H1N1 Vaccine Safety Risk Assessment Working Group
Charge
The H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG) conducts rapid reviews of 2009 H1N1 vaccine safety data and provides ongoing updates of their findings to the National Vaccine Advisory Committee (NVAC). They meet regularly to review and assess data for six months after the conclusion of the 2009 H1N1 influenza vaccination program. The VSRAWG makes monthly reports to the NVAC on public conference calls.
The working group’s primary objectives are to:
- Serve as a sounding board for the federal government to independently assess possible adverse events of interest
- Objectively and rapidly review potential vaccine-associated adverse events
- Identify and establish priorities for additional studies that will inform their assessment of an association between a vaccine and a health event
- Assess the likelihood of a causal relationship between a vaccination and a health event
- Identify any special populations who may be at increased risk
- Provide information needed for action by the health officials through the National Vaccine Advisory Committee in a timely manner
The working group reviews data from federal vaccine safety monitoring systems, described in Federal Plans to Monitor Immunization Safety for the Pandemic 2009 H1N1 Influenza Vaccination Program.
Reports from the working group approved by the NVAC are available on the NVAC Reports and Recommendations page.
The working group continues to review data and is drafting its final report.
Roster
Members of the working group were selected based on qualification criteria to ensure a broad, comprehensive range of scientific expertise. Membership included experts in vaccinology, biostatistics, epidemiology, maternal and child health, pediatrics, internal medicine, family medicine, and infectious diseases. One member from each of the five federal advisory committees that had a role in the H1N1 vaccination program were selected, in addition to members with other expertise. The advisory committees include:
- NVAC
- Advisory Committee on Immunization Practices (ACIP)
- Defense Health Board (DHB)
- National Biodefense Science Board (NBSB)
- Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Stephen Cantrill, M.D.
Associate Professor of Emergency Medicine
University of Colorado
NBSB member
John Clements, Ph.D.
Professor of Microbiology and Immunology
Tulane University School of Medicine
DHB member
Vicky Debold, Ph.D., R.N.
Director of Patient Safety
National Vaccine Information Center
VRBPAC member
Kathryn Edwards, M.D.
Sarah Sell Professor of Pediatrics; Director, Division of Pediatric Clinical Research
Vanderbilt Kennedy Center
Vanderbilt University
Former ACIP and VRBPAC member
Theodore Eickhoff, M.D.
Professor Emeritus,
Division of Infectious Disease
University of Colorado School of Medicine
Current VRBPAC consultant
Former VRBPAC, ACIP, and NVAC member
Susan Ellenberg, Ph.D.
Senior Scholar Biostatistics
Professor of Biostatistics
University of Pennsylvania
Marie McCormick, M.D. (Chair)
Sumner and Esther Feldberg Professor of Maternal and Child Health
Department of Society, Human Development, and Health
Harvard School of Public Health
NVAC member
Laura Riley, M.D.
Assistant Professor of Obstetrics, Gynecology and Reproductive Biology
Massachusetts General Hospital
NVAC member
Mark Sawyer, M.D.
Professor of Clinical Pediatrics
University of California, San Diego
ACIP member