VACCINE GLOBALIZATION
Better, cheaper vaccines could be on their way to poor countries, as vaccine makers in low-cost countries like India not only improve their own capabilities but license technology from the U.S. and other developed countries. The Scientist reports:
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, 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.