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Medical need, not purchase power, should determine the global response to the Influenza A (H1N1) pandemic

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Faced with this vaccine shortage, the WHO is advising poor countries to vaccinate health workers first, while wealthy countries are also focusing on vaccinating wider vulnerable groups. This approach is not only inequitable, it is medically unsound when taking into account the global scarcity of the vaccine.

In this interview, Dr. Fournier describes why a global response to the H1N1 pandemic must, in the short term, focus not only on vaccination, but on reducing mortality worldwide by emphasizing the identification and treatment of the most severe cases; and argues why access to the vaccine in the future must be based on medical need, not purchasing power of wealthy countries.

Is Influenza A (H1N1) affecting people in the developing countries where Médecins Sans Frontières (MSF) is working?

In Africa, a dozen countries - from South Africa and Sudan to the Ivory Coast and Ethiopia - have reported confirmed H1N1 cases. Some African countries have not declared any cases, but this must be considered cautiously as laboratory test confirmation is not available in many countries. In other countries where MSF is working in South America and Asia, cases have been declared almost everywhere, including in Sri Lanka, Myanmar and Afghanistan.

MSF teams have not yet confirmed cases in our programs nor have we seen a rise in respiratory infections that could indicate undetected cases. Overall, the number of cases declared by African countries is still low for the time being. It is difficult to predict when the outbreak will spread further, but we need to be mobilized and ready.

What is the potential for a massive impact of the disease in poor countries?

First of all, we have to recognize that there remain many uncertainties about this pandemic. We have to be cautious in predicting what might happen, but as medical professionals, we must also be vigilant in preparing for possible scenarios. This is a new virus against which humans, especially the young, appear to have no immunity. So the number of people who will be contaminated is likely to be very high. Some epidemiologists are predicting that as much as 30 percent of the population worldwide could become infected, with a death rate of as high as 0.5 percent. Although this flu is relatively mild at this point, it is difficult to determine how lethal it is because the number of cases is probably being underestimated. But even if we conservatively assume a death rate that does not exceed 0.1 percent of those affected, it will likely lead to significant numbers of deaths if severe cases are not identified and treated. High risk populations such as young children, pregnant women, and those with underlying chronic illnesses and compromised immune systems will be the most affected.

What should be the priority in responding to the pandemic in poor countries - vaccination or treatment?

Medically the only appropriate way to respond to a pandemic is on a global scale. Those most at risk of dying from the disease should be the highest priority for vaccination and treatment - no matter where they live. Based on our experience, the appropriate strategy in an epidemic is two-fold: first, strengthen hygiene and infection control measures to prevent the virus from spreading, and, second, treat patients to limit the number of deaths. However, in the case of this virus, which is transmitted extremely quickly and easily, the effectiveness of isolating infected patients is no longer an option. The most affected countries - such as the United States and the United Kingdom - quickly abandoned such a strategy.

Vaccinating is also one way to halt the spread of the virus. But in this case we must question the impact of a vaccination campaign on the epidemiological curve once the epidemic is already advanced. The virus continues spreading quickly and, possibly, kills patients even in the midst of efforts to reach the most at risk and organize mass vaccination campaigns.

In the case of H1N1, the vaccine is not ready yet. It is currently in the clinical development phase and will not be available for mass production until September. It is therefore quite likely that the vaccine won’t be ready to help seriously tackle the first wave of the epidemic. If we want to reduce the mortality that will be caused by the H1N1 pandemic, we cannot rely on the vaccine. We must focus on identifying and treating the most severe cases. If we want to treat the severe cases most at risk of death - in particular those with bacterial acute respiratory secondary infections - standard antibiotic and, when possible, oxygen will have to be available in great quantities everywhere. Given the rapid spread of the pandemic and the many unknowns, doctors must be prepared for a massive influx of patients. The lack of health care workers, medicine and supplies in many countries where we work is a legitimate cause for grave concern. Preparedness for people who become seriously ill should be a top priority.

Are you saying we will not be able to rely on vaccines to help tackle the epidemic in the coming months?

