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Infectious diseases have caused widespread misery, and have wreaked havoc physically, mentally, economically, politically, and socially. Fortunately, in more recent years, scientists have developed vaccines. Vaccines are generally very safe, but cause side effects in a small percentage of cases. The United States Congress has passed two major pieces of legislation that provide sweeping tort immunity to vaccine manufacturers and others. In 1986 Congress passed the National Childhood Vaccine Injury Act (NCVIA) and in 2005 it passed the Public Readiness and Emergency Preparedness Act (PREP ACT). Both Acts were passed to encourage manufacturers to develop vaccines, particularly in times of public emergencies, in exchange for expansive liability protection. Both Acts established no-fault type compensation schemes to compensate those suffering injury or death from vaccines without having to resort to typical litigation. The author discusses both Acts in detail, in the context of the current Covid-19 crisis.

The article discusses the history of vaccine jurisprudence and in particular how the lower courts have not followed Jacobson v. Massachusetts properly but instead have deferred to the legislatures, creating a significant imbalance of power among the branches of government, bad public policy, and corruption. Vaccine safety and efficacy research is juxtaposed to vaccine policies and mandates. The immunity created by the National Childhood Vaccine Injury Act of 1986 and how it has affected vaccine policy is also addressed. The article concludes that some vaccine mandates, including the flu vaccine and HPV vaccine mandates in NY and HI, are unconstitutional.

With an increase in popularity of television shows such as Bones, Crossing Jordan, Law and Order, and NCIS, the interactions between law and medicine have become topics of popular interest.1 Cases ...

Generally, under the National Childhood Vaccine Injury Act of 1986 (Vaccine Act), vaccine administrators and manufacturers are shielded from medical malpractice or products liability actions stemming from vaccine-related injuries and deaths. That said, as generous as these protections may be, they have boundaries, some of which are clear and others of which are unsettled. This is particularly so for in utero injuries stemming from immunization of pregnant women. The issue of whether in utero injuries are afforded such protections, vis á vis compensation by the National Vaccine Injury Compensation Program (VICP) under the Vaccine Act, has not definitively been resolved by the courts. Short of a decision by the Court of Appeals for the Federal Circuit or a statutory amendment by Congress specifically addressing this issue, the uncertainty remains.

The Supreme Court's ruling in Bruesewitz v. Wyeth interpreted the National Childhood Vaccine Injury Act to mean that vaccine manufacturers, unlike the manufacturers of other products, are not liable for injuries caused by defective designs.

The doctrine of informed consent forms an integral part of any doctor-patient relationship. It serves two-fold as it develops trust and confidence in the patient for the doctor after being told about the plan of action; conversely the doctor can carry out planned medical interventions in a more composed manner, being confident in the protection of this doctrine if anything untoward occurs. Informed consent gives a blanket shield against compensation and criminal negligence charges filed by patients if the doctor has not deviated from standard practices of treatment or intervention or if no evidence of mal intention is forthcoming. Informed consent is applicable in most of the treatment modalities in which any intervention/invasive procedure is to be done or if any risk of complication is well known or documented. Surprisingly, even when serious life threatening complications are not only reported but on a steady rise due to vaccines, informed consent in vaccination is neither in vogue nor practice. Even in the US, there is no federal requirement for informed consent before vaccination, even though National Childhood Vaccine Injury Act and the Vaccine Compensation Amendments are in place. This paper attempts to present an overall comment on the necessity of informed consent before any vaccination especially in the Indian context in the backdrop of the beginning of vaccine compensation claims and litigation against the complications of vaccination in India.

The National Childhood Vaccine Injury Act of 1986, as amended, established the Vaccine Injury Compensation Program (VICP). The VICP went into effect on October 1, 1988 and is a Federal "no-fault" system designed to compensate individuals, or families of individuals, who have been injured by covered vaccines. From 1988 until July 2006, a total of 2531 non-autism/thimerosal and 5030 autism/thimerosal claims were made to the VICP. The compensation paid for the non-autism/thimerosal claims from 1988 until 2006 was $902,519,103.37 for 2542 awards. There was no compensation for any of the autism/thimerosal claims. On the basis of the deaths and extensive suffering to patients and families from the adverse reactions to vaccines, all physicians must provide detailed information in the Vaccine Information Statement to the patient or the parent or legal guardian of the child about the potential dangers of vaccines as well as the VICP.

