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National Vaccine Advisory Committee Teleconference Meeting

National Vaccine Advisory Committee (NVAC)
Teleconference Meeting

February 26, 2010

Meeting Overview

The National Vaccine Advisory Committee (NVAC) met via conference call primarily to receive a report from the H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG) and an update on the National Vaccine Plan. The VSRAWG reviewed and discussed H1N1 safety data available as of February 8, 2010, and concluded that the data do not favor a signal between the outcomes examined and the H1N1 vaccines. NVAC members also voted on a recommendation that the Assistant Secretary for Health (ASH) undertake efforts to maintain and preserve state and local public health department vaccination infrastructure created in response to the 2009 H1N1 influenza pandemic. NVAC members also discussed and voted on recommendations on the National Vaccine Plan.

Committee Members in Attendance
Guthrie S. Birkhead, M.D., M.P.H., Chair
Tawny Buck
Richard D. Clover, M.D.
Cornelia L. Dekker, M.D.
Geoffrey Evans, MD
Mark Feinberg, M.D.
Lisa Jackson, M.D., M.P.H.
Clement Lewin, PhD, MBA
James O. Mason, MD, DrPH
Julie Morita, M.D.
Christine Nevin-Woods, DO, MPH
Trish Parnell
Andrew Pavia, MD
Laura E. Riley, MD
L. J. Tan, M.S., Ph.D.

Executive Secretary
Bruce G. Gellin, M.D., M.P.H., Deputy Assistant Secretary for Health; Director, NVPO

NVAC Liaison Representatives
Paul Etkind, DrPH, MPH, NACCHO
Wayne Rawlins, M.D., M.B.A., America’s Health Insurance Plans

Introductory Remarks

Guthrie Birkhead, M.D., M.P.H, Chair, NVAC
Dr Birkhead called the NVAC meeting to order and gave an overview of the agenda, which is primarily to receive an update on the National Vaccine Plan and hear a report from the H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG). He announced that there would be time for public comment at the end of the agenda and that speakers would not take questions from the general public during the meeting. This NVAC meeting is open to public; the meeting notice was posted on 12/1/09 in the Federal Register and the agenda is available at http://www.hhs.gov/nvpo/nvac. If a member of the public who wishes to make a comment does not get the opportunity, he or she is invited to submit the comment in writing to nvpo@hhs.gov for inclusion in the minutes.

Report of H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG)

Dr. Dan Salmon (NVPO)
Dr. Salmon presented for Dr. McCormick and briefly reviewed the report’s content. The VSRAWG has met seven times and reviewed the available data from the Federal vaccine safety monitoring systems listed in the report. Based on the review and discussion of H1N1 safety data available as of the Working Group’s meeting on February 8, 2010, VSRAWG has concluded that there are adequate data to identify a signal between the outcomes examined and the H1N1 vaccines and that the data do not favor a signal between the outcomes examined and the H1N1 vaccines. (A signal is defined as an event that could be temporally occurring more often after vaccine receipt than anticipated by chance alone.) 

There has been an effort to harmonize surveillance approaches and create standardizations. Dr. Salmon noted that active surveillance will continue with larger samples and data, as available. Dr. Salmon noted that VSRAWG members have been pleased with the thoughtfulness and thoroughness with which Federal agencies have examined the data and their thoughtful response to VSRAWG’s requests for data and analyses. He noted that the table entry for Post-Licensure Rapid Immunization Monitoring System (PRISM) was omitted and should read: “844,081 doses.”

Discussion

Dr. Pavia asked whether a plan exists for conducting additional analyses in the future, when the vaccine is likely to be given in smaller amounts. The response was that there are still data coming in and VSRAWG will continue to meet and keep looking at this.

Dr. Mason asked if there had been any collaborations to track other countries that might be using a different vaccine and/or adjuvants, in order to compare safety issues and complaints. Dr. Salmon responded that there have been many such collaborations, including conference calls with the World Health Organization (WHO) and a great deal of communication back and forth. He suggested that aggregate reporting on other countries’ could be made available if this was interesting to NVAC members. Members agreed they would like to see this information, particularly with respect to adjuvants.

Recommendation
NVAC recommends that the Federal government continue to monitor H1N1 vaccine safety as more doses are administered and captured under active surveillance and the body of evidence accumulates on the safety profile of H1N1 vaccines and to continue work towards harmonizing surveillance approaches.

A motion to adopt was made by Dr. Mason; seconded by Dr. Lewin; and adopted by the Committee.  The recommendation on vaccine safety monitoring will be formally transmitted to the Assistant Secretary for Health, who will review and consider it for potential implementation options to include communications with various components of the Department.

NVAC Recommendation on State and Local Health Department Sustainability

Dr. Gus Birkhead (NVAC Chair)
This motion was first made by Dr. Mason at the February NVAC meeting and tabled at that time. The motion was created in response to the H1N1 influenza pandemic. Since then, Dr. Mason has led an effort to create a new motion that includes background information; this was distributed to members in advance of the call. Dr. Birkhead noted that NVAC has previously made recommendations on state and local vaccine infrastructure, including recommendations from September 2008 that Congress should request an annual report on the Centers for Disease Control and Prevention’s (CDC) professional judgment of the size and scope of the Section 317 program appropriation needed, and should ensure that adequate funding is provided for this program.

