Update on the National Vaccine Injury Compensation Program

Do Vaccines Cause Postural Orthostatic Tachycardia Syndrome? Review of Cases in the National Vaccine Injury Compensation Program

In 1986, Congress created the Vaccine Injury Compensation Program (VICP) under the National Childhood Vaccine Injury Act (1986 Law). This Program has original jurisdiction for children’s claims of vaccine injury. Because almost all children receive multiple vaccinations for daycare and school, it is critically important that the Program provides fundamental fairness, due process and transparency.\nThis empirical investigation, published in a peer-reviewed law journal, examines claims that the VICP compensated for vaccine-induced encephalopathy and seizure disorder. The VICP has compensated approximately 2,500 claims of vaccine injury since the inception of the program. This study found 83 cases of acknowledged vaccine-induced brain damage that include autism, a disorder that affects speech, social communication and behavior. In 21 published cases of the Court of Federal Claims, which administers the VICP, the Court stated that the petitioners had autism or described autism unambiguously. In 62 remaining cases, the authors identified settlement agreements where Health and Human Services (HHS) compensated children with vaccine-induced brain damage, who also have autism or an autism spectrum disorder.\nParents reported the existence of autism in telephone interviews and supplied supplemental materials including medical diagnoses, school records, and completed, standard autism screening questionnaires to verify their reports. In 39 of the 83 cases, or 47% of the cases of vaccine injury reviewed, there is confirmation of autism or autism spectrum disorder beyond parental report.\nThis finding of autism in compensated cases of vaccine injury is significant. U.S. government spokespeople have been asserting no vaccine-autism link for more than a decade. This finding calls into question the decisions of the Court of Federal Claims in the Omnibus Autism Proceeding in 2009 and 2010 and the statement of Health and Human Services on its website that “HHS has never concluded in any case that autism was caused by vaccination.”\nUsing publicly available information, the investigation shows that the VICP has been compensating cases of vaccine-induced brain damage associated with autism for more than twenty years. This investigation suggests that officials at HHS, the Department of Justice and the Court of Federal Claims may have been aware of this association but failed to publicly disclose it.\nThe study calls on Congress to thoroughly investigate the VICP, including a medical investigation of compensated claims of vaccine injury. This investigation calls on Congress to get answers to these critically important unanswered questions.

In February 2009, the National Vaccine Injury Compensation Program (VICP) released decisions for the first three test cases heard under the program's Omnibus Autism Proceeding. In each of the cases — Cedillo v. Secretary of Health and Human Services, Hazlehurst v. Secretary of Health and Human Services, and Snyder v. Secretary of Health and Human Services — the petitioners alleged that a child's autism spectrum disorder was caused by the combination of the measles–mumps–rubella (MMR) vaccine and thimerosal-containing vaccines. The decisions will have a substantial effect on vaccine policy and practice in the United States and will influence the analysis . . .

New guidelines for the national Vaccine Injury Compensation Program (VICP) have been announced. Several important changes are included in the revised Vaccine Injury Table. First, a new condition of chronic arthritis was added to the Table for vaccines containing the attenuated rubella virus. Second, the time of onset for certain conditions in relation to the time of vaccine administration was altered. For instance, the interval for onset of anaphylaxis after vaccination was shortened from 24 hours to 4 hours. Clarification of definitions of conditions such as encephalopathy were made in the Qualifications and Aids to Interpretation that accompany the Table. Finally, some conditions, such as residual seizure disorder and hypotonic-hyporesponsive episode after diphtheria-tetanus-pertussis (DTP) immunization, were removed from the Table.

Two decades ago, a liability crisis brought on by concerns about the safety of diphtheria and tetanus toxoids and pertussis vaccine led to supply shortages and calls for rationing of the vaccine. Vaccine prices skyrocketed, and research on new products was threatened. In response, Congress created the National Vaccine Injury Compensation Program, which is tort reform legislation designed to compensate individuals quickly, easily, and generously. Since 1988, the Vaccine Injury Compensation Program has stabilized the marketplace, as evidenced by high immunization rates, stable pricing, and an increasing number of vaccine candidates in development. Although current vaccine shortages do not appear to be related to issues of liability, a new wave of tort litigation alleging that some vaccines cause autism has led to speculation that history could repeat itself.