The purpose of this report is to provide further information about vaccine information statements (VISs) that are revolutionary but neglected educational advances in the United States. Because the use of VISs is mandated by the Federal Government in every individual being immunized, it is the goal of this report to further awaken health professionals and society to the mandatory use of these superb educational statements. With the passage of the National Childhood Vaccine Injury Act of 1986, the Federal Government required that VISs would be given to all vaccine recipients. As of September 2001, the VISs that must be used are diphtheria, tetanus, pertussis, (DTaP); diphtheria, tetanus (Td); measles, mumps, rubella (MMR); polio (IPV); hepatitis B; Haemophilus influenzae type b (Hib); varicella; and pneumococcal conjugate. Copies of the VISs are available at www.cdc.gov/nip/publications/VIS. The National Childhood Vaccine Injury Act of 1986 mandated that all health care providers report certain adverse events that occur following vaccination. As a result, the Vaccine Adverse Events Reporting System (VAERS) was established by the FDA and the Centers for Disease Control and Prevention (CDC) in 1990. In order to reduce the liability of manufacturers and healthcare providers, the National Childhood Vaccine Injury Act of 1986 established the National Vaccine Injury Compensation Program (NVICP). This program is intended to compensate those individuals who have been injured by vaccines on a no-fault basis. While the use of VISs has been mandated since 1996, a national survey of private practice office settings has revealed that many immunized patients do not receive the VISs. When these forms were used, physicians rarely initiated discussions regarding contraindications to immunizations or the National Vaccine Injury Compensation Program. Fortunately, the state boards of medical examiners, like the one in Oregon, are taking a strong stand for the use of VISs, with the warning that failure to use a VIS may result in disciplinary action. Our nation and practicing physicians must be awakened to the importance of the use of VISs to ensure that every vaccinated individual receives this statement at the time of vaccination.

Introduction.— The National Childhood Vaccine Injury Act (NCVIA) requires that physicians distribute the appropriate Vaccine Information Statements (VIS) at each immunization visit and discuss the risks/benefits of every vaccine given. In a national study, 31% of pediatricians reported not using the VIS and 56% indicated that time was a barrier to vaccine risk/benefit communication. Parents, however, indicated they want their primary providers to personally tell them about risks/benefits. Objective.— To test the feasibility of an Immunization Education Package (IEP) intervention to improve compliance with the federal mandate and to improve physician/parent vaccine risk/benefit communication. Setting.— Two multiphysician private pediatric practices in Shreveport, La. Design.— A before-after trial with comparison of 130 preintervention and 78 postintervention visits. Research assistants recorded content and duration of immunization discussions during well-baby visits during which immunizations were scheduled. Clinic staffs were masked as to variables recorded. Intervention.— The IEP was a multifaceted intervention, involving a practice-based in-service and distribution and discussion of ready-to-use materials including an exam room poster entitled "7 Questions Parents Need To Ask About Baby Shots." Results.— Patients were 90% white and 96% privately insured. Pre and post results revealed a significant increase in VIS distribution (33% vs 91%, P P P Conclusions.— This IEP was a feasible way to facilitate compliance with the NCVIA. A significant amount of additional information was provided to parents with only a slight increase in time.

In the United States recording accurate vaccine lot numbers in immunization records is required by the National Childhood Vaccine Injury Act and is necessary for public health surveillance and implementation of vaccine product recalls. However, this information is often missing or inaccurate in records. The Food and Drug Administration (FDA) requires a linear barcode of the National Drug Code (NDC) on vaccine product labels as a medication verification measure, but lot number and expiration date must still be recorded by hand. Beginning in 2011, FDA permitted manufacturers to replace linear barcodes with two-dimensional (2D) barcodes on unit-of-use product labels. A 2D barcode can contain the NDC, expiration date, and lot number in a symbol small enough to fit on a unit-of-use label. All three data elements could be scanned into a patient record. To assess 2D barcodes' potential impacts, a mixed-methods approach of time-motion data analysis, interview and survey data collection, and cost-benefit analysis was employed. Analysis of a time-motion study conducted at 33 practices suggests scanning 2D-barcoded vaccines could reduce immunization documentation time by 36-39 s per dose. Data from an internet survey of primary care providers and local health officials indicate that 60% of pediatric practices, 54% of family medicine practices, and 39% of health departments would use the 2D barcode, with more indicating they would do so if they used electronic health records. Inclusive of manufacturer and immunization provider costs and benefits, we forecast lower-bound net benefits to be $310-334 million between 2011 and 2023 with a benefit-to-cost ratio of 3.1:1-3.2:1. Although we were unable to monetize benefits for expected improved immunization coverage, surveillance, or reduced medication errors, based on our findings, we expect that using 2D barcodes will lower vaccine documentation costs, facilitate data capture, and enhance immunization data quality.

