National Vaccine Advisory Committee Teleconference Meeting
National Vaccine Advisory Committee Teleconference Meeting
2009 H1N1 Influenza Outbreak and Response
December 16, 2009, 3–5 p.m., E.S.T.
The National Vaccine Advisory Committee (NVAC) met via conference call to discuss updates to the implementation of the Federal 2009 H1N1 influenza vaccination program. Representatives of the Institute of Medicine (IOM) summarized key recommendations on the draft revision of the National Vaccine Plan. 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. NVAC liaison members representing State and local public health agencies described the status of vaccination efforts on the ground and proposed topics for NVAC to address in future meetings.
Committee Members in Attendance
Guthrie S. Birkhead, M.D., M.P.H., Chair
Jon R. Almquist, M.D.
Mark Feinberg, M.D.
Lisa Jackson, M.D., M.P.H.
Clement Lewin, Ph.D., M.B.A.
James O. Mason, M.D., Dr.P.H.
Marie McCormick, M.D., Sc.D.
Christine Nevin-Woods, D.O., M.P.H.
Andrew T. Pavia, M.D.
Laura E. Riley, M.D.
L. J. Tan, M.S., Ph.D.
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 (NACCHO)
Claire Hannan, M.P.H., Executive Director, Association of Immunization Managers (AIM)
Paul Jarris, M.D., Association of State and Territorial Health Officials (ASTHO)
Wayne Rawlins, M.D., M.B.A., America’s Health Insurance Plans
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.
National Vaccine Plan Update
Raymond A. Strikas, M.D., CAPT, U.S. Public Health Service (USPHS), NVPO
Dr. Strikas explained that NVPO contracted with the IOM to form an expert committee to gather input from stakeholders and review the revised draft of the National Vaccine Plan. The IOM committee completed its review and presented recommendations for revising the plan, prioritizing activities, and coordinating implementation efforts. Priorities for the National Vaccine Plan was published December 11, 2009.
Dr. Strikas outlined the timeline for finalizing the National Vaccine Plan. He said Howard Koh, M.D., Assistant Secretary for Health, will seek input from Department leaders about their priorities and implementation of the plan. Dr. Strikas hoped a revised draft of the plan would be available for public comment by the end of January and that the strategic plan would be finalized in the summer of 2010. Once the strategic plan is finalized, NVPO will begin working on an implementation plan for the National Vaccine Plan.
IOM Report Highlights
Ed Marcuse, M.D., and David Reuben, M.D., IOM Committee on Review of Priorities in the National Vaccine Plan
Dr. Marcuse described the IOM’s information-gathering and review process. He said the IOM’s recommendations stress the need for better coordination. To achieve the goals set for public health, we need an updated National Vaccine Plan, Dr. Marcuse said, and implementing it requires leadership. It also requires that Federal government agencies and private-sector organizations be receptive and responsive to efforts to coordinate the vaccine enterprise.
Dr. Marcuse and Dr. Reuben summarized a few of the 18 recommendations in the report:
Safety: Because sustaining public confidence in vaccine safety is a prerequisite to a successful vaccine program, vaccine safety activities should be strengthened, for example, by formalizing and making more transparent the efforts of NVAC’s Vaccine Safety Working Group.
Communication: Communication research should be expanded and coordination of communication enhanced to improve public knowledge and understanding of vaccines and immunization.
Financial Barriers: To achieve optimal effectiveness, barriers to immunization—including the cost to providers of acquiring, storing, and administering vaccines as well as the financial barriers that prevent low-income and underinsured people from getting vaccines—should be removed at every stage.
Health Information Technology (HIT): The Federal American Recovery and Reinvestment Act (ARRA) provides an opportunity to require that immunization information be part of efforts to improve and expand HIT, which can help meet NVPO’s goals.
Research and Expansion: While it’s not clear which Federal agency should take the lead, the National Vaccine Plan should push for more research and expansion of vaccines beyond the traditional targets of infectious disease.
Wayne Rawlins, M.D., M.B.A., said the IOM’s report overlooked important research around vaccine financing, such as the efforts of NVAC’s Vaccine Finance Working Group and recent publications from CDC staff (e.g., “Net Financial Gain or Loss From Vaccination in Pediatric Medical Practices,” by Margaret Coleman et al., published in the December 2009 Supplement to the journal Pediatrics).
Dr. Strikas noted that NVPO would incorporate the IOM recommendations as appropriate into the next draft of the plan. Dr. Birkhead suggested NVAC discuss the IOM recommendations in more detail at its January teleconference. Bruce G. Gellin, M.D., M.P.H., pointed out that NVPO sought input from multiple sources, and the priorities and suggestions from all the sources will be taken into account as Department leaders consider how to move forward with the National Vaccine Plan over the next several months.
