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National Vaccine Advisory Committee Teleconference Meeting

National Vaccine Advisory Committee Teleconference Meeting
2009 H1N1 Influenza Outbreak and Response
November 6, 2009, 3–5 p.m., E.S.T.

Meeting Summary

 

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. Representatives of the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) presented overviews on vaccine distribution efforts, clinical trials, and communication challenges. NVAC liaison members representing State and local public health agencies described the status of vaccination efforts on the ground. The chair of a new NVAC working group on vaccine safety risk assessment described the group’s initial meeting. In closing, NVAC members considered areas for the Committee to address in light of the current H1N1 influenza pandemic and vaccination efforts.

Committee Members in Attendance

Guthrie S. Birkhead, M.D., M.P.H., Chair
Jon R. Almquist, M.D.
Tawny Buck
Cornelia L. Dekker, 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.
Julie Morita, M.D.
Christine Nevin-Woods, D.O., M.P.H.
Trish Parnell
Andrew T. Pavia, M.D.
Laura E. Riley, M.D.
L. J. Tan, M.S., Ph.D.

Executive Secretary
Bruce G. Gellin, M.D., M.P.H., Deputy Assistant Secretary for Health; Director, National Vaccine Program Office (NVPO)

NVAC Ex Officio Members
Norman Baylor, PhD, Food and Drug Administration
Jeffrey Kelman, M.D., MMSc, Centers for Medicare and Medicaid Services (CMS)
Margaret McCluskey, RN, M.P.H., US Aid for International Development
Barbara Mulach, PhD, National Institutes of Health (NIH)
RADM Anne Schuchat, M.D., US Public Health Services (USPHS), Centers for Disease Control and Prevention (CDC)
Ron Valdiserri, M.D. M.P.H., Veterans Affairs

NVAC Liaison Representatives
Anne Bailowitz, M.D., M.P.H., National Association of County and City Health Officials (NACCHO)
Jim Blumenstock, M.A., Association of State and Territorial Health Officials (ASTHO)
Claire Hannan, M.P.H., Executive Director, Association of Immunization Managers (AIM)
John Modlin, M.D., Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Patricia Quinlisk, M.D., M.P.H., National Biodefense Science Board

Invited Speakers
CAPT Jay Butler, M.D., USPHS, CDC
Linda Lambert, Ph.D., NIH
Stephanie Marshall, NVPO
Dan Salmon, Ph.D., M.P.H., NVPO
Kristine Sheedy, PhD, CDC
Abbigail Tumpey, CDC

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 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

Federal H1N1 Vaccination Program Implementation Update

Overview—RADM Anne Schuchat, M.D., United States Public Health Service (USPHS), CDC
RADM Schuchat said that H1N1 influenza has spread across all of the States, and influenza-like illness (ILI) currently accounts for about 7 percent of all outpatient hospital visits, which is higher than usual for this time of year. Rates of illness, hospitalization, and death from influenza are up, and 129 pediatric deaths from H1N1 influenza have been reported to date. RADM Schuchat said 90 percent of cases of H1N1 influenza occur in people under 65 years old, and 55 percent of cases occur in people under 25 years old.

The underlying conditions associated with severe outcomes are asthma, chronic lung disease, chronic heart disease, and diabetes. RADM Schuchat said 11 percent of adults who have been hospitalized with H1N1 influenza are pregnant women. About two thirds of pediatric deaths have occurred in children and young adults who have underlying conditions. Asthma is an important contributor to pediatric deaths from H1N1 influenza, but RADM Schuchat said a variety of neurologic conditions have also been noted, such as neuromuscular disorders and seizures.

RADM Schuchat said H1N1 influenza has appeared most prominently in those ages 5–24 years old, but providers are beginning to see more cases in those ages 40–50 years old. Patterns have been spotty, she said. The outbreak appears to be waning in the Southeast, but influenza rates there are still above the typical level expected for this time of year. RADM Schuchat said the virus has not mutated and few cases of antiviral resistance have been reported.

