National Vaccine Injury Compensation Program Research Articles

Characterization of Brighton Collaboration criteria for myocarditis and pericarditis following COVID-19 vaccine in Korean adolescents

BackgroundVaccines are vital for public health, but concerns about adverse effects, particularly myocarditis and pericarditis linked to COVID-19 vaccines-, persist. This study investigates the application of Brighton Collaboration case definition to national vaccine safety data related to post-COVID-19 vaccine myo/pericarditis, utilizing claims under the Korea National Vaccine Injury Compensation Program (NIVCP). MethodsThis study analyzed 190 medical records of individuals who claimed to have developed myo/pericarditis after receiving the COVID-19 vaccine, as reported to the NVICP between specified dates, categorizing cases based on the Brighton criteria for myocarditis or pericarditis. ResultsBetween 2021–2022, NVICP received 190 cases meeting the Brighton criteria for myocarditis or pericarditis at levels 1, 2, or 3. Most cases fell into Level 2 (70%), followed by Level 1 (29%), and one at Level 3 (1%), with Level 1 cases showing a higher hospitalization rate (87.3%) and a notable proportion requiring admission to the Intensive Care Unit (25.5%). Chest pain and Troponin-I/T elevation were common findings in Level 1 cases, while Level 2 cases exhibited similar patterns but at a slightly lower frequency. Electrocardiogram and echocardiography findings differed between the two levels. ConclusionThe Brighton Collaboration case definition proved valuable for classifying and assessing AEFI data, enhancing our understanding of the potential relationship between myocarditis and the COVID-19 vaccine.

COVID-19 Vaccine Injury Compensation Program: Lessons Learned From a Review of 10 Implementing Countries.

National vaccine injury compensation serves as a crucial and significant safety net for individuals affected by government-recommended vaccines during a pandemic, contributing to the community's overall safety. In the Republic of Korea, compensation for adverse events resulting from coronavirus disease 2019 (COVID-19) vaccinations has been provided through the National Vaccine Injury Compensation Program introduced in 1995. However, there have been limitations with these measures during the COVID-19 pandemic owing to strict criteria for substantiating causality between the vaccine and injury, its nontransparent process of determining whether to compensate, and the compensation amount that is not practically calculated. This article reviewed the Vaccine Injury Compensation Programs in 10 major countries to present implications for improving the Korean system. Expanding the scope of national accountability is essential to compensate for the consequences of adhering to national policies during public health crises. Therefore, valuable insight can be obtained from examining the systems in Germany, Japan, and Taiwan, which have implemented more relaxed criteria for determining causality in compensation cases; Thailand's system, which provides the mandatory payment of preliminary compensation for damage caused by vaccination; systems in Germany, France, and Japan, which offer compensation for vaccine injuries from a practical perspective; and systems in France and the United Kingdom, which have a process allowing the assessment records to be shared with the claimants. Furthermore, a dedicated agency for vaccine injury compensation, as seen in France, the United Kingdom, and Australia, is necessary to enhance the efficiency of the Korean system.

Do vaccines cause epilepsy? Review of cases in the National Vaccine Injury Compensation Program.

The National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program (VICP), a no-fault alternative to the traditional tort system. Since 1988, the total compensation paid exceeds $5 billion. Although epilepsy is one of the leading reasons for filing a claim, there has been no review of the process and validity of the legal outcomes given current medical information. The objectives were to review the evolution of the VICP program in regard to vaccine-related epilepsy and assess the rationale behind decisions made by the court. Publicly available cases involving epilepsy claims in the VICP were searched through Westlaw and the US Court of Federal Claims websites. All published reports were reviewed for petitioner's theories supporting vaccine-induced epilepsy, respondent's counterarguments, the final decision regarding compensation, and the rationale underlying these decisions. The primary goal was to determine which factors went into decisions regarding whether vaccines caused epilepsy. Since the first epilepsy case in 1989, there have been many changes in the program, including the removal of residual seizure disorder as a vaccine-related injury, publication of the Althen prongs, release of the acellular form of pertussis, and recognition that in genetic conditions the underlying genetic abnormality rather than the immunization causes epilepsy. We identified 532 unique cases with epilepsy: 105 with infantile spasms and 427 with epilepsy without infantile spasms. The petitioners' experts often espoused outdated, erroneous causation theories that lacked an acceptable medical or scientific foundation and were frequently criticized by the court. Despite the lack of epidemiological or mechanistic evidence indicating that childhood vaccines covered by the VICP result in or aggravate epilepsy, these cases continue to be adjudicated. After 35 years of intense litigation, it is time to reconsider whether epilepsy should continue to be a compensable vaccine-induced injury.

