National Vaccine Advisory Committee Teleconference Meeting

2009 H1N1 Influenza Outbreak and Response

March 23, 2010, 3–5 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). A member of the group summarized its analysis so far and said the group will continue to review new data as they become available, such as pregnancy outcomes data.

Committee Members in Attendance

Guthrie S. Birkhead, M.D., M.P.H., Chair

Jon R. Almquist, M.D.

Richard D. Clover, M.D.

Cornelia L. Dekker, M.D.

Mark Feinberg, M.D.

Lisa Jackson, M.D., M.P.H.

Clement Lewin, Ph.D., M.B.A.

Julie Morita, M.D.

Christine Nevin-Woods, D.O., M.P.H.

L. J. Tan, M.S., Ph.D.

Executive Secretary

Bruce G. Gellin, M.D., M.P.H., Deputy Assistant Secretary for Health; Director, National Vaccine Program Office (NVPO)

NVAC Liaison Representatives

Anne Bailowitz, M.D., M.P.H., National Association of County and City Health Officials

Anna DeBlois Buchanan, M.P.H., Association of State and Territorial Health Officials

Wayne Rawlins, M.D., M.B.A., America’s Health Insurance Plans

Ronald Valdiserri, M.D., M.P.H., Department of Veterans Affairs

Claire Hannan, M.P.H., Executive Director, Association of Immunization Managers

COL Renata Engler, Department of Defense

Geoffrey Evans, M.D., HRSA, Vaccine Injury Compensation Program

Melinda Wharton, M.D., M.P.H., Centers for Disease Control and Prevention (CDC)

Invited Presenter

Vicky Debold, Director of Research and Patient Safety, National Vaccine Information Center

NVPO Staff

Cheryl Fortineau

Mark Grabowsky

Dan Salmon, Ph.D., M.P.H.

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

Vicky Debold, Director of Research and Patient Safety, National Vaccine Information Center

Ms. Debold read the March report of the Working Group, which is available online at

http://www.hhs.gov/nvpo/nvac/reports/index.html. The Working Group continues to find that the data are adequate to assess the presence or absence of a signal (i.e., an event that could be temporally related to administration of a vaccine and that occurs more often than would be anticipated by chance alone) and do not favor a signal between the outcomes examined and the H1N1 vaccines.

Discussion

Members said it would be helpful to identify the pre-specified outcomes for the data sources reviewed.

Action Item

NVPO staff will circulate to NVAC members a document that shows the pre-specified outcomes for the data sources reviewed by the VSRAWG (Table 1 of the VSRAWG monthly report). The pre-specified outcomes will be included in the next VSRAWG monthly report.

Some of the data sources can distinguish between doses distributed and administered, but, for example, the Vaccine Adverse Event Reporting System does not. Dr. Birkhead said State-level reporting is slow and probably undercounts doses administered, but the CDC is preparing to release data through February 2010 that should provide accurate estimates of the number of doses administered.

At its next meeting, the VSRAWG will review new data from systems that are just getting up to speed, such as the Vaccines and Medications in Pregnancy Surveillance System. The Working Group attempts to compare like data whenever possible, separating, for example, seasonal from H1N1 vaccine and live attenuated from inactivated vaccine.

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

Public Comment

Jim Moody pointed out the potential for bias in assessing safety of the H1N1 vaccine because of the inability to distinguish doses distributed from doses administered. Doses administered may be a more meaningful denominator than doses distributed. Mr. Moody suggested that more work be done to understand the difference between a population-level signal and adverse effects on an individual. Adverse effects on an individual may be vaccine-related but wash out at the population level.

Mr. Moody said the CDC recommended suspending use of the Rotarix (rotavirus) vaccine because it contains a pig virus. The CDC recommendation states that there is no evidence that the vaccine is not safe, said Mr. Moody, but the burden is on the Federal government and the Food and Drug Administration to determine that the vaccine is safe. Such concerns fuel doubt and should have been detected earlier, he noted. Mr. Moody asked NVAC to recommend surveillance of the 30 million children inadvertently administered a pig virus to determine whether the vaccine has long-term effects or could be linked to autoimmune reactions.

Summary/Wrap-Up/Next Steps

Guthrie Birkhead, M.D., M.P.H, Chair, NVAC

Dr. Birkhead said it was prudent of the CDC to recommend suspension of the Rotarix vaccine, and NVAC members will hear an update from CDC on the issue at a future meeting. He thanked the speakers and adjourned the meeting at 3: 25 p.m.

Appendix A: Other Attendees