Vaccine-making resources in the United States are stretched alarmingly thin. There are only three manufacturers responsible for making more than 80 million doses of the human flu vaccine each year, with no guarantee that the entire supply will be sold or adequately distributed. In 2004 the entire 50 million-dose batch made by Chiron (a US company whose manufacturing plant is in Britain) had to be discarded because it was found to be contaminated with a common bacteria known as serratia.
As recently as the 1970s, there were thirty-seven vaccine makers in the United States. But because of the narrow profit margin and fear of litigation, many manufacturers left the game. Tommy Thompson, when he was Secretary of the US Department of Health and Human Services, attempted to corral funding to upgrade the country’s capability of making flu vaccine. Concerned about the possibility of a pandemic, Thompson requested $100 million in 2002 for the purpose of helping the vaccine industry switch over from using chicken eggs to make vaccine to the latest cell-based method that relies on genetic technology. In 2002, his request was denied. In 2003, $50 million was approved. Finally, in 2004, it took the public panic over a flu vaccine shortage to put enough pressure on Congress to approve the entire $100 million allocation.
But even at a time of such great difficulty with the flu vaccine supply, in the post-9/11 era, lawmakers have focused their attention elsewhere. In early 2005, a powerful group of Republican lawmakers began pushing Project BioShield 2 through Congress. The original Project BioShield, signed into law in July 2004, allocated $5.6 billion over ten years to the Department of Homeland Security for the purchase of countermeasures against anthrax, smallpox and other terrorist threats. This expenditure includes allocation for 75 million doses of a second-generation anthrax vaccine to be made available for stockpiling.
BioShield 2 also proposes to shield the drug companies against lawsuits, one of the major disincentives against making vaccines, while expanding by several billion the money allocated for an ultra-expensive anthrax vaccine against a theoretical threat that remains remote.
Last fall, the federal government’s vaccine focus switched dramatically to bird flu, when articles in Nature and Science disclosed the final sequencing of the 1918 Spanish Flu H1N1 molecules. The fact that the Spanish flu originated in birds had been known for at least thirty years, and the exact way it made its jump to humans was known for at least a year. Nevertheless, these studies, combined with the continued spread of the H5N1 virus among birds migrating from Asia to Europe, fueled a concern that was useful to public health officials who wanted more attention put on avian flu in general and on the bird flu vaccine in particular.
A vaccine against H5N1 had already been developed using a virus isolated from a Vietnamese patient in 2004. In 2005 the National Institutes of Health began testing this vaccine against humans; preliminary results showed that it was effective at causing an immune response.
But with the odds of a bird flu pandemic looking very slim this year, it would appear to be far more cost effective to improve the ability to respond to a future pandemic. One of the weakest links in our preparation chain is vaccine production. When we vaccinate, a dead or weakened virus is injected into a person, where it generates an immune response, but without causing any symptoms of the disease. The body then carries, for some extended period of time, the specific antibodies for that virus or bacteria and has the capacity to make more if actually challenged by the actual virus or bacteria.