Longitudinal Cognitive Screening Findings in Pediatric MS vs. Pediatric Controls and Adult MS in a Multi-center Cohort (S31.008)

Longitudinal Cognitive Screening Findings in Pediatric MS vs. Pediatric Controls and Adult MS in a Multi-center Cohort (S31.008)

Real-world effectiveness of switching treatment after initial platform injectable disease-modifying therapies in pediatric multiple sclerosis in the US (P14-3.008)

Real-world effectiveness of switching treatment after initial platform injectable disease-modifying therapies in pediatric multiple sclerosis in the US (P14-3.008)

Recommended Adult Immunization Schedule, United States, 2023.

Recommended Adult Immunization Schedule, United States, 2023.

Identifying Cases of Shoulder Injury Related to Vaccine Administration (SIRVA) in the United States: Development and Validation of a Natural Language Processing Method.

BackgroundShoulder injury related to vaccine administration (SIRVA) accounts for more than half of all claims received by the National Vaccine Injury Compensation Program. However, due to the difficulty of finding SIRVA cases in large health care databases, population-based studies are scarce.ObjectiveThe goal of the research was to develop a natural language processing (NLP) method to identify SIRVA cases from clinical notes.MethodsWe conducted the study among members of a large integrated health care organization who were vaccinated between April 1, 2016, and December 31, 2017, and had subsequent diagnosis codes indicative of shoulder injury. Based on a training data set with a chart review reference standard of 164 cases, we developed an NLP algorithm to extract shoulder disorder information, including prior vaccination, anatomic location, temporality and causality. The algorithm identified 3 groups of positive SIRVA cases (definite, probable, and possible) based on the strength of evidence. We compared NLP results to a chart review reference standard of 100 vaccinated cases. We then applied the final automated NLP algorithm to a broader cohort of vaccinated persons with a shoulder injury diagnosis code and performed manual chart confirmation on a random sample of NLP-identified definite cases and all NLP-identified probable and possible cases.ResultsIn the validation sample, the NLP algorithm had 100% accuracy for identifying 4 SIRVA cases and 96 cases without SIRVA. In the broader cohort of 53,585 vaccinations, the NLP algorithm identified 291 definite, 124 probable, and 52 possible SIRVA cases. The chart-confirmation rates for these groups were 95.5% (278/291), 67.7% (84/124), and 17.3% (9/52), respectively.ConclusionsThe algorithm performed with high sensitivity and reasonable specificity in identifying positive SIRVA cases. The NLP algorithm can potentially be used in future population-based studies to identify this rare adverse event, avoiding labor-intensive chart review validation.

Editor's Spotlight/Take 5: Discussing Two Systematic Reviews With Opposing Conclusions on Shoulder Pain After Vaccine Administration.

Editor's Spotlight/Take 5: Discussing Two Systematic Reviews With Opposing Conclusions on Shoulder Pain After Vaccine Administration.

Effect of mycophenolate mofetil dose on antibody response following initial SARS-CoV-2 vaccination in patients with systemic sclerosis.

Effect of mycophenolate mofetil dose on antibody response following initial SARS-CoV-2 vaccination in patients with systemic sclerosis.

Rapid Onset Functional Tic-Like Behaviors in Young Females During the COVID-19 Pandemic.

Rapid Onset Functional Tic-Like Behaviors in Young Females During the COVID-19 Pandemic.

Addressing People's Vaccine Hesitancy Will Be Helpful for COVID-19 Vaccination in China.

