The ability of developing countries to combat a swine flu pandemic could be undermined by the fact that most major vaccine producers are based in developed countries — and likely to have commitments to meet the needs of the populations in those countries, a leading development organisation has warned.
Sangeeta Shashikant, a researcher at the Third World Network, points out that almost all of the world's vaccine production capacity is located in just nine developed countries and that the governments of these countries will have entered into advance purchase agreements with their vaccine producers, giving them priority in the event of a pandemic.
"If [developing countries] don't have capacity [to produce vaccines] then they'll have to rely on the goodwill of developed countries, as well as companies," Shashikant told SciDev.Net.
UN secretary general Ban Ki-moon said at a press conference this week (27 April) that developing countries are especially vulnerable to the swine flu outbreak and need protection against it. "They have been hit hard by other crises this year: food, energy, the global economy, climate change," he said. "We must ensure that they are not also hit disproportionately hard by a potential health crisis."
Strains of the swine flu virus taken from infected people are already being used in a handful of labs in developed countries to create a vaccine virus — a version of the virus that contains the correct antigens against the swine flu strain but is not dangerous to humans. The disabled virus will be sent to manufacturers to grow the vaccine in eggs.
But the process is time-consuming. Even if the WHO requests manufacturers to switch from seasonal to pandemic vaccine production — a step it has not yet taken — it could be up to six months before a vaccine is available.
Vaccine manufacturers have already been donating their H5N1 pandemic flu vaccines to a WHO stockpile. According to Tachi Yamada — executive director of the global health programme at the Bill and Melinda Gates Foundation — GlaxoSmithKline has donated 50 million doses and Sanofi 60 million doses, while Novartis has also indicated that it would take part in the scheme.
But Yamada told SciDev.Net that "this is a whole new ballgame" because H5N1 was not the main concern in the current pandemic.
"The vaccine manufacturers are all quite aware of their role and responsibilities in reacting to this kind of crisis, and they're all very interested in doing the right thing," he said. "They're just waiting for instructions on what to do."
The utmost importance
Ravini Thenabadu, a spokesperson for the WHO, told SciDev.Net that the organisation is currently in talks with vaccine manufacturers to assess their production capacity and the percentage of their vaccine output that could go to developing countries.
She described developing country access as being of "the utmost importance" to the WHO, and said that the organisation would fight to ensure that developing countries received sufficient supplies of the vaccine.
When a new virus emerges the WHO coordinates a set of procedures under which virus samples are sent to WHO collaborating centres, and may then be sent on to companies to make vaccines and drugs that the companies are permitted to patent.
In recent years, however, critics have claimed that this provides an unfair opportunity to such companies to profit financially from vaccine sales. Indonesia caused controversy in 2007 when it stopped sharing bird flu samples until a benefit-sharing mechanism had been set up (see Indonesia stops sharing bird flu samples).
Developing countries have already been in negotiations with the WHO about a benefit-sharing procedure to ensure that when a pandemic virus originates in a developing country, poorer countries are guaranteed access to any vaccine developed against the virus in question.
Suggested mechanisms include setting aside a percentage of the vaccine for developing countries to purchase at a reduced price, creating an emergency WHO stockpile of the vaccine and placing a portion of vaccine manufacturers' profits into a fund for developing countries.
Until a mechanism has been established poorer countries will be exposed to the danger of inadequate or unaffordable supplies of vaccine Flickr/sarihuella
Until a mechanism has been established poorer countries will be exposed to the danger of inadequate or unaffordable supplies of vaccine
But no mechanism has yet been agreed upon — leaving poorer countries exposed to the danger of inadequate or unaffordable supplies of vaccine, says Shashikant.
Nandula Raghuram, reader in biotechnology at the Indraprastha University in Delhi, points out that although the avian flu case offers a good example of international research collaboration, "that cooperation does not extend to a more liberal policy on sharing of drugs and vaccines that emerge from such research".
"The licenses for production and mass manufacture are given to companies which prefer to have exclusive manufacturing rights at such times," Raghuram told SciDev.Net.
Graham Dutfield, professor of international governance at the University of Leeds, United Kingdom, suggests that there is a need to plan for such situations in advance. "The private sector will almost certainly need to be involved but [the challenge is] how to reconcile the profit motivation of firms, and the likelihood of heavy patenting activity, with the need to get vaccines where they are most needed," he says.
To many observers, the debate over the need to secure access to vaccines in the case of a pandemic has highlighted the lack of research and vaccine production facilities in the developing world.
Raghuram, for example, points out that the uneven capacity for vaccine production between developed and developing countries is particularly noticeable in the case of newly-emerged infections, such as avian or swine flu.
"In such cases, research on new vaccines involves international collaborative efforts with the WHO, where often scientists from developing countries do not participate," he says.
Shashikant blames the lack of participation on the lack of research capacity in developing countries. "The aim should be to build [developing country] capacity for them to be able to … analyse the virus sample and give information," she says.
"Each region should have some capacity to produce drugs or vaccines when there is a situation such as this."