August 1998
ROCKVILLE, Md. - The 1980s were filled with turmoil for the vaccine industry after controversy surrounding whole-cell pertussis vaccines fueled provider apprehension to immunize and led to an eventual decline in the production of childhood vaccines.
The industry was weakened by these controversies, in addition to a liability crisis that threatened the industry's financial well-being and confidence in childhood immunization.
To combat these problems, in 1986 Congress passed the National Childhood Vaccine Injury Act and by 1988 the Vaccine Injury Compensation Program (VICP) was going full force. The program is designed to cover all routinely given childhood vaccines; 10 vaccines are now covered. The program is financed by an excise tax on every dose of the covered vaccine sold.
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As part of the VICP, the federal government instituted mandates for office record keeping, scientific studies of vaccine reactions by the Institute of Medicine (IOM), distribution of vaccine information for families and patients, and a national surveillance system to monitor vaccine adverse events, known as the Vaccine Adverse Events Reporting System (VAERS).
Since its implementation 10 years ago, the Vaccine Injury Table has been updated twice to include additional adverse events based on reports from the IOM. A major change in the program occurred last year when Congress voted to include in the VICP three childhood vaccines recommended by the Centers for Disease Control and Prevention, according to Thomas Balbier, director of the VICP.
Also last year, Congress voted to change the excise tax to a flat rate of 75 cents for each dose. Therefore, the tax on each dose of diphtheria-tetanus-acellular pertussis vaccine is $2.25.
The Advisory Commission on Childhood Vaccines, the overseeing body of the VICP, in a recent meeting discussed expanding program coverage to include vaccines in clinical trials, which could allow for more freedom in vaccine research. Liability concerns can become an obstacle for vaccine manufacturers if they aren't willing to take on the liability risk associated with clinical trials, Balbier said.
"It's a very exciting time for the program," he added. "From the vaccine companies' perspective ... I would imagine it would be reassuring to know that the administration is taking these issues very seriously and that they are at the forefront of national immunization policy debates."
On the dark side of vaccine progress, the global village has a nasty side effect, said Walter Vandersmissen, director of government affairs, SmithKline Beecham Biologicals, Rixensart, Belgium.
"Activism against vaccines, like rumors of true - but mostly alleged - side effects easily find their way around the world. They are easily picked up by the media in a not so responsible way and can cause a scare," he said. "This happens because today these infectious diseases aren't seen anymore, so the vaccine is perceived to be the worst of the two. Vaccines are a pharmaceutical product, and like all human endeavors, none is safe to 100%."
For more information:
- Freed GL, Kauf T, Freeman VA, et al. Vaccine-associated liability risk and provider immunization practices. Arch Pediatr Adolesc Med. 1998;152:285-9.
- Evans G. Vaccine liability and safety revisited. Arch Pediatr Adolesc Med.1998;152:7-10.
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