The latest news about global vaccine research and development shows that we have made great progress in vaccine development. However, in China, a large population of people are hesitant to get vaccinated due to various reasons. In this article, we focus on how to address people's hesitancy on the coronavirus disease 2019 (COVID-19) vaccine. It is important that governments fully prepare for both pre-risk prevention and post-event relief to promote the vaccination program's smooth implementation. In particular, the government should establish and improve a national vaccine injury compensation program in response to COVID-19's adverse events following immunization. Only through multilateral efforts and comprehensive measures can the people's confidence in vaccination improve and their worries about the future be relatively eased.

Vaccination Adverse Outcomes and Costs of Vaccine Injury Claims (VICs): Past, Present and Covid-19

The US National Vaccine Injury Compensation Program (VICP) has paid out US$4,431,468,456 for 7,575 vaccine injuries from (financial years) 1989 through 2020. The average settled claim was US$585,012 per claimant. Of the total claims filed (n=22,372), 94% were claims for non-fatal injury (n=21,035) and 6% were claims for death (n=1,337). Of the total claims filed, 34% were successful (n=7,611), 52% were dismissed (n=11,671), and 14% were not progressed (n=3,090). The VICP acts as an indemnity shield for the vaccine industry. The VICP offers a non-litigious path to compensation for the vax-injured. The VICP is funded by a vax tax of US 75 cents per disease per dose. Injury claims can be rejected because the claim is filed out of time, the particular vaccine is not a VICP-listed vaccine, the injury is not a VICP-listed injury (e.g. autism is not listed), or the injury is not sufficiently severe. There were 1.39 compensated injuries per one million distributed vaccine doses (n=5,233 compensated injuries for 3,761,744,351 distributed vaccine doses; 2006 through 2018). The VICP payout rate is US$813 million for vax injuries per one billion vax doses. Based on past experience of vaccination injury, mass vaccination of billions of people for Covid-19 can be anticipated to produce vaccine injuries (including deaths). Based on the historical data of the VICP across 30 different vaccines, vaccinating a billion people with Covid-19 vaccines, can be anticipated to manifest a scenario of US$813 million of vaccine injuries (as an underestimate). Vaccinating the world's population (n=7.8 billion) with an initial Covid-19 vaccine dose may generate US$6.3 billion of vaccine injuries. A two dose Covid-19 vaccine (prime-boost regimen) may generate US$12.7 billion of vaccine injuries. A Covid-19 vax regime of (say) three booster shots may generate US$25.4 billion of vaccine injuries. These scenario extrapolations assume that the Covid-19 vaccines (although developed and administered under pandemic duress), are neither more nor less injurious than the vaccines (n=30) of VICP experience, which have been tested, certified, manufactured, stored and administered to US standards, and that there is no differential between the compensable value of US and non-US injuries.

Overview of Vaccine Drug Delivery System

Until the 20th century, infectious diseases were the leading cause of death and disability worldwide, and this is still the case in much of the developing world. Immunisation has played a central role in radically reducing the incidence of many dangerous diseases, and some diseases have been wiped out entirely (e.g. smallpox). This article presents the World Health Organization’s (WHO) recommendations on the use of various vaccines. Vaccines prevent an estimated two –three million deaths worldwide every year. But, a further 2 million lives could be saved annually with better global vaccine coverage. Vaccines prevent an estimated two – three million deaths worldwide every year. But, a further 2 million lives could be saved annually with better global vaccine coverage. The purpose of vaccination is to produce immunity. Vaccines contain the same germs that cause disease. (For example, measles vaccine contains measles virus.) But they have been either killed or weakened. A vaccine provides a conducted exposure to a pathogen, training and encourage the immune system so it can fight that disease quickly and effectively in future. The national Vaccine Injury Compensation Program covers routine vaccines for children (against a total of 16 diseases). Vaccines are safe and effective. Because vaccines are given to millions of wholesome people. Vaccines have one of the greatest impacts on public good health. The prevention of disease has had an enormous impact on commercial development by limiting the costs of curative care and saving billions of dollars in countries where diseases have been well controlled or eliminated.

Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain-Barré Syndrome.

