HEALTH: AIDS Vaccine Elusive – Even for Patents

By Gustavo Capdevila Reprint | | Print |

Gustavo Capdevila

GENEVA, Feb 8 2005 (IPS) - An AIDS vaccine will not be achieved until perhaps 10 years from now, but when that does happen, it will likely be made widely available around the world, without facing hurdles from the question of patent rights, according to WHO officials.

The director of the World Health Organisation (WHO) Initiative for Vaccine Research, Marie-Paule Kieny, said the search for a vaccine is still in the stage at which "we are testing concepts on what may or may not protect against HIV", the AIDS virus, which 39.4 million people were living with by late 2004.

This means the research will continue for "the medium term at least," she said. "We can only say that it is very unlikely that an HIV vaccine will be available in less than five years", but that it is "more plausible that something will be available" in around 10 years.

The results of clinical trials carried out in the United States and Thailand in 2003 and 2004 "were disappointing, and demonstrated that the population immunised was not protected against HIV," said Kieny.

Since then, a third large scale vaccine trial has been launched in Thailand, where some 16,000 volunteers are to be inoculated. Results from this new clinical trial are expected in 2007 or 2008, she added.

The WHO official also said a future HIV vaccine would likely be able to get around any restrictions created by the World Trade Organisation (WTO) intellectual property agreement.

"HIV is a question of emergency," stressed Kieny.

"It is absolutely true that most of the vaccines being tested currently are associated with patent protection or at least with patent applications, but we have little doubt that when a product has been proven to be effective, the global community will come together and make sure that these patent rights do not provide hurdles for the vaccine to become available to the affected population."

She pointed to the case of antiretroviral medicines, which curb the spread of HIV in the body.

After an international campaign by developing countries led by South Africa, India and Brazil, and leading human rights organisations, the 2001 WTO ministerial conference in Doha, Qatar agreed that poor countries should have access to low-cost drugs for fighting epidemics like AIDS, malaria and tuberculosis.

The "Doha Declaration" stated that the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement "does not and should not prevent (WTO) members from taking measures to protect public health", and reaffirmed the right of member nations to issue compulsory licences to generic drug manufacturers to produce affordable drugs, and to make use of parallel importing.

As Kieny pointed out, the question of access to antiretroviral drugs took time, but was finally resolved, and "we have no reason to think that this will not be the case for the (HIV) vaccine."

Moreover, unlike the drugs used to treat people living with HIV, the search for vaccines "is heavily subsidised by public sector money. So the public sector will certainly make sure that the product will become available for the targeted populations," she added.

Efforts to come up with an HIV vaccine began in 1987, when the first clinical trials using human subjects were carried out in the United States. Since then, more than 70 phase I vaccine trials have taken place in a number of countries around the world.

The most recent was announced Monday in New Delhi, where India has begun its first human trials of an HIV vaccine, involving a group of 30 healthy male and female volunteers between the ages of 18 and 45.

The vaccine is based on the sub-type of HIV that is prevalent in India, Saladin Osmanov, acting coordinator of the WHO-UNAIDS HIV Vaccine Initiative, explained in Geneva.

He said the announcement by India is a "positive sign…since we don’t know what vaccine approach would be most effective, and the multiple vaccine candidates would need to be tested in the populations where the vaccines would eventually be used."

"That’s why trials must be conducted in different parts of the world".

Osmanov added that it is especially important that such research is being carried out in India, a country of 1.1 billion, which has a large population at risk of contracting HIV, who would benefit from success in developing a vaccine.

He underscored that the process of developing a vaccine is extremely costly, requiring hundreds of millions of dollars, from the basic research through preclinical research to clinical trials.

Many aspects of the global effort to come up with an HIV vaccine were discussed by experts from industrialised and developing countries in a meeting last week in the Swiss city of Montreux.

Participants in the conference agreed that it is important to boost clinical trial capacity worldwide, and for trials to be conducted at multiple sites around the world, against different HIV strains that have different transmission patterns.

They also recommended that WHO and UNAIDS (joint UN Programme on HIV/AIDS) promote the inclusion of women and teenagers in clinical trials of HIV vaccines.