National Vaccine Advisory Committee Teleconference Meeting
2009 H1N1 Influenza Outbreak and Response
January 20, 2010, 3–5 p.m., E.S.T.
The National Vaccine Advisory Committee (NVAC) met via conference call primarily to discuss updates to the implementation of the Federal 2009 H1N1 influenza vaccination program. Staff of the National Vaccine Program Office (NVPO) summarized the status of the National Vaccine Plan and sought input from NVAC on criteria for determining priority objectives in the plan. NVAC liaison members representing State and local public health agencies described the status of vaccination efforts on the ground. Representatives of the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) described vaccine distribution and communication efforts to date. The chair of NVAC’s Vaccine Safety Risk Assessment Working Group (VSRAWG) summarized the group’s analysis so far, indicating that the data to date do not suggest significant adverse outcomes related to the H1N1vaccine, but continued monitoring is needed.
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.
Marie McCormick, M.D., Sc.D.
Julie Morita, M.D.
L. J. Tan, M.S., Ph.D.
Bruce G. Gellin, M.D., M.P.H., Deputy Assistant Secretary for Health; Director, NVPO
NVAC Liaison Representatives
Anne Bailowitz, M.D., M.P.H., National Association of County and City Health Officials (NACCHO)
Paul Jarris, M.D., Association of State and Territorial Health Officials (ASTHO)
Wayne Rawlins, M.D., M.B.A., America’s Health Insurance Plans
All other attendees are listed in Appendix A.
Guthrie Birkhead, M.D., M.P.H, Chair, NVAC
Dr. Birkhead called the meeting to order and gave an overview of the agenda. He noted that time is allotted for public comments but that presenters would not be taking questions from the general public or the media. Dr. Birkhead said NVAC members should send their comments about the priorities outlined in the draft National Vaccine Plan to Bob Bednarczyk by January 27 for consideration at NVAC’s February meeting.
National Vaccine Plan Update
Raymond A. Strikas, M.D., CAPT, U.S. Public Health Service (USPHS), NVPO
Dr. Strikas described NVPO’s efforts to date to gather input on the National Vaccine Plan, including a stakeholders meeting and three public engagement meetings. Howard Koh, M.D., Assistant Secretary for Health, will seek input from Department leaders about their priorities and implementation of the plan. That information, along with recommendations from the Institute of Medicine (IOM) and NVAC on prioritization of the plan’s objectives, will be incorporated into a revised draft of the plan that may be available for public comment in February. Dr. Strikas said the strategic plan should be finalized in June 2010. Once the strategic plan is finalized, NVPO will begin working on an implementation plan for the National Vaccine Plan.
Dr. Strikas said the current plan includes more than 30 objectives, and it would be helpful to prioritize which of those objectives should be the focus of efforts over the next 10 years. To that end, the IOM outlined three criteria for determining priority actions:
- What is the feasibility, both financial and technical, of accomplishing the objective?
- What is the potential impact on morbidity and mortality?
- Does the objective represent a strategic opportunity that is likely to require or motivate involvement of multiple stakeholders?
Marie McCormick, M.D., Sc.D., suggested that the concept of public salience—that is, whether the general public sees the objective as meaningful and valuable—be considered. She noted that, for example, modernizing manufacturing technology would probably not rank high among the public’s priorities. However, public perception would just be one factor to consider, Dr. McCormick noted, with more or less weight as appropriate for a given objective. Dr. Birkhead and Dr. Strikas said the values and goals of the public and stakeholders were expressed during the stakeholder and public engagement meetings as well as through public comment periods. Dr. Strikas summarized the input from the public engagement meetings as follows:
Values (i.e., what’s important) for the development and delivery of vaccines
- Achieving equity
- Emphasizing safety
- Promoting education and awareness
- Protecting the homeland
- Protecting the most vulnerable populations
Activities in the development and delivery of vaccines that are most important or most in need of improvement
- Making vaccines affordable and available to all
- Ensuring high rates of vaccination among children
- Improving vaccine monitoring
- Improving vaccine safety
- Ensuring there is enough vaccine
The Committee voted unanimously in favor of considering public values as part of the prioritization process.
NVAC recommends that NVPO add a fourth criterion for prioritizing the objectives described in the National Vaccine Plan: How important is the objective to the public, in the context of the top five values and top five priority activities identified through the public engagement process?
State and Local H1N1 Influenza Response Role
ASTHO—Paul Jarris, M.D.
Dr. Jarris said the Association of Immunization Managers is having a meeting and that organization regrets that no representatives are available to attend this NVAC teleconference. He expressed concern that funding for the Public Health Emergency Response grants to support State and local public health infrastructure will end in August 2010. He said Federal funding for epidemiology and surveillance will continue, but no further funding will be provided for vaccine development. Dr. Jarris worried that about half of the U.S. population is still susceptible to the novel H1N1 virus. He added that he is extremely concerned about concurrent infection with H1N1 and seasonal influenza.
