THE surprisingly rapid global transmission of the so-called swine flu has captured the attention of the Rudd government and his counterparts in North America and Europe, sparking a worldwide race to develop an effective vaccine. Two Australian biotechnology companies, Adelaide-based Vaxine and Melbourne-based CSL Biotherapies, initiated the first vaccine trials in late July, followed by Europe and the US.
Finding a technological solution to swine flu _ technically, Influenza (A) H1N1 (swine flu) _ will be a key scientific advance, but vital questions of scarcity, fairness and safety loom large. The swine flu vaccine will almost certainly be scarce, with manufacturers unable to meet the huge global demand.
The industry is struggling to produce good vaccine yields with the H1N1 seed virus. At the same time, the vaccine may not be fully effective against the present strain of the virus or, worse, the virus may mutate, rendering the vaccine ineffective. The vaccine, moreover, will probably require two doses, further reducing supplies.
The World Health Organisation recommends the use of adjuvants, a substance added to a vaccine to improve the immune response so that less vaccine is needed.
Yet the US may not follow WHO guidelines, thereby depleting an already short vaccine supply. The US Food and Drug Administration has never approved a human vaccine containing adjuvants, and clinical trials in the US do not include adjuvants.
Governments face hard choices on how to ethically ration a scarce lifesaving resource such as a flu vaccine, particularly if the virus becomes more lethal: Who shall live when not all can live? In Australia and most developed countries, children and the elderly have had priority for seasonal influenza vaccines. Children and their careers should certainly be a high priority for swine flu vaccine because they rapidly spread the infection in day care and school. Yet privileging the elderly would be a mistake because they have contracted the new strain at the lowest rate and appear to have some immunity because of exposure to distantly related flu strains that circulated decades ago.
Instead, government should assign top priority to the most vulnerable who have died at a disproportionate rate from swine flu: those who have poor health such as heart disease, asthma or diabetes. This is also the fairest way to allocate scarce vaccines because people with multiple health conditions also tend to be the most disadvantaged in society, such as the Aboriginal community and other minorities. Healthcare and emergency workers also deserve priority because they provide essential services in the face of an epidemic.
It is vital that government makes allocation decisions fairly and transparently. The public has a right to know which groups will have priority access and why.
One key problem, however, is that the private market is still likely to privilege the rich and politically connected in gaining access. Business culture is geared towards satisfying consumer demand, so the industry will charge what the market will bear for a scarce, valuable vaccine.
Rich countries will face scarcity, but they will have much more ample supplies than poor countries. The pressure on governments to protect their citizens will be intense during a pandemic. The vaccine industry is likely to supply markets that can afford to pay and in countries where they are located. More than 90 per cent of the world's capacity to manufacture influenza vaccines is concentrated in Europe and North America.
Australia will also be well off because of its economic resources, small population and the fact key vaccine producers are based here. As the rich stockpile vaccines, poor countries in Africa, Asia and Latin America are left much more vulnerable.
Australia, Europe and the US are spending a fortune on vaccines and antiviral medication for influenza, but virtually none of these resources will benefit poor countries. Serious questions of global social justice arise when wealth, rather than need, becomes the primary allocation criterion. The mal-distribution of vaccines in the face of a global financial crisis will only widen the already yawning health gaps between the rich and the poor. Rich countries hoarding vaccines is also is a bad public health strategy because it allows the virus to circulate unchecked in highly populated developing countries.
Safety, of course, is just as important as equitable access. There is intense political and market pressure to move quickly on vaccine development. Many national regulatory agencies have set up fast-track approval processes, and the vaccine industry is pushing hard to finish clinical trials and gain government approval. The politics of swine flu is pushing toward mass public vaccinations in September and October, the beginning of the flu season in the northern hemisphere.
Dose-sparing strategies to avoid depletion of an already short vaccine supply will increase risks. Studies show that vaccines containing adjuvants cause more adverse effects. More worrying, because the clinical trials are so small, is that adverse effects will not be detected until the vaccine has already been used on a large population. It's essential to conduct rigorous post-marketing surveillance to pick up rare, but serious, effects.
Hefty public and private spending on influenza treatments will result in a windfall for the pharmaceutical industry, with Roche reporting that sales of Tamiflu (an antiviral medication that ameliorates flu symptoms) have tripled. GlaxoSmithKline is predicting huge profits from a vaccine. At the same time, the industry is seeking liability protection in the event that the vaccine causes unintended harm to health. Patients groups, too, will want to be sure to be compensated for any ill-effects from vaccinations.
Reminiscent of the present situation, the media fanned emotions about a catastrophic swine flu epidemic in 1976 that never emerged. Pharmaceutical companies lobbied governments hard _ and successfully _ for resources and liability protection. In the US, Gerald Ford advocated a mass immunisation campaign. Unfortunately, the vaccine caused several cases of a serious paralysis called Guillain-Barre syndrome, which was politically disastrous for the president. The 1976 swine flu affair is instructive and suggests caution in rushing to vaccinate the public without proper clinical trials.
The Rudd government needs to assess carefully the risks and benefits of rapid approval and roll-out of a vaccine. Thus far swine flu has been mild, with most patients making a full recovery. The fear, of course, is that H1N1 will mutate, becoming much more lethal. This was what happened with the second wave of the 1918 Spanish flu, which killed more than 50 million people in a much less populated world. It is a remote possibility, but one that demands watchfulness.
The most prudent course today would be to conduct careful clinical trials with due scientific deliberation; use the vaccine on high-risk groups, phasing in the full population only as evidence of safety and effectiveness becomes clearer; and conducting post-market surveillance for adverse effects.
And even if it's not politically expedient, justice requires that scarce and safe vaccines go to the most disadvantaged in Australia and worldwide. Equitable access to a vaccine against swine influenza is not merely a moral imperative. It is also critically necessary for the success of any pandemic strategy to safeguard global health.
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