With growing public fear about vaccine safety, declining vaccination rates and reports of pertussis outbreaks, this article is a thought-provoking and critical account of vaccine policymaking and vaccination law in the United States. This topic is of utmost importance to current public health policy. Vaccines are legally classified as unavoidably unsafe products, yet they are mandated for day care or school entry for all American children unless an exemption is granted. Vaccines are the only medical intervention mandated for healthy children, and each child is at risk of adverse side effects. U.S. government health officials and U.S. vaccine manufacturers endorse them as a safe and effective means of preventing infectious disease. Mounting evidence, however, suggests otherwise.This article provides a unique commentary on morality and justice in our society through the prism of the diphtheria-tetanus-pertussis vaccine. A historical account of this vaccine highlights its known dangerous propensities as an example of an unsafe vaccine and defectively designed vaccine. History demonstrates how the U.S. has lagged behind international countries on vaccine safety. Since the 1950’s U.S. government health officials were aware of this vaccine causing serious adverse reactions including death and severe neurological impairment in children. Despite this knowledge and U.S. vaccine manufacturers having the methodology and technology to develop a safer alternative feasible vaccine, it took many decades of litigation, consumer advocacy, international scientific research and congressional action to effectuate change for a safer vaccine for children.In the 1980’s, increasing lawsuits against U.S. diphtheria-tetanus-pertussis vaccine manufacturers and mounting political pressure led to a crisis. Instead of making vaccine safety a top priority by having U.S. vaccine manufacturers develop a safer alternative feasible vaccine, Congress enacted the National Childhood Vaccine Injury Act of 1986. Effectively, this legislation was a government bailout of the U.S. vaccine manufacturing industry as it gave U.S. vaccine manufacturers, physicians and health care professionals who administer vaccines substantial liability protection from vaccine injury claims. The immense liability protection granted to U.S. vaccine manufacturers is particularly troubling given its pervasive influence and significant omnipresence in vaccine policymaking. U.S. government health officials in charge of promulgating vaccine policy are often in the same circle as those who profit financially from vaccine sales. With liberal grants of waivers to numerous and substantial conflict of interests, U.S. government health officials allow the approval of unsafe vaccines on the market. As a result, this law not only insulated U.S. vaccine manufacturers from liability, but it also created perverse incentives and paved the way for potentially more unsafe vaccines to flood the market.Since 1986 rights to compensation for vaccine injuries have significantly narrowed. Through administrative and judicial interpretation, the vaccine injury compensation process has become increasingly adversarial, expensive, difficult and lengthy. In 2011, the U.S. Supreme Court ruled that U.S. vaccine manufacturers cannot be held liable for defectively designed vaccines. This decision greatly exacerbates the danger facing American schoolchildren and allows unsafe vaccines to remain on the market and bypass all current safeguards under the law.Based upon the evidence, U.S. government officials, U.S. medical organizations and individuals with substantial financial relationships with U.S. vaccine manufacturers generate propaganda to endorse the belief that vaccines are safe and effective despite knowledge they are not; use scare tactics, coercion and other deceptive means to increase vaccination rates; withhold vaccine safety information from the public; and disseminate false information about the risks of infectious disease, infectious disease outbreaks and adverse side effects following vaccination. Furthermore, there is credible evidence U.S. vaccine manufacturers exert undue influence in Congress and in other government entities to systematically restrict the rights to vaccine injury compensation while simultaneously use that influence to generate vast financial profits for themselves. Based upon the evidence, corruption, fraud and malfeasance leave little choice for parents and forces them to participate unwillingly or unknowingly in a dangerous and fraudulent financial scheme. Lastly, this compelling article provides original recommendations for Congress to rectify the grave, immediate danger in order to provide better protection and give justice to our nation’s children.