Dr. Birkhead noted that, in the absence of a developed vaccine delivery infrastructure and in response to the H1N1 influenza pandemic, Public Health Emergency Response (PHER) funding was provided to states to support vaccine and vaccination functions. These included state and local health department staff and resources for: health care provider relations around enrollment and delivery of vaccinations; provider education; enhanced ordering systems; management of state and county-level inventories; to support systems for accounting for vaccine doses administered; vaccine safety monitoring; support for conducting vaccine points of distribution (PODs) and school-located vaccination programs; and enhanced laboratory and epidemiology capacity to support vaccination efforts. 

Discussion

Dr. Mason endorsed the new language but suggested removing the first sentence (“Following a motion made by Dr. James Mason at the meeting of the National Vaccine Advisory Committee [NVAC] on February 4, 2010 which was tabled, the following revised motion was written”) and starting the recommendation with: “NVAC recommends.” This suggestion was accepted.

Recommendation
NVAC recommends that the Assistant Secretary for Health work with the Secretary of the Department of Health and Human Services (HHS) and other Assistant Secretaries in HHS to identify ways to preserve and maintain the critical improvements in state and local public health department vaccination infrastructure created in response to the 2009 H1N1 influenza pandemic.

A motion to adopt was made by Dr. Mason, seconded by Dr.  Nevin-Wood and adopted by the Committee.  The recommendation on sustainability will be formally transmitted to the Assistant Secretary for Health, who will review and consider it for potential implementation options to include communications with various components of the Department.

  • see Revised NVAC Recomm.doc

NVAC Recommendations on the National Vaccine Plan Prioritization in the National Vaccine Plan

Dr. Gus Birkhead (NVAC Chair)
At the last NVAC in-person meeting in February, members spent a lot of time discussing the recommendations on the Draft National Vaccine Plan, as requested by the ASH. Dr. Birkhead noted that he has received many comments, which have been incorporated into the recommendations.

The recommendations are structured in four general recommendations related to the assignment of authority and responsibility to achieve the goals. NVAC also recommended that terms such as “independent” and “transparent” be defined. There are two recommendations on Goal 1 urging the development of new and improved vaccines; two recommendations on Goal 2 promoting the strengthening of vaccine safety research and stable research funding; two recommendations on Goal 3 concerning informed decision-making; three recommendations on Goal 4 about ensuring a stable supply of vaccines; and a recommendation on Goal 5 addressing global health promotion.

NVAC members have received a scoring sheet to rank the top five recommendations within each section. Final scores and rankings will be provided to the National Vaccine Program Office (NVPO) for its use in developing the final National Vaccine Plan. Next steps are to consider the committee comments in the next draft, complete one more cycle of public comment, and possibly hold a stake-holder’s meeting. The desired timeline is to complete the plan by June 2010 and work on implementation by the Fall of 2010.

Discussion

Dr. Gellin noted that it has been a year since the draft was distributed and there has been much opportunity for comments both in writing and at meetings. A typo in recommendation #13 where text was duplicated was noted and corrected in the draft. Ms. Buck reminded the group that there had been an agreement to remove the text “and ease of administration” from Goal 1, #6; this change was made in the text.

Dr. Birkhead said that he had sent an email with the summary thus far that includes results from half of the NVAC members. He commented that it was challenging to prioritize, given that there are so many levels of recommendations (i.e., IOM recommendations, NVAC recommendations on IOM recommendations, etc.). Dr. Tan said that he had prioritized based on the highest-level of recommendations – if an NVAC recommendation referred to an IOM recommendation, he prioritized the broadest one because it contained all of the more narrow recommendations. Dr. Birkhead agreed that many members had taken the same approach. He will group the final scores so NVAC members can get a better sense of the priority areas. He said that any member who wishes to re-prioritize and re-submit is welcome to do so. Prioritizations will continue to be collected after this phone call.

Recommendation
To accept these final recommendations on the Draft National Vaccine Plan, and transmit them to the ASH for his review and consideration of options for implementation.

A motion to adopt was mad by Dr. Pavia, seconded by Dr Tan and adopted by the Committee.  The Committee voted unanimously in favor of the motion to approve these changes.

Action Item
Members who have not yet provided their scores were asked to do so.

Public Comment

Jim Moody of SafeMinds commented on the National Vaccine Plan and recommendations, stating that the Plan continues to fail to achieve a rigorous, safety-first agenda. He said it is particularly necessary for a safety-first process to include an independent and accountable oversight mechanism and a rigorous, science-based method for identifying adverse events. An immediate analysis should be conducted comparing vaccinated children both prospectively and into the future. Mr. Moody said that he appreciates the IOM’s recommendation for a permanent subcommittee but felt that this recommendation did not go far enough to establish a science-based, safety-first agenda. Public confidence in vaccines is dropping and will continue to do so until we have a science-based response, he concluded.

Summary/Wrap-Up/Next Steps

Guthrie Birkhead, M.D., M.P.H, Chair, NVAC
Dr. Birkhead commented that the staff and committee members had conducted significant amounts of work to get the resolutions into such good shape and their efforts are greatly appreciated. Dr. Birkhead thanked the speakers and adjourned the meeting at 4:00 p.m.