National Vaccine Advisory Committee (NVAC)

February 3-4, 2004 meeting

Meeting Overview

The major focus of this meeting was the 2003 influenza epidemic. Presentations included those by senior personnel of the Centers for Disease Control and Prevention, and representatives of the vaccine manufacturers, insurers and the Center for Medicare and Medicaid Services (CMS). The three subcommittees in their respective meetings also discussed influenza from their perspectives of immunization coverage, communication and future vaccines. Dr. Beato requested that NVAC examine the Nation's influenza system and prepare a report with recommendations for the Department.

Committee Members in Attendance

Dr. Georges Peter-Chair
Dr. Ann Margaret Arvin
Dr. Jeffrey P. Davis
Dr. Patricia Fast
Dr. Fernando A. Guerra
Dr. Charles M. Helms
Dr. Alan Richard Hinman
Ruth Katz
Dr. Jerome O. Klein
Mary Beth Koslap-Petraco
Dr. Bruce Gellin (Executive Secretary)

Liaison Representatives
Dr. Steven Black
Dr. Patricia N. Whitley-Williams
Dr. Donald E. Williamson
Ms. Jackie Noyes - AACV
Dr. Gary D. Overturf - VRBPAC

Ex Officio Members
Dr. Norman Baylor, Microbiologist, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA)
Dr. Steve Cochi, Acting Director, National Immunization Program (NIP), Centers for Disease Control and Prevention (CDC)
Dr. George Curlin, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH
Col. Renata J. M