Vaccine Program Implementation—CAPT Jay Butler, M.D., USPHS, CDC
Dr. Butler reviewed the vaccine distribution mechanism in place. Providers place orders with their local or State health department, which transmits the orders to CDC. On a daily basis, CDC processes orders and forwards them to the distributor. The distributor receives vaccine from the four licensed manufacturers through its centralized distribution system, then ships it to providers under the direction of State health departments. Beginning October 12, CDC revamped its system to transmit orders to the distributor every day at 5 a.m., so that 90 percent of orders ship that day for delivery the next day.

The biggest challenge has been the supply of vaccine available, said Dr. Butler. As of November 6, the cumulative amount of vaccine available for order was 38 million doses. About one fourth of the vaccine available to date is in intranasal form; the rest is injectable. Dr. Butler acknowledged the frustration of pushing States to prepare for mass vaccination and then having such a limited supply of vaccine. He noted that a year ago, the ability to create and distribute 38 million doses of vaccine for a novel virus less than 7 months after it was detected would have made the CDC happy with its progress. However, the H1N1 influenza vaccination program was designed around a much larger supply.

To compensate for the lack of vaccine supply, some State and local health departments have focused on vaccinating large populations or targeted priority groups, such as health care workers at children’s hospitals. Others have limited early doses of vaccine to health care providers. Some States have allotted vaccine on a pro rata basis to local health departments to distribute as they see fit.

Dr. Butler said CDC is tracking influenza and vaccination using a weekly immunization survey (i.e., the National Immunization Survey format but without the review of medical records). By October 23, about 2 percent of the country had been vaccinated. In addition, CDC is gathering data from the Behavioral Risk Factor Surveillance System (BRFSS), which is a slower process but provides more complete information. Dr. Butler anticipated that October data would be available by mid-November and would provide a better assessment of variability in vaccine coverage by State and coverage among groups at high risk.

Discussion

In response to NVAC member questions, Dr. Butler said CDC has not yet posted information by State because its numbers have been so small. The BRFSS can provide a good view of coverage by risk and age groups for adults. Some States are collecting pediatric data. The current CDC information systems do not provide data at the local level.

James O. Mason, M.D., Dr.P.H., pointed out that, according to national news sources, some vaccine has gone to major Wall Street firms and other big companies. RADM Schuchat said the New York City Health Department issued a statement on its distribution of vaccine, noting that most went to school-based clinics, hospitals, and doctors’ offices, and about 6 percent went to employer-based clinics. She emphasized that CDC made recommendations on priority populations for vaccination but gave State and local health departments flexibility to determine the best way to reach those populations, whether through doctors’ offices, schools, commercial venues, or the workplace. RADM Schuchat reminded NVAC members about the challenges of adult immunization and said State and local health departments have tried to be innovative in reaching adults. She added that many people may wish to avoid doctors’ offices to avoid coming in contact with sick people, so many States are dividing vaccine among providers at various venues.

 L. J. Tan, M.S., PhD., said 23 percent of New York’s vaccine has gone to pediatric physicians’ offices; he suggested CDC communicate that information to ameliorate concerns and address rumors. RADM Schuchat agreed that communication is important to ensure people know how and where to get vaccinated, to preserve the integrity of the vaccination program, and to manage expectations. However, she felt it would be an inefficient use of CDC resources to track and publicly disseminate details about where vaccine is shipped. More States are sharing information about vaccine availability through their own websites, which link with the national Flu.gov site. RADM Schuchat said that when State and local health providers communicate well with their citizens, people better understand how the prioritization approach works. Dr. Butler said that detailed data would have to come from the local level. At present, CDC believes that vaccine has been evenly split between public and private providers. RADM Schuchat added that over time, venues that have been serving as public health providers may shift into private providers, and some public health providers are awaiting larger supplies before making the vaccine available at large public clinics.