Dr. Jarris said that many people seem to believe the H1N1 epidemic will be over by this summer and at that point, the country will revert to the system previously in place, or rather, return to the “nonsystem” for dealing with epidemics and public health emergencies. States will soon have to determine what vaccine to purchase for the fall 2010 influenza season, which may include a combined H1N1/seasonal influenza vaccine. It is unclear how State and local health departments could sustain the infrastructure they’ve put in place (e.g., in schools and clinics) without further funding, said Dr. Jarris. He said he is not confident that the H1N1 epidemic will be gone by next fall, and he cautioned that the Federal government will look very foolish if support is withdrawn before the outbreak is over.
On a positive note, Dr. Jarris said State and local health departments have done a very good job so far. States administered more vaccines this year than ever before.
NACCHO—Anne Bailowitz, M.D., M.P.H.
Dr. Bailowitz said the decline in disease activity, post-holiday “torpor,” and diminishing attention to promotional/advertising efforts have all combined to decrease public demand for H1N1 vaccine. In Baltimore, MD, however, turnout for school-located vaccination clinics remains steady. Local public health entities have taken creative approaches to outreach, including use of Twitter (for microblogging) and, in Baltimore, sandwich-board messages at the city’s busy Inner Harbor area. Other ideas include sidewalk-painting and autodialer telephone calls.
Dr. Bailowitz said staff burnout is a significant concern as the vaccination effort continues, and temporary staffing is essential to complete the mission. Despite the challenges, providers have administered the same amount of pediatric vaccine for the “traditional” vaccine-preventable diseases as in previous years.
Dr. Bailowitz pointed out that vaccine supply now exceeds demand. As a result, local public health providers are able to provide second doses of vaccine to children in some sites. Dr. Bailowitz noted that 16 percent of Baltimore City’s 82,000 school children have received at least one dose of vaccine through the health department, and 63 percent of all Baltimore health department H1N1 vaccine doses were administered via school-located programs. Also in Baltimore, providers are traveling to underserved areas, e.g., shelters, and to high-volume areas, e.g., churches and post offices, to give vaccines.
Dr. Bailowitz said local health departments must work with CDC to determine how and when to step down H1N1 vaccine efforts. Data are needed about disease activity and public demand for vaccine to support such decision-making.
For the near future, local health departments will continue administering second doses of vaccine in schools and expand vaccination programs to daycare centers. Outreach to special populations will continue, and providers will shift away from mass clinics in favor of decentralized operations, e.g., mobile vaccine units. Local health departments will facilitate the restoration of the medical home concept for immunization as soon as feasible, said Dr. Bailowitz.
Dr. Birkhead said the New York State health department is also experiencing a slowdown in vaccination efforts. Programs are focusing on tracking vaccinations, he said, and it is not clear what the State will do with its remaining vaccine supply.
Federal H1N1 Vaccination Program Implementation Update
RADM Anne Schuchat, M.D., USPHS, CDC
Dr. Schuchat said an enormous amount of work had been accomplished through partnerships across the public and private sectors. Despite challenges, CDC has made available 144 million doses of H1N1 influenza vaccine, and about 121 million doses have been shipped. On January 15, 2010, Morbidity and Mortality Weekly Report (MMWR) published interim results of an analysis of H1N1 vaccine coverage from October through December 2009. About 61 million people have been vaccinated, mostly those in groups designated as target populations according to the Advisory Committee on Immunization Practices (ACIP). Children and pregnant women were the highest covered population. The numbers published by MMWR, the results of CDC’s weekly influenza surveillance, and monthly information gathered from the Behavioral Risk Factor Surveillance System (which allows for State-specific comparisons) together provide a national snapshot of vaccine coverage, said Dr. Schuchat. The next step is to evaluate which approaches were most successful and why.
Dr. Schuchat noted that CDC released its first estimates of the burden of disease. About 55 million people were sickened by H1N1 virus, and about 246,000 were hospitalized as a result. About 11,000 people died, and more than 90 percent of deaths occurred in people under age 65, in contrast to seasonal influenza (in which deaths are more likely among those over 65).
At present, CDC has ample supply of H1N1 vaccine and is seeking to get the vaccine to those who still need it. January 10–16 was National Influenza Vaccination Week, and CDC promoted vaccination through various channels. More pharmacies and retail stores are promoting availability of the H1N1 vaccine. The CDC hopes to leverage the partnerships and infrastructure developed to distribute H1N1 vaccine to sustain public health efforts in nonemergency settings. Dr. Schuchat asked NVAC to consider how to capitalize on the efforts to date.