Nobel Laureate Charles Richet demonstrated over a hundred years ago that injecting a protein into animals or humans causes immune system sensitization to that protein. Subsequent exposure to the protein can result in allergic reactions or anaphylaxis. This fact has since been demonstrated over and over again in humans and animal models. The Institute of Medicine (IOM) confirmed that food proteins in vaccines cause food allergy, in its 2011 report on vaccine adverse events. The IOM’s confirmation is the latest and most authoritative since Dr. Richet’s discovery. Many vaccines and injections contain food proteins. Many studies since 1940 have demonstrated that food proteins in vaccines cause sensitization in humans. Allergens in vaccines are not fully disclosed. No safe dosage level for injected allergens has been established. As a result, allergen quantities in vaccines and injections are not regulated. Allergen quantities in vaccine excipients are also not regulated. It has been demonstrated that a smaller quantity of allergen is needed to cause sensitization than elicitation. It is well recognized that many currently approved vaccines have enough allergen to cause anaphylaxis. Therefore, they contain more than enough allergen to cause sensitization. Children today have fewer childhood infectious diseases. They have less exposure to helminths. C-section birth rates have increased in the last few decades by 50%. C-section births are known to result in sub-optimal gut micro biome in the newborn. All the above result in an immune imbalance biased towards atopy. Vaccine schedules today include 30-40 shots. Up to five shots may be simultaneously administered in one sitting. Vaccines contain adjuvants such as pertussis toxins and aluminum compounds that also bias towards allergy. Adjuvants also increase the immunogenicity of injected food proteins. This combination of atopic children and food protein injection along with adjuvants, contributes to millions developing lifethreatening food allergies. Given the scale and severity of the food allergy epidemic, urgent action is needed to change vaccine policy concerning vaccine specifications, manufacture, vaccine package insert documentation requirements, the Vaccine Adverse Event Reporting System (VAERS) and the National Vaccine Injury compensation program. Many researchers have called for the removal of food proteins from vaccines and re-evaluation of adjuvants such as aluminum compounds. In the interim, food allergy warnings can be included in vaccine package inserts. Simultaneous administration of multiple vaccines can be stopped to avoid the combined negative effects of multiple food proteins and adjuvants.

<i>Sir</i>.—Orenstein's letter,¹published in the May 1990 issue of<i>AJDC</i>, points out what is naive and bad in current thinking concerning litigation over the diphtheria and tetanus toxoids and pertussis vaccines. The National Vaccine Injury Compensation Program, effective October 1, 1988, was the most naive, if not the most stupid attempt at controlling a segment of our legal system that needs to be controlled. Intended to offer a good method of avoiding costly legal battles, it did just the opposite. Lawyers now have two recourses to sue. They can always sue if the National Vaccine Injury Compensation Program is not to their liking. For the private sector, the program did nothing but increase our cost of the vaccine to approximately $17 per dose (not the $7.96 the government pays). Numerous studies have indicated that the vaccine itself had nothing to do with the "brain damage" reported by attorneys

Vaccination has been an effective method to prevent and control diphtheria, tetanus, pertussis and polio diseases in infancy and adults for years. To maintain the protective effect, a DTaP-IPV vaccine, Tetraxim, was introduced into Taiwan’s national immunization program for children at 5 years of age after primary series vaccination in infancy in October 2017 replacing a Tdap-IPV. To survey the safety of this vaccine, data between 01 October 2017 and 31 December 2020 from two surveillance systems, the Vaccine Adverse Events Reporting System (VAERS) and Vaccine Injury Compensation Program (VICP), were reviewed. We analysed patient’s demographics, symptoms, time of onset, and outcome. A total of 667,497 doses of DTaP-IPV vaccine were administered during the study period. We combined data from VAERS and VICP and deleted duplicate subjects and reports. There was a total of 59 subjects with AEs and the reporting rate of AEs was 8.8 subjects per 100,000 doses. The most common AEs were injection site erythema and swelling. AEs occurred with a median 1 day after vaccination (range 0–3 days). Among the 59 subjects, eight (13.6 %) with serious AEs were hospitalized. These serious AEs included injection site erythema, swelling or extensive limb swelling after vaccination and hospitalization might have been due to ELS that was misdiagnosed as cellulitis. The national passive surveillance data support the safety profile of Tetraxim as a school-entry booster in children at 5 years old in Taiwan.

