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What made vaccine industry so sickly?

Red tape, price controls, lawsuits have decimated U.S. vaccine makers.

The United States isn’t ready for the possibility of a swine flu pandemic. We could have been, we should have been, but we’re not.

While officials have done their best to stockpile antiviral treatments like Tamiflu and Relenza, the most effective means of fighting against an outbreak of the H1N1 swine flu would be a vaccine.

Sadly, no vaccine exists for this strain of swine flu, and experts predict that it could take as long as six month to develop one.

The absence of an effective swine-flu vaccine is the natural result of government policies that have crippled our nation’s once-thriving vaccine industry over the past several decades.

In 1957, 26 companies supplied the market for standard children’s vaccines. By 2005, there were four. And even though at least 10 U.S. firms manufactured vaccines three decades ago to treat seasonal flu, only five of those companies remained by the late 1990s. Today, only one company is manufacturing flu vaccine in the United States.

According to the consulting firm Oliver Wyman, in the event of a pandemic, it would take roughly four years for drug makers to meet the global demand for vaccines.

Developing vaccines against the next major outbreak – whether it’s swine flu, SARS, the West Nile virus, or an avian flu – is well within the reach of science. So why don’t U.S. drug companies, which dominate the global medicine market, make vaccines?

For one thing, vaccines are subject to excessively strict screening by the Food and Drug Administration. FluMist, a flu vaccine delivered via nasal spray, has been approved for use only by people ages 2-49. Our youngest and oldest, though, run the greatest risk of catching the flu. Indeed, the first casualty of the swine flu on U.S. soil was a 23-month-old toddler in Texas.

Second, vaccines are very expensive to produce. Using one common method of making flu vaccine – growing weakened viruses in chicken eggs – it costs about $300 million to build a factory. Even then, it takes almost five years to get the new plant fully up and running.

Third, out-of-control lawsuits have scared companies away from developing and producing vaccines. For example, a researcher claimed in the 1970s that the whooping-cough vaccine caused brain damage. More than 800 lawsuits were subsequently filed in the U.S. against vaccine makers. Scientists later proved that there was no link, but by that time, the manufacturers were already out of business.

If companies stood a chance of recouping their investments, these high costs of doing business might be manageable. But government price controls on vaccines make getting a return next to impossible.

The Vaccines for Children Program was the final nail in the coffin of the American vaccine industry. Established by the Clinton administration in 1994, it created a single-buyer system for children’s vaccines. The government buys more than half of all childhood vaccines – at a huge discount. No wonder most manufacturers have left the country or gone out of business.

It doesn’t have to be this way. If we remove the red tape and the price controls plaguing the vaccine industry, we can be prepared for the next pandemic.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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