South Korea operates a National Vaccine Injury Compensation Program (VICP) for people who experience adverse events following immunization (AEFI). To run this program rationally, it is a prerequisite to confirm whether adverse events were caused by immunization. Guillain–Barré syndrome (GBS), a severe neurological disease with limb pain and muscle weakness as cardinal symptoms, is attracting attention as an AEFI. However, algorithm or guidelines for assessing the causality between vaccination and the incidence of GBS are lacking. We aimed to develop guidelines for causality assessment of GBS as an AEFI and suggest using these guidelines in alignment with the VICP. We systematically searched for other previously published algorithms or guidelines and found a WHO-AEFI guideline used worldwide; however, it only provides general instructions and is not tailored to specific adverse events. We translated and locally adapted the structure of this guideline and then added contents related to GBS. The GBS-specific guideline consists of four steps: case ascertainment of GBS, checklist (including (1) order of incidence, (2) temporal proximity, (3) evidence for other causes and (4) published evidence), an algorithm, and final classification. We listed key information on confirming GBS and whether any other causes of GBS were present. For real world application of the guideline along with the VICP, we collaborated with a panel of neurologists, epidemiologic investigators, and committee members from the VICP. To ensure transparency and a scientific approach, regular updates and collaboration with neurologists are essential. We expect that this guideline will contribute to logical causality assessment and compensation decisions for GBS and will provide the basic structure for causality assessment of other AEFIs.

Shoulder Injury Related to Vaccine Administration (SIRVA): Petitioner claims to the National Vaccine Injury Compensation Program, 2010–2016

BackgroundSince 2010, petitioner claims of shoulder injury related to vaccine administration (SIRVA) to the National Vaccine Injury Compensation Program (VICP) have been increasing. ObjectiveTo conduct a scientific review of clinical characteristics of SIRVA petitions to the VICP. MethodsWe queried the VICP’s Injury Compensation System database for medical reports of alleged SIRVA and SIRVA-like injuries. Medical reports are summaries of petitioner claims and supporting documentation along with a VICP clinician reviewer diagnosis and assessment of criteria for concession. We conducted a descriptive analysis of SIRVA petitioner claims recommended by the VICP for concession as SIRVA injuries. ResultsWe identified 476 petitioner claims recommended for concession. Claims per year increased from two in 2011, the first full year in the analytic period, to 227 in 2016. Median age was 51 years, 82.8% were women, and median body mass index was 25.1 (range 17.0–48.9). Four hundred cases (84.0%) involved influenza vaccine. Pharmacy or store (n = 168; 35.3%) was the most common place of vaccination followed by doctor’s office (n = 147; 30.9%). Fewer than half of cases reported a suspected administration error; 172 (36.1%) reported ‘injection too high’ on the arm. Shoulder pain, rotator cuff problems, and bursitis were common initial diagnoses. Most (80.0%) cases received physical or occupational therapy, 60.1% had at least one steroid injection, and 32.6% had surgery. Most (71.9%) healthcare providers who gave opinions on causality considered the injury was caused by vaccination. A minority (24.3%) of cases indicated that symptoms had resolved by the last visit available in medical records. ConclusionsMost conceded claims for SIRVA were in women and involved influenza vaccines. Injection too high on the arm could be a factor due to the risk of injecting into underlying non-muscular tissues. Healthcare providers should be aware of proper injection technique and anatomical landmarks when administering vaccines.

The National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program

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

The question of whether vaccines cause autism has been extensively studied. Studies from different countries around the world, looking at millions of children in total, examined it and found no link. In spite of this powerful evidence, the actions of a small group of fervent believers may lead people to question the data. One tactic used to argue that vaccines cause autism is the use of compensation decisions from the National Vaccine Injury Compensation Program to claim such a link. This article demonstrates that not only does the nature of proof in the program make its decisions ill-suited to challenging the science, but the cases used do not, in their content, support that conclusions. Even the cases that most closely address the question of vaccines and autism do not show the link opponents claim exists, and many of the cases used are misrepresented and misused.

