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The Serum Institute of India (SII) this week signed an agreement with the international Meningitis Vaccine Project (MVP) to develop a new conjugate meningitis A vaccine at a cost of 40 cents per dose for the African meningitis belt, which stretches from Ethiopia to Senegal.
Existing polysaccharide vaccines cannot be used in children younger than 2 and do not produce long-lasting protection. The MVP, run by the World Health Organization (WHO) and the international charity PATH, hopes that the new conjugate vaccine will overcome these problems.
"We won't have to vaccinate every 3 to 5 years, and we'll create herd immunity—and that's a major thing," said William Perea, WHO's coordinator of responses to disease outbreaks.
To create the vaccine, SII—which already claims to supply 75% of the measles vaccine needed worldwide by the United Nations Children's Fund—has applied a new US technology to conjugate a tetanus toxoid with a meningitis A polysaccharide from a Dutch company, SynCo BioPartners.
US Food and Drug Administration scientist Carl Frasch, who created the high-efficiency conjugation technology using hydrazine along with Che-Hung Lee, told The Scientist, "The agreement represents a new paradigm for vaccine or drug development-a consortium so the raw materials come from one place, the technology from another, and the manufacturing facility from another."
"Concerned scientists are very interested in trying to make vaccines—that are largely first-world products—more widely available," said Frasch.
The US National Institutes of Health negotiated the license agreement with SII. Suresh Jadhav, the Indian firm's executive director for regulatory affairs, told The Scientist they would pay $2.4 million over 10 years, or around 1 cent a dose, for the technology.
The vaccine could not be created entirely off the shelf, and so represents a tentative new step in R&D for developing country vaccine companies. "When we stepped up from pilot to production scale," said Jadhav, "we had to make a lot of changes."
There's also a good prospect that companies like SII will expand their R&D capacity substantially in the future, to allow cheaper creation of more new drugs and vaccines for poor countries, said Jadhav, who is also president of the Developing Countries Vaccine Manufacturers' Network.
"More than three or four could do it. For example BioFarma in Indonesia, Bio-Manguinhos in Rio, Instituto Butantan in Sao Paolo, and CIGB in Cuba," said Jadhav.
According to Frasch, this will also "give the opportunity for academic scientists to see a way to get their technologies out [to poor countries]… otherwise 'Big Pharma' is sort of a gatekeeper."
Marc LaForce, director of the MVP, told The Scientist he sensed things were changing for vaccine development in poorer countries. "Just look at Bio-Manguinhos," he said. "They are developing a B conjugate C meningococcal vaccine in Rio, and if you'd have thought that was likely 5 or 10 years ago, people would have said you're crazy."
Jadhav told The Scientist he thought companies like his could one day cut the cost of creating a new pharmaceutical "by a factor of 10." In developing countries, researchers have lower wages and companies do not have the need for such big profits as major pharmaceutical firms, he said.
However, Rino Rappuoli, head of vaccines research at biotech firm Chiron, is less hopeful. "I'm very happy that finally they got the meningitis vaccine program going—it's an extremely important project," he told The Scientist. But he criticized the program for focusing too much on cost.
Chiron, Aventis, and other firms have conjugate meningitis vaccines in later stages of development, Rappuoli said. For humanitarian reasons, they were prepared to sell such vaccines for around $2 a dose, a figure he considered not much different to SII's 40 cents. The MVP should have focused on raising money rather than making new products, said Rappuoli.
However, according to WHO's William Perea, cost was "a big issue." The existing GlaxoSmithKline polyvalent (multistrain) polysaccharide cost $1, "and we had a hell of a hard time raising money for that this year," he told The Scientist. At $2, a vaccine would "just not be affordable in Africa."
Clarification (posted July 1, 2004): When originally posted, this article omitted the co-inventor of the high-efficiency conjugation methodology, Che-Hung Lee. The Scientist regrets the omission.
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