Is It Time To Revisit The National Vaccine Injury Compensation Program?

According to the National Center for Health Statistics (NCHS), there were 11,647 new whooping cough cases diagnosed in 2003, which represents 4.0 cases per 100,000. Of these 11,647 cases, there were 18 deaths. The Centers for Disease Control (CDC) also reported that respiratory distress was among the Top Ten causes of mortality of children in 2002.

As of late, there has been an increased incidence of reported outbreaks related to whooping cough (pertussis) in the United States. According to the CDC, there is a significant need to protect children and adults from this contagious infection. Moreover,pertusis which was initially considered a childhood disease, affects people of all ages. The CDC reported 5,000 to 7,000 cases last year in the United States alone (CDC). This is important because those who have a cough may not realize that they have pertussis and may be the primary source of infection for infants, who have the greatest risk of dying from the disease.

“While there is no lifelong protection against pertussis, immunization by vaccine is the best preventive measure available. Vaccines currently licensed by the Food and Drug Administration to prevent the disease and reduce related illness and death are available for children up to age 7, and for adolescents between 10 and 18. The children’s vaccine is part of a routine series of childhood immunizations called diphtheria-tetanus-acellular pertussis (DTaP) that is strongly recommended by the National Immunization Program at the CDC. It is administered in five doses, given at 2, 4, 6, and 15 to 18 months of age, and between 4 and 6 years. All five doses are recommended for maximum protection (Food and Drug Administration).” Moreover, FDA approved an adolescent vaccine in May 2005, which has the same components as the DtaP vaccnine for infants and adolescents, but in reduced quantities. Based on this data alone, it may be time to revisit the existing program which manages vaccination injury.

The National Childhood Vaccine Injury Act of 1986 (PL-99-660) is a vaccine safety and compensation system which (1) created a no-fault compensation alternative to suing vaccine manufacturers and providers on behalf of citizens injured or killed by vaccines; (2) helps prevent future vaccine injuries through education and an adverse reaction reporting system; and (3) creates incentives for the production of safer vaccines. Compensation to victims is divided into two parts (Refer to THE VACCINE INJURY COMPENSATION PROGRAM, The National Childhood Vaccine Injury Act of 1986 (PL-99-660).To date, this program has awarded over 600 million dollars, with total outlays of 700 million dollars. Even the though the number of awards has reduced from 64 to 45 (NVICP Statistics Report), it appears that this program still requires fine tuning. Specifically, as it relates to the DTP and DTaP vaccinations.

According to the NVICP, the number of aggregrate claims filed for DTP & DTaP was over 4000, as of February 7, 2006. Hence, compensated claims represented approximately 1,300 claims and dismissed claims well over 2,700. This data appears to suggest, that there is an existing issue with efficacy of DTap acellular vaccine and Tdap adolescent preparation.

In the Unites States, most infants are immunized against pertussis. Whereas, the immunity of these combination vaccinations fades as a child enters early adulthood. “Pertusssis is a serious bacterial infection of the lining of the breathing passages, particularly in the windpipe area (American Medical Association)”. Pertussis, also called whooping cough, is caused by Bordetella pertussis bacteria and is extremely contagious. Symptoms of the infection include prolonged, violent, coughing spasms that often cause thick mucus and severe inhaling difficulties. The labored inhalation, or breathing in, of air causes the person to make a high-pitched, crowing, or whooping sound. Pertussis can be fatal, but in the United States, widespread vaccination against the infection has made the disease rare, until now.

Pertussis is usually spread by infected respiratory droplets from the coughs and sneezes of people who have the infection. Infants younger than 1 year are most susceptible and have the most severe symptoms, but teenagers and adults may also contract milder cases of pertussis that are often mistaken for bronchitis. There is a danger that people with less severe, undiagnosed cases may spread the infection to infants who have not yet been immunized (American Medical Association).

Finally, this issue has not been a “hot button” item for legislators due to current world events. But as the medical community confronts other contagious diseases (e.g. avian flu, meningitis), it is highly recommended that pertussis cough be given a second look [in this light]. Incidentally, based on the current operating scheme of the NVICP, it appears that there is a lack of synergy among federal agencies. Particularly,with the FDA. Increased transparecny is required to further reduce more outbreaks and financial burden to the NVICP.

References

American Medical Asssociation. Pertussis (Whooping Cough). [Online]. Retrieved June 8, 2006. http://www.medem.com/medlb/article_detaillb

Food & Drug Administration. (May-June 2005). Controlling The Whooping Cough. [Online]. Retrieved June 8, 2006. http://www.fda.gov/fdac/features/2005/305_cough.html

Kochanek, K., Murphy, S, Anderson, R & Scott, C. (2002). National Vital Statistics Report. Deaths: Final Data 2002.Centers for Disease Control: 53, 5 pp.1-25 & 60-100.

National Institute of Allergy and Infectious Disease. (July, 2003). Understanding Vaccines: What They Are? How They Work. National Institute of Health Publication No. 03-4219; pp.30-31.

Vaccine Injury Compensation Program. [Online]. Retrieved June 8, 2006. http://www.909shot.com/Issues/Comp_Summary.htm.