The California Department of Health recently categorized a local outbreak of whooping cough as an epidemic. Seven newborns have already died from the disease. And the total number of California whooping-cough cases is six times what it was last year, with more than 2,000 illnesses confirmed thus far in 2010. Authorities are urging Californians of all ages to get vaccinated.

America is hardly safe from the threat of epidemics. Each week, hundreds of vaccine-preventable illnesses are reported to the Centers for Disease Control. Decades of poor policymaking have radically reduced our country’s ability to make and develop vaccines. We all have good reason to worry about future outbreaks.

A century ago, epidemics easily morphed into catastrophes. When the Great Influenza spread across the world in 1917-18, there were no treatments, and an estimated 30 million people died.

Over the next 50 years, however, the vaccine industry made tremendous progress. By 1967, 26 companies were serving the vaccine market. Ten firms focused exclusively on the seasonal flu.

Since the mid-60s, however, much of that progress has diminished. Now, just four companies worldwide dominate the vaccine market, and a single company in the United States manufactures flu vaccines.

This has seriously harmed the supply of vaccines. Between November 2000 and May 2003, for example, eight of the 11 vaccines for childhood diseases faced shortages. At one point during last year’s swine flu outbreak, the United States was about 130 million vaccinations short of the number needed to inoculate all high-risk individuals.

A big reason vaccine production has fallen is that Food and Drug Administration regulations make the manufacturing process so much more expensive and time consuming than it needs to be.

Across Europe, for instance, manufacturers are now producing vaccines quickly and safely through a process that involves mammalian cells. This process hasn’t yet been approved in the United States, though, so American vaccine makers are largely stuck employing an older, slower production method involving chicken eggs.

The FDA has also been slow to approve vaccine additives like “adjuvants.” These are pharmacological agents that enhance the effectiveness of vaccines without compromising patient health, allowing supplies to be extended. Without adjuvants, patients receive higher vaccine doses, and supplies are exhausted faster.

An abundance of lawsuits has also has caused many companies to get out of the business of developing and producing vaccines. In the 1970s, more than 800 lawsuits were filed on the claim that the whooping cough vaccine caused brain damage. That claim was quickly and definitively disproved, but by then, many vaccine manufacturers had left the industry.

Government-induced price distortions have also made the production of some vaccines economically unsustainable. Thanks in large part to the Vaccines for Children Program – spearheaded in 1994 by then-first lady Hillary Clinton – the government is responsible for nearly 60 percent of child vaccine purchases. The federal government uses its huge bargaining power to suppress product prices, resulting in such small returns for manufacturers that many have little choice but to scale down or halt production. The low returns also leave companies little or no revenue to invest in research for new products and production processes.

Vaccines can have a dramatic effect on the pervasiveness of a disease. For instance, in the 1990s, around 20,000 children were hit with Hib disease, which causes bacterial meningitis. Since the introduction of the Hib vaccine, that number has dropped by 99 percent.

Junk lawsuits, government price fixing and over-regulation have combined to cause a vaccine shortage. California’s current whooping-cough epidemic is a reminder that vaccines are crucial in the fight against disease.

Policymakers must reform its regulatory and pricing policies so vaccine production can once again become a viable enterprise. Otherwise, new vaccines may not be available when we need them, putting us all at risk. Our lives literally could depend upon it.

Published in The Orange County Register, August 12, 2010.

The California Department of Health recently categorized a local outbreak of whooping cough as an epidemic. Seven newborns have already died from the disease. And the total number of California whooping-cough cases is six times what it was last year, with more than 2,000 illnesses confirmed thus far in 2010. Authorities are urging Californians of all ages to get vaccinated.

America is hardly safe from the threat of epidemics. Each week, hundreds of vaccine-preventable illnesses are reported to the Centers for Disease Control. Decades of poor policymaking have radically reduced our country’s ability to make and develop vaccines. We all have good reason to worry about future outbreaks.

A century ago, epidemics easily morphed into catastrophes. When the Great Influenza spread across the world in 1917-18, there were no treatments, and an estimated 30 million people died.

Over the next 50 years, however, the vaccine industry made tremendous progress. By 1967, 26 companies were serving the vaccine market. Ten firms focused exclusively on the seasonal flu.

Since the mid-60s, however, much of that progress has diminished. Now, just four companies worldwide dominate the vaccine market, and a single company in the United States manufactures flu vaccines.

This has seriously harmed the supply of vaccines. Between November 2000 and May 2003, for example, eight of the 11 vaccines for childhood diseases faced shortages. At one point during last year’s swine flu outbreak, the United States was about 130 million vaccinations short of the number needed to inoculate all high-risk individuals.

A big reason vaccine production has fallen is that Food and Drug Administration regulations make the manufacturing process so much more expensive and time consuming than it needs to be.

Across Europe, for instance, manufacturers are now producing vaccines quickly and safely through a process that involves mammalian cells. This process hasn’t yet been approved in the United States, though, so American vaccine makers are largely stuck employing an older, slower production method involving chicken eggs.

The FDA has also been slow to approve vaccine additives like “adjuvants.” These are pharmacological agents that enhance the effectiveness of vaccines without compromising patient health, allowing supplies to be extended. Without adjuvants, patients receive higher vaccine doses, and supplies are exhausted faster.

An abundance of lawsuits has also has caused many companies to get out of the business of developing and producing vaccines. In the 1970s, more than 800 lawsuits were filed on the claim that the whooping cough vaccine caused brain damage. That claim was quickly and definitively disproved, but by then, many vaccine manufacturers had left the industry.

Government-induced price distortions have also made the production of some vaccines economically unsustainable. Thanks in large part to the Vaccines for Children Program – spearheaded in 1994 by then-first lady Hillary Clinton – the government is responsible for nearly 60 percent of child vaccine purchases. The federal government uses its huge bargaining power to suppress product prices, resulting in such small returns for manufacturers that many have little choice but to scale down or halt production. The low returns also leave companies little or no revenue to invest in research for new products and production processes.

Vaccines can have a dramatic effect on the pervasiveness of a disease. For instance, in the 1990s, around 20,000 children were hit with Hib disease, which causes bacterial meningitis. Since the introduction of the Hib vaccine, that number has dropped by 99 percent.

Junk lawsuits, government price fixing and over-regulation have combined to cause a vaccine shortage. California’s current whooping-cough epidemic is a reminder that vaccines are crucial in the fight against disease.

Policymakers must reform its regulatory and pricing policies so vaccine production can once again become a viable enterprise. Otherwise, new vaccines may not be available when we need them, putting us all at risk. Our lives literally could depend upon it.

Published in The Orange County Register, August 12, 2010.