The National Childhood Vaccine Injury Act of 1986 was funded with an earmarked tax in an attempt to prevent a perceived crisis that was developing in the United States regarding the availability and affordability of vaccines for life-threatening childhood illnesses. The federal government felt compelled to intervene in a perceived failure of the private marketplace. In short, the inability of several pharmaceutical firms to obtain liability insurance due to high damage awards forced them to leave the marketplace or self-insure. This article details the history of the vaccine tax policy issues and updates the experiences of the financing mechanism. As the federal government attempts to broaden its role in the health care delivery system, the possibility of similar interventions exist.

The National Childhood Vaccine Injury Act of 1986 established the National Vaccine Injury Compensation Program to compensate people thought to be injured by certain vaccines. The act's goals are to ensure an adequate supply of vaccines, to stabilize vaccine costs, and to establish and maintain an accessible and efficient setting for providing compensation to people found to have been injured by certain childhood vaccines. In addition, the legislation called for the reporting of adverse events after vaccination, the creation of vaccine-information materials that detail vaccine benefits and risks, and Institute of Medicine studies of possible vaccine-related injuries and encouraged research and development of new and safer vaccines. Over its 22-year history, the National Vaccine Injury Compensation Program has been a key component in stabilizing the US vaccine market through liability protection to both vaccine companies and health care providers and by providing a forum for people, no matter what age, to seek compensation.

On July 3, 1991, the National Academy of Sciences' Institute of Medicine (IOM) released a reported entitled, Adverse Effects of Pertussis and Rubella Vaccines,1 in response to a congressional request to review evidence about a set of serious adverse events and immunization with pertussis and rubella vaccines. The request originated in the 1986 National Childhood Vaccine Injury Act (Public Law 99-660), whose primary purpose was to establish a federal compensation scheme for persons potentially injured by a vaccine; Section 312 of Public Law 99-660 called for the IOM review. Over the course of its 20-month study, the 11-member interdisciplinary committee constituted by IOM to conduct the review examined altogether 18 adverse events for pertussis vaccine—infantile spasms; hypsarhythmia; aseptic meningitis; acute encephalopathy; chronic neurologic (permanent brain) damage; deaths classified as sudden infant death syndrome (SIDS); anaphylaxis, autism; erythema multiforme or other rashes; Guillain-Barré syndrome (polyneuropathy); peripheral mononeuropathy; hemolytic anemia; juvenile diabetes; learning disabilities and hyperactivity; protracted inconsolable crying or screaming; Reye's syndrome; shock and "unusual shock-like state" with hypotonicity, hyporesponsiveness, and short-lived convulsions (usually febrile); and thrombocytopenia—and 4 adverse events for rubella vaccine—acute arthritis; chronic arthritis; radiculoneuritis and other neuropathies; and thrombocytopenic purpura. In conducting its review, the committee recognized that its charge was to focus on questions of causation and not broader topics, such as cost-benefit or risk-benefit analyses of vaccination. This summary begins with a brief history of events leading to the IOM study, then reviews the methods used by the committee to evaluate the evidence, summarizes the committee's conclusions for these adverse events, and offers directions for future investigation of adverse events in connection with widely used health interventions, such as vaccination.

The purpose of this article is to look at the effect of the federal compensation scheme under the National Childhood Vaccine Injury Act on the people and institutions involved in the administration of vaccinations. More vaccine-injured children will probably recelve compensation than would have been true under state law, but each child will probably receive less money for damages. Manufacturers will pay excise taxes to fund the compensation scheme and receive, in return, substantial immunity from liability under state law. Although these provisions create incentives that work in opposite directions, producers likely will still have reason to improve the safety and efficacy of vaccines. The situation for those who administer vaccinations is less clear. Freeing them from the threat of litigation would leave them with little incentive to use immunizations appropriately because they do not contribute to the compensation scheme. Although Congress intended to make those who give vaccines immune from state claims, it may have failed to do so, leaving providers with their liability largely unchanged (see addendum to this article for recent congressional action). The most pervasive uncertainty is that the Act is designed to self-destruct and may soon return vaccine-injured children, manufacturers, and providers to the state of the law before Congress acted.