Julie Morita, M.D., said response to live, attenuated influenza vaccine (LAIV) has been less enthusiastic in Chicago and asked whether national efforts have been made to communicate the safety and efficacy of LAIV. Dr. Butler said CDC has tried to address concerns about the safety of LAIV in general, stating that no concrete risk has been identified except in very rare situations. RADM Schuchat hoped that people would not go unvaccinated because of fears about LAIV.

Clinical Trials Update—Dr. Linda Lambert, National Institutes of Health (NIH)
Dr. Lambert stressed that trials conducted by the National Institute of Allergy and Infectious Diseases (NIAID) focus on assessing safety of the available H1N1 influenza vaccine preparations and addressing gaps in the current research, not on providing data to support licensure. The vaccine research supported by NIAID is intended to inform policy decisions. Dr. Lambert gave a broad overview of the vaccine research network and described the multiple mechanisms in place to facilitate continuous safety monitoring. She described the protocols and preliminary results to date of several targeted H1N1 influenza trials. Key findings are as follows:

  • In most healthy adults, a single 15-mcg dose results in high antibody titers (consistent with the dose recommended for currently licensed vaccines).

  • In children ages 6 months through 9 years old, two doses of 15-mcg each provides a much more robust response than one dose.

  • Researchers saw no differences in response between 15-mcg and 30-mcg doses (in adults or children).

  • In healthy adults and the elderly, neither concurrent nor simultaneous vaccination with H1N1 and seasonal influenza vaccine had an adverse effect on immune response.

  • Researchers found high levels of immune response after one dose of vaccine in pregnant women and no significant differences between the 15-mcg and 30-mcg doses in these women.

Dr. Lambert noted that no serious adverse events have been reported in the studies and that there have been no safety concerns that resulted in modification of study protocols. The patterns of local reactions to vaccine have been similar to those for seasonal influenza vaccine.

Dr. Lambert said NIAID is also sponsoring studies of H1N1 influenza vaccine in people with Human Immunodeficiency Virus (HIV) (including children and pregnant women) and people with asthma. Studies are also evaluating the effectiveness of mixing one manufacturer’s antigen with another’s adjuvant.

Discussion

Trish Parnell asked whether studies take into account weight as well as age when enrolling children; Dr. Lambert responded that enrollment relies on age only. In response to Tawny Buck, Dr. Lambert said that studies are addressing children with HIV or asthma but not those with neurologic conditions or developmental disabilities, who, Ms. Buck noted, are experiencing the most severe responses to H1N1 influenza.

HHS Communication Plan—Kris Sheedy, Ph.D., CDC; Stephanie Marshall, NVPO; and Abigail Tumpey, CDC

Communicating about H1N1 Influenza

Dr. Sheedy summarized some public opinion polls about the availability of vaccine and described the communications challenges CDC has faced over the past week:

  • Providing estimates of vaccine supply

  • Acknowledging the importance of patience as well as the importance of vaccination

  • Recognizing variability among locations in terms of supply and how its distributed (whenever a product is scarce, issues of fairness and access arise)

  • Communicating a complex message, that is, how the vaccine production process works and where it slowed down

The overarching communication strategy continues to rely on sound communications principles, said Dr. Sheedy: be transparent, provide information, share what’s known, and explain the challenges and dilemmas. She said communicators have to be comfortable sharing their own frustration with the process and acknowledging the frustration of others. Communication efforts continue to emphasize that the vaccine is safe and effective and went into production soon after the virus was identified. Supply is limited, so State and local health departments should focus on reaching priority populations. The vaccination endeavor is massive, and the current infrastructure is challenging, “but the virus leaves us no choice,” said Dr. Sheedy.

Currently, CDC would like the public to know that it anticipated bumps in the road and has been working with State and local entities to smooth out the process. Most importantly, the public should be aware that more vaccine will be available soon. The influenza season is long and always unpredictable, so variations in the disease course and vaccine availability are to be expected. Dr. Sheedy added that CDC is providing frequent updates on influenza activity and communicating primarily through the most flexible channels: television, Internet, press briefings, and partnerships.

