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Mandatory immunization requirements protect both the individual and the community against the morbidity and mortality associated with vaccine-preventable illnesses. Despite the overwhelming evidence of safety and societal benefit, vaccines are associated with a small degree of risk to the individual of untoward reactions even when the vaccine is properly manufactured, handled, and administered. Some people who are unaware or misinformed regarding the risk-benefit ratio of vaccines, who do not believe the science of clinical trials and other study designs, or who hold personal beliefs inconsistent with vaccination may have a different opinion regarding the balance of individual rights and community benefit. Mandatory immunization laws may result in restrictions on individual or parental rights (such as excluding some unvaccinated children from school), although justification of state laws requiring immunizations have been upheld by numerous courts throughout the country, including the US Supreme Court. The basis of this restriction of individual rights is that failure to vaccinate affects the safety of others and does not fulfill the obligation of society to ensure that children receive optimal preventive health care.
A decision by the US Court of Appeals for the Fifth Circuit in 1974 held a vaccine manufacturer liable for a child who developed paralytic poliomyelitis following administration of the oral polio vaccine.1 The court’s determination was not based on the safety of the vaccine but on the finding that insufficient information of potential harm had been presented prior to immunization. Two years later, a warning was issued regarding an impending swine influenza pandemic. Vaccine manufacturers hesitated to produce a vaccine because of concern about liability related to potential vaccine adverse effects (eg, Guillain-Barré syndrome). In response, Congress passed the National Swine Influenza Immunization Program of 1976 Act to indemnify the vaccine industry. However, in the next few years the number of vaccine-related lawsuits against vaccine manufacturers increased, particularly in relation to whole-cell pertussis vaccines. In several instances, claims against vaccine manufacturers resulted in damage awards despite the absence of scientific evidence to support vaccine injury allegations.
As a consequence of increasing litigation in the late 1970s and 1980s, manufacturers began to withdraw from vaccine production. The decrease in the number of vaccine manufacturers raised justifiable concerns about the effect on vaccine cost, the ability to maintain an adequate supply of vaccines, and the loss of incentive for the pharmaceutical industry to develop new vaccines. Also, there was a concern regarding physician liability from vaccine administration. To address these issues, Congress passed the National Childhood Vaccine Injury Act of 1986 (Vaccine Act), which created the Vaccine Injury Compensation Program (VICP).2 This program is a no-fault alternative to the traditional legal system for resolving vaccine injury cases to provide compensation for individuals thought to be injured by mandatory childhood vaccines recommended for routine use. Creation of the VICP was based on the understanding that if the government restricts specific individual rights for the collective good, the government assumes responsibility for the consequences that accrue.
The intent of the Vaccine Act was multifold: compensate vaccine recipients and families alleged to have experienced a vaccine-related injury, stabilize the vaccine supply by reducing the number of claims brought against vaccine manufacturers, minimize the number of inappropriate claims, coordinate immunization record keeping, require health care professionals to report certain adverse events after immunization through the Vaccine Adverse Event Reporting System, standardize vaccine-specific warnings by creating Vaccine Information Statements, and decrease civil litigation by providing liability protection for vaccine manufacturers and administrators.
The Vaccine Act authorizes the Vaccine Injury Table (eTable in the Supplement).3 The table provides a legal mechanism for review of a claim; it lists the covered vaccines and associated illness, disability, injury, or condition that may be caused by a vaccine based on current scientific evidence. Modification or amendments to the table are made by the secretary of Health and Human Services (HHS) and are based on reports published in the peer-reviewed literature, public input, and reports issued by the National Academy of Medicine. New vaccines recommended by the Centers for Disease Control and Prevention (CDC) are added to the table upon the effective date of an excise tax on the vaccine.4
Injury categories recently added to the table include shoulder injury related to vaccine administration, Guillain-Barré syndrome related to influenza vaccine, and vasovagal syncope. In April 2018, the table was modified to reflect amendments in the 21st Century Cures Act requiring that the VICP cover vaccines recommended for routine administration in pregnant women, stating that a vaccinated pregnant woman and her unborn child or children both can file a claim with the VICP. Autism as a possible complication of vaccine administration has been considered by the US Court of Federal Claims, and in decisions issued in 2009 and 2010, the court found no credible evidence that the measles-mumps-rubella vaccine, alone or in combination with thimerosal-containing vaccines, or thimerosal-containing vaccines alone, cause autism.5 The decisions were affirmed on appeal.
