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Vaccine Safety Working Group

Overview

The NVAC provides advice to the Assistant Secretary for Health, as Director of the National Vaccine Program, on issues of vaccine policy. Membership of the NVAC’s Vaccine Safety Working Group, encompasses a broad range of expertise including pediatric and adult infectious diseases, genomics, immunology, epidemiology, public health, maternal and child health, pharmacoepidemiology, and biostatistics.

Active since April 2008, the VSWG completed its first charge to review the CDC Immunization Safety Office’s Scientific Agenda in July of 2009. A detailed summary of Working Group activities and public engagement around Charge 1 can be found here and the VSWG full report and recommendations can be found here.

Currently, the VSWG is completing their second charge to review the federal vaccine safety system.

 



Comment on Draft Report

The Vaccine Safety Working Group (VSWG) of the National Vaccine Advisory Committee (NVAC) is accepting comments on a draft report and recommendations, as detailed in a May 10, 2011 Federal Register notice. The public comment period is open until June 6, 2011.

Comments can be submitted electronically to the National Vaccine Program Office at: vaccinesafetyRFI@hhs.gov By mail, comments can be sent to:

NVAC VSWG Report Comments
c/o Kristin Goddard
National Vaccine Program Office
200 Independence Avenue, SW
Room 715-H
Washington, DC 20201

 


Stakeholder Meeting

The Vaccine Safety Working Group of the National Vaccine Advisory Committee held an open stakeholder meeting to gain broad input and review on their draft report and recommendations for the federal vaccine safety system.

The stakeholder meeting consisted of a series of panels organized by sector:

  • Public Health;
  • Medical Associations;
  • Industry, Advocacy;
  • and Other Perspectives.

There was not time at this stakeholder meeting for public comment. However, comments were welcomed through the aforementioned Federal Register notice. The stakeholder meeting was held in advance of the full meeting of the NVAC on June 14-15, 2011. Read an agenda for the June NVAC meeting or download the certified minutes (PDF). A summary of stakeholder commentary is also available (PDF).

 


NVAC Vaccine Safety Working Group Roster

Tawny Buck (Co-Chair)*
Director of Government Relations
National Vaccine Information Center
Parent of a child injured by a vaccine
Group Representation: Public Representative

Marie McCormick, MD, ScD* (Co-Chair)
Sumner and Esther Feldberg Professor of Maternal and Child Health
Harvard School of Public Health
Discipline: Maternal and Child Health
Group Representation: Academia

Andrew Pavia, MD** (Co-Chair)
George & Esther Gross Presidential Professor
Department of Pediatrics
University of Utah School of Medicine
Discipline: Pediatric and Adult Infectious Diseases
Group Representation: Academia

Robert L. Beck, JD
ACIP Member
Discipline: International business/law
Group Representation: Public Representative

Guthrie S. Birkhead, MD, MPH* (NVAC Chair)
Deputy Commissioner, Office of Public Health
New York State Department of Health
Discipline: Epidemiology
Group Representation: State Health Department

Christopher Carlson, PhD
Fred Hutchinson Cancer Research Center
Discipline: Genomics
Group Representation: Academia

Vicky Debold, PhD, RN
Affiliate Faculty
Health Administration and Policy Department
George Mason University
VRBPAC Member
Discipline: Public Health/Nursing
Group Representation: Public Representative

Cornelia Dekker, MD**
Professor of Pediatrics & Medical Director
Stanford-LPCH Vaccine Program
Division of Pediatric Infectious Diseases
Stanford University School of Medicine
Discipline: Pediatrics
Group Representation: Academia

Lance Gordon, PhD
ImmunoBiologics Corp
Discipline: Immunology
Group Representation: Industry

Sean Hennessy, PharmD, PhD
Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania School of Medicine
Discipline: Pharmacoepidemiology
Group Representation: Academia

Clement Lewin, PhD, MBA*
Head, Strategic Immunization Planning
Novartis Vaccines and Diagnostics
Discipline: Immunization Policy
Group Representation: Industry