Inside the Agency Class Action

Federal agencies in the United States hear almost twice as many cases each year as all the federal courts. But agencies routinely avoid using tools that courts rely on to efficiently resolve large groups of claims: class actions and other complex litigation procedures. As a result, across the administrative state, the number of claims languishing on agency dockets has produced crippling backlogs, arbitrary outcomes and new barriers to justice. A handful of federal administrative programs, however, have quietly bucked this trend. The Equal Employment Opportunity Commission has created an administrative class action procedure, modeled after Rule 23 of the Federal Rules of Civil Procedure, to resolve “pattern and practice” claims of discrimination by federal employees before administrative judges. Similarly, the National Vaccine Injury Compensation Program has used “Omnibus Proceedings” resembling federal multidistrict litigation to pool common claims regarding vaccine injuries. And facing a backlog of hundreds of thousands of claims, the Office of Medicare Hearings and Appeals recently instituted a new “Statistical Sampling Initiative,” which will resolve hundreds of common medical claims at a time by statistically extrapolating the results of a few hearing outcomes. This Article is the first to map agencies’ nascent efforts to use class actions and other complex procedures in their own hearings. Relying on unusual access to many agencies — including agency policymakers, staff and adjudicators — we take a unique look “inside” administrative tribunals that use mass adjudication in areas as diverse as employment discrimination, mass torts, and health care. In so doing, we unearth broader lessons about what aggregation procedures mean for policymaking, enforcement and adjudication. Even as some fear that collective procedures may stretch the limits of adjudication, our study supports a very different conclusion: group procedures can form an integral part of public regulation and the adjudicatory process itself.

Preemption, the Virus-Serum-Toxin Act, and the USDA: a case study using iatrogenic abortion due to BoHV-1 vaccines in pregnant cows

Three major vaccine manufacturers in the United States currently sell multivalent vaccines containing modified live bovine herpesvirus 1 (BoHV-1) for use in pregnant cattle. The first of these products entered the US market in 2003. Yet it has been known since the early 1960 s that vaccinal BoHV-1 causes abortion in cattle. The products became popular as they can be used year-round, regardless of pregnancy status in herds. Abortifacient effects have been considered to be minimal, provided initial vaccination is done during the previous 12 months using specific vaccine products and in accordance with label directions. Single nucleotide polymorphisms (SNPs) in BoHV-1 can be used to resolve whether post-vaccination outbreaks of abortion in cattle herds are iatrogenic (Fulton et al.; Vaccine. 2013; 31(11):1471-1479). We tested tissues from 10 abortion episodes (2010–2014) where an apparent association existed between recent use of modified live BoHV-1 and abortion 1–3 months later. Products were used on or off label in individual outbreaks. All 10 episodes had SNP patterns consistent with those of commonly-used modified live BoHV-1 strains (O’Toole et al.; Vet Pathol. 2014, In press ). In spite of this, it is likely such products will remain on the market. This is due the absence of meaningful post-marketing surveillance of suspect adverse reactions in animals by the USDA, compounded by the courts’ interpretation of the Virus-Serum-Toxin Act of 1913 [Lynnbrook Farms v. SmithKline Beecham Corp., 79 F.3d 620 (7th Cir.)]. Interesting differences exists between the handling of adverse vaccinal reactions in human patients through the National Vaccine Injury Compensation Program (VICP), and similar reactions in animals following use of federally licensed vaccines.

Adjudicating non-knowledge in the Omnibus Autism Proceedings.

After 5600 families of children diagnosed with autism filed claims with the National Vaccine Injury Compensation Program in the United States, the court selected 'test' cases consolidated into the Omnibus Autism Proceedings, held from 2007 to 2008, to examine claims that vaccines caused the development of autism. The court found all of the causation theories presented to be untenable and did not award damages to any parents. We analyze the Omnibus Autism Proceedings as a struggle within the scientific field between the scientific orthodoxy of the respondents and the heterodox position taken by the plaintiffs, suggesting that the ruling in these cases helped to shore up hegemony on autism causation. Drawing on the literature on non-knowledge, we suggest that only the respondents had enough scientific capital to strategically direct non-knowledge toward genetic research, thereby foreclosing the possibility of environmental causation of autism. The plaintiffs, who promote a non-standard ontology of autism, suggest that the science on autism remains undone and should not be circumscribed. In analyzing the Omnibus Autism Proceedings with field theory, we highlight the way in which scientific consensus-building and the setting of research agendas are the result of struggle, and we show that the strategic deployment of non-knowledge becomes a major stake in battles for scientific legitimacy and the settling of scientific controversies.