Vaccine injury

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Vaccine injury is a term used in both medicine and law to designate alleged injuries sustained by individuals subsequent to having been vaccinated. Historically, allegations of vaccine injuries have come in waves, and have been closely related to litigation, and publicity surrounding that litigation.

Recent apparent increases in allegations of vaccine injuries in recent decades, have been focussed on litigation in the United States [1], and in the United Kingdom [2]. Numerous legislative bills have been introduced in the United States to shield pharmaceutical companies from liabilities stemming from vaccine injury claims. Globally, billions of dollars have been paid out to the families of alleged victims, and potential cumulative liability many times that amount has been estimated.

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[edit] Risk/benefit equation

Vaccines are regarded to be amongst the safest pharmaceutical interventions. Vaccines have been responsible for sharp declines in many infectious diseases, such as smallpox, diphtheria, measles, whooping cough, polio and tetanus. The expected benefits of vaccines, to protect individuals and safeguard public health from the spread of infectious diseases, are derived from their ability to generate immune responses, which are remembered by the immune system. Vaccines, however, are not universally effective at the individual level, but shortcomings are partially remedied by herd immunity, by which the infectious agent is controlled at the population level.

Many studies published in medical journals have documented vaccine failures and serious adverse vaccine events. Some adverse events following vaccination, as with all pharmaceutical interventions, are widely recognized as very rare events. High profile allegations, such as those which propose a link between autism and the preservative thimerosal and/or MMR vaccine, are not widely accepted within medicine.

Critics of widespread vaccination point out allegedly serious flaws in immunization theory and practice. However, most pediatricians and parents do not accept, or are unaware of, these minority viewpoints, which are not accepted by the mainstream medical community. [3]

In 1998, concerns arising from allegations of a possible link between MMR vaccines and autistic spectrum disorders arose after the publication of a controversial paper, by Dr. Andrew Wakefield, et al, in the Lancet. This described an alleged novel inflammatory bowel disease, later named autistic enterocolitis by Wakefield. The interpretatin of this link, however, was later retracted. Other campaigners, including Bernard Rimland, had earlier expressed concerns about a possible relationship between vaccines and an increase in autism diagnoses.

[edit] United States

According to vaccine critic and alternative medicine proponent Dr. Joseph Mercola, "It seems that one of the most effective strategies for ending this nightmare of autism caused by mercury and vaccines will be through legal actions. The drug companies need to be held accountable for selling products that may be causing damage.[4]

[edit] VICP

In 1988, the National Vaccine Injury Compensation Program (VICP) was established to compensate victims, protect vaccine manufacturers and health care personnel from liability resulting from vaccine injuries and deaths. It is a no-fault alternative dispute resolution system for resolving vaccine injury claims. The VICP covers all vaccines listed on the vaccine schedule recommended by the Centers for Disease Control for children.[5] VICP claims must be filed within three years of the onset of symptoms, four years of the date of the injury, or within two years of death, whichever is first.

Although "reasonable efforts to inform the public of the availability of the Program" are required by law, most parents, teachers, physicians, and many attorneys are unaware of its existence.[6]

[edit] NCVIA

In 1988, the National Childhood Vaccine Injury Act (NCVIA) was enacted "to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals thought to be injured by childhood vaccines." This followed extensive litigation against vaccine manufacturers, most of whom withdrew from production on grounds that the cost of lawsuits outweighed any profit in making them. The VICP is administered jointly by the U.S. Department of Health and Human Services (HHS), the U.S. Court of Federal Claims, and the U.S. Department of Justice (DOJ). As of February, 2003, 3,482 vaccine victims have received compensation totaling over $1.4 billion.[7]

For vaccine injuries ruled to have been sustained after its enactment, the NCVIA allows 'reasonable compensation' for past and future unreimbursable medical, custodial care, and rehabilitation costs, lost earnings, reasonable legal fees, and places a cap of $250,000 for actual and projected pain, suffering and emotional distress. The HHS is represented by the DOJ in hearings before a "special master", who makes initial decision for compensation under the VICP. A special master is appointed by the judges of the Court. Decisions can be appealed to the Court, then to the US Court of Appeals for the Federal Circuit, and then to the Supreme Court.

[edit] VAERS

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.

[edit] VSD

The Vaccine Safety Datalink (VSD) is comprised of databases from seeral 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 unvaccinated populations, and for the identification of possible groups at risk for adverse events. Such studies, which have been called for by investigators such as Dr. Jeff Bradstreet and Dr. Edward Yazbak, might include the Amish, who rarely allow their children to be vaccinated, or the thousands of child patients of Homefirst Health Services, virtually none of whom have received vaccinations.

Dr. Mark Geier and his son David, who are prominent expert witnesses for litigants and have campaigned for many years over what they say are cases of vaccine injury, are the only outside researchers who have been allowed to examine the data. The Geiers contend the VSD data shows that children who had been exposed to higher amounts of mercury, from thimerosal containing vaccines (TCVs), were much more likely to receive pervasive developmental disorder diagnoses. The Institute of Medicine and extensive published research refute these findings, and have recommended research funding to be spent elsewhere, while denying other researchers access to the data based on confidentiality concerns.

[edit] United Kingdom

In 2003, parents of over 1,000 United Kingdom children diagnosed with autistic 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.

A former British government medical officer responsible for medical safety decisions, and an expert witness retained by the litigants, has accused the National Health Service (NHS) of "utterly inexplicable complacency" over the MMR vaccine. Dr. Peter Fletcher, a former principle medical officer at the Department of Health, said he has seen a "steady accumulation of evidence" from scientists worldwide that the measles, mumps and rubella jab is causing brain damage in certain children, and that, if proof arises confirming the MMR causes autism, "the refusal by governments to evaluate the risks properly will make this one of the greatest scandals in medical history."[8]

[edit] VDPS

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 £100,000. 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.[9]

[edit] See also

[edit] External links

v • d • e
Vaccination/Vaccine (and Immunization, Inoculation. See also List of vaccine topics and Epidemiology)

Development: Models - Timeline - Toxoid - Trial

Administration: ACIP - GAVI - VAERS - Vaccination schedule - VSD

Specific vaccines: Anthrax - BCG - Cancer - DPT - Flu - HIV - HPV - MMR - Pneumonia - Polio - Smallpox

Controversy: A-CHAMP - Anti-vaccinationists - NCVIA - Pox party - Safe Minds - Simpsonwood - Thiomersal controversy - Vaccine injury

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