Vaccine risk/benefit communication is a mandatory requirement set forth by the National Childhood Vaccine Injury Act and is essential in enabling parents to make an informed decision about having their children vaccinated. This article is designed to improve vaccine risk/benefit communication in pediatric primary care. Current research related to previous efforts used to educate parents about vaccine safety are reviewed. Time-efficient strategies to improve vaccine risk/benefit communication are recommended. An example of an open communication letter and a list of reputable vaccine information resources are also provided.

The National Childhood Vaccine Injury Act of 1986 (the Act) established the National Vaccine Injury Compensation Program (VICP) as a federal "no-fault" compensation system for individuals who may have been injured by specific covered vaccines. Entering its ninth year of operation, the VICP has ensured childhood vaccine supplies by dramatically reducing vaccine companies' and providers' liability that threatened the production of vaccines during the 1980s. The VICP has received 5057 petitions filed for possible injury from vaccines covered under the VICP, including 4240 filed for vaccines administered before October 1988, and 817 for vaccines administered between October 1988 and August 1996. Over 3700 claims have been adjudicated, 985 of which have been found to be compensable, and the remainder have been dismissed. The Vaccine Injury Table (the Table) lists specific injuries or conditions and timeframes after vaccination that may be compensated under the VICP. The Table establishes legal presumptions about causation, which are used by the US Court of Federal Claims (the Court) to adjudicate petitions. The VICP covers seven "childhood" vaccines: diphtheria, pertussis, tetanus, measles, mumps, rubella, and polio. Effective March 10, 1995, the Table was revised to better reflect current scientific knowledge about vaccine injuries (Table 1). As part of the Act, Congress mandated a review of the scientific literature and other information on specific adverse consequences of pertussis and rubella vaccines. The Institute of Medicine (IOM) performed and published a report of this review in 1991, and a review of a follow-up study of the National Childhood Encephalopathy Study in 1994.

On February 22, 2011, in the case of Bruesewitz v Wyeth ,1 the US Supreme Court preserved the crucial role of the National Childhood Vaccine Injury Act (NCVIA) in ensuring the continuing availability of children's vaccines in the United States. Although at first glance the Bruesewitz case may seem to be simply a technical decision that addressed the legal intricacies of products liability law, the case has important implications for pediatricians, their patients, and the continuity of our vaccine supply. By the 1980s, vaccines had become so successful at preventing many infectious diseases that the public was becoming much less alarmed by those diseases2 and much more concerned with the risk of injury from the vaccines themselves.3 As a result, the number of lawsuits alleging vaccine-related injuries exploded, driving manufacturers from the market and producing vaccine shortages. In 1986, the US Congress enacted … Address correspondence to Gary N. McAbee, DO, JD, Department of Neuroscience, New Jersey Neuroscience Institute, 65 James St, Edison, NJ 08818. E-mail: gmcabee{at}solarishs.org

