|Classification and external resources|
A vaccine injury is an injury caused by vaccination.
Allegations and confirmed instances 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 many public health officials have said that the claims of injuries are unfounded. In response, several vaccine makers stopped production, threatening public health, and laws were passed to shield makers from liabilities stemming from vaccine injury claims.
Adverse events following vaccination
All vaccines may have side effects although almost all are minor, and immunization safety is a real concern. Unlike the case with most other medical interventions, vaccines are given to healthy people, which is why some people are far less willing to tolerate adverse effects of vaccines 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.
Concerns about immunization safety often follow a pattern. First, some investigators suggest that a medical condition of increasing prevalence or unknown cause is due to an adverse effect of vaccination. The initial study, and subsequent studies by the same investigators, have inadequate methodology, typically a poorly controlled or uncontrolled case series. A premature announcement is made of the alleged adverse effect, which resonates with individuals suffering from the condition and which underestimates the potential harm of not being vaccinated. The initial study is not reproduced by other investigators. Finally, it takes several years before the public regains confidence in the vaccine.
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. Allegations particularly focus on disorders claimed to be caused by the MMR vaccine and thiomersal, a preservative used in vaccines routinely given to U.S. infants prior to 2001. Current scientific evidence does not support claims of vaccines causing the various disorders cited in the claims.
Vaccine-derived polio, although it has been found in hundreds of cases worldwide, can be mitigated with more vaccinations and careful disease surveillance.
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. 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.
The VICP covers all vaccines listed on the Vaccine Injury Table 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.
Vaccine Adverse Event Reporting System
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. 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.
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.
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.
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.
- 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.
- 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.
- 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.
- "Thimerosal in Vaccines".
- "What is vaccine-derived polio?".
- 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.
- "Vaccine Injury Table" (PDF). 2008. Retrieved 2008-04-04.
- "National Vaccine Injury Compensation Program statistics reports". Health Resources and Services Administration. 2011-03-03. Retrieved 2011-04-04.
- 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 . PMID 14500418.
- BBC NEWS | Health | £3.5m paid out in vaccine damages