Vaccine injury

Vaccine injury
Classification and external resources
ICD-10	T88.1, Y58-Y59
ICD-9	E948, E949

A vaccine injury is an injury caused by vaccination.

Allegations of vaccine injuries in recent decades have appeared in litigation in the United States. Some families have won substantial awards from sympathetic juries, even though most public health officials believed that the claims of injuries were unfounded.^[1] In response, several vaccine makers stopped production, threatening public health, and laws were passed to shield makers from liabilities stemming from vaccine injury claims.^[1]

Adverse events following immunization

All vaccines may cause side effects, and immunization safety is a real concern. Unlike most other medical interventions, vaccines are given to healthy people, and people are far less willing to tolerate vaccines' adverse effects than adverse effects of other treatments. As the success of immunization programs increases and the incidence of disease decreases, public attention shifts away from the risks of disease to the risk of vaccination.^[2]

Concerns about immunization safety often follow a pattern. First, some investigators suggest that a medical condition of increasing prevalence or unknown cause is an adverse effect of vaccination. The initial study, and subsequent studies by the same group, have inadequate methodology, typically a poorly controlled or uncontrolled case series. A premature announcement is made of the alleged adverse effect, resonating with individuals suffering the condition, and underestimating the potential harm to those whom the vaccine could protect. The initial study is not reproduced by other groups. Finally, it takes several years to regain public confidence in the vaccine.^[2]

Controversies in this area revolve around the question of whether the risks of adverse events following immunization outweigh the benefits of saving people from tragic outcomes of common diseases. There is some scientific evidence that immunizations can cause serious adverse effects, such as gelatin measles-mumps-rubella vaccine (MMR) causing anaphylaxis, a severe allergic reaction.^[2] Controversy exists over whether more-common disorders such as autism are caused by vaccines. Allegations particularly focus on the MMR vaccine and on thiomersal, a preservative that is used in vaccines routinely given to U.S. children less than 24 months of age.^[3] Current scientific evidence does not support causation for these disorders.^[2] Nearly 5,000 U.S. families of children diagnosed with autism have claims for compensation from a federal fund, saying that their health problems were caused by common childhood vaccines. Large scientific studies have found no association, and no autism claim has been paid from the fund so far.^[1] In one autism-related case, the government conceded that the child had a pre-existing mitochondrial disorder with autism-like symptoms aggravated by simultaneous immunizations against nine diseases.^[4][5]

United States

Vaccine Injury Compensation Program

In 1988, the National Vaccine Injury Compensation Program (VICP) went into effect to compensate individuals and families of individuals who have been injured by covered childhood vaccines.^[6] The VICP was adopted in response to an earlier scare over the pertussis portion of the DPT vaccine. These claims were later generally discredited, but some U.S. lawsuits against vaccine makers won substantial awards; most makers ceased production, and the last remaining major manufacturer threatened to do so. It uses a no-fault alternative dispute resolution system for resolving vaccine injury claims. Funding for claims of harm after 1988 comes from a patient fee of 75 cents per vaccination. To win an award, a claimant must show a causal connection; if medical records show a child has one of several listed adverse effects soon after vaccination, the assumption is that it was caused by the vaccine. The proof standard is the civil-law preponderance of the evidence, showing that causation was more likely than not. Claims that are denied can be pursued in regular lawsuits, though this is rare. Some claimants are suing thimerosal makers instead of vaccine makers, filing class-action suits, or demanding monitoring for vaccinated children who do not show signs of autism.^[1]

The VICP covers all vaccines listed on the Vaccine Injury Table^[7] maintained by the Secretary of Health and Human Services. From 1988 until March 3, 2011, 5,636 claims relating to autism, and 8,119 non-autism claims, were made to the VICP. 2,620 of these claims, one autism-related, were compensated, with 4,463 non-autism and 814 autism claims dismissed; awards (including attorney's fees) totaled over $2 billion. The VICP also applies to claims for injuries suffered before 1988; there were 4,264 of these claims of which 1,189 were compensated with awards totaling $903 million.^[8]

Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance program administered jointly by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC).

