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National Vaccine Advisory Committee Teleconference Meeting

National Vaccine Advisory Committee Teleconference Meeting
2009 H1N1 Influenza Outbreak and Response
April 23, 2010, 3–4 p.m., E.S.T.

Meeting Summary

 

Meeting Overview

The National Vaccine Advisory Committee (NVAC) met via conference call to review the monthly report of the Vaccine Safety Risk Assessment Working Group (VSRAWG). The chair of the Working Group summarized its preliminary findings regarding three specific adverse events: Guillain-Barré syndrome (GBS), thrombocytopenia/idiopathic thrombocytopenic purpura (TP/ITP), and Bell’s palsy (BP). The VSRAWG offered specific suggestions to Federal agencies for further analysis of the vaccine safety data, and NVAC members agreed unanimously to recommend those ideas to the Assistant Secretary for Health.

Committee Members in Attendance
Guthrie S. Birkhead, M.D., M.P.H., Chair
Jon R. Almquist, M.D.
Tawny Buck
Richard D. Clover, M.D.
Cornelia L. Dekker, M.D.
Lisa Jackson, M.D., M.P.H.
Clement Lewin, Ph.D., M.B.A.
James O. Mason, M.D., Dr.P.H.
Marie McCormick, M.D., Sc.D.
Julie Morita, M.D.
Christine Nevin-Woods, D.O., M.P.H.
Trish Parnell
Andrew T. Pavia, M.D.
Laura E. Riley, M.D.
L. J. Tan, M.S., Ph.D.

NVAC Liaison Representatives
Anne Bailowitz, M.D., M.P.H., National Association of County and City Health Officials (NACCHO)
Anna DeBlois Buchanan, M.P.H., Association of State and Territorial Health Officials (ASTHO)
Geoffrey Evans, M.D., HRSA, Vaccine Injury Compensation Program
Claire Hannan, M.P.H., Executive Director, Association of Immunization Managers

Other Federal and Regional Representatives
Donna Brown, J.D., M.P.H., NACCHO
Hector Izurieta, M.D., M.P.H., Food & Drug Administration (FDA)
Limone Collins, M.D., Department of Defense    
RADM Nicole Lurie, M.D., M.S.P.H., U.S. Public Health Service (USPHS); Assistant Secretary for Preparedness and Response, Department of Health and Human Services
Barbara Mulach, Ph.D., National Institutes of Health
RADM Stephen Redd, M.D., Centers for Disease Control and Prevention (CDC)
RADM Anne Schuchat, M.D., USPHS, CDC
Andrea Sutherland, FDA
Kathy Talkington, ASTHO

NVPO Staff
Cheryl Fortineau
Mark Grabowsky
Dan Salmon, Ph.D., M.P.H.
CAPT Raymond A. Strikas, M.D., USPHS, NVPO

All other attendees are listed in Appendix A.

Introductory Remarks

Guthrie Birkhead, M.D., M.P.H, Chair, NVAC
Dr. Birkhead called the meeting to order, noting that the agenda includes only one item. He said time is allotted for public comments but presenters would not be taking questions from the general public or the media.

VSRAWG Report

Marie McCormick, M.D., Sc.D.
Dr. McCormick read the April report of the Working Group, which is available online at http://www.hhs.gov/nvpo/nvac/reports/index.html. She described the guidelines provided to the Working Group to assess the evidence and distinguish among a signal, an association, and causality. Dr. McCormick also summarized how the data from the surveillance systems that the Working Group reviews are assessed.

At the Working Group’s meeting on April 5, preliminary results were seen from five reporting systems for three adverse events for H1N1 monovalent inactivated vaccine: GBS, TP/ITP, and BP. A potential weak signal between H1N1 vaccine exposure and GBS was initially detected; additional analyses further weakened the signal. A weak signal linking H1N1 vaccine exposure and BP emerged in two monitoring systems; in one system, further analysis yielded inconsistent results. A weak signal between H1N1 vaccine exposure and TP also emerged in three systems; these cases are being reviewed to determined whether the diagnoses are valid. Dr. McCormick described the factors involved in assessing the strength of a signal and the additional steps needed to validate the findings. The Working Group offered specific suggestions for more detailed review and analysis of the evidence.

