Tinkering, not marking the great leap
Research on some diseases is taking off in a big way. These diseases have been out of the ambit of routine immunisation programmes, because they have traditionally been concentrated in developing countries. Now that they are increasingly being transmitted to the developed world because of increased and easier contact, research is concentrating on them. But new research is tinkering with existing vaccines rather than focussing on radical, cutting-edge solutions. One significant feature of the research scenario is that the majority of the funding is coming from the Bill and Melinda Gates Foundation.
Current levels of funding, though massive, still fall almost halfway short of the us $1.2 billion that is estimated to be necessary to develop an effective vaccine. The Gates foundation, which is heavily involved in funding the development of a hiv/aids vaccine through the Global hiv Vaccine Enterprise, has set up has made numerous contributions to research on a hiv/aids vaccine. One of the most significant was a us $100 million grant to iavi in 2001.
New vaccines are being developed through the Rotavirus Vaccine Program (rvp), initiated in 2003 by path, an ngo that is a gavi member. rvp received an initial us $30 million from the Vaccine Fund. It will use this money to promote new vaccines that are being developed. At present there are a total of eight candidates in various stages of development. Rotarix will be marketed by gsk, and is likely to be ready for routine immunisation in Asia and Africa by 2009. Though not against Rotarix, who had informal consultation in February 2005 on quality, safety and efficacy specifications for rotavirus vaccines. Experts then agreed safety data on the vaccine was insufficient.
There are suggestions that trials are being carried out in developing countries to test safety standards before the new drugs are marketed in the us.
Worldwide, 250 million people are at risk of contracting the disease. In sub-Saharan Africa, a vaccine developed in the West is used as an emergency measure, but it doesn't protect young children. It also gives immunity for only three to five years. A new vaccine is being developed through a collaboration of three groups: the SynCo Bio Partners B V in Amsterdam, sii and the Centre for Biologics Evaluation and Research of the us Food and Drugs Administration (fda), which is providing the technology. fda has transferred the technology to sii, which will manufacture the vaccine . At a target price of us $0.40 per dose, it will cost us $100 million to cover a population of 250 million people over 10 years. This translates into raising about us $10-12 million annually.
Trials for one, developed by Merck, are being carried out on 20,000 women. The results are awaited. The other vaccine is being tested by gsk -- trials began in 2004. The vaccines are against type 16 and 18 hpv, which account for 70 per cent of cervical cancer cases. The duration of immunity is not known. The new vaccines would have to be given to adolescent girls, unlike traditional vaccines which are given to infants and pregnant women. who received a us $7-million grant from the Gates foundation in June 2005 to promote the development of these vaccines.
gavi is now funding a project to develop a variant of the existing vaccine for children below the age of two, to the tune of us $30 million. The research project, a public-private partnership, is being conducted by a team called Pneumo adip, which is based in the Bloomberg School of Public Health at Johns Hopkins University, usa. The vaccine industry, which is involved in the project, has already developed some new vaccines that are effective against some of the strains m ost common in developing countries. These vaccines are now being evaluated in large-scale field trials in Africa, Asia and Latin America.
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