Dr. Birkhead was gratified to see IOM’s emphasis on coordination and asked whether IOM recommended organizational changes for NVPO. Dr. Marcuse said IOM believes the current structure should be more empowered, which, Dr. Birkhead said, aligns with NVAC recommendations. In response to a question about the global health goals of the plan, Dr. Marcuse said the IOM recommendations emphasize that the United States must participate fully in global health efforts. Dr. Reuben added that the United States should seek to build capacity and strengthen infrastructure for immunization, especially in low-income countries.
Jon R. Almquist, M.D., asked whether the IOM’s recommendations on improving the public health system includes individual providers. Dr. Marcuse emphasized that vaccine delivery is a collaborative effort between the public and private providers, and the public health infrastructure requires maintenance so that it can continue to play its part.
Dr. Birkhead asked whether IOM had considered other mechanisms for evaluating vaccine safety. Dr. Marcuse said many Federal agencies have some responsibility for vaccine safety assessment and monitoring, and much work is being done. However, much of that work is invisible to the public. He stressed that safety issues must address public concerns, not just scientific concerns, and that safety research must be expanded and more visible.
Federal H1N1 Vaccination Program Implementation Update
RADM Anne Schuchat, M.D., USPHS, CDC
Dr. Schuchat said that, as of December 16, CDC had distributed 96.4 million doses of H1N1 influenza vaccine over two-and-a-half months, more than the Vaccines for Children program typically distributes in a year. Approximately 235,000 individual shipments of vaccine have gone out to 75,000 entities, some of which distribute vaccine to other entities. About half of the States have broadened their outreach beyond the target groups identified by the Advisory Committee on Immunization Practices (ACIP). About two thirds of States implemented a school-based vaccination effort. CDC is gathering data to identify the vaccination approaches that had the highest uptake, efficiency, and acceptability. Many States are including retail stores and pharmacies in an effort to reach more people, and retail outlets are keenly interested in providing vaccinations. As the vaccine supply improves and disease decreases, said Dr. Schuchat, it is critical to continue promoting vaccination.
Dr. Schuchat explained that on December 15, Sanofi Pasteur voluntarily recalled 800,000 doses of H1N1 vaccine in pre-filled syringes intended for children ages 6–35 months. Routine quality control testing by the manufacturer indicated the effectiveness of the vaccine in the syringes had diminished. Further CDC testing found four lots that did not meet the specifications required for long-term action of vaccines. The Food and Drug Administration (FDA) found that the amount of antigen in vaccines that were distributed was sufficient to induce an immune response in those children who received it. Therefore, those children are protected. However, the recall removes from the market the only thimerosal-free vaccine indicated for very young children. Dr. Schuchat noted that supplies of nasal spray vaccine are ample and appropriate for healthy children over 2 years of age and that doses from appropriate multi-dose vials can be used for children under two years.
Dr. Schuchat said it is not yet clear why the recalled vaccine lost some of its effectiveness, and the FDA and Sanofi Pasteur are trying to determine the cause. She clarified that Sanofi Pasteur discovered the problem as part of routine testing.
HHS H1N1 Communication Plan
Kris Sheedy, Ph.D., CDC; and Stephanie Marshall, NVPO
Dr. Sheedy described efforts underway to promote influenza vaccination, including a recent partnership with the Ad Council on a national public service campaign. She stressed that there is a small window of opportunity during which vaccine supply and public demand are equal, so communication should focus on the availability of vaccine now. Dr. Sheedy was happy that the new Surgeon General is engaged in provider outreach. She noted that HHS is finalizing plans for National Influenza Vaccination Week, January 10–16, 2010.
Ms. Marshall described efforts by HHS to address concerns about vaccine safety, including a CDC webinar for State and local public health information officers. Every Thursday, CDC posts data from the Vaccine Adverse Event Reporting System (VAERS). On December 17, 2009, HHS hosted a press conference with Secretary Sebelius and other high-ranking officials of HHS.
Asked what the key messages of H1N1 communication are right now, Dr. Sheedy said that influenza is unpredictable, therefore, people should consider getting the vaccine despite the recent decrease in disease, because the vaccine appears to be safe and effective. Dr. Sheedy noted that in January, HHS will place some paid advertising promoting influenza vaccination, but the Department adjusts its outreach efforts in response to the disease.
Ms. Marshal said the Flu.gov website will include information on the recall of the Sanofi Pasteur thimerosal-free vaccine. The site encourages parents to weigh the pros and cons of the available vaccines with their providers and emphasizes that the available vaccines are safe and effective on the basis of information collected so far.