Discussion
Dr. Birkhead reminded the participants that the VSRAWG was established to facilitate transparent, independent, and timely review of H1N1 vaccine safety data. He noted that a true signal must be identified before moving on to the next level of determining the epidemiology and a causal association. Dr. Birkhead emphasized that the VSRAWG is reviewing preliminary data. Signals are not infrequent, he noted, and many don’t indicate a true problem. The VSRAWG process highlights the overall complexity of identifying vaccine safety issues and the challenges of characterizing for private citizens and policy-makers the degree of concern about potential adverse effects.

Andrew T. Pavia, M.D., asked whether the denominators for the data are likely to change. Dr. McCormick pointed out that many of the surveillance systems have precise data on the number of vaccines administered. Therefore, further review to confirm the diagnoses of adverse events may affect the numerators but would not alter the denominators. However, the period of observation following vaccination varies; therefore, the Working Group suggested end-of-season analyses to capture additional adverse events.

Dr. Pavia noted that an unprecedented amount of H1N1 vaccine safety data has been collected, which increases the likelihood of finding more “noise,” or unrelated incidents. He stressed the importance of communicating to the public that it’s too early to know whether the potential signals identified represent real concerns. Dr. McCormick added that 90 percent of weak signals turn out to be false alarms, and the identification of an adverse event following vaccination does not necessarily indicate an association. Lisa Jackson, M.D., M.P.H., cautioned against appearing too dismissive of the preliminary evidence, especially given the biological plausibility of an association with GBS.

In response to Clement Lewin, Ph.D., M.B.A., Andrea Sutherland of the FDA said the United States and several other countries have an international protocol on GBS, and an in-depth evaluation to detect potential signals is underway.

Dr. McCormick said the VSRAWG’s will further evaluate the initial findings to determine whether they meet widely accepted criteria for an adverse event and will conduct comparisons to rule out other potential associations. Additional rigorous comparison will help to distinguish true from spurious associations, Dr. McCormick said. She added that although Federal bodies already are assessing the validity of the data from their surveillance systems, the VSRAWG has not reviewed specific research plans for end-of-season analysis or cross-system analysis. Therefore, the Working Group believes that NVAC should continue to recommend further review.

In response to Tawny Buck, Dr. McCormick said that while seeing the same potential signal across multiple systems could be considered more serious, the preliminary data are inconsistent and the variations across systems have yet to be sorted out. James O. Mason, M.D., Dr.P.H., pointed out that even if an association with GBS were validated, it is estimated that the H1N1 vaccine would cause one additional case of GBS per one million people vaccinated. Comparable data are not available for BP or TP/ITP. Dr. Birkhead added that influenza itself increases the risk of GBS. In response to Dr. Pavia, Dr. McCormick said it was beyond the VSRAWG’s scope to estimate the number of patients with GBS who had influenza to compare those who received vaccination and those who were infected with influenza. Cornelia L. Dekker, M.D., said California is conducting an ongoing, real-time survey of GBS that may provide some information, but Drs. Pavia and McCormick agreed there are no reliable data on absolute numbers of infection.

Action Item
NVPO staff will circulate to NVAC members a 2008 article from the American Journal of Epidemiology comparing the risk of GBS following influenza vs. infection.

Dr. McCormick said the VSRAWG is just beginning to evaluate data from one surveillance system on immediate pregnancy outcomes following H1N1 vaccination. An end-of-season analysis is scheduled to evaluate that data in depth. Dr. McCormick noted that the Working Group is planning to write a final summary report of its findings but wants to incorporate the results of end-of-season studies and other, more definitive analyses.

Action Items
At the May 2010 NVAC teleconference, the VSRAWG will present a proposed timeline for its final report to NVAC.

Should the VSRAWG complete its charge before the September 2010 face-to-face NVAC meeting, the agenda for that meeting will include an update on vaccine safety surveillance data.

NVAC members voted unanimously to accept the report of the VSRAWG.

Recommendation
NVAC recommends that the Federal government continue to monitor H1N1 vaccine safety as the body of evidence accumulates. Moreover, NVAC recommends that Federal agencies and departments prepare and present analytic plans to:

  • assess the validity of the observations noted,
  • define end-of-season analyses for adverse events, and
  • conduct analyses across monitoring systems to have sufficient power to assess the effect of H1N1 exposure on relatively rare events and to assess the consistency of estimates across the different databases.