Primary care providers are uniquely able to have an impact on the lives of their patients. Patients generally respect their physicians and will follow advice given about preventive care. The well-informed physician can guide patients about commonly needed vaccines as well as vaccines with fewer indications, such as those for Haemophilus influenzae type B or Lyme disease. Some patients express concerns and reasons to avoid immunization; however, contraindications to vaccination are few and specific. A history of severe immediate-type hypersensitivity reaction to a vaccine or its components (e.g., neomycin, gelatin, egg, baker's yeast) and concurrent moderate-to-severe illness form the basis for most contraindications. A personal history of allergies, penicillin allergy, or a family history of vaccine reaction do not constitute reasons not to vaccinate patients. A history of mild local reaction at the injection site, mild concurrent illness with or without fever, current antibiotic use, or the convalescent phase of an infection also are not valid contraindications. Occasionally, there is concern about the number of vaccines given simultaneously. There is no documented risk of decreased efficacy or increased adverse events with simultaneous administration of numerous vaccines. Any of the vaccines discussed in this article can be administered simultaneously. There is a theoretical concern that an attenuated live virus vaccine might impair the response to a live virus vaccine given subsequently. One should either give these vaccines simultaneously or wait 30 days to give the second one. The administration of immune globulin via packed red blood cells, whole blood, intramuscular immune globulin, or intravenous immune globulin may interfere with viral replication in attenuated vaccinations. After an immune globulin preparation is received, live vaccine should not be administered before the recommended interval, at least 3 months. One should not delay measles-mumps-rubella (MMR) vaccinations in a rubella- or measles-susceptible woman because the patient required anti-RHO immunoglobulin or any other blood product during pregnancy or delivery. If necessary, these patients can be vaccinated after delivery and subsequently tested in 3 months to ensure immunity to rubella or measles. Immune globulin preparations do not interfere with the efficacy of killed vaccines. Breastfeeding is not affected by either killed or live vaccines. No vaccination is contraindicated by breastfeeding. Health care providers in the United States must give a vaccine information statement (VIS) to all vaccine recipients at each dose of diphtheria, tetanus, pertussis, measles, mumps, rubella, polio (either oral or inactivated), hepatitis B, H. influenzae type B, and varicella vaccine as required by the National Childhood Vaccine Injury Act (NCVIA) of 1986. The Centers for Disease Control (CDC) have prepared VISs for other vaccines as well, including pneumococcal polysaccharide, hepatitis A, influenza, and Lyme disease. VISs covered under the NCVIA must not be amended, although the health care worker can add his or her practice name and address. Copies are available from local health departments or on the Web at www.cdc.gov/nip/publications/vis. These documents may be photocopied without prior permission. 1,4 Although current vaccines are safe and efficacious, adverse events have been reported following all vaccines. Selected events must be reported to the Vaccine Adverse Events Reporting System (VAERS). Any adverse event should be reported via this mechanism regardless of whether it is thought to be causally related to the vaccination. VAERS forms are available in the Physician's Desk Reference or by calling a 24-hour recording at 1-800-822-7967.

* Abbreviations: AAP = : American Academy of Pediatrics • ACIP = : Advisory Committee on Immunization Practices • IPV = : inactivated polio vaccine • FDA = : Food and Drug Administration • DTwP = : diphtheria and tetanus toxoids and whole-cell pertussis vaccine • DTaP = : diphtheria and tetanus toxoids and acellular pertussis vaccine • DTP = : diphtheria, tetanus, and pertussis vaccine • CDC = : Centers for Disease Control and Prevention • NCVIA = : National Childhood Vaccine Injury Act • VICP = : Vaccine Injury Compensation Program • IOM = : Institute of Medicine • OPV = : oral polio vaccine • VIS = : Vaccine Information Statements Concern over vaccine safety has been a major determinant of immunization policy—from passage of the Biologics Control Act in 1902 to the recent American Academy of Pediatrics (AAP) and Advisory Committee on Immunization Practices (ACIP) recommendations for expanded use of inactivated polio (IPV) and acellular pertussis vaccines.1-4 With the availability of new vaccines and vaccination options comes the challenge of how best to communicate these options to patients and their parents. Lessons from the field of risk communication on predictors of risk acceptability and vaccination decision heuristics provide insight into why some parents resist vaccination. This article provides a historical perspective on vaccine adverse events and applies lessons from risk communication research to help physicians improve their ability to discuss vaccine risks. Immunizations have been described as the single most effective health intervention after clean water and sewage disposal,5 and have an extraordinary safety record. However, public policy has long reflected concern for the safety of vaccines and related biologics. In 1902, Congress passed the Biologics Control Act in response to the death of 13 children who had received injections of diphtheria antitoxin contaminated with tetanus toxin.6 This act required biologics to be manufactured in a manner that assured their safety, purity, and potency. Responsibility for these regulations was assigned originally to the Hygienic Laboratory of the Public Health Service, which evolved into the National Institutes of Health. The regulation of biologics including vaccines was transferred to the Food and Drug Administration (FDA) in 1972. The first published accounts of serious adverse events after whole cell pertussis vaccine occurred in 1933 with Madsen's7 report of two deaths within 48 hours of immunization, and in 1948 with the report in Pediatrics by Byers and Moll8 of encephalopathy after diphtheria and tetanus toxoids combined with whole-cell pertussis …

ON FEBRUARY 22, 2011, THE US SUPREME COURT decided Bruesewitz v Wyeth LLC, holding that the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts all design defect claims against vaccine manufacturers in which the plaintiff seeks compensation for injury or death caused by a vaccine’s adverse effects. The public health implications are profound because Congress designed the NCVIA to safeguard a social compact—ensuring access to vaccines by preventing the uncertainty of litigation, while also ensuring vaccine safety and effectiveness.

