- Swine Flu Vaccine:What Is Fair?
Anovel strain of influenza A (H1N1)—so-called swine flu—spread through Mexico in April 2009, and by June 11th, the World Health Organization raised the alert level to a full-blown pandemic.1 The virus spread widely during the Southern hemisphere's regular flu season, with the Northern hemisphere bracing for its peak flu season. The United States continues to report the largest number of cases of any country worldwide.
The surprisingly rapid global transmission has focused political attention on developing an effective vaccine. Australia initiated the first vaccine trials in July, followed by Europe and the United States. Finding a medical solution to this threat is attractive but also raises questions of fundamental fairness.
In 2009 Congress authorized $7.65 billion in spending for the Department of Health and Human Services, the vast majority of which is for therapeutic interventions such as vaccine development and distribution and stock-piling of the antiviral Tamiflu. This funding, together with private spending and the more than $7 billion federal authorization for research and development on and medical interventions for influenza A (H5N1)—avian flu—amounts to a windfall for the pharmaceutical industry. Roche has reported that sales of Tamiflu have tripled, and GlaxoSmithKline predicts huge profits from a vaccine.2
Politicians on all sides of the spectrum support large expenditures, but it is not obvious that novel influenza should be such a high resource priority. Human-to-human transmission of H5N1 is rare, with only a small number of human cases and deaths worldwide.3 Although H1N1 is widespread, the first wave was not highly pathogenic; it caused far fewer deaths than seasonal influenza, which kills some thirty-six thousand Americans and up to five hundred thousand globally each year. And even the number of deaths pales in comparison to those caused by chronic diseases such as diabetes, coronary heart disease, and respiratory disease.4 But while government falls over itself to fund therapeutic interventions for exotic infections such as anthrax, SARS, and novel strains of influenza, it continues to chronically underfund more cost-effective public health services. Approximately 2 percent of total health expenditures goes to prevention and population-based services.
The political dilemma, of course, is that H1N1 could mutate—through re-assortment with H5N1, for example—rendering it much more lethal. We should recall that the first wave of the 1918 Spanish flu, which killed some fifty million people in a much less populated world, was relatively benign. It is that slight but serious potential that has the public and health officials concerned.
Research: Detecting Adverse Events
Clinical trials of swine flu vaccine have enrolled relatively few human subjects and are being conducted in a compressed time frame. In Australia and Europe, there are calls to truncate the research even further and to fast-track the vaccine. In the United States, initial trials are being conducted on healthy adult volunteers, including the elderly, followed by children as young as six months and pregnant women, who are at higher risk. The problems of obtaining informed consent among participants with limited capacity can probably be managed. More worrying is the inability of small trials to detect rare but serious adverse effects that cannot be fully understood until the vaccine is rolled out to a mass population. Although the first trials did not use adjuvants that stimulate the immune system, these may be necessary to stretch the vaccine supply, even though they cause more side effects.
For its part, the Food and Drug Administration will be under public and political pressure to quickly approve vaccines without large clinical trials for safety and effectiveness. Also, the FDA has never approved a human vaccine containing adjuvants, which could increase the complexity of its decision.5
When the vaccine is marketed, key issues involving liability protection for manufacturers and fair compensation for patients will become paramount. The industry will insist on protection, as well as economic incentives from government. And patient groups will call for inclusion in the no-fault vaccine compensation system.
Effective vaccines will almost certainly be scarce—the antigen yield for candidate vaccines may be much lower...