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National Vaccine Advisory Committee Teleconference Meeting2009 H1N1 Influenza Outbreak and Response Meeting Overview The National Vaccine Advisory Committee (NVAC) met via conference call to discuss updates to the implementation of the Federal 2009 H1N1 influenza vaccination program. Following a summary from the Assistant Secretary for Health (ASH) of progress on NVAC's most recent recommendations, the Committee heard from representatives of several agencies within the Department of Health and Human Services (HHS), State and local partners, and the National Biodefense Science Board (NBSB). Much of the meeting focused on communication plans and messaging under development at the Federal level. The Committee approved two recommendations: one on vaccine safety monitoring issues and the other on developing a comprehensive plan to address general communications issues. Committee Members in AttendanceGuthrie S. Birkhead, M.D., M.P.H., Chair 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. He reminded all on the call that this was a full public NVAC meeting and briefly reviewed the agenda for the meeting. He welcomed four new NVAC members to the Committee: Tawny Buck, Clement Lewin, Ph.D., M.B.A.; Julie Morita, M.D.; and L. J. Tan, M.S., Ph.D. Howard Koh, M.D., M.P.H., ASH Dr. Koh said the public health leaders from across HHS meet daily to discuss H1N1 influenza. All of the H1N1 vaccine produced for this country will be purchased by the U.S. Government, he noted, in addition to the requisite syringes, needles, and other supplies. CDC has given States $440 million for contractors and other supplies to administer the vaccine. HHS is involved in intense coordination with State and local public health providers, and the effort is moving forward at impressive speed. Dr. Koh reported progress on the recommendations made by NVAC at the July teleconference. To improve national monitoring capability for vaccines, the Food and Drug Administration (FDA) and CDC representatives are working with AHIP to link available vaccine registry databases to health plans to monitor adverse events in time for the fall H1N1 vaccination campaign and for future vaccination efforts. As recommended by NVAC, HHS is working to finalize a comprehensive plan for monitoring vaccine safety, with completion anticipated by mid -September. NVAC's recommendations on vaccine financing are under consideration by CMS leadership. Dr. Koh said medical advisors within CMS are eager to collaborate on financing issues. Dr. Koh commended NVPO's Bruce Gellin, M.D., M.P.H., and Dan Salmon, Ph.D., M.P.H., for their tireless efforts on vaccine safety issues and thanked NVAC for its input on key areas of concern. He felt that HHS is making strong progress thanks to collaborations with NVAC and other key advisors. Federal H1N1 Vaccination Program Implementation UpdateIntroduction - Beth Bell, M.D., CDCDr. Bell reported much progress on vaccine development, clinical trials, program implementation, communication, monitoring, and significant coordination among various agencies. She noted that ACIP's recommendations on priority populations to receive H1N1 vaccine were recently published in the Morbidity and Mortality Weekly Report. [Note: Link to report: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e 0821a1.htm] CDC's website now includes additional supporting material for these recommendations.. Vaccine Development - Robin Robinson, Ph.D., DASH and Director, BARDA Dr. Robinson reviewed the vaccine development timeline to date, noting that clinical trials that focus primarily on immunogenicity are underway by all five vaccine manufacturers and NIH. Data will be available starting in mid-September. To date, no adverse events beyond the expected injection site tenderness, etc., have been reported. Additional studies will assess the use of adjuvants, but those data probably will not be available until October, said Dr. Robinson. Manufacture of vaccine began in late July. HHS has purchased 195 million doses of bulk antigen and 120 million doses of bulk adjuvant. In mid-August, HHS decided to begin the formulation, fill, and finish process for a 15-microgram inactivated vaccine dose and 107 plaque-forming units live-attenuated influenza vaccine dose. Dr. Robinson anticipated that 45 - 50 million doses of vaccine would be available by mid-October, with additional vaccine available throughout the year and into 2010. Vaccine Safety Working Group (VSWG) Subgroup on H1N1 Recommendation - Marie McCormick, M.D., Sc.D., VSWG Co-Chair Dr. McCormick said the subgroup had been focusing on safety monitoring issues for pregnant women in particular but it was informed that the CDC is already working on this issue. The second issue the Working Group discussed was communication regarding vaccine safety, which led to a recommendation (to be voted on later in the meeting) that focused on effective communication on issues surrounding vaccine safety monitoring: The VSWG Subgroup on H1N1 recommends that the ASH and HHS develop and, where possible, test in advance a strong and organized response to scientific and public concerns about vaccine safety that may emerge during the 2009 H1N1 vaccination campaign. The challenge will be to communicate effectively and to differentiate rapidly between adverse events that may be causally related to the vaccine and those that would be expected by chance alone. Such a response could involve:
These activities will allow agencies to formulate responses in advance so that they are able to make policy decisions promptly and effectively and communicate about H1N1 vaccine safety to the media and the public. Dr. McCormick said the subgroup believes it has accomplished its short-term goals and should not meet again unless other issues emerge for its consideration. Implementation of July 2009 Vaccine Safety Recommendations - Dan Salmon, Ph.D., M.P.H., NVPO As Dr. Koh mentioned, HHS is revising its current document on vaccine safety monitoring to provide a more comprehensive, detailed plan, as recommended by NVAC. It is also increasing monitoring of adverse events by exploring use of existing databases, such as Vaccine Safety Datalink, Defense Medical Surveillance System, Veterans Affairs, and Indian Health Services, including some that target pregnant women. FDA and CDC are working with AHIP to expand surveillance by using claims data from ICD-9 codes from three large health care plans, which represent about 50 million covered lives. HHS is working to link State vaccine registries with data from these large health care plans to conduct rapid-cycle analyses for pre-specified events to enhance its ability to respond. Finally, the recommendation to create an independent review board on vaccine safety has yielded much discussion at HHS, but no decision has been rendered. DiscussionAndrew Pavia, M.D., asked whether the AHIP collaboration to increase surveillance could become a permanent resource to evaluate safety concerns. Dr. Salmon said HHS hopes its efforts to enhance surveillance for H1N1 vaccine safety will be applied more broadly. If the effort to capture more data using the health care plans' databases succeeds, it may serve as a model for future initiatives. Dr. Gellin said that part of HHS' goal is to identify data sources that could be activated when a need arises. Dr. Salmon reiterated that HHS intends to begin using the health care plans' databases for surveillance by this fall. Action Item The VSWG subgroup on H1N1 will provide an update on the progress of its recommendations at the fall NVAC meeting. However, the subgroup will no longer meet unless a new issue for consideration arises. HHS Communication Plan - Jenny Backus, Acting Assistant Secretary for Public Affairs Ms. Backus reported that, under the leadership of the White House National Security Council, all Federal agencies are working together to raise awareness among the public about the importance of influenza planning and the steps people can take now to prepare for the influenza season. Efforts also include raising awareness of the future availability of the H1N1 vaccine. Ms. Backus said the Office of the Assistant Secretary for Public Affairs is planning to circulate a variety of consumer education materials to all Federal agencies for distribution to the general public. She said that HHS and CDC are taking the lead on the Federal medical response and the Department of Homeland Security is working with States to support their response efforts. Supplies of seasonal influenza vaccine are becoming available in traditional distribution points around the country, and HHS is encouraging people to get seasonal influenza vaccination early, while no H1N1 vaccine is available. With schools starting, the current communication initiatives are focusing on community mitigation and prevention of influenza. Ms. Backus said traditional influenza messaging is especially important for the next 45 - 60 days while we await the implementation of H1N1 messaging. HHS has already begun outreach through CDC and others. CDC has received more than $15 million of supplemental funding for communication, and many outreach and communication projects are planned, especially for those who fall into the ACIP priority target groups. Ms. Backus noted that HHS is testing public service announcements (PSAs) on community mitigation and laying the groundwork for H1N1vaccine messages. The current message is simply, “Get a flu shot.” HHS leaders and White House representatives are meeting with media members to provide key information. Outreach calls with the White House Office of Public Engagement are using existing messaging and guidance from CDC. HHS is pursuing collaborations with the creators of Sesame Street and Jim Henson Productions to target communications to children. Ms. Backus said Flu.gov will be the central website for information. HHS holds daily calls with sister agencies throughout the government and the White House on communications, as well as weekly communication planning calls. It also holds weekly calls with members of the private sector. A press conference on seasonal influenza to be held by the National Foundation for Infectious Diseases is scheduled for September 10. Ms. Backus anticipated