The US Supreme Court has ruled by a 6-2 majority that vaccine manufacturers cannot be sued over claims of design defects in their products. The court was ruling on a case brought by the parents of a child who developed seizures after a routine diphtheria-pertussis-tetanus (DPT) vaccination (Bruesewitz v Wyeth Inc). It ruled that an act passed by Congress in 1986, which set up a no fault scheme to compensate any child injured by vaccine side effects, bars lawsuits against vaccine manufacturers. “The National Childhood Vaccine Injury Act pre-empts all design defect claims against vaccine manufacturers brought …

Practitioners seeing individual patients and those charged with improving immunization practices in that population need accurate information on the epidemiology of immunizations within the population. To meet this need, we have developed a computer-based record of data required by the National Childhood Vaccine Injury Act of 1986 for all immunizations given to 350,000 enrollees in a large health maintenance organization. In the first eight months of operation, 102,271 immunizations representing 11 separate antigens given to 65,676 enrollees were entered into the database. Comparison of immunizations given and recorded in the medical record with the database shows that the system has high sensitivity, specificity, and positive predictive value, but a relatively low negative predictive value. The database is being used for analysis of current immunization practices for Haemophilus influenzae b vaccine and for research on adverse outcomes of childhood immunizations.

Sir .—A government committee report on the reputed adverse effects of pertussis vaccine 1 continues a "sorry saga whose principle victims are children." 2 This committee was selected in consultation with the Advisory Commission on Childhood Vaccines, a nine-member group composed of at least two pediatricians and five attorneys or legal representatives, in accordance with the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660). The government committee concluded that an acute encephalopathy can result from the administration of killed whole-cell pertussis vaccine, or, in their words, "the evidence is consistent with a causal relation" between diphtheria and tetanus toxoids and pertussis vaccine administration and an acute encephalopathy. This conclusion is contrary to that of the American Academy of Pediatrics, the Canadian National Advisory Committee on Immunization, the British Pediatric Association, 3 and Golden, 4 a member of an Academy of Pediatrics Task Force that issued a separate report

is less than $20 million. Greater investment in postmarket vaccinesafety studiesandsurveillancewould allow scientists to apply genetics research tools and other scientific advances to problems such as identifying the individuals at greatest risk for vaccine-associated adverse events. Efforts should also be made to ensure that such research is well coordinated, free of conflicts of interest, and transparent. “While we make the case for how overwhelming the benefits are of vaccines compared to the low risks that exist, we owe it to the public to assure them how rigorous our studies of vaccine safety are,” Cooper said. Tayloe agreed that greater investments in vaccine safety efforts should be made to bolster public support for vaccines. Additionally, he noted that because vaccines are very safe but not completely risk-free, the United States has a system to compensate individuals who experience vaccine-associated adverse events. A lawsuit against Tayloe’s father, David Tayloe Sr, MD, by parents who believed the diphtheria-pertussistetanus vaccine harmed their child, was among the factors that led to the passage of the National Childhood Vaccine Injury Act of 1986. The act established a special vaccine court and a fund to provide compensation when an individual has an injury linked to a vaccine. The court helped to shore up public confidence in vaccines and to ensure that physicians and vaccine manufacturers could continue to offer vaccinations. The alliance is encouraging individuals to discuss vaccine-related questions with their physicians and to rely on credible information about vaccines to make decisions about their child’s health. In addition, the group is urging journalists and others communicating about vaccines, such as bloggers, to learn about the evidence supporting vaccine use and to take care in providing scientifically accurate information about vaccine safety and effectiveness. Tayloe said the coordinated approach advocated by the alliance and an ongoing commitment to ensuring high rates of vaccine coverage are essential to the public’s health. “We can’t be complacent,” he said. “These diseases will come back with a fury if we drop these efforts.”