L. J. Tan, M.S., Ph.D., asked whether NVAC could assist in communicating messages that CDC has not yet addressed. For example, he noted that very few health care workers chose to receive H1N1vaccine despite an ACIP recommendation for early vaccination. Dr. Schuchat responded that the data on vaccination rates among health care workers are mixed. She felt it would be helpful to better understand why some priority populations that are typically reluctant to be vaccinated were willing to get H1N1 vaccine while others weren’t. Specifically, she said many pregnant women were vaccinated, but many adults with chronic diseases were not.
Dr. Birkhead asked what CDC is planning in terms of after-action evaluation of its efforts. Dr. Schuchat said various efforts are under consideration, including the Secretary’s proposal to review the entire countermeasures program. Certainly, there will be discussion of the process, from research and development through treatment, for developing and delivering influenza vaccines and countermeasures. Dr. Schuchat said CDC will work with other public health organizations, and some privately funded evaluations will also occur. Recently, CDC held its fifth in-progress review, and further after-action evaluation will occur in the spring. The Office of the Inspector General is planning to evaluate school immunization programs, Dr. Schuchat noted. Bruce G. Gellin, M.D., M.P.H., said that, just as they did before the pandemic, the relevant advisory bodies (e.g., NVAC, the National Biodefense Science Board) should come together to assign “lanes” (i.e., areas of focus) to avoid duplication of effort. Dr. Schuchat added that the Department of Education has been a tremendous partner in the vaccine effort, and that agency will also share its after-action findings with CDC.
At the February 2010 NVAC meeting, CDC will provide information on planned after-action evaluation efforts.
Jon R. Almquist, M.D., pointed out that, unlike public health providers, private-sector health care providers who use electronic health records have the potential to identify high-risk patients and reach out to them personally, encouraging them to get vaccinated. He hoped such avenues would be considered in the future. Dr. Almquist pointed out that, early in the H1N1 outbreak, many private providers were unable to ensure that children at high risk were vaccinated.
HHS H1N1 Communication Plan
Glen Nowak, Ph.D., CDC; and Stephanie Marshall, NVPO
Dr. Nowak said each day during National Influenza Vaccination Week, communication efforts highlighted a different target population. Media outreach included providing expert spokespeople for interviews, airing public service announcements, and buying advertising. For example, Sec. Sebelius appeared on “The Colbert Report” to encourage vaccination, and paid ads were aired during some of the college football bowl games. Dr. Nowak said HHS will continue purchasing some advertising as part of its continued communication efforts.
In addition, Dr. Nowak said, HHS is working with the Harvard School of Public Health on a survey to assess who saw the vaccination messages and whether they affected beliefs and behaviors. He said survey results should be available in about a month and will be useful for future planning.
Ms. Marshall said that, since August, her office has hosted a weekly coordination call among Federal government agencies about vaccine safety. Representatives from the CDC, the Food and Drug Administration (FDA), the National Institutes of Health, the Health Resources and Services Administration, the Department of Veterans Affairs, and the Department of Defense take part. Participants discuss what their agencies or departments are doing to communicate vaccine safety messages. The meetings help to ensure the Federal government delivers a consistent, coordinated message. Participants have shared materials and talking points and plan to continue meeting through 2010 and possibly longer.
Marie McCormick, M.D., Sc.D., Chair
Dr. McCormick said the Working Group evaluated additional data available since its December meeting and confirmed its previous findings:
- 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 expected).
- The data do not favor a signal between the outcomes examined and the H1N1 vaccines.
The Working Group based these conclusions on the following evidence: No serious adverse events have been reported in clinical trials. The adverse events reported so far are similar to those reported with seasonal influenza vaccine. For those systems conducting rapid-cycle analysis, the rates of adverse events for pre-specified outcomes are within expected values.
Dr. McCormick emphasized that the size of the population surveyed is limited, and more data are needed to detect rare adverse events. The data collected and analyses conducted across systems are not uniform, making consistent interpretation difficult. Thus, the Working Group 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.
Dr. McCormick indicated that the Working Group reviews data at a much more granular level than is described in the report’s summary of data sources. Dr. Birkhead clarified that once the Working Group’s report is endorsed by NVAC, it is forwarded to the Assistant Secretary for Health. At that point, NVPO may make the report public by posting it on the NVPO website. Dr. McCormick stated that the report represents the consensus of the Working Group members, who deliberate among themselves on the data presented by Federal representatives.