Marie McCormick, M.D., Sc.D., Chair
Dr. McCormick described the formal decision-making process established by the Working Group for evaluating data. The group defined a “signal” as an event that could be temporally related to administration of a vaccine and that occurs more often than would be expected. When a signal is identified, the data are further examined to determine whether there is a true association of the signal with the vaccine. The next step is to evaluate whether a causal relationship exists between the vaccine and the signal event.
Given the available data sources, the VSRAWG determined that data are adequate to assess the presence or absence of a signal. The data to date do not favor an association between the outcomes examined by the group and administration of H1N1 influenza vaccine. 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. The rates of adverse events appear to be consistent with rates for seasonal influenza vaccine.
Dr. McCormick emphasized that the H1N1 influenza vaccination program is in its early stages and data are limited. Several analyses are based on small numbers of adverse events, and more data are needed to detect rare adverse events. Some adverse events are still being validated (e.g., to determine whether reported cases of Guillain-Barré syndrome [GBS] are in fact GBS cases). Therefore, the VSRAWG suggests that the Federal government continue to monitor the safety of H1N1 influenza vaccine as the volume of data increases.
Dr. McCormick noted that two more candidates are expected to join the group once they complete the clearance process. The group meets every other week by phone. Various Federal agencies (within and outside HHS) present data to the group for consideration. In response to a question about deaths reported, Dr. McCormick said many of the deaths are still being examined to determine the cause; of the approximately 20 deaths reported to the group, most have been found not to be related to the vaccine. She clarified that identifying a signal is just the first step in determining whether further analysis is needed.
Dan Salmon, Ph.D., M.P.H., of NVPO noted that data are not yet available from the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) surveillance program, a public-private partnership that combines information from Vaccine Safety Datalink, several large health insurance plans’ databases, and State vaccine registries. Those data will draw from a population of approximately 24 million people.
NVAC members voted unanimously to accept the report of the VSRAWG.
State and Local Response Role
AIM—Claire Hannan, M.P.H.
Ms. Hannan said a University of Michigan survey of 54 vaccination programs found that most had already expanded their programs to provide vaccinations to the general public and several are planning to do so this year. Driving the decision to expand the programs is the desire to use all the vaccine ordered and ensure that none is left over, as was the case in the 2004-05 influenza season, when early vaccine shortages led programs to prioritize groups for vaccination. Programs are also responding to strong public demand, especially from seniors. About half of programs are using retail pharmacies to expand their reach. Ms. Hannan pointed out that expansion does not necessarily mean that vaccination needs have been met for all those in priority groups, but programs are concerned about missing opportunities by waiting too long to expand availability of the vaccine.
Ms. Hannan described the typical process that public health programs go through daily in ordering and distributing vaccine. In a typical week, programs are involved in conference calls with the CDC, providers, and State and local public health agencies as well as in media and education campaigns. Most programs are challenged by the amount and frequency of requests for information. For example, identifying which providers had received pre-filled syringes from the recalled lots requires sorting through papers by hand.
Ms. Hannan suggested NVAC look at the following topics:
- Role of the private sector and public health programs in future vaccination efforts given this year’s experience, in which all H1N1 vaccine was purchased by the Federal government and mostly distributed through public health entities
- Possible incorporation of H1N1vaccine into the annual seasonal influenza vaccine and the related implications for public expectations, school-based programs, and funding
- Building on the infrastructure created by States to support H1N1 vaccination and the enthusiasm of new vaccine providers (e.g., obstetrician-gynecologists [ob-gyns]) for future vaccination efforts
- Improving systems for centralized vaccine ordering and distribution
ASTHO—Paul Jarris, M.D.
Dr. Jarris said States administered an historic number of vaccines this year, despite many problems. ASTHO’s data indicate that vaccine is available to all residents in 24 States. Programs are expanding to include retail stores and pharmacies, which can reach people over holiday weekends and during holiday shopping. Dr. Jarris said there has been some discussion about whether the Federal government should be more prescriptive about who gives the vaccine and where, but ASTHO believes the flexibility given to State and local public health programs has helped distribution of the vaccine.
Not only are Federal, State, and local governments increasing their communication efforts, but opinion leaders are talking to the media and the public about H1N1 vaccination, Dr. Jarris said. Retail pharmacies and chain stores are spreading the message in malls and stores and also through their newsletters. The impact on demand of expanding availability of the vaccine is not known, although retailers say that seniors are seeking the H1N1 vaccine. Also, the return of students to campuses after the winter break may trigger a third wave of disease, which could affect demand.