The experience in the United States with the vaccine liability crisis demonstrates the vulnerability of public health policy and practice standards to independent developments in the legal arena. Scientific progress in the fields of immunology and molecular biology offer promise for the control of an increasing number of communicable diseases through immunization. Legal protections for pharmaceutical laboratories, manufacturers, and providers are appropriate incentives to continued development, supply, and administration of effective, affordable vaccines. At the same time, potential recourse to litigation in the courts in the event of vaccine-related injury provides society with desirable assurances of enforceable industrial and professional standards, as well as financial support for those who sustain serious adverse reactions to licensed vaccines. The National Childhood Vaccine Injury Act of 1986 is an attempt to construct an equitable solution to this dilemma. Interested physicians and lawyers will have a role to play in the search for an appropriate balance between these important but competing values. Progress in science and the law in the field of public health generally, and vaccine development specifically, should be a collaborative enterprise. Familiarity with, and respect for, the basic principles and theories of both fields will be essential to this endeavor.

Children have reactions to the diphtheria and tetanus toxoids and pertussis vaccine (DTP), but whether they have serious reactions is a matter of dispute, definition, and, perhaps, intention. The articles by Rosenthal et al 1,2 concerning the safety of whole-cell vaccine and the newly licensed acellular vaccine mentioned the word "serious" many times: reactions were characterized as serious, serious adverse, and, as a variation, severe events. Because more serious neurologic events were not reported in the prelicensure trials of the new acellular vaccines, Rosenthal et al have pursued reputed serious reactions from a much larger database, that of the United States, the largest denominator in the industrialized world. It has been, and still is, the position of the Centers for Disease Control and Prevention, Atlanta, Ga, and the National Childhood Vaccine Injury Act that acute encephalopathy can rarely follow DTP vaccination. Yet, in this study of the United States from

This volume attempts to answer many of the questions asked by pediatricians, as well as their patients, about immunization practices. A very simple statement of fact begins the report: Childhood immunization has been one of the foremost public health measures of the twentieth century. It has allowed control and prevention of many diseases from which morbidity and mortality can be staggering. The next paragraph introduces the issue, "The public policy debate regarding immunization stretches beyond the question of how to meet the goals of universal immunization," to the question of safety of pertussis vaccine and other vaccines, the media publicity attendant on the concerns, and the many groups of "interested citizens." The 1986 National Childhood Vaccine Injury Act e stablished the compensation program and the reporting system and also required the Institute of Medicine of the National Academy of Sciences to study the adverse effects via two specific studies: the

STARTING TODAY, pediatricians may want to provide more diversions in their reception rooms for young patients awaiting immunization. Children will probably have time to look through several picture books or build a fairly large house of blocks in the time it takes their parents to read one of the new federally mandated educational pamphlets about vaccines, according to several physicians familiar with the materials. Three vaccine information pamphlets, known informally as VIPs, have been produced by the Immunization Division of the Centers for Disease Control (CDC), Atlanta, Ga. Their creation was mandated to satisfy one requirement of the National Childhood Vaccine Injury Act of 1986. And now (April 15), health care providers who administer any of seven specified vaccines to a child must provide the parent or guardian with detailed information about the procedure. Adults who are about to be immunized must also be fully informed. State and local health

In Reply .—Dr Lynch raises an important point in regard to the diphtheria-pertussis-tetanus "Important Information" forms currently being distributed by the Centers for Disease Control. As noted in the 1988 Report of the Committee of Infectious Diseases of the American Academy of Pediatrics, "The National Childhood Vaccine Injury Act (PL99-660; Amended by PL100-203), which became effective in 1988 includes requirements for detailed notification of patients/parents about vaccine benefits and risks in both the private and public sectors. This legislation requires development and distribution of standardized benefits/risk statements when administering vaccines for which vaccine injury compensation is available. These statements are in preparation and physicians will be notified by the federal government when their use becomes mandatory." The Centers for Disease Control has been working on the new forms ( which will be mandatory ), and draft editions have been reviewed by many people. At present, members of the Vaccine Commission and members

In recent years, several manufacturers of vaccines have stopped or modified production because of liability claims won by injured persons. Since immunization is one of the most important preventive health care measures, the federal government has passed a new law that establishes a trust fund to compensate persons injured by vaccines. The vaccine injury law requires new recording and reporting procedures for health care providers who give vaccines or toxoids. The record-keeping and reporting requirements of the law took effect March 21, 1988. The National Childhood Vaccine Injury Act of 1986 was signed into law by President Reagan in December 1987. The law stipulates that children injured after October 1, 1988, must go through the compensation system and reject an award before attempting to sue either the manufacturer or the person who gave the vaccine. An award to a legitimate claimant in