Vaccine Poker

By Dr. Marc Siegel, The Nation. Posted October 18, 2004.

With the announcement that 50 million influenza vaccines from the British manufacturer Chiron won't be available in the United States this year because of possible contamination, the Centers for Disease Control (CDC) has been put in a quandary, its credibility once again damaged. From pushing the yearly flu vaccine accelerator pedal, urging everyone to get a shot, it suddenly has had to slam on the brakes.

"Take a deep breath, this is not an emergency," Dr. Julie Gerberding, the agency's director said, trying to ward off a stampede of shot-seekers. But such attempts are bound to fall flat, especially with the elderly, who need the vaccine to protect them from serious illness and death.

One of the main reasons a shortage like this can occur is because drug manufacturers are not eager to produce vaccines in the first place. This is why there are only two major flu vaccine makers – Chiron and Aventis – worldwide. Without a patent to insure high prices, the profit margins for "generic" vaccines is narrow. Plus, proper sterilization methods are quite expensive and cut further into the profit margin.

Forget altruism, or concern for patients; drug companies are not eager to make a product they can't make a lot of money on. The only way to ensure adequate supplies and reserves is for the government to step in and subsidize the manufacturing of vaccines. Yet last year Congress approved only half the $100 million requested to develop better flu vaccines and improve the distribution system.

Instead of worrying about the flu, our government has been busy spending millions stockpiling over a million doses of anthrax vaccine (with no use for it in the foreseeable future), and more than 200,000 doses of smallpox vaccine (without a single case occurring here since 1949). These actions were taken so that the Department of Homeland Security can look like it takes the threat of biological agents seriously. A bioterror attack would likely affect only hundreds, or at the worst thousands, yet the expensive preparations are for millions of potential victims.

BioPort makes the only anthrax vaccine, an unwieldy six-dose process that many military recruits have complained gives them a flu-like syndrome. But fearing an anthrax attack since 2001, Congress has contracted with this company for millions of dollars in vaccine production. Since the vaccine is perishable, and there is no anthrax, most of what is produced is thrown away.

Similarly, panicked over smallpox in 2002 and 2003, the government purchased 291,400 doses of the antiquated live virus vaccine, which was found to have significant side-effects, including heart problems. Ultimately, only 38,549 people were vaccinated and more than 250,000 doses were discarded. Meanwhile, influenza kills approximately 40,000 people in the United States every year and hospitalizes more than 200,000.

The CDC has asserted that at least 185 million Americans are at sufficiently high risk to warrant their getting the flu vaccine. This number includes those in contact with high-risk patients with chronic illnesses, pregnancy, asthma, advanced age. Flu is passed easily from person to person by airborne droplets. Hand washing and staying away from sick people offers some protection, but vaccine offers the most protection.

As of this writing, the supply of vaccine available this year is only about 54 million doses. The CDC has been begging Aventis to produce more, but the company has agreed to produce only 1 million additional doses. Is this all they can make, or all they will make? No one I've spoken to at the manufacturer has been able to give me a straight answer to that question.

Instead of spending all its vaccine money on the production of all but useless bioterror vaccines, the government, through a more prudent flu subsidy, could increase the availability of a vaccine that might actually save lives.

Dr. Marc Siegel is an internist and clinical associate professor of medicine and a fellow in the Master Scholars Society at New York University.

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