Dr. Jarris said his biggest concern is that, as a nation, we will have learned nothing from the experience of this year. He noted that funding for preparedness ran out in August and programs had no money from ARRA funding until after the H1N1 outbreak began. If disease wanes in the spring, Dr. Jarris worried, apathy may take over again. The capacity built and expertise developed during the pandemic may go unused. He hoped that the Congressional response to an Obama Administration request for more funding would signal whether the Federal government will provide sustained funding for vaccine programs. ASTHO is petitioning Congress for an effective, ongoing, pandemic response system that has sustained funding.
NACCHO—Anne Bailowitz, M.D., M.P.H.
Dr. Bailowitz said NACCHO is delighted about the expansion of vaccine availability, which meets a lot of pent-up demand. She confirmed that seniors are eager to get vaccinated. However, Dr. Bailowitz noted that Maryland, for example, has an abundance of vaccine, and with disease declining and the holiday season approaching, she anticipates less enthusiasm for vaccination. Still, Dr. Bailowitz noted that 40 percent of those visiting a Baltimore clinic offering both seasonal and H1N1 vaccine received both vaccines. In keeping with the season, providers are offering vaccine at malls and churches and at clinics in the evenings and on weekends.
Dr. Bailowitz described some lessons learned:
- Increased funding supports progress. Baltimore, for example, quadrupled its staff, greatly increasing its capacity to administer vaccines.
- The pandemic has helped organizations become more prepared and to use the continuity of operations approach.
- School-based programs require a lot of planning, paperwork, and, ideally, four to five months’ lead time.
- Immunizers should be paid by the hour, not the shot, or they may immunize everyone, regardless of prioritization.
- Immunization subject matter expertise and field experience can blend well in an incident command structure.
Over the next few months, local health departments will return to schools to administer second doses of vaccine to children and expand vaccination programs to daycare centers. Mass clinics will be open to the general public, although there will be fewer such clinics. Some clinics will revert back to normal operations as the medical home concept is restored. A medical home for immunization is critical for health care, especially for children, said Dr. Bailowitz.
When the pandemic subsides, Dr. Birkhead said, he would like NVAC to play a role in after-action reporting to address issues such as leveraging seasonal vaccine efforts, modernizing the vaccine manufacturing process, improving the public health infrastructure, and identifying best practices for immunization. Dr. Gellin said it’s not clear yet which agencies and advisory bodies will address which issues, but just as they did before the pandemic, entities should come together to assign “lanes” (i.e., areas of focus) to avoid duplication of effort.
Dr. Jarris emphasized that evaluation of efforts should involve governments at all levels. He suggested evaluation be categorized not just by sector but by distribution channels, such as schools, retail stores, and public health clinics. He noted that the Center for Infectious Disease Research and Policy (http://cidrappractices.org) is collecting information on best practices, and he encouraged providers to submit their experiences.
Andrew T. Pavia, M.D., said there will be no shortage of reporting; the challenge lies in coordinating the lessons learned, ensuring that reports include unvarnished outside opinions, and identifying what works. Another member noted that the longer we wait to collect information about what happened, the less accurate it will be.
Laura E. Riley, M.D., hoped to capitalize on the momentum of the vaccine program, which spurred ob-gyns and others to become more involved in vaccinations. She hoped the experiences of this year would be a starting point for furthering adult immunization efforts, especially among those practices who added infrastructure to support vaccination. Dr. Birkhead agreed and suggested the Adult Immunization Working Group look into the issue.
Dr. Almquist felt that many parents of children at high risk avoided getting their children vaccinated because of the long lines at clinics, and because private providers did not have access to the vaccine, they could not administer it in children’s medical home. Dr. Birkhead said that if the vaccine supply had lived up to original projections, it might have been possible to use both approaches.
CAPT Jay Butler, M.D., said the CDC does collect data on an ongoing basis, and it has established mechanisms to help providers learn and adjust to situations on the fly. He said that in many ways, CDC’s preparations for a short-term response were not effective because of the shortage of vaccine.
James O. Mason, M.D., Dr.P.H., asked how to address the discrepancy between manufacturers’ promises and the amount of vaccine delivered. Dr. Birkhead suggested deferring the topic for more thorough consideration at a later time.
Theresa Wrangham of SafeMinds asked what findings would indicate that a third wave of disease is possible. She said her organization received calls about the lack of thimerosal-free vaccine and noted that some States reported no access to thimerosal-free vaccine, so the Sanofi Pasteur recall is alarming. It is not clear what percentage of vaccine would have been thimerosal-free even without the recall, she said. Ms. RINGHAM hoped information on outcomes among the ACIP-identified priority groups would be posted on the website. She thanked NVAC for publishing the roster of the VSRAWG and asked for more information on that group’s process, specifically whether it is looking at immune response.
