- The Washington Times - Monday, November 8, 2004

The flu vaccine is not the only vaccine that Americans could find in short supply due to a lack of enough manufacturing facilities licensed by the U.S. Food and Drug Administration. In the past six years there have been U.S. shortages of more than half of the 12 recommended childhood vaccines, and there could be more.

Because of low supplies, Americans have faced shortages of vaccines against cholera, plague, rotavirus, adenovirus, polio, measles, mumps, rubella, chickenpox, diphtheria, meningitis, hepatitis B and other serious diseases in recent years.

Such shortages leave many people vulnerable to naturally occurring infectious diseases — among them the flu — that kill more than 100,000 people in the United States each year. In contrast, known acts of bioterrorism have killed just five people in the country. Yet until the current flu vaccine shortage made headlines, efforts to protect Americans from the threat of bioterrorism have received far more public attention than efforts to protect us from infectious diseases.

The news that 48 million doses of flu vaccine destined for the United States are unavailable because regulators found contamination at the Chiron Corp.’s manufacturing plant in England exposed our vulnerability. Now we all know a single incident can cripple America’s defenses against potentially deadly diseases. This one incident at an American-owned manufacturing plant that is one of only two in the world licensed by the FDA to make the flu vaccine instantly deprived the United States of nearly half the doses of the vaccine expected to be on hand this season.

What can be done to avoid a repeat of this year’s flu vaccine shortage and to avoid shortages of other vaccines?

The federal government could use a combination of tax incentives, liability protection, purchasing guarantees and patent protections to do much more to ensure the adequate supply of vaccine and protect Americans from one of the largest sources of preventable death. The Congress enacted, and President Bush signed the Bioshield Act in July to do all these things to defend America against bioterror. Now they should do the same to defend America against naturally occurring diseases.

Congress is now working on Bioshield II to spur production by biotechnology companies of vaccines and treatments to prepare for and respond to bioterrorism attacks. These efforts are clearly important. But more people would be protected were such production incentives expanded to fight diseases such as the flu, and were they designed to appeal to the full spectrum of companies in the pharmaceutical industry, including the large ones.

The U.S. government may be forced to examine the possibility of manufacturing needed vaccines itself. The Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving Weapons of Mass Destruction, better known as the Gilmore Commission, recommended this as a potential approach.

However, there are several problems with the government going into the vaccine business. Government salaries make it is difficult to attract employees with the right expertise and experience to build and operate vaccine-manufacturing plants. In addition, it will take years to develop the infrastructure and operations to deliver significant amounts of vaccines. And building and maintaining vaccine-manufacturing facilities approved by the FDA requires hundreds of millions of dollars per facility. Each facility would likely manufacture one vaccine.

The federal government could contract to purchase additional doses of vaccines in the future on a continuing basis, replacing expired doses as necessary. This would ensure adequate supplies of vaccine on hand in an emergency and would create a more stable and potentially lucrative market for vaccine manufacturers. This could encourage more drug companies to make vaccines. It would be provide the ability to share vaccines globally in a large-scale outbreak, without harming Americans.

But none of these efforts will work unless, federal, state and local public health officials design effective outreach and education initiatives to inform the public of the importance and safety of vaccinations. Vaccination program improvements need to be permanent — not done just for crises.

Once a vaccine shortage strikes, a rapid response becomes difficult and often impossible. This makes it all the more important to prevent shortages with sound advanced planning.

Jennifer Brower is a science and technology policy analyst at the RAND Corp., a nonprofit research organization, and helped prepare sections of the Gilmore Commission reports on bioterrorism threats.

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