James O. Mason, MD, DrPH*
Former Director, Centers for Disease Prevention and Control (CDC)
Former U.S. Assistant Secretary for Health
Discipline: Public Health

William Raub, PhD
Former Deputy Director of the National Institutes of Health
Former Science Advisor to the Secretary, Department of Health and Human Services
Discipline: Public Health

Litjen (L.J.) Tan, PhD, MS*
Director, Medicine and Public Health
American Medical Association
Discipline: Immunology and Policy
Group Representation: Professional Organizations

* NVAC Member

** Past NVAC Member

Consultants to the Working Group

Steven Goodman, MD, PhD
Professor
Co-director, Epidemiology Doctoral Program
Johns Hopkins Bloomberg School of Public Health
Discipline: Biostatistics/Epidemiology
Group Representation: Academia

Lawrence Gostin, JD, LL.D (Hon)
Associate Dean, Professor of Global Health
Georgetown University Law Center
Discipline: Ethics/Law
Group Representation: Academia

Gerald Medoff, MD
Division of Infectious Diseases
Washington University School of Medicine
Discipline: Immunology
Group Representation: Academia

Ex-Officios Members

Robert Ball, MD, MPH
Center for Biologics Evaluation and Research
Food and Drug Administration

Norman Baylor, PhD
Center for Biologics Evaluation and Research
Food and Drug Administration

Jessica Bernstein, MPH
National Institute of Allergy and Infectious Diseases
National Institutes of Health

Vito Caserta, MD
Countermeasures Injury Compensation Program
Health Resources and Services Administration

Geoffrey Evans, MD
National Vaccine Injury Compensation Program
Health Resources and Services Administration

Bruce Gellin, MD, MPH
National Vaccine Program Office
Department of Health and Human Services

Rita Helfand, MD
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention

Karen Midthun, MD
Center for Biologics Evaluation and Research
Food and Drug Administration

Barbara Mulach, PhD
National Institute of Allergy and Infectious Diseases
National Institutes of Health

Dan Salmon, PhD, MPH
National Vaccine Program Office
Department of Health and Human Services

Melinda Wharton, MD, MPH
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention

Cindy Weinbaum, MD, MPH
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease and Prevention

 


Charge 1: Review of the draft CDC Immunization Safety Office (ISO) Scientific Agenda

Completed June 9, 2009

The VSWG undertook a scientific review of the draft CDC Immunization Safety Office (ISO) Scientific Agenda. The Working group focused on:

  • Content of the agenda (are the topics of the agenda appropriate, should other topics be included),
  • Prioritization of the research topics, and
  • Possible barriers to implementation of the agenda and suggestions for addressing them.

A detailed review of the public engagement completed for Charge 1 can be found here.

ISO Scientific Agenda

NVAC Report on ISO Agenda

ISO Response to NVAC Recommendations

 


Charge 2: Review the Current Federal Vaccine Safety System

The VSWG is focused on its second charge: “To review the current federal vaccine safety system and develop a White Paper describing the infrastructure needs for a federal vaccine safety system to fully characterize the safety profile of vaccines in a timely manner, reduce adverse events whenever possible, and maintain and improve public confidence in vaccine safety.”

In July 2009 the VSWG began work on the current charge to review the federal vaccine safety system at a two day meeting-- hearing from a variety of stakeholders and experts through five panel discussions. Since that time, the Working Group has gathered data through diverse federal and non-federal informational briefings, held monthly working group conference calls, and met at three in-person meetings.

The VSWG has completed a draft report and recommendations describing relative benefits and risks of vaccines, current vaccine coverage levels, successes and challenges of the current system, methodology for VSWG recommendation development, and the conclusions of the VSWG from these findings.

From these conclusions, the VSWG has currently developed draft recommendations in eight categories:

  • Leadership
  • Coordination
  • Research
  • Post Licensure Surveillance
  • Clinical Practice
  • Communications
  • Stakeholder and Public Engagement
  • Assurance and Accountability

This draft report is the basis for broad public comment (via a Federal Register notice, detailed above), and a one day stakeholder meeting to be held in Washington, D.C. on June 13th in advance of the June 2011 NVAC Meeting.