NATIONAL VACCINE INJURY COMPENSATION PROGRAM

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1 NATIONAL VACCINE INJURY COMPENSATION PROGRAM Lawrence D. Frenkel, MD, FAAP, FACAAI, FPIDS Professor, Departments of Pediatrics and Microbiology University of Illinois College of Medicine Member, Division of Allergy, Immunology, and Infectious Diseases The Children s Hospital at Saint Peters University Hospital

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3 VACCINE SAFETY Must be preeminent in the development of new vaccines, adjuvants and delivery systems Low tolerance for risk increases cost and time requirements for development Vaccines are very safe; they are extensively tested and licensed under the guidance of the FDA They are reviewed for safety, efficacy, and cost benefit by ACIP followed for adverse reactions by several organizations

4 VACCINE SAFETY All vaccines are followed after being licensed using several mechanisms by several organizations: Vaccine adverse event reporting system (signal detection) Vaccine safety data link (causality and population studies) Clinical immunization safety assessment centers (study of adverse events in patients)

5 VACCINE SAFETY Vaccines and their use are periodically and extensively reviewed, with access to all available data and studies, after they are licensed and the results published by the Institute of Medicine. This organization is independent of pharmaceutical companies, the ACIP, CDC, NIH, and other physician organizations

6 VACCINE INJURY COMPENSATION ACT The National Vaccine Injury Compensation Program (NVICP) was established in 1986 to evaluate claims of adverse reactions to vaccines and award compensation to those individuals possibly injured. The major impetus for this federal legislation was the threat by pharmaceutical companies to halt manufacture of all vaccines because of increasing litigation.

7 NATIONAL VACCINE INJURY COMPENSATION PROGRAM (US) A no-fault compensation system (paid for by a small fee added to each vaccine) for individuals who sustain serious adverse events determined to be related to vaccines On-table injuries precisely defined and well established to be vaccine related are automatically compensated by the government program Other injuries must be proven by the claimant (in the US Court of Federal Claims) to be causally related to a vaccine in a biologically plausible fashion

8 NVICP This program was specifically passed by the US congress to transfer financial liability from health care providers and pharmaceutical companies to preserve the continued existence of the extraordinarily effective system of vaccine development and use.

9 NVICP Parties who believe that they have been injured by a vaccine bring suite in the federal judicial system Their legal fees, including those for expert witnesses, are paid by the federal government, regardless of judicial findings The government has its own lawyers and expert witnesses The cases are herd in federal court by one of 8 experienced magistrates

10 NVICP The magistrates bend over backward to arrange a settlement or they adjudicate on the side of the plaintive even in some cases where extensive scientific data and medical experience are generally accepted to confirm that the vaccine and adverse effect, although temporally related are not causally related.

11 NVICP CLAIMS: Average annual number approx 200 Major types of injury claimed and vaccine: DPT seizures, developmental delays, sudden death, Guillain-Barre Syndrome (GBS) (Many less claims since acellular replaced whole cell vaccine) MMR autism (subsequently discredited as a cause) HB neurologic (immune mediated) and chronic fatigue Influenza death, GBS, chronic fatigue *Weakness of association between vaccines and adverse effects discussed in: Schattner, Ami. Vaccine 23:

12 MORE RECENT CLAIMS Tdap Td Influenza HB HB/HIB HPV MMR Rotavirus Gullian Barre Syndrome (GBS) Rhabdomyolysis Death, Chronic fatigue, GBS, Aplastic anemia Multiple Sclerosis (MS) and Candidiasis Recurrent infections Myelitis, Seizure, GBS,MS, Systemic Lupus Encephalitis Kawasaki s

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