that vaccine safety will be a critical issue for communications, and she thanked NVAC and other experts for enhancing HHS' understanding of public concerns. She said the vaccine campaign faces communication challenges, especially because many of those identified as priority groups for H1N1 vaccination have only recently been included among the target groups who should get seasonal influenza vaccination. Discussion Ms. Backus explained that “Get a flu shot” is a very simple message that intentionally does not indicate which type of influenza is meant. Messaging is being rolled out in three stages, focusing on 1) basic hygiene for prevention (which began in July), 2) the need for seasonal influenza vaccination (which began in mid- August and will continue through mid-September), and 3) H1N1 vaccination when available (which begins in late September/early October). As we learn more, we will explain more, said Ms. Backus, but we don't want to confuse people with incomplete data. At present, HHS is making the transition from the basic hygiene message to the need to get seasonal influenza vaccine. HHS is currently using paid media and partnerships to develop and disseminate PSAs, and messages are directing people to Flu.gov. Ms. Backus said HHS has taped 41 PSAs featuring members of Congress that focus on community mitigation and planning. A competition to create a PSA received 220 entries. Ms. Backus added that HHS is reaching out to new audiences and redesigning Flu.gov to incorporate more new media (e.g., viral media and social networking sites). She said those who are most vulnerable to influenza don't think they need vaccinations and probably are not watching televised PSAs. She added that PSAs and toolkits are available free on the website. Dr. Morita asked whether Flu.gov is geared toward the general public. Ms. Backus said the redesign will clearly distinguish information for the public from that aimed at professionals. She anticipated the new website to launch by the end of September. In response to Dr. Birkhead, Ms. Backus said safety is a critical issue and she would have more to report in September. She said people should know that no vaccine comes with a 100-percent safety guarantee, but communicators can distinguish common from rare side effects. The H1N1 vaccine is closely related to the current seasonal influenza vaccine, for which there is good science supporting its safety and effective dosing, she added. Dr. Gellin said current communication efforts are building on NVPO's other work to communicate about the safety of vaccines, which began a year ago. Cornelia L. Dekker, M.D., asked whether messages would address thimerosal. Ms. Backus responded that it is important to acknowledge concerns about thimerosal but to communicate clearly that HHS does not see a scientific basis for those concerns. Laura E. Riley, M.D., praised the communication plans but underscored the importance of being prepared to address emerging information as it comes out, especially if it lacks a solid scientific basis. She pointed to the widespread media coverage of a recent publication casting doubt on the effectiveness of human papillomavirus vaccine. Ms. Backus said HHS recognizes the concern and plans to hold some media tabletop exercises to prepare government agencies to respond rapidly and refer members of the media to reliable sources of information. The redesigned website will have a robust section on myths and facts. HHS is also partnering with bloggers and other new media members to enlist their aid in debunking rumors. Ms. Backus added that gathering more information on background events will help counter false associations of causality. Dr. Gellin noted that discussion among government agencies will help identify emerging issues of concern. Dr. Pavia praised the approach described, noting that the communication “circuit” will be closed effectively if safety studies and epidemiological assessments of background events are conducted quickly and the results communicated through tabletop exercises. Dr. Birkhead presented a draft recommendation on communication, to be voted on later in the meeting: A clear Federal plan to coordinate communications regarding the H1N1 influenza pandemic and vaccination campaign is needed. A comprehensive and detailed plan should be developed that outlines the HHS plan for clearly providing accurate information as rapidly as possible on topics including but not limited to:
Implementation Plan for Vaccine Financing Recommendations - Bruce Gellin, M.D., M.P.H., DASH and Director, NVPO Dr. Gellin said NVAC's recommendations on vaccine financing have been discussed with AHIP and CMS. For example, NVAC recommended that community vaccinators and national, regional, and local insurance plans work together to develop formalized relationships allowing community vaccinators to bill insurance plans for administration of 2009 H1N1 influenza vaccine to plan beneficiaries, and NVPO is organizing a meeting with AHIP to discuss provider reimbursement options. Jeffrey Kelman, M.D., said CMS appreciates the NVAC recommendations, especially those suggesting full reimbursement of H1N1 vaccine at the Medicare rate for Medicaid and State Children's Health Insurance Program beneficiaries and other non-Medicaid Vaccines for Children program (VFC)-eligible children served by VFC providers and establishing a national policy enabling community vaccinators to bill Medicaid for H1N1 vaccination. He said Medicare will cover vaccine administration with no copay and no deductible for the beneficiary. CMS leadership is discussing mechanisms for community providers to bill Medicaid under Title 19, and Dr. Kelman said he would report back when CMS determines the best way to address the issue. Dr. Kelman clarified that, despite rumors, Medicaid patients are not limited to receiving one influenza vaccination per year. Rather, guidance about payment indicates that beneficiaries may not be charged the updated rate for vaccine administration until the new rates take effect in October. The Medicare administrative contractors recognize that multiple administrations (e.g., one seasonal influenza vaccination and two H1N1 vaccinations) may be needed. Dr. Birkhead hoped additional updates would be provided to NVAC in September. Vaccine Program Planning/Implementation - CAPT Jay Butler, M.D., USPHS, CDC Dr. Butler said vaccine will be allocated to States and grantees on a pro rata basis through a centralized distribution system managed by a contractor (McKesson Specialty), which will receive vaccine from all five manufacturers and ship it to providers under the direction of State health departments. Providers may include clinicians' offices, hospitals, occupational health clinics, public health centers, pharmacies, facilities for in-State distribution, or anyone else designated by the State as appropriate to administer the vaccine. The system will operate similarly to the VFC program: Providers will place orders with the State health department. Orders will be transmitted to CDC for processing and forwarded to the distributor. The vaccine will be shipped directly to the provider as directed by health departments. Under VFC, 45,000 sites receive vaccine; it is estimated that up to 90,000 sites may get the H1N1 vaccine. A third-party contractor will combine ancillary supplies (needles, syringes, etc.) from four manufacturers and vaccine record cards from CDC into vaccination kits and ship them to the vaccine distributor. For Federal employees, CDC will act as the State health department, coordinating orders on behalf of Federal agencies. Dr. Butler said the distribution plan was created in consultation with State and local public health officials and allows for flexibility in meeting local needs. The plan facilitates distribution of vaccine without rebuilding infrastructure for in-State distribution. The primary system for tracking doses is the Countermeasures Response Administration (CRA), which enables web-based aggregate data reporting by age group. CRA may underestimate the number of doses administered, but its data can be compared with shipping data to get a more complete picture. To assess coverage, CDC will rely on the National Immunization Survey, which can begin collecting data as early as the week of October 10, 2009, and will provide weekly national coverage estimates, and the Behavioral Risk Factor Surveillance System, which will provide a more complete picture of vaccine coverage by State and in specific risk groups with updated data available as frequently as twice a month. Dr. Butler noted many aspects of vaccine delivery and administration remain unknown:
He thanked the Vaccine Implementation Steering Committee, which has been meeting twice a week, for its valuable input. Dr. Morita said the current amount of vaccine purchased (195 million doses) does not appear to be sufficient to cover the whole population, especially if two doses are needed. Dr. Butler responded that the government is taking an incremental approach and will expand the vaccination plan as needed. John Modlin, M.D., pointed out that demand for seasonal influenza vaccine has never exceeded 100 million doses. He acknowledged that public demand for H1N1 vaccine may be higher but felt 195 million doses at the start seems prudent as long as manufacturers have the capacity to make more. State and Local Response Role ASTHO - Anna DeBlois Buchanan, M.P.H. Ms. Buchanan explained that ASTHO is engaged in a rapid assessment project launched by ASPR to determine State and local preparedness to deliver H1N1 vaccination. Currently, interviews are underway with State health officials to understand current challenges and how the Federal government might help. Ms. Buchanan said she hopes State and local public health departments will receive reports developed at the Federal level on the basis of the interviews. ASTHO is working with chain stores and pharmacies to develop a template for involving pharmacies in the H1N1 vaccination campaign. The initiative includes a meeting hosted by ASTHO on August 27, 2009, with Federal, State, and local public health representatives. The first template under development is a memorandum of understanding that can be used in combination with the CDC's provider agreement. The