I was surprised – more than scared – by a recent NY Times article titled "Swine Flu Vaccine may be Months away." Although production is much faster than it would have been even a few years ago, it still may not be on time to avert illness if the virus starts spreading widely and becomes more virulent. However, the virus might also mutate in the coming month while the northern hemisphere enjoys a brief warm weather pause and then come back in a more virulent form in the cooler autumn weather. A few more articles helped me understand the process to create the vaccine and the opportunity for accelerating it and making it more efficient.
Despite years of effort, the world is still relying on half century old technology to make the flu vaccines. The first step is to turn the flu virus into seed stock – an essential first step, so the CDC has sent samples of the new strain to about 10 governments and academic labs in the US, Australia, GB, Hungary, and Russia. The vaccine is made by growing samples of flu virus inside fertilized chicken eggs then breaking out the key proteins that provoke an immune response. The process is time consuming as each egg is injected with repeated rounds of virus, each round of virus growth takes about 42 hours. The ultimate goal is to create a uniform seed stock from a single virus and to produce 80 vials of it, each containing millions of viruses. Then they are purified tested, and packaged into syringes. Once production is started, four months are needed for the vaccine to be ready.
In parallel, there is also a process for selecting which strains will be in the next few vaccines that started in February when a Government advisory committee selected three flu vaccines based on surveillance data indicating which strains are more likely to be circulating in the fall and winter. The Swine flu strain could be swapped for one of the other strains or added as a fourth. A second vaccine could also be developed, which would raise capacity issues.
Scientists are working on technology that would allow flu vaccines to be manufactured somewhat faster as the egg method is ill suited for a potential pandemie. The vaccine industry is in a much stronger position to respond now than it was five years ago when the US had only two flu vaccine suppliers and was hit by a severe shortage. Now, there are five suppliers to the domestic markets and the vaccine is attracting new investment lured by Government subsidies and higher prices. The Government is encouraging manufacturers to set up production in the US since all companies but Sanofi Aventis now import their flu vaccines. The government also gave $1.3B to develop ways of producing the vaccines in vats of animal cells rather than in eggs. Novartis is building a cell culture flu vaccine factory in NC which by be ready for use in 2010. By contrast, Solvay decided it was too risky to build a flu vaccine plant in the US and Sanofi Aventis put its efforts to develop the flu vaccine on a back burner. It seems that great opportunities for improvement exists not only at the technology level (capacity and productivity), but also at the supply chain level (delocalization, prioritization). Which industry is still relying on 50 year old technology anyway?