Allison Fedarko, who described herself as a parent not affiliated with any organization, said that if NVAC is interested in increasing VAERS reporting, it should suggest some kind of mandate that local health departments provide the name of the vaccine manufacturer and the lot number to the vaccinee at the time of administration. Without that information, adverse events cannot be reported to VAERS. Dr. Birkhead said that information is given to vaccinees, but Ms. Fedarko said her son received only a form letter with his name and the date of vaccination.
Deb Huber expressed concern about the fear-mongering that the public is exposed to and the fact that no alternatives to vaccination are given. She pointed to an article in a virology journal that said if we were not vitamin-D deficient, we would be less susceptible to influenza, and 50–84 percent of the population is deficient in vitamin D at this time of year. She said she would like to hear a different tone from the medical community rather than hearing about every person who dies of respiratory failure. She would also like to see a change of direction.
Ms. Fedarko suggested that availability of vaccine to local health departments be contingent on reporting to VAERS and on providing sufficient manufacturer information to vaccinees. She said the current requirements should be subject to some kind of enforcement or should drive availability of the vaccine.
Eileen Dannemann of the National Coalition of Organized Women complained about the lack of vaccine program oversight in the States. She said her organization went to Walgreen’s, Walmart, and a local pharmacy; pharmacists at all the stores wrongly said the H1N1 vaccine they distributed did not contain thimerosal (although all were distributing the multidose vaccine). When the organization reported the misinformation to the Iowa Department of Public Health, that department said the Iowa Department of Inspections and Appeals is the regulatory body in charge. The latter department denied authority for regulating the vaccine program. No one is watching the hen house, Ms. Dannemann said. Stores are giving erroneous information, and pregnant women are being told the vaccine they are receiving does not contain thimerosal.
State health departments should have more oversight over vaccine providers, said Ms. Dannemann, and also over adverse event reporting. She added that ob-gyns are not reporting adverse events related to vaccines. Her organization has collected hundreds of reports of spontaneous abortions within two to three days of H1N1 vaccination that have not been reported to VAERS. Should we tell pregnant women to be concerned about H1N1or thimerosal in the vaccine, Ms. Dannemann asked.
Dr. Birkhead said miscarriage is an outcome of concern but he was not sure whether it can be reported to VAERS. Ms. Dannemann said ob-gyns don’t believe there is a risk, so they don’t report to VAERS even when events do occur, despite the requirements of a 1986 law. Further, the consumer has no clear indication or directions on when or how to report adverse events to VAERS. Ms. Dannemann said States should tell physicians that they are required to report events, regardless of whether the physician believes it is related to the vaccine. Dr. McCormick said there is a pregnancy-related surveillance system for vaccines. The VSRAWG has not yet reviewed any data from that system, she said, but she believed that data would address this question.
Jim Moody of SafeMinds said there has been no action on NVAC’s recommendation for a comparative study that would provide good baseline data on vaccines in children. The communication strategy is only as good as the science, he said, and there is competing science on thimerosal. Mr. Moody said the CDC will soon release data that show an increase in autism with the introduction of the hepatitis B vaccine that contained thimerosal.
Mr. Moody said NVAC has not discussed the fact that about half of the refusals were due to safety concerns.. Without good baseline data, he said, many people still have doubts about vaccine safety. Transparency is not enough, Mr. Moody said; an independent review of safety is needed, as is done by the National Transportation Safety Board. Despite NVAC’s efforts, money for research has been removed, he said. Without an independent body focused on safety first, doubts will grow. he concluded.
Paul King of the Coalition for Mercury-Free Drugs said no studies have ever been done to prove that thimerosal is safe, so public officials should stop saying it’s safe. Studies intended to evaluate thimerosal were never completed, he said. When thimerosal is injected into rats, it is toxic at levels 23 times lower than the reference dose of the Environmental Protection Agency, said Mr. King. Furthermore, there are no data showing the H1N1 vaccine is safe or effective—that is, that it results in a 95 percent or better chance of protection. Mr. King says the rate is more likely around 65 percent and in real numbers close to 36 percent. A vaccine that is no more than 30-percent effective is a crime, he concluded, as that level is less than chance.
Timothy Welsh said that raising the specter of a third wave is like crying wolf, and the public is getting knocked off balance.
Guthrie Birkhead, M.D., M.P.H, Chair, NVAC
Dr. Birkhead said the next NVAC teleconference will take place January 20, and the next in-person meeting is scheduled for February 2010. He thanked the speakers and adjourned the meeting at 5:07 p.m.