Dr. Sheedy said CDC is looking ahead and considering future scenarios, e.g., the possibility that vaccine supply will increase but public demand will drop. People who suffer from ILI may feel it’s too late to get vaccinated, and they may be right, said Dr. Sheedy, but many people who have not been infected could still benefit from vaccination. She said the challenge ahead will likely be quite different from the current challenges.

If demand is low, CDC will use its traditional messaging, which emphasizes that vaccination is the best way to prevent getting and spreading disease. It will identify who is at risk and provide regular updates on ILI, noting that influenza is unpredictable.

If demand matches supply, communications will focus on letting people know where and when they can get vaccinated. However, CDC expects that availability will vary across the country, so public health messages should continue to focus on reaching priority populations first.

As supplies of vaccine increase, CDC will broaden the communication channels it uses, adding more radio, television, and print advertising, including a new public service announcement with the slogan “The flu ends with you.” New CDC communication products will be launched during National Influenza Vaccination Week, December 6–12.

Communicating about Vaccine Safety

Ms. Marshall described efforts by HHS to address concerns about vaccine safety, including organizing a CDC Clinician Outreach and Communication Activity teleconference, promoting public education about managing influenza, adding content to the Flu.gov website on vaccine safety, developing a video that includes information on clinical trials, and disseminating a report that describes safety monitoring. The report received much media coverage, including an editorial in the New York Times. Ms. Marshall said that public education efforts will use both traditional and new media to support the CDC’s messages and to focus on reporting adverse events.

Ms. Tumpey said the Vaccine Adverse Event Reporting System (VAERS) data are publicly reported on a weekly basis. Beginning November 9, CDC plans to provide more contextual information about the data collected, for example, identifying the number of reports received, distinguishing serious from mild adverse events, and describing CDC and Food and Drug Administration responses. In addition, CDC will explain the limitations of the data. It will also identify for States and others key data points to articulate for the media.

Ms. Tumpey said CDC is talking with organizations that represent State and local public health departments on how to improve communication. In addition, CDC is offering a webinar on how to articulate vaccine safety monitoring and adverse event reporting.

Discussion. Mark Feinberg, M.D., said he’s been disappointed by the media’s focus on safety issues that don’t exist. Ms. Marshall said HHS has held two media sessions already and is planning a third. She said national media outlets have been better than regional and local outlets at reporting on vaccine safety. Ms. Tumpey added that NVPO has coordinated calls with communications leaders from many Federal agencies to help agencies strategize on ways to present vaccine safety information.

Ms. Buck pointed out how current communication efforts have failed to reach people concerned about safety, and guidance on adverse event reporting is difficult to find. She suggested communication focus specifically on how members of the general public can report adverse events and reactions. Ms. Tumpey said CDC has advertised to clinicians in journals but has not reached out to the public about adverse event reporting. In addition, CDC has discussed enhancing the Vaccine Injury Compensation Program website.

Vaccine Safety Risk Assessment Working Group (VSRAWG)—Marie McCormick, M.D., Sc.D., Chair
Dr. McCormick described the initial meeting of this new working group, which includes a consumer representative and experts in vaccines, influenza, the immune system, vaccine clinical trials, vaccine safety, children’s health, pregnancy, and other fields. At its meeting, the VSRAWG heard an overview of safety systems in place for monitoring H1N1 vaccines (NOTE: summary available at http://www.flu.gov/professional/federal/monitor_immunization_safety.html). Dr. McCormick summarized a number of surveillance systems and listed the approximate number of people captured by each.

The VSRAWG heard some preliminary findings from trials and surveys on adverse events associated with H1N1 vaccine and adjuvant. Dr. McCormick said that VAERS is useful for identifying potential signals but cannot be used to confirm causation. She summarized some current data from VAERS on adverse events related to H1N1 vaccine.

