Wednesday, June 24, 2009

The Vaccine Conundrum

Three years ago, when I worked at a publication that served researchers in drug discovery and development, I wrote an article on efforts to develop vaccines and update production techniques for them.

The story, and the efforts that inspired it, arose from intense public fear about the H5N1 strain of influenza, the so-called "bird flu." At that time, researchers around the world were working tirelessly to isolate strains like H5N1 and H9N2, clone them, and develop vaccines that could be used for inoculation.

But there was one catch: Even after the vaccines were developed, there was still the problem of production to contend with. The sad truth is that the vast majority of flu vaccines are produced today the same way they were 50 years ago. Although this process is proven, it is painstaking and can take several months.

To address this problem, government agencies like the National Institutes of Health (NIH) and pharmaceutical companies investigated the use of cell culture techniques and novel methods such as DNA approaches.

"We definitely would like to see the cell-based vaccine technology come up to speed, not only for the avian flu, but also for the regular circulating strains," David Cho, PhD, the influenza program officer at NIH’s National Institute on Allergy and Infectious Diseases, said in an interview with me at the time. "Having that technology up to speed would really enhance vaccine development."

I’ve been thinking of this story, and the interviews I did for it, quite a bit over the last several weeks in the wake of the recent H1N1 swine flu outbreak.

The day I wrote this letter, Reuters reported that cases of the new H1N1 flu virus have been found in all 50 states, and tests have confirmed the virus in more than 10,000 Americans. There have been 19 fatalities nationwide.

The World Health Organization said that 17,564 people in 64 countries have contracted the swine flu and 115 have died. There were fears early on that this outbreak could be very deadly, so those relatively low numbers are reassuring. But scientists fear that a mutation or two could change the situation quickly.

It’s important to remember how deadly a severe outbreak could be. The infamous 1918 outbreak of Spanish flu (H1N1) was the most devastating flu pandemic in recent history. It killed more than 500,000 in the United States and 20 to 50 million people worldwide. The 1957-58 outbreak of Asian flu (H2N2), although much less severe, caused roughly 70,000 deaths in the United States.

Although some progress has been made in modernizing vaccine production since my article three years ago, not nearly enough has been done, and the infrastructure that is needed to produce millions and millions of doses is nowhere near realization. If a full-scale pandemic were to emerge, we would be in very serious trouble indeed.

The main problem is that vaccines are not moneymakers, so they don’t draw the attention of the vast majority of pharma and biotech companies. And organizations like NIH and the Centers for Disease Control and Prevention are at the mercy of governments that tend to think about money for vaccine research only when the threat of a pandemic emerges, when it is clearly too late.

Here’s hoping that this latest outbreak has gotten the attention of legislators and will move them to put real money and resources behind this vital public health issue

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