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NVIC Vaccination & Health Research Program

NVIC 2009 ConferenceOn October 2-4, 2009, NVIC sponsored the Fourth International Public Conference on Vaccination. The rallying point for the 700 parents and health care professionals, who traveled to Washington, D.C. from 44 states and 11 nations, was “Show Us the Science and Give Us a Choice.” The historic conference featured presentations by more than 40 world experts in the areas of vaccine science, policy, law, and ethics.

On October 3, the audience launched a fundraising effort for NVIC to sponsor and supervise scientific research that evaluates the short- and long-term health outcomes and potential health differences between vaccinated and unvaccinated individuals. The audience raised more than $100,000 in donations and pledges, kicking off a fundraising drive for NVIC to develop a scientific research program to address outstanding questions about differences in morbidity and mortality outcomes associated with the administration of multiple vaccines shortly after birth and throughout childhood.

The conference also generated interest in research to identify genetic and other biological high risk factors for development of immune and brain dysfunction following vaccination and to identify biological mechanisms associated with vaccine injury and death.

NVIC supports scientific investigation into the safety and effectiveness of current public health policies that involve:

  • Vaccination of children when they are sick;
  • Revaccination of those who have suffered convulsions, mental regression, development of immune dysfunction and other serious health problems after previous vaccinations;
  • Simultaneous administration of up to 12 vaccines on within a population as biologically diverse as that of the U.S., which may place some individuals at higher risk than others for suffering vaccine-induced brain and immune system disorders; and
  • Evaluation of adverse health outcomes that occur following vaccination, including the sudden onset of brain and immune system dysfunction or death routinely dismissed as “coincidence”.

General Description of NVIC’s Vaccination & Health Research Program

Targeted research at NVIC will focus on obtaining information about short- and long-term health outcomes for vaccinated and unvaccinated individuals. As a starting point, a small preliminary study will be undertaken in 2010 to analyze retrospectively existing historical health data systematically collected by the U.S. government on vaccinated and unvaccinated Americans. Below are links to specific information regarding NVIC’s Vaccination & Health Research Program:

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Extramural Program & Research Portfolio
The extramural research program includes the newly established Vaccinated and Unvaccinated Health Outcomes Research Project. Proposals will be solicited from scientists across several disciplines. 

NVIC’s extramural research program related to the vaccinated and unvaccinated health outcomes project will be conducted in several phases. The program is evaluating the suitability of a portfolio of human and cell-based studies. The initial phase will include solicitation of proposals for studies that are national in scope and evaluate a variety of health outcomes among fully, partly and never vaccinated American children. Future extramural work may involve prospective clinical trials and observational studies in humans and animals as well as in vitro cell-based experiments.
Intramural Program & Research Portfolio
The intramural research program includes analyses of data collected by the Vaccine Adverse Events Reporting System (VAERS) as well as analysis, synthesis and critique of published literature. These efforts are conducted by staff and scientists affiliated with NVIC. 

Historically, NVIC co-founders were responsible for inclusion of vaccine safety provisions in the National Childhood Vaccine Injury Act of 1986. Among those safety provisions is the legal requirement for vaccine providers to report hospitalizations, injuries, deaths and other serious adverse health outcomes following vaccination to a federal Vaccine Adverse Events Reporting System (VAERS).

Since 1982, NVIC has published a number of reports analyzing VAERS data. In 2005, NVIC added the MedAlerts database to its website. Between 2007 and 2010, NVIC published four special VAERS analyses on adverse events reports involving Gardasil vaccine.

NVIC’s intramural research program will include a number of ongoing analyses that are vaccine-specific, such as trend analyses of VAERS reports, and analysis of vaccine policy protocols that involve identification of potential biological high risk factors to help prevent vaccine injury and death. The intramural research program will also conduct analysis, synthesis and critique of published medical literature.

Program Funding
NVIC’s Vaccination & Health Research Program Fund includes the $100,000 raised at the Fourth International Public Conference on Vaccination and additional private donations made to the Fund since October 2009.  NVIC is grateful for the donations made to this program. These funds will be used to conduct preliminary studies that contribute to the scientific literature related to the effects of vaccination on health outcomes.   
Indirect Costs Policy
The National Vaccine Information Center (NVIC) is a charitable non-profit 501c3 educational organization funded by donations from individuals and family foundations. NVIC supports a targeted research program. It does not pay Facilities & Administration (F&A) costs or other overhead or indirect costs.

Vicky Debold, PhD, RN
Director of Research & Patient Safety
Dr. Debold has been employed in the health care field for more than 30 years as an ICU nurse, health care administrator and health policy analyst primarily focusing on pediatrics and patient safety. Currently, she is a Research Scientist and Affiliate Faculty member at George Mason University in the Health Administration and Policy Department where she teaches Health Services Research Methods. She has worked with NVIC since 2006 on vaccine safety analytical and education projects and is a member of the FDA Vaccines & Related Biological Products Advisory Committee; the consumer representative to the H1N1 Vaccine Safety Risk Assessment Working Group and the Vaccine Safety Working Group of the National Vaccine Advisory Committee; and has served as a consultant to the CDC Board of Scientific Counselors.

Dr. Debold received her doctoral degree from the University of Michigan (1999) — School of Public Health (Health Services Organization and Policy) and School of Nursing (Health Systems Administration). She was a University of Michigan Regent's Fellow and completed a post-doctoral fellowship in health systems research. She was an Assistant Professor at the University of Michigan and an Associate Professor and Director of the Health Systems Management Program at the University of Detroit, Mercy. She has worked as a health policy analyst for the U.S. Congress’s Physician Payment Review Commission; for the Michigan Health and Safety Coalition; and for the Michigan State Commission on Patient Safety.

Dr. Debold has successfully competed for research funding from the Robert Wood Johnson Foundation, the University of Michigan Health Systems Health Services Research Initiative, and the Health Care Financing Administration. Her analyses and papers have been published in the Journal of the American Medical Association; Advances in Patient Safety: New Directions and Alternative Approaches; Journal of the American Academy of Physician Assistants, and Critical Care Nursing Clinics of North America.

Steven Rubin, PhD
Director of Vaccine Research Analytics

Dr. Rubin is a computer scientist who maintains the online searchable VAERS database, MedAlerts. He has managed this database voluntarily and independent of his official work since 2003 and has worked with the NVIC since 2005.

Dr. Rubin received a Ph.D. from Carnegie Mellon University (1978) in the field of Artificial Intelligence. He worked in the computing field for over 40 years, both as a teacher and a researcher. He has taught computer graphics at Carnegie Mellon University and at Stanford University and has worked at Bell Telephone Laboratories, Schlumberger/Fairchild, Apple Computer, Interval Research, Sun Microsystems and currently Oracle. The author of "Electric," an open-source program for designing integrated-circuit chips, he also wrote a textbook on chip design software.
Research Program Steering Committee
NVIC is assembling a Research Program Steering Committee of scientists, physicians, health care professionals and health research experts to assist with development, review and operation of intramural and extramural research projects. To protect the integrity of the research and the privacy of professionals working with NVIC on scientific research projects, the identification of committee members and research scientists conducting studies may not be made public until research is published.
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