Burkina Faso alone needs 14 million dollars to immunise the part of its population that is most at risk. In December, 70 percent of the 15 million Burkinabés will be vaccinated, covering the reservoir population for the disease. The country’s health minister explains that the remaining 30 percent of the population should then enjoy de facto protection.

According to WHO, 500 million dollars will be needed to vaccinate the at-risk population under 29 years of age across sub-Saharan Africa; the agency is working to mobilise this money from donor countries and institutions.

 
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