Dr. McCormick said the VSRAWG would review data from clinical trials and surveillance systems as they become available. The group will develop a procedure for reporting its findings to NVAC. Dr. McCormick said she would circulate the VSRAWG roster to NVAC as soon as the membership is finalized.

State and Local Response Role

AIM—Claire Hannan, M.P.H.
Ms. Hannan said most allocation decisions are being made at the State level, but some are being made at the local level, and some are the result of a mixed process. One common strategy for distributing vaccine has been to allocate supplies to both public and private providers on a pro rata basis, ensuring that every provider gets some vaccine, and focusing on large vaccination sites and priority populations. Most efforts are focusing on the priority groups identified by the Advisory Committee on Immunization Practices, but some are prioritizing subgroups or working to ensure that children get the recommended two doses of vaccine. In response to a letter from CDC, some States are working with their partners and reaching out to parents to identify children at high risk.

With the small amount of vaccine available, providers have been challenged to distribute the vaccine appropriately. Some States are targeting distribution to small clinics, and some require providers to prove they’ve used the vaccine they have before they can receive additional supplies. Crowd control has been a challenge, and some providers have responded with innovative approaches, such as timed tickets, phone registration, by-appointment clinics, and express lines for LAIV.

Allocation has been a daily challenge, as States and providers don’t know what they will receive until the morning of delivery. Communicating to the public which providers have vaccine available has been complicated. Ms. Hannan asked for some targeted communication to address public reluctance to use LAIV that describes its benefits.

ASTHO—Jim Blumenstock. M.A.
Mr. Blumenstock said States have been staying true to their vaccination plans but are incorporating various tactics to meet their populations’ needs. Despite a rough start, communication and information sharing between Federal and State public health entities is now outstanding. The weekly projections from the Federal level on vaccine availability have been helpful to State and local public health departments in planning, although availability varies on a daily basis. States have increased their ordering as supplies increase.

Mr. Blumenstock said ASTHO anticipates challenges regarding communication, vaccine safety, and resources. In terms of communication and public education, it is difficult to determine how and when to encourage people to get vaccinated. In addition, providers need more information about what is and is not happening and specifically how States are approaching vaccine distribution.

In terms of safety, the public should be better informed about how to report adverse events and how to get more information. States need more education on how to collect and share information.

Mr. Blumenstock said he sees ample financial resources available through the end of 2009 but expects more funding will be needed in 2010. States have been realigning their priorities, and CDC has allowed some flexibility in its grants to help States accommodate their needs. Mr. Blumenstock hoped other HHS agencies would follow CDC’s lead.

NACCHO—Anne Bailowitz, M.D., M.P.H.
Dr. Bailowitz described steps taken by her own facility in Baltimore, MD, as an example of how counties and cities are disseminating H1N1 influenza vaccine. She reported that funding has enabled her local public health department to hire staff, such as nurse coordinators and physician consultants. Local government entities have risen to the challenge and are rapidly turning around contracts. Volunteers with health care experience (including medical and nursing students as well as professional providers) have stepped in.

Vaccine availability is improving, and the department received half of its entire order in the past three days. It has used a number of nonclinical as well as clinical settings to distribute vaccine. To manage crowds at its large public clinics, the department instituted a telephone appointment system. Dr. Bailowitz said the uptake of seasonal influenza vaccine has been extremely impressive.

Communication has been challenging, especially around hospitalizations and deaths of children. Communication efforts have expanded to include more businesses and faith-based organizations and is benefitting from a strong citywide bus advertising campaign. Dr. Bailowitz concluded that the overall picture for H1N1 vaccination is improving.

 

Public Comment

Jim Moody of SafeMinds hoped the H1N1 vaccination campaign would be seen as a teachable moment about both the reality and the appearance of vaccine safety efforts. He said 40–50 percent of people are not getting vaccinated because of safety concerns, and the lack of vaccine safety data has become a topic of jokes among talk-show hosts. Mr. Moody said the belief that the H1N1 vaccine is safe is not a substitute for sound science.