Using and Misusing Legal Decisions: Why Antivaccine Claims About NVICP Cases Are Wrong

National vaccine injury compensation program

In the United States, drugs are jointly regulated by the US Food and Drug Administration, which oversees premarket clinical trials designed to ensure drug safety and efficacy, and the liability system, which allows patients to sue manufacturers for unsafe drugs. In this paper, we examine the potential welfare effects of this dual system aimed at ensuring the safety of medical products, and conclude that product liability exemptions for FDA regulated activities could raise economic efficiency. We show that while reductions in liability, such those associated with pre-emption, may lower welfare in the absence of the FDA, they may raise welfare in its presence. In the presence of the FDA, product liability may reduce efficiency by raising prices without pushing firms, who are already bound by the agency's requirements, to invest further in product safety. We consider as a case study the National Vaccine Injury Compensation Program, which sharply reduced vaccine manufacturer's liability in 1988. We find evidence that the program reduced prices without affecting vaccine safety, suggesting that liability reductions can enhance economic efficiency in the presence of the FDA.

Vaccines are so far proven to be safe, although related adverse events cannot be excluded. The urgency for COVID-19 vaccines determined a dilution of the general expectations of safety and efficacy of vaccination (from safe and effective to safe and effective enough). In many countries, a no-fault program was established to compensate individuals who experienced serious vaccine-related injuries. The impressive number of administrations worldwide and the legal indemnity afforded to manufacturers of approved vaccines that cannot be pursued for compensation fed the debate about the availability of a compensation model for COVID-19 vaccine-related injuries. Several European countries have long introduced a system, Vaccine Injury Compensation Programs, to compensate people who suffer physical harm because of vaccination. In Europe, COVID-19 vaccination is strongly recommended for the general population and in many states is declared mandatory for healthcare workers. In 1992, Italy edited Law no. 210 providing legal protection for individuals who reported injuries after mandatory and recommended vaccinations as a no-fault alternative to the traditional tort system. Despite its recommended nature, COVID-19 vaccination is excluded from the no-fault model in several European states, and the Italian government is called to provide clear and firm instructions for the management of the many requests for compensation. The authors provide an overview of the existing compensation models in Europe and analyse available legislative proposals.