second template will describe an operational framework for planning. Recently, Ms. Buchanan said, insurance companies approached ASPR and ASTHO with an interest in supporting the H1N1 vaccine campaign beyond paying for administration of vaccine - for example, by disseminating targeted messages to those at high risk. As this concept matures, ASTHO will seek involvement from CDC, NVPO, and AHIP. NACCHO - Anne Bailowitz, M.D., M.P.H. Dr. Bailowitz reported that staffing efforts at local public health departments are hamstrung because promised funding has not yet materialized. She said delays in Federal funding translate into local delays in staffing of at least four to six weeks. She anticipated that staff will not be hired until at least mid- October. Information about the amount of vaccine available and when it will be distributed is shifting frequently, making it difficult for public health departments to create realistic and detailed planning scenarios. It is not yet clear what role local health departments will play in delivering vaccine. Dr. Bailowitz said the if local health departments are responsible for disseminating vaccine to community providers as well as for vaccinating patients, the local health departments are being set up for failure. Dr. Bailowitz acknowledged that messaging has increased but more is needed. Communication must be developed to address concerns about thimerosal and misinformation about the safety of the vaccine. She called for more education for the public about surveillance and mitigation, such as what the public can do to minimize the medical surge. Messaging should emphasize the need for both seasonal and H1N1 influenza vaccination. Dr. Bailowitz suggested outreach include both television and radio and that more communication target businesses and 18 - 24-year-olds in universities and the workplace. AIM - Claire Hannan, M.P.H. Ms. Hannan said States are participating in weekly planning calls and meeting with stakeholders. Many are creating provider lists, and some have lists identifying children's providers. The CDC has requested customer lists from manufacturers to identify who has ordered and administered vaccine in the past, and Ms. Hannan said States also want that information. The media has shown interest in school-based planning. A number of pieces are still missing from planning, said Ms. Hannan. For example, public health providers are trying to enroll in databases but can't move forward until the Provider Enrollment Agreement Form is complete. Also, many States may require providers to collect and report data beyond what is required by CRA but, overall, the requirements have not yet been approved by CDC. Ms. Hannan echoed Dr. Bailowitz's comment that the amount of funding States will receive for implementing programs remains unknown. Without that information, public health agencies cannot take advantage of all the available providers because they cannot guarantee reimbursement. States have noted that getting reimbursement from insurers will be challenging unless contracts are already in place, and many community vaccinators charge for seasonal influenza vaccine without a contract. Questions remain about how such vaccinators will get paid. In addition, States need more information to inform their plans for storing and distribution of vaccine. AIM is working with CDC to ensure that the Vaccine Management System can handle a potential doubling of orders. Ms. Hannan said AIM appreciates NVAC's recommendations, especially those on financing. DiscussionDr. Birkhead said the Vaccine Finance Working Group would look at efforts to push promised funding forward to the State and local levels. In response to a question about making State information systems and registries available to providers, Ms. Hannan said AIM surveyed 28 programs and found mixed results about how they intended to use their registries. She thinks those with robust registries will use them and will have feedback mechanisms for providers. Federal Advisory Committees UpdatesRecent recommendations of the ACIP are available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e 0821a1.htm. A transcript of the July 23, 2009, VRBPAC meeting is available at http://www.fda.gov/AdvisoryCommittees/CommitteesM eetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm129568 .htm. NBSB Recommendations - Patricia Quinlisk, M.D., M.P.H., Chair, NBSB Dr. Quinlisk said NBSB recommended making H1N1 vaccine available in September, an optimistic goal. The group has discussed use of unadjuvanted vaccine and live, attenuated vaccine and the possibility of mixing and matching vaccine types if supplies are restricted. NBSB and its Disaster Mental Health Subcommittee have discussed the psychological consequences and public concerns that may arise from H1N1 vaccination. Dr. Quinlisk said that dealing with such concerns through effective communication will be an important part of the campaign. A summary of NBSB's most recent recommendations is available at http://www.hhs.gov/aspr/conferences/nbsb/090717-nbsb-meeting.html. Dr. Pavia added that NBSB meets September 24 - 25, 2009. He hoped that NBSB's