Medicine:Vaccine injury

Vaccine injury

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

According to the U.S. Centers for Disease Control and Prevention, "[a]ny vaccine can cause side effects". Although most side effects are minor, primarily including sore arms or a mild fever, 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 preventing infectious disease. 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.

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 specified 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.

Vaccine Injury Compensation Program Procedure & Legal Requirements

The VICP uses a no-fault, streamlined system for litigating vaccine injury claims. Claims that are denied can be pursued through civil lawsuits, though this is rare, and the statute creating the VICP also imposes substantial limitations on the ability to pursue such lawsuits. The VICP covers all vaccines listed on the Vaccine Injury Table which is maintained by the Secretary of Health and Human Services. To win an award, a claimant is required to show a causal connection between an injury and one of the vaccines listed in the Vaccine Injury Table. Compensation is payable for "table" injuries, those listed in the Vaccine Injury Table, as well as, "non-table" injuries, injuries not listed in the table.

In addition, an award may only be given if the claimant’s injury lasted for more than 6 months after the vaccine was given, resulted in a hospital stay and surgery or resulted in death. Awards are based on medical expenses, lost earnings and pain and suffering (capped at $250,000).

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. As of September 2017, over 2,000 individuals have been paid a total of nearly $3.8 billion since the VICP began in 1988.

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. 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.

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 when the Legal Services Commission withdrew 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.

Canada

Quebec has a legal process to compensate certain forms of vaccination injuries; the program's first awards were made in 1988.