The decision to award compensation often involves challenges in determining whether a medical event following vaccine administration is causally related or merely temporally related to the vaccine. In view of the tens of millions of vaccine doses administered annually in the United States, almost any condition will have a temporal association with vaccine administration. Specific conditions or medical events that are temporally related to vaccination often are presumed by the patient to be a vaccine-related adverse effect if no alternative explanation is found, but this may not be an accurate presumption for each case.6 After review of the medical records by HHS medical personnel, a recommendation is made as to whether an alleged injury should be compensated or defended. If an individual (petitioner) has experienced an injury or condition listed in the table following vaccination within a specified period, the petitioner receives a presumption of causation. If a claim is defended, the US Court of Federal Claims determines whether an injury more likely than not was caused by a vaccine or meets the requirements of the table. The Department of Justice represents HHS in the litigation before the court where petitions alleging vaccine injury are heard by attorneys known as special masters. In general, when a causal relationship between a medical condition and vaccination is uncertain, an award is made to the petitioner even if scientific evidence is lacking. This is stated clearly on the program’s website: “Being awarded compensation for a petition does not necessarily mean the vaccine caused the alleged injury. In fact, almost 80% of all compensation awarded by the Vaccine Injury Compensation Program comes as a result of a negotiated settlement between the parties, in which HHS has not concluded, based on a review of the evidence, that the alleged vaccine caused the alleged injury.7”
Regardless of the outcome of the hearing, attorneys’ fees and outside expert fees generally are paid by VICP so the individual filing the claim does not incur legal costs. In most cases, a claim is resolved in negotiated settlement prior to a hearing. A settlement is not an admission that the vaccine caused the alleged injury but rather represents an agreement by the involved parties to resolve a case quickly and efficiently. Compensation to a petitioner is provided from the Vaccine Injury Trust Fund that derives its resources from a $0.75 excise tax on vaccines licensed by the US Food and Drug Administration and recommended by the CDC for routine use.
The CDC data indicate that between 2006 through 2016, 3.1 billion doses of all vaccines were distributed in the United States.7 During this period, the court adjudicated 5531 petitions and of those, 3749 were compensated, resulting in approximately 1 compensation award for every 1 million vaccine doses distributed.7 During the 5 years from 2013 through 2017, an average of $229 million per year was awarded to an average of 530 petitioners per year or approximately $430 000 per adjudication. During this same 5-year period, attorneys’ fees averaged $29 000 per adjudication.7
Overall, the VICP has been successful; the United States presently has the highest immunization rates and the lowest rates of most vaccine-preventable disease in the nation’s history. The overall favorable acceptance of vaccines suggests that the CDC achieves success when recommendations are based on well-conducted surveillance programs to monitor vaccine safety and identify rare adverse events that may occur following immunization, together with a compensation program.
Although establishment of the VICP may support some arguments of those who question the safety of vaccines, its existence promotes wide acceptance of vaccination as a public good that is also humane to those who perceive they have been injured by this public good. Control of infectious diseases through the use of vaccines has proven critical to the maintenance of public health and protection against epidemics. For a person truly injured as a consequence of vaccination, compensation should be available in an equitable, consistent, and timely manner that encourages support for protection of the public by vaccination and continued commitment to the development of novel vaccines.
Corresponding Author: H. Cody Meissner, MD, Tufts Medical Center, Department of Pediatrics, Tufts University School of Medicine, 800 Washington St, Boston, MA 02111 (email@example.com).
Published Online: January 4, 2019. doi:10.1001/jama.2018.20421
Conflict of Interest Disclosures: Dr Nair reported that he is employed at the Health Resources and Services Administration of the US Department of Health and Human Services and serves as the director of the Division of Injury Compensation Programs (which administers the Vaccine Injury Compensation Program). Dr Plotkin reports that he has served as a paid consultant to Sanofi, Merck, GlaxoSmithKline, Pfizer, and Dynavax. Dr Meissner reports that he is vice chair of the Advisory Commission on Childhood Vaccines.
Disclaimer: Any views expressed in this article are those of the authors and do not necessarily represent the positions of the US Department of Health and Human Services.
eTable. Vaccine Injury Table
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Meissner HC, Nair N, Plotkin SA. The National Vaccine Injury Compensation Program: Striking a Balance Between Individual Rights and Community Benefit. JAMA. Published online January 04, 2019. doi:10.1001/jama.2018.20421
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