VAERS is intended to track adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of US licensed vaccines. The program's success in tracking vaccine injuries has been questioned by some, who allege medical practitioners frequently fail to make reports.^{[citation needed]} Others say that it may overstate possible injuries since many neurological problems in childhood may manifest at around the ages when vaccines are routinely administered.^{[citation needed]}

Vaccine Safety Datalink

The Vaccine Safety Datalink (VSD) is composed of databases from several organizations containing information regarding health outcomes for millions of US citizens and to enhance assessment of vaccine injuries. It was designed to allow for such things as comparisons between vaccinated and non-vaccinated populations, and for the identification of possible groups at risk for adverse events.

United Kingdom

In 2003, parents of over 1,000 United Kingdom children diagnosed with autism spectrum disorders, alleging the MMR vaccine was the culprit, were dealt a major setback by decision by the Legal Services Commission to withdraw legal aid. This followed advice to the commission by the lawyers representing the parents themselves that the lawsuit had no reasonable prospects of success.^[9]

Vaccine Damage Payment Scheme

Under the Vaccine Damage Payment Scheme (VDPS), it is thought that thousands of unsuccessful claims have been made. The maximum payment per claim is currently £120,000. Disabled vaccine injury patients are allowed to file a claim up to the age of 21. The 'disability threshold' before payments are granted is 60%. The scheme covers vaccinations for illnesses such as tetanus, measles, tuberculosis and meningitis C. As of 2005, the British government had paid out £3.5 million to vaccine injury patients since 1997.^[10]

References

1. ^ ^{a b c d} Sugarman SD (2007). "Cases in vaccine court—legal battles over vaccines and autism". N Engl J Med 357 (13): 1275–7. doi:10.1056/NEJMp078168. PMID 17898095. http://content.nejm.org/cgi/content/full/357/13/1275. 
2. ^ ^{a b c d} Bonhoeffer J, Heininger U (2007). "Adverse events following immunization: perception and evidence". Curr Opin Infect Dis 20 (3): 237–46. doi:10.1097/QCO.0b013e32811ebfb0. PMID 17471032. 
3. ^ McMahon AW, Iskander JK, Haber P, Braun MM, Ball R (2008). "Inactivated influenza vaccine (IIV) in children <2 years of age: examination of selected adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) after thimerosal-free or thimerosal-containing vaccine". Vaccine 26 (3): 427–9. doi:10.1016/j.vaccine.2007.10.071. PMID 18093701. 
4. ^ Stobbe M, Marchione M (2008-03-07). "Analysis: vaccine-autism link unproven". Associated Press. http://www.boston.com/news/health/articles/2008/03/07/analysis_vaccine_payment_no_landmark/. Retrieved 2008-06-06. 
5. ^ Honey K (2008). "Attention focuses on autism". J Clin Invest 118 (5): 1586–7. doi:10.1172/JCI35821. PMC 2336894. PMID 18451989. http://jci.org/articles/view/35821. 
6. ^ Edlich RF, Olson DM, Olson BM et al. (2007). "Update on the National Vaccine Injury Compensation Program". J Emerg Med 33 (2): 199–211. doi:10.1016/j.jemermed.2007.01.001. PMID 17692778. 
7. ^ "Vaccine Injury Table". 2008. http://www.hrsa.gov/vaccinecompensation/table.htm. Retrieved 2008-04-04. 
8. ^ "National Vaccine Injury Compensation Program statistics reports". Health Resources and Services Administration. 2011-03-03. http://www.hrsa.gov/vaccinecompensation/statistics_report.htm. Retrieved 2011-04-04. 
9. ^ Dyer C (2003). "Commission withdraws legal aid for parents suing over MMR vaccine". BMJ 327 (7416): 640. doi:10.1136/bmj.327.7416.640. PMC 1142521. PMID 14500418. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1142521. 
10. ^ BBC NEWS | Health | £3.5m paid out in vaccine damages