Public Comment

Theresa Wrangham, executive director of the National Vaccine Information Center, thanked NVAC and the VSRAWG for their hard work and encouraged additional and speedy evaluation of outcomes among pregnant women. She noted that VSRAWG’s findings are important to the public, particularly as the health care community considers whether to incorporate H1N1 vaccine in the seasonal influenza vaccine for 2010–2011.

Jim Moody pointed out several possible limitations of the VSRAWG report. The reliance on agreed-upon case definitions can result in over- or undercounting, as cases must meet official diagnostic criteria. Such definitions may exclude other, similar neurologic conditions; that is, the criteria may be too restrictive. Mr. Moody said data should evaluate adverse events following vaccination against a baseline of similar adverse events in cases in which no vaccine was administered—not just comparing events following H1N1 and seasonal influenza vaccines.

Mr. Moody asked whether the three conditions addressed in the VSRAWG report were the only ones that arose from the analysis. He noted that some adverse events may not yet be captured by databases. By using such large surveillance systems, Mr. Moody warned that data on subpopulations—such as pregnant women, children under 2 years old, the elderly, and young adults—may be lost through aggregation. He said that in the name of transparency, the underlying raw data must be available to all those who can bring their expertise to bear on the question of safety. Mr. Moody added that increasing the sample size improves the ability of the system to detect noise and therefore should be encouraged.

Summary/Wrap-Up/Next Steps

Guthrie Birkhead, M.D., M.P.H, Chair, NVAC
Dr. Birkhead thanked the speakers and participants. The next NVAC teleconference is scheduled for May 21, and the next in-person meeting will take place June 2–3. Dr. Birkhead said NVAC could meet via teleconference on short notice if an urgent issue arises. He adjourned the meeting at 4 p.m.

 

Appendix A: Other Attendees

First Name

Last Name

Organization

Emily

Adams

Phyllis

Arthur

Biotechnology Industry Organization

Jenny

Backus

Department of Health and Human Services (HHS)

Pali

Barcshalom

Office of Management and Budget

Steven

Bingham

Ruder Finn

Paul

Burgdorf

Dale

Burwen

Food & Drug Administration (FDA)

Doug

Campos-Outcalt

American Academy of Family Physicians

Vito

Caserta

Countermeasures Injury Compensation Program

Howard

Choi

John Hopkins University

Vicky

Debold

National Vaccine Information Center

Frank

Destefano

Centers for Disease Control & Prevention (CDC)

Chris

Downey

Emily

Eisenberg

CDC

Paul

Etkind

National Association of County and City Health Officials (NACCHO)

Cindy

Fowler

CDC

Neal

Halsey

Johns Hopkins University

Crystal

Harrington

National Institute of Allergy and Infectious Diseases

Rita

Helfand

CDC

Angelique

Higgis

Brandi

Hight

National Vaccine Program Office (NVPO), HHS

Sarah

Hoiberg

Advisory Commission on Childhood Vaccines

Hayle

Hughes

Department of Defense

Hector

Izurieta

FDA

Paul

Jarris

Association of State and Territorial Health Officials

Curtis

Johnson

Karen

Kane

Sarah

Landry

National Institutes of Health

Grace

Lee

Harvard Pilgrim HealthCare Group

Emily

Levine

HHS

Nancy

Levine

CDC

Tracy

Lieu

Harvard Medical School

Barbara

Loe-Fisher

National Vaccine Information Center

Stephanie

Marshall

NVPO

John

Martin

MI Hope Inc.

Michelle

Mergler

NVPO

Jim

Moody

Safe Minds

Joe

Quimby

CDC

John

Redd

Indian Health Service

Bellinda

Schoof

American Academy of Family Physicians

Angela

Shen

HHS

Nasrin

Sorock

Health Resources and Services Administration

Rob

Stein

Washington Post

Charles

Suehs

Dripping Springs

Jessica

Tytel

HHS

Kirsten

VanNice

NVPO

Claudia

Vellozzi

CDC

Melissa

Viray

CDC

Melinda

Wharton

CDC

Dave

Wilson

Theresa

Wrangham

National Vaccine Information Center

Katie

Wright

National Autism Association

Lauren

Wu

NVPO

Katherine

Yih

CDC

Herbert

Young

American Academy of Family Physicians