Off Beat

  • 30/01/2006

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.

HIV/AIDS More than 40 preventive vaccines for HIV/AIDS are being tested around the world. Aventis, Merck, Chiron and GlaxoSmithKline GSK are some of the companies in the forefront of research. But two phase-III trials carried out in Thailand and the US have not demonstrated any significant level of efficacy. Though VaxGen's AIDSVAX was shown to be ineffective in North America, Europe and Thailand, it was combined with another failed vaccine, Aventis Pasteur's ALVAC-HIV, and further trials were carried out in Thailand in 2004. International AIDS Vaccine Initiative (IAVI) estimates total annual spending on AIDS vaccine research at US $682 million.

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.

Rotavirus Rotavirus kills about 500,000 children annually. Around 80 per cent of cases occur in the developing world, though the disease, a severe form of diarrhoea, is fairly common even in developed countries. In the us, 50,000 children are hospitalised each year for rotavirus. To protect them, the us Food and Drug Administration (fda) had licensed RotaShield, a rhesus-based recombinant vaccine, in August 1998. The drug was, however, removed from the market when post-marketing surveillance showed there were increasing reports that it caused fatal intestinal damage, after about 1.8 million doses of vaccine had already been sold.

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.

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.

Meningitis project Meningitis a causes major epidemics in sub-Saharan Africa, with a fatality rate of about 10 per cent. In 2001, the Gates foundation gave who and path us $70 million over 10 years for the Meningitis Vaccine Project (mvp), to eliminate the disease, an infection of the fluid around the brain and spinal cord caused by the bacterial group called meningococci.

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.

Malaria Developing a malaria vaccine is difficult because the malaria parasite goes through several stages, even while inside the human host. Protection at each stage requires a different response, which a single vaccine might not be able to provide. As of now, there are 10 vaccine development projects. Two of these are conducting clinical trials in Africa. Nine projects target P falciparum , the most deadly form of malaria, while one focusses on P. vivax , the most widespread form. But a report by Malaria R&D Alliance, an international coalition of malaria research groups, found that annual spending on malaria research totalled us $323 million in 2004

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