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Letter from the Chair to the Assistant Secretary for Health, RE: NVAC – Nov 6, 2009 Meeting

Howard K. Koh, M.D., M.P.H
Assistant Secretary for Health
Department of Health and Human Services
200 Independent Avenue, SW, Rm. 701-H
Washington DC 20201

RE: NVAC – November 6, 2009 Meeting

Dear Dr. Koh:

This letter summarizes the National Vaccine Advisory Committee (NVAC) meeting held on November 6, 2009.  This meeting was an off-schedule meeting, held by teleconference, designed to gather information about the evolving H1N1 influenza situation, particularly in light of the implementation of the H1N1 influenza vaccination program since our last meeting.  The agenda for this meeting is enclosed.

While there were no new recommendations approved by the NVAC at this meeting to transmit to you, there were many updates on the H1N1 influenza situation that provided us with valuable information for further evaluation of this vaccination campaign.

Federal H1N1 Vaccine Program Implementation Update
The first update was presented by RADM Anne Schuchat, Centers for Disease Control and Prevention (CDC), who informed the Committee that there have been no major deviations in the epidemiology of H1N1 influenza from what has been seen recently.  While the influenza activity is widespread throughout nearly all of the United States, the circulating virus appears not to have undergone any major mutations that would impact pathogenicity, or change the antigenic match to the vaccine or susceptibility to antiviral drugs.  RADM Schuchat did note that some decreases in influenza activity were beginning to be seen in the southeastern US, though activity levels were still above where they typically are in early November.

CAPT Jay Butler, CDC, reviewed the distribution mechanisms for H1N1 influenza vaccine, and highlighted that vaccine supply has been the biggest challenge to date.  Programmatic changes have been made as needed to respond to identified barriers to consistent vaccine distribution.  Now that more vaccine has been made available, efforts will be made to generate coverage estimates using a weekly survey done in the style of the National Immunization Survey and additional Behavioral Risk Factor Surveillance System modules.  Discussion around this topic highlighted the need for better adult immunization activities, another task underway by the NVAC, and efforts to encourage the uptake of live, attenuated influenza vaccine (LAIV) amidst misconceptions about this type of vaccine.

Dr. Linda Lambert, National Institutes of Health, discussed a series of clinical trials underway to better understand the immune response to H1N1 influenza vaccine in a variety of populations (healthy adults and elderly, healthy children, pregnant women (both HIV+ and HIV-), HIV+ children and other HIV+ adults) and a variety of formulations utilizing vaccine from one manufacturer and adjuvant from another manufacturer.  Many of these trials are still underway, but preliminary data indicate that the H1N1 influenza vaccine provokes a strong immune response with no serious adverse events reported and no recommended halting or modifications to any study protocol in response to safety concerns.

Communication strategies around the H1N1 influenza vaccination campaign were reviewed by Dr. Kris Sheedy, CDC, Ms. Stephanie Marshall, National Vaccine Program Office, and Ms. Abigail Tumpey, CDC.  It was reported that there is widespread awareness of vaccine shortages, and while two-thirds of those who attempted to get vaccinated were unable to, 91% of these individuals indicated they would try again.  The complexity of the vaccine communication messages was highlighted, with efforts to describe the vaccine production process, the emphasis on getting safe and effective vaccine out for distribution out as quickly as possible, and the need to carefully communicate the recommended target populations for immunization.  Vaccine safety communication has been a key focus of the communications program, with a wide variety of outreach done on this topic.  Targeted communication about adverse events following immunization has also been done, with tabletop exercises with the media held by CDC as well as workshops with the press and ethnic media.  Committee member discussion focused on the need to be honest about what is known and what is not known, to prevent a sense of either complete panic or conspiracy.

Dr. Marie McCormick, NVAC, briefly presented on the structure of the newly formed H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG) that met for the first time on Monday November 2.  This Working Group will review existing vaccine safety systems as well as safety data from a variety of sources, including clinical trials and the Vaccine Adverse Events Reporting System.  While the VSRAWG will not conduct primary analyses of adverse event data, it will provide an opportunity for external, independent review of existing data from multiple data streams.  The NVAC will receive periodic updates from the VSRAWG throughout the H1N1 influenza vaccination campaign. 

State and Local Response Role
Ms. Claire Hannan, Association of Immunization Managers, provided an overview of the efforts of immunization programs to allocate and distribute H1N1 influenza vaccine, while highlighting some of the issues that have been encountered.  These issues include the decision about whether to hold vaccine until large amounts are available to hold large clinics versus releasing vaccine to use as it is available, hesitancy towards use of LAIV.

Mr. Jim Blumenstock, Association of State and Territorial Health Officials, described the differences seen across jurisdictions on vaccination planning based on differential distribution methodologies and the variability in the vaccine type and manufacturer, which have different prescribing indications, leading to differences in where vaccine types can be distributed.  The last two issues Mr. Blumenstock identified the need to address vaccine safety concerns and resources and funding, with current utilization of Public Health Emergency Response grant money expected to be sufficient through December 31, 2009.

Dr. Anne Bailowitz, National Association of County and City Health Officials (NACCHO), provided updates on issues identified previously by NACCHO, including staffing, vaccine availability and communication.  Overall, Dr. Bailowitz indicated that the situation is improving, with increased staffing and utilization of volunteer networks, a slow increase in vaccine availability and widespread uptake of seasonal influenza vaccine, and improved communication between partners, though issues still exist in all areas.  Two key areas for further work are communication around vaccine supply and delivery dates, and increased utilization of radio for messaging.

Public Comment
One public comment was offered, from Mr. James Moody, SafeMinds.  Mr. Moody indicated that the H1N1 influenza vaccine campaign provided a teachable moment for a safety first immunization agenda, where all vaccine could have been formulated without the use of mercury, as well as stating that there is a need for sound science because even a small amount of doubt can lead to difficulties in vaccine uptake. 

The final discussion centered on future roles the NVAC can take to address vaccination issues as well as the role of the H1N1 vaccine program as a microcosm of the larger vaccine enterprise.  The following topics were identified for further discussion: (1) manufacturers discussion of problems with yield and production; (2) stability of vaccine supply; (3) the need to collaborate with partners; (4) the limited number of manufacturers producing influenza vaccine for young children and associated availability issues; (5) differences in manufacturers’ formulations and indicated age cutoffs that have lead to difficulties in allocating vaccine to appropriate providers; (6) the need to take advantage of new engagement with public health and willingness to vaccinate evidenced by the large number of providers who have enrolled to receive H1N1 vaccine.

Please feel free to contact me with any questions or concerns you may have in regard to any of the Committee’s activities.  I would also like to invite you to attend our next regularly scheduled NVAC meeting, which is scheduled for February 3-4, 2010, as well as any off-schedule meetings that will be held to address the H1N1 influenza situation or the revision of the National Vaccine Plan.  Of course, I am available at any time to speak to you by telephone or to meet in person.



Guthrie S. Birkhead, M.D., M.P.H.
Chair, National Vaccine Advisory Committee