The Covid pandemic reinforced the significance of vaccinations. Vaccines are the most effective public health measure for eliminating disease and preventing disease outbreaks. Vaccination, along with sanitation and clean drinking water, are public health interventions that are undeniably responsible for improved health outcomes globally[1]. Immunization has led to the elimination and control of various infectious diseases; hence the practice of vaccination is vastly valued and protected within the health care community[2]. The added value of vaccination, on a population level, is the potential to generate herd immunity. Where a sufficiently high proportion of the population are vaccinated, transmission of the infecting agent is halted thereby protecting the unvaccinated, who may be those too young, too vulnerable, or too immunosuppressed to receive vaccines[3].
In the United States, the most significant impact of vaccines has been to prevent morbidity and mortality from serious infections that disproportionately affect children[4]. The Vaccines for Children Program was implemented in the United States to fund vaccinations for children after a measles epidemic revealed half the children were shown to be unvaccinated. The program is an entitlement program (a right granted by law) for eligible children, ages 18 and younger[5] .
The schedule for childhood vaccination ages 0-6 is shown below:
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. 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[6]. The National Childhood Vaccine Injury Act (NCVIA) of 1986 is a no-fault alternative to the tort system and 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 and provides tort liability protection for manufacturing companies.
In recent years, much debate has surfaced about whether adverse effects from the diphtheria, tetanus, and pertussis (DTP) vaccines correlate with the development of autism. Concerns are focused on thimerosal, a mercury-containing preservative that is used in vaccines [7]. Claims filed through NCVIA have proven to be unsubstantiated in finding a link between autism and childhood vaccinations. 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 issue is whether Wyeth LLC, a 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 [8].”
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[9]. 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[10]. 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[11].
Case law supports a state’s enforcement of vaccination as a public health measure. In Jacobson v Massachusetts, the Supreme Court rejected a Fourteenth Amendment Due Process challenge to a state law mandating smallpox vaccination by an inhabitant who argued the state law violated his liberty rights. Ultimately, the Court ruled that the state of Massachusetts acted constitutionally within its police powers by implementing a mandatory vaccination law during an epidemic to protect the health and safety of the public and that Jacobson’s liberty interest must give way to the “common good.”In Zucht v. King, the Supreme Court reinforced this precedent of compulsory vaccination by not allowing unvaccinated children attend school even when there is no epidemic.
In Laurel Hill Cemetery v San Franciso, the court ruled that whatever the tribunal, in questions of this kind, great caution must be used in overruling the decision of the local authorities or in allowing it to be overruled…the Court is reluctant to interfere with the deliberate decisions of the highest court of the state whose people are directly concerned. The plaintiff must wait until there is a change in practice, or at least an established consensus of civilized opinion, before it can expect this Court to overthrow the rules that the lawmakers and the court of his own state uphold. [12].
The end of the 20th century marked a revolution in vaccine development as mRNA vaccines emerged as promising alternative platforms to conventional vaccines[13]. The interest in mRNA stems from its simple and inexpensive production, its transient activity and natural degradation in the human body, and its safety advantages compared to DNA therapeutics[14].
The importance of vaccines cannot be understated in terms of preventing disease and lowering health care costs. Claims of adverse effects help to reinforce the development of safe and efficacious vaccines as an ongoing process in providing quality care.
[1] Rodrigues CMC and Plotkin SA (2020) Impact of Vaccines; Health, Economic and Social Perspectives.
[2] Rosenthal, Ken S. & Zimmerman, Daniel H. (2006). Vaccines All Things Considered. Clinical and Vaccine Immunology, 13(8).
[3] Rodrigues CMC and Plotkin SA (2020) Impact of Vaccines; Health, Economic and Social Perspectives.
[4] Ibid.
[5] Centers for Disease Control (2023, December 19). About the Vaccines for Children program CDC. Retrieved June 14, 2024, from https://www.cdc.gov/vaccines/programs/vfc/about/index.htmlCopy Citation
[6] Rosenthal, Ken S. & Zimmerman, Daniel H. (2006). Vaccines All Things Considered. Clinical and Vaccine Immunology, 13(8).
[7] Vaccine Policy Issues. CRS Report for Congress. May 19, 2005. <http://www.fas.org/sgp/crs/misc/RL31793.pdf>.
[8] Bruesewitz et al. v. Wyeth LLC, FKA Wyeth, Inc., et. al., 562 U.S. (2011).
[9] Id.
[10] United States. Centers for Disease Control & Prevention. Manual for the Surveillance of Vaccine-Preventable Diseases. Atlanta: Centers for Disease Control & Prevention, 2012. Print.
[11] Ibid.
[12] Laurel Hill Cemetery v San Franciso, 216 US. 358 (1910).
[13] Karam, M., & Daoud, G. (2022). mRNA vaccines: Past, present, future. Asian Journal of Pharmaceutical Sciences, 17 (4), 491–522.
[14] Ibid.