He noted that the government is missing an opportunity to address public concerns by failing to require that mercury be removed from all vaccines, as it promised to do in 1999. He asked that NVAC take steps to ensure that mercury-free vaccine be available at all 90,000 H1N1 vaccine distribution sites and that children’s medical records include documentation of lot numbers and other vaccine information as required by law.

Discussion

Dr. Birkhead said the input and presentations underscored the continuous need to focus on vaccine communication, safety, supply, and long-term funding. He noted that every issue NVAC has addressed over the past several years has come to the forefront during the H1N1 influenza pandemic and asked members to consider how the lessons learned can lead to a different way of doing business across the entire vaccine enterprise. Christine Nevin-Woods, D.O., M.P.H., said she was impressed by the cooperation across multiple levels of government. She added that exercises intended to prepare her State for emergency response to a pandemic proved to be helpful in addressing the H1N1 pandemic. She called for more education about the safety of LAIV. Dr. Tan suggested more collaboration with other partners, for example, through the National Influenza Vaccine Summit.

Members identified a number of areas for NVAC to consider:

  • Cornelia L. Dekker, M.D., suggested NVAC evaluate the roots of the supply problem, particularly the communication breakdowns.

  • Dr. Birkhead said NVAC and the National Influenza Vaccine Summit should look for lessons that can apply to seasonal influenza vaccination.

  • Jon R. Almquist, M.D., suggested NVAC discuss the limited number of manufacturers producing vaccine for children, which affects vaccine availability, and how the government can support or encourage more pediatric vaccine manufacturing.

  • Dr. Morita recommended NVAC explore ways to build on the engagement of providers who have newly enrolled in the Vaccines for Children program.

 

Summary/Wrap-Up/Next Steps

Dr. Birkhead said the next NVAC in-person meeting is scheduled for February 2010, and he anticipated one more H1N1 influenza update teleconference, possibly in early January. A summary of this meeting will be sent to the Assistant Secretary for Health and posted on the NVAC website. Dr. Birkhead thanked the speakers and adjourned the meeting at 5 p.m.

 

Appendix A: Other Attendees

First Name

Last Name

Organization

AliciaAultInternal Medicine News
BobBallFDA
ScottBrownCitizen
DannyChanDISA
ChrisColwellBD
CatherineCoreyGW Student
NancyCoxCDC
VickyDeBoldNVIC
DanielDeNoonWeb MD
VivianDoellingImmunoBioSciences
AnjelicaDortchMcKenna Long Albridge
KathrynEdwardsVanderbilt University
ElaineEsberConsultant
GeoffreyEvansHHS
RitaHelfandCDC
JamesJamesNBSB
AllisonKassirKing & Spalding
JeffKelmanCMS
RichardKnoxNational Public Radio
SarahLandryNIH
EmilyLevineHHS
SansanLinSanofi Pasteur
MeganLindleyCDC
MichelleMerglerNVPO
JimMoodySafeMinds
SheenaMorrisonNational Library of Medicine
KatherineMuthNIAID
AmyNevelHHS
CorinneNewhartGeorge Washington University
KorishaRamdhanieGeorge Washington University
GregReedMD Department of Health
PeggyReinekingBlue Cross Blue Shield
JoSchweinleBARDA
LisaSengGeorge Washington University
AngelaShenHHS
AmandaSmithHHS-ASPR
NasrinSorockHRSA
JovonniSpinnerNational Vaccine Program Office
RaymondStrikasDHHS
JeffSuralAlston Bird
EllenTanGeorge Washington University
Dr.RonaldValdiserriDepartment of Veterans Affairs
KirstenVanniceNational Vaccine Program Office
DevinVatorskiBlue Cross & Blue Shield Association
CindyWeinbaumCDC
EvanWilliamsonGeorge Washington University
ElizabethWoodyBD
CaseyWrightHHS