Health ministers from most of the world gathered last weekend in Egypt to plan against bird ‘flu, with the UN saying the threat of a deadly global pandemic is as high as ever and a future vaccine as important as ever.
Science is usually the biggest hurdle in vaccine development but this time it’s politics, with samples being held hostage by Indonesia.
The 1918-1919 influenza pandemic killed more people than the First World War, between 20 and 40 million people around the world.
The World Bank estimates a new pandemic could kill up to 71 million people and cost US$3trillion. Researchers must therefore get hold of every weapon in the arsenal if they are to prevent it.
Indonesia is vital to this research. The World Health Organisation says at least 53 types of H5N1 bird ‘flu viruses have appeared in humans and chickens in the country, meaning that any global pandemic is most likely to start there.
Vaccine development companies are therefore keen to get their hands on samples of viruses, which are the key to a vaccine that could save millions of lives.
The Indonesian government knows this and can smell an opportunity. At negotiations at the World Health Organisation, health minister Siti Fadilah Supari insisted that, in return for sharing virus samples, foreign vaccine companies should subsidise manufacturing capacity in Indonesia; guarantee stockpiles for Indonesians; pay significant royalties to Indonesia and transfer to local Indonesian producers their cutting-edge technologies.
Although anti-corporate activists will applaud her demands, everyone else should be very scared. While Indonesia legitimately worries about the availability of vaccines in the event of a pandemic, the current generation of vaccines is unlikely to deal with a future virus that causes a pandemic. Stockpiling current vaccines would therefore be futile.
According to U.N. influenza coordinator David Nabarro, most of the focus has to date been on the H5N1 virus, but “any influenza virus could cause a pandemic.”
It is therefore vital that the private sector engages is as much research and development as possible before any outbreak.
Vaccine research is a risky business with an extremely high failure rate: even if a company does get access to the virus samples, it is unlikely anything marketable will emerge for ages.
For a drug to make it to market, drug approval bodies (such as the FDA in the US) require it to pass through at least four phases of trials. Less than one in a thousand molecules make it past the first, pre-clinical, stage.
The chances of a drug making it all the way to approval are less than 0.03%. It therefore costs on average $1 billion to bring a new vaccine to market, a huge amount for even the biggest company to risk.
Another issue in pandemic control is the need to produce huge quantities of vaccines rapidly. It takes several months to mass-produce seasonal ‘flu vaccines via the traditional, egg-based method.
This won’t be quick enough in times of emergency. Therefore millions need to be spent on researching new, speedier cell-based methods of vaccine production.
If the Indonesian government demands that the private sector hand over too much in the way of intellectual property and technology in return for samples of body fluid in which viruses reside, companies will be deterred from researching an avian ‘flu vaccine. And without a preventative vaccine, the chances increase of a 1918-style pandemic.
Indonesia may have already pushed too far on this: at the World Health Assembly in May, Member States of the World Health Organization rubber-stamped many Indonesian proposals relating to mandatory private-sector technology-transfer in return for virus sharing.
These kinds of provisions make it too risky for companies to invest in vaccine research so they render a vaccine less likely: while governments can be good at early stage research, the vast majority of medicines available today were developed by the private sector.
The WHO will discuss this again in Geneva in December. Indonesia’s health minister has already stated that her plan will win global support.
Kartono Mohamad, former head of Indonesia’s doctor’s association has said: “She’s not only gambling with the virus but the safety and security of the Indonesian people as well.”
This gamble could leave, Indonesia and vaccine companies with nothing. The losers will be the ordinary people of the world who will be left defenceless against an avian ‘flu pandemic.
Susan Crowley is a consultant on relations between the private sector and international organisations and has been a guest lecturer at the Yale School of Public Health.