efforts address issues not currently being considered by NVAC and ACIP. Public CommentJim Moody of SafeMinds urged complete transparency around the clinical trials for immunogenicity, noting that Flu.gov did not mention the trials, and ClinicalTrials.gov indicated most trials were not yet recruiting patients. He said media reports differ on whether the H1N1 vaccine will contain thimerosal. The government is missing an opportunity to address public concerns by requiring that thimerosal be removed from all vaccines. Mr. Moody emphasized that parents, scientists, doctors, and public health officials are all committed to having the safest possible vaccines for all people. Deborah Robinson of Robinson Consulting said her quick online survey of community- and faith-based organizations indicated that 29 percent had questions about vaccine safety. She suggested the Federal government communicate what will be learned through trials and what can only be learned from post-vaccination monitoring. Ms. Robinson said she does not believe that the public views the H1N1 vaccine as similar to the seasonal influenza vaccine. She said many of those she surveyed wanted proof that the vaccine was necessary before they would agree to get the H1N1 vaccine. Twelve percent of those surveyed said the vaccine should be free and don't distinguish between the cost of the vaccine and administration. Ms. Robinson suggested that messaging address all of these concerns. Dr. Birkhead summarized the comments submitted by the National Association of Community Health Centers (see Appendix B), which requested that NVAC consider recommending support for health center reimbursement for uninsured patients and allowing transfer of H1N1 vaccine between all locations of an incorporated health center under one provider agreement. Discussion of RecommendationsJon R. Almquist, M.D., suggested adding to the recommendation on vaccine safety monitoring some direction to educate the public about reporting on side effects or adverse events. Dr. Birkhead said a previous NVAC recommendation identified the need for a comprehensive communication plan, which should cover Dr. Almquist's concern. Dr. Tan, asked how surveillance could distinguish adverse events when vaccines are given simultaneously. Dr. Birkhead said CDC data may not provide answers in such cases, but States that collect dose-specific information may be able to distinguish such events, and the databases from private insurance plans may also give useful data. Dr. Dekker said children get simultaneous vaccines all the time, so the issue is not new. Dr. Gellin said the epidemiologic curves of seasonal and H1N1 influenza may overlap, making it difficult to sort out associations in an individual, but he thought the bigger picture may show different rates of adverse events at different points in the curves. NVAC members voted unanimously in favor of accepting the recommendation of the Vaccine Safety Working Group Subgroup on H1N1. Dr. Dekker suggested the general communication recommendation also include a suggestion to develop a specific plan about monitoring vaccine safety. Others felt the issue was sufficiently addressed. NVAC members voted unanimously in favor of accepting the general recommendation on communication. Recommendations Approved August 24, 2009The following recommendations were adopted by unanimous votes of the Committee. Recommendation #1The VSWG Subgroup on H1N1 recommends that the ASH and HHS develop and, where possible, test in advance a strong and organized response to scientific and public concerns about vaccine safety that may emerge during the 2009 H1N1 vaccination campaign. The challenge will be to communicate effectively and to differentiate rapidly between adverse events that may be causally related to the vaccine and those that would be expected by chance alone. Such a response could involve:
These activities will allow agencies to formulate responses in advance so that they are able to make policy decisions promptly and effectively and communicate about H1N1 vaccine safety to the media and the public. Recommendation #2A clear Federal plan to coordinate communications regarding the H1N1 influenza pandemic and vaccination campaign is needed. A comprehensive and detailed plan should be developed that outlines the HHS plan for clearly providing accurate information as rapidly as possible on topics including but not limited to:
Summary/Wrap-Up/Next StepsDr. Birkhead said much of the September NVAC meeting will be devoted to updates and follow-up on H1N1 vaccine. The two recommendations passed at this meeting would be forwarded to Dr. Koh. Dr. Birkhead thanked the speakers and adjourned the meeting at 5 p.m.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
These minutes will be formally considered by the Committee at its next meeting, and any corrections or notations will be incorporated in the minutes of that meeting. Appendix A: Other Attendees Liz Adams, Ector County Health Department
Appendix B: Comments of the National Association of Community Health Centers |
Last revised: October 5, 2009
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