The answer is quite simple: There will not be enough vaccine to meet the needs in poor countries in the coming months. That is why our focus now should be on identification and treatment of the sickest cases, not on waiting for the vaccine. Even if all companies that are currently able to produce this vaccine assigned their full production capacity to the task, they would still not be able to produce enough vaccine for people in resource poor settings. And wealthy countries in North America, Europe and elsewhere have already ensured that they will have access to at least 90 percent of the vaccine production for this year by making pre-purchase deals with the main producers. We are seeing that purchase power - not medical need - is driving rich countries to monopolize access to the vaccine before it has even been produced. The vaccine will clearly not be the solution to reducing deaths from this pandemic in the short term. Instead, we need to step up global efforts on case recognition and treatment.

What is being done to secure wider access to the vaccine for the future?

Two years ago, the WHO called for global solidarity regarding flu response, but the process largely failed as it was impossible to get consensus on a global flu preparedness plan. Instead, developed countries have taken a unilateral rather than a global approach. In the face of a global pandemic, this is unacceptable. Now the WHO is scrambling to secure a meager part of the vaccine production for poor countries. WHO Director General Margaret Chan has so far managed to negotiate a donation of 10 percent of the production of the vaccine by GlaxoSmithKline and Sanofi-Aventis to be allocated to the developing world, out of which the first 50 and 100 million respectively will be a donation to WHO (Novartis has refused). But this is far from enough of what is needed and there is no clarity on how these donations will be distributed or whether the prices charged for any remainder will be affordable to those in need.

The first 150 million doses of the vaccine that have been donated will only be ready in six months. So again it is questionable that this vaccine will have a significant effect on the epidemic before the end of the year and given this delay, vaccination is not an immediate strategy. Faced with this vaccine shortage, the WHO is advising poor countries to vaccinate health workers first, while wealthy countries are also focusing on vaccinating wider vulnerable groups. This approach is not only inequitable, it is medically unsound when taking into account the global scarcity of the vaccine. The strategy should be to use the vaccine we do have available to vaccinate the most vulnerable worldwide versus seeing what “spare capacity” is leftover once the wealthy countries have used what they want.

World leaders and the WHO have a responsibility to avoid a two-tiered response to the pandemic. Rich countries, the pharmaceutical companies and the WHO must work to facilitate access to the vaccine based on medical need, not purchasing power. More must also be done to increase vaccine production for the future. Vaccine makers in India and elsewhere are working on vaccines, but could use some technical assistance to speed up the process. WHO needs to increase support to those companies in developing countries ready to produce the vaccine including reviewing and proposing ways to remove any intellectual property or technological know-how barriers to production. Developed countries must support this process, rather than block attempts to remove such barriers as they have in the past.

But again, I stress that with the current vaccine capacity, our efforts should be on identifying and treating those who fall seriously ill from the virus. The vaccine will not be the solution in the short term, nevertheless the potential scope of this pandemic requires us to act now for both the short and long term.

Given these uncertainties and limitations, what are MSF's priorities?

Based on assessments from the field, our objective is to provide as much support as possible to existing medical teams, particularly where the health system is weak and fragile, to help them deal with any possible influx of patients, set up treatment management systems that we have already planned and ensure that patients suffering from other illnesses are not forgotten. We are giving priority in emergency preparedness in order to be able to support the early detection and treatment of severe cases. We expect to concentrate on vulnerable populations that may be seriously affected, particularly infants, pregnant women, and patients with underlying chronic illnesses or who are immuno-suppressed.

Our priority is to provide high-quality care to our patients by treating symptoms and prescribing antibiotics. Antivirals like oseltamivir, marketed as Tamiflu but also produced as generics and prequalified by WHO, have limited effectiveness unless administered within 48 hours of the illness appearing. We will therefore make limited use of them, particularly as the patients we see in our programs often wait a long time before seeking treatment.

Finally, even beyond the destitute circumstances people face in the contexts where we work, we must remain vigilant and responsive when facing such an extensive pandemic. Given its twists and turns, and its severity even in the best-prepared and wealthiest countries, we cannot possibly state that the provisions taken today will be effective tomorrow.