Vaccines are the most effective public health tool in combating infectious diseases. In scientific terms, vaccines are biologics; they introduce attenuated viruses into a human to stimulate a future immune response[1]. Vaccination in this country is state-mandated, meaning that to go to school or be considered fit to participate in certain activities, the administration of a vaccine is required. Immunization has led to the elimination and control of various infectious diseases[2]. Hence, the practice of vaccination is vastly valued and protected within the health care community. Recently, the American Academy of Pediatricians reversed their position on vaccines that contain thimerosal endorsing such vaccines noting their importance in combating disease. Safeguards are in place to ensure vaccines are developed in a safe, efficient, and effective manner. The National Vaccine Program Office and the Food and Drug Administration coordinate vaccine-related activities and regulate vaccines as a means of ensuring safe and effective delivery of vaccines[3]. Yet, there is no guarantee adverse effects will be absent.

The National Childhood Vaccine Injury Act (NCVIA) of 1986 was implemented in response to the overuse of the civil liability system as a means of resolving injury claims related to a vaccine’s adverse effects. Optimal success in vaccination development is attained when vaccine manufacturers are reassured their efforts will not be stifled by repeated litigation. The Act created a no-fault compensation program designed to alleviate litigation resulting from a defective vaccine. The Act intends to provide tort liability protection for manufacturing companies. As of March 2011, $2.1 billion has been awarded to individuals and families through this program. [4]. In recent years, much debate has surfaced about whether adverse effects from the diphtheria, tetanus, and pertussis (DTP) vaccine correlate with the advent of autism. Concerns are focused on thimerosal, a mercury-containing preservative that is used in vaccines[5]. More than 300 claims made through the Vaccine Injury Compensation Program linking autism and the adverse effects of vaccines were rejected on the grounds of insufficient proof[6]. However, one such claim made it to the United States Supreme Court.

In Bruesewitz et al. v. Wyeth LLC, FKA Wyeth, Inc. et. al, the plaintiff, sued Wyeth LLC, a vaccine manufacturing company, on a legal theory of strict liability for the physical injury their daughter suffered after being administered a vaccine manufactured by the company. The trial court granted judgment for the defendant. The plaintiff claims their daughter became disabled after receiving a vaccine manufactured by the defendant. A pleading was filed in the Federal Court of Claims and, judgment was granted in favor of the defendant. The suit was then filed in Pennsylvania state court but subsequently moved to Federal District Court. This court granted the defendant summary judgment based on the National Childhood Vaccine Injury Act of 1986 and later reaffirmed by the Third Circuit Court. The issue is whether Wyeth LLC, vaccine manufacture, should be held strictly liable for the injury and resulting disabilities sustained by Hannah Bruesewitz after receiving a defective vaccine manufactured by the defendant. The Supreme Court affirmed the Third Circuit Court’s ruling. The applicable rule of law, in this case, is grounded in 42 U.S.C. §300aa-22(b)(1). The statute states,

“[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings[7].”

Based on this statute, the court reasoned that state-law design-defect claims rooted in products liability law are preempted, further suggesting the design in and of itself taken into consideration with safe manufacturing and adequate warnings is not subject to tort action[8]. Thus, the Supreme Court ruling reaffirmed the application of the National Childhood Vaccine Injury Act of 1986 as a means of delineating liability from the result of any adverse effects related to vaccine injury. Consequently, the most effective public policies directed at addressing the issue of adverse effects related to the vaccine are rooted in comprehensive vaccine-preventable disease surveillance systems. The Department of Health and Human Services funds vaccine surveillance programs that collect data from patients, clinicians, and manufacturers concerning vaccine-related injury. In 1990, the Vaccine Adverse Event Reporting System (VAERS) was established to monitor the adverse effects of vaccines [9]. The data from VAERS is utilized in myriad ways such as detecting new, unusual, or rare adverse effects from vaccines and identifying potential risk factors[10].

The data collected about the vaccine provides information that will help scientists better understand the dynamics of thimerosal concerning vaccine safety and whether intervention is necessary. As a means of enhancing the monitoring of any undocumented adverse effects, epidemiologists are essential. Vaccine-preventable disease surveillance systems are structured to incorporate the full support and cooperation of health care providers who are privy to any initial adverse effects after vaccine administration. Health care providers are required to report “any clinically significant event” that occurs after administering the vaccine as well as any well-documented adverse effect provided in a list by the Department of Health & Human Services[11]. Reporting to the VAERS by a health care provider is carried out either online through the mail or by fax[12]. Thus, a concern to any vaccine-preventable disease surveillance system is underreporting. Underreporting can occur when there is valid surveillance information not being reported because of a lack of recognition of an adverse effect[13]. Gaps in information delay any effort to implement an intervention eliminating future exposure to adverse effects from vaccines. Surveillance efforts can be enhanced by taking additional steps to improve the accuracy of information gathered by requesting supporting documents such as hospital records or verifying incomplete information.