By Paul A. Offit New Haven:Yale University Press, 2005. 238 pp. ISBN: 0-300-10864-8, $27.50 This entertaining, well-written book provides valuable insights into three interrelated areas, all built around the story of the Cutter incident, a landmark case that in some ways continues to have implications for product liability and the health of the vaccine industry today. The author, Paul Offit, has an admirable ability to present complicated issues in a way that is easy to understand for both technical and nontechnical audiences, and the book should (and does) have wide appeal. The first part of the story deals with the actual incident, which involved the failure to completely inactivate the very first lots of inactivated poliovaccine licensed for use in the United States, and the resulting epidemic of iatrogenic paralytic polio. This incident holds many lessons for us today. Offit shows how the ultimate outbreak was really the consequence of multiple factors: an inactivation procedure that was not completely understood by the manufacturers, testing algorhythms that were relatively insensitive for detection of remaining live virus in the final preparations, the use of an extremely virulent virus as the starting material for one of the three strains, and, most unpredictable of all, the enormous consequences of a seemingly trivial process change—the substitution of glass filters in a critical step in the processing of the culture lysates. Most disasters are the result of multiple synergistic failures, not all of which are predictable, and the Cutter incident is a good illustration of this. The second part of the story describes the resulting product liability trial, in which the manufacturer of the vaccine, Cutter Laboratories, was found to be liable even though it was not negligent. Cutter followed all available guidelines in production of the vaccine and only released lots that had passed recommended safety tests. However, the vaccine, rather than preventing polio as it was supposed to do, actually caused polio instead. In the trial, the jury did not find Cutter to have been negligent in the manufacture of the vaccine. However, Cutter was found to have violated the implied warranty that its product, when used as directed, would be safe and effective for its intended purpose. The author makes a convincing argument that this case set a precedent for liability without negligence that ultimately almost destroyed the vaccine industry in the United States. Only the Vaccine Injury Compensation Program, in which claims against manufacturers are first arbitrated by a panel of experts, has kept manufacturers in the game. The third part of the story is a more speculative discussion of the role product liability has played in the currently tenuous situation facing our supply of critical vaccines in the United States. This complex situation involves not only product liability but the economics of the marketplace, the role of government funding for vaccines, and probably other issues as well. However, product liability clearly also plays a role, and continues to have an impact today. For example, legislation protecting manufacturers of potential pandemic vaccines against product liability claims has emerged as a critical issue, which will be required for adequate control of the current avian influenza threat, much as it was in 1976. Thimerosal, which has now been convincingly demonstrated to have no association with neurodevelopmental disorders, has in the meantime continued to be a source of liability claims and state legislation. Vaccines have had a profound influence on human health and have been responsible for the complete elimination of smallpox, the elimination of measles and polio transmission in the Western Hemisphere, and many other benefits. However, to be effective, vaccines must be administered to very large numbers of healthy individuals. For this reason, vaccine safety always has been, and will remain, a preeminent concern among those involved in controlling human disease. This book should be of value to anyone who must deal with issues related to exposure of large populations to interventions.

ObjectivesThis study aimed to assess the impact of high-level versus low-level construal messages about the coronavirus disease 2019 (COVID-19) Vaccine Injury Compensation Program (CVICP) on public attitudes toward the program and COVID-19 vaccination.MethodsA randomized controlled experimental design was employed. Adults aged 18 to 64 residing in the Republic of Korea were randomly assigned to either an experimental group (high-level construal message) or a control group (low-level construal message). Both groups viewed a 2-minute video about the CVICP, with construal level as the sole variable. Pre- and post-intervention questionnaires evaluated attitudes toward the CVICP and COVID-19 vaccination, including satisfaction, perceived necessity, and perceived effectiveness in enhancing vaccine acceptance. Data were analyzed using the paired t-test, repeated measures 2-way analysis of variance, and multiple linear regression.ResultsThe experimental group showed statistically significant improvements across all 6 attitude measures following exposure to the high-level construal message. By contrast, the control group demonstrated significant improvement in only 3 attitudes: satisfaction with the CVICP, willingness to recommend vaccination, and willingness for future vaccination. A significant difference between groups was observed for perceived effectiveness of the CVICP in enhancing vaccine acceptance (p=0.01), with high-level construal messaging being more impactful.ConclusionHigh-level construal messages are more effective than low-level messages in shaping public perceptions and addressing vaccine hesitancy. Policymakers and health authorities should incorporate high-level construal elements into communication strategies to build trust and support for vaccination programs.

The COVID-19 vaccination has proven to be the most effective prevention measure, reducing deaths and hospitalizations and allowing, in combination with non-pharmacological interventions, the pandemic to be tackled. Although most of the adverse reactions to vaccination present mild symptoms and serious effects are very rare, they can be the cause of legal action against the healthcare workers (HCWs) who administered it. To highlight differences in the medical liability systems, we performed a search for the three most populous countries in each continent on vaccine injury compensation programs, new laws or policies to protect HCWs administering vaccinations introduced during the COVID-19 pandemic, and policies on mandatory vaccinations, on literature databases and institutional sites. We found that in seven countries the medical liability system is based on Common Law, while in eleven it is mainly based on Civil Law. Considering the application of specific laws to protect HCWs who vaccinate during the pandemic, only the USA and Canada provided immunity from liability. Among the countries we analyzed, fourteen have adopted compensation funds. From an international perspective, our results highlight that in eleven (61.1%) countries medical liability is mainly based on Civil Law, whilst in seven (38.9%) it is based on Common Law.