Dr. McCormick described the various approaches taken to evaluate adverse events. For example, the Vaccine Adverse Event Reporting System (VAERS) data compares the rate of adverse events reported for H1N1 vaccine with those reported for seasonal influenza vaccine. The FDA’s system allows for comparison of events reported for all live vaccines with events reported for all inactivated vaccines. Rapid-cycle analysis looks at individuals before and after vaccine exposure. Dr. McCormick emphasized that the VAERS system does not confirm that vaccine was actually given in a specific case, while rapid-cycle analysis does confirm exposure. Researchers are combing through the VAERS data for cases that may be appropriate for further analysis of potential vaccine-related events. Dr. McCormick noted that data will be available in late January from the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) surveillance program, a public-private partnership that combines information from several large health insurance plans’ databases, and State immunization information systems vaccine registries.
NVAC members voted unanimously to accept the report of the VSRAWG.
Dr. McCormick thanked the NVPO staff for their “spectacular work” assisting the VSRAWG. Dan Salmon, Ph.D., M.P.H., of NVPO said the Working Group will continue to meet for up to six months after the end of H1N1 vaccination program.
Jim Moody of SafeMinds said that polls show the public has refused the H1N1vaccine because of safety concerns; therefore, vaccine safety concerns should be addressed more thoroughly. Better baseline data are needed, particularly for those in vulnerable populations, such as pregnant women and people with chronic diseases. Mr. Moody pointed out that no action has been taken on NVAC’s recommendation to gather good information on unvaccinated and partially vaccinated populations.
Theresa Wrangham of SafeMinds said her organization remains concerned about the availability of thimerosal-free H1N1 vaccine. She asked whether evaluation of adverse events would be limited to immune responses or to health outcomes beyond six months post-vaccination. Ms. Wrangham asked the VSRAWG to identify the 18 pre-specified health outcomes referenced in its evaluation of data.
Ms. Wrangham appreciated the move to include public input in the determination of priorities for the National Vaccine Plan. She called for an opportunity for the public to participate meaningfully in the development of the National Vaccine Plan, recommending a process similar to the Salt Lake City Writing Group, which brought together knowledgeable members of the public to weigh in on the CDC’s Immunization Safety Office scientific agenda.
Ms. Wrangham questioned the validity of findings based on VAERS data given the underreporting of adverse events. She hoped NVAC would respond to questions posed in writing by various organizations.
Guthrie Birkhead, M.D., M.P.H, Chair, NVAC
Dr. Birkhead said the next NVAC meeting is scheduled for February 3–4, 2010, in Washington, DC. He noted that NVAC’s 2009 State of the Program report will be finalized at that time.
Dr. Almquist complimented CDC on rapidly updating its communications for providers regarding immunization and the use of Tamiflu. He encouraged the agency to consider establishing an advisory group that includes health care providers who can provide expertise in decision-making. At the February NVAC meeting, the Committee will discuss mechanisms for assisting CDC with rapid decision-making during an emergency response.
Dr. Birkhead thanked the speakers and adjourned the meeting at 4:31 p.m.
Appendix A: Other Attendees
|First Name||Last Name||Company|
|Anthony||Vascom||Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health and Human Services (HHS)|
|Anna||Buchanan||Association of State and Territorial Health Officials (ASTHO)|
|Jay||Butler||Centers for Disease Control and Prevention (CDC)|
|Jody||Carrillo||Pueblo County Health Department|
|Vito||Caserta||Health Resources and Services Administration (HRSA)|
|Angela||Chen||National Vaccine Program Office (NVPO)|
|Limone||Collins||Department of Defense|
|Dack||Dalrymple||Dalrymple & Associates LLC|
|Sandra||Davis||Logan County Health Department|
|Vicky||Diebold||National Vaccine Information Center (NVIC)|
|Carter||Diggs||U.S. Agency for International Development (USAID)|
|Paul||Etkind||National Association of County and City Health Officials (NACCHO)|
|Becky||Fowler||American Academy of Pediatrics|
|Lance||Gordon||Sabin Vaccine Institute|
|Maria||Gutierrez||Clinica Sierra Vista|
|Jordan||Head||Texas State Senate|
|Rick||Hill||U.S. Department of Agriculture|
|Deborah||Kilto||Jefferson County Department of Health|
|Chris||Laborde||Department of Health and Social Services, State of Alaska|
|Molly||Lamb||Illinois Department of Public Health|
|John||Martin||Institute of Progressive Medicine|
|Natalie||Matthews||America’s Health Insurance Plans|
|Leslie||McGorman||Infectious Diseases Society of America (IDSA)|
|Ann||Mosher||National Institutes of Health (NIH)|
|Barbara||Mulach||National Institute of Allergy and Infectious Diseases (NIAID)|
|Patricia||Quinlisk||National Biodefense Science Board|
|Laura||Scott||Families Fighting Flu|
|Margaret||Tomecki||American Pharmacists Association|
|Thomas||Weaver||Association for Professionals in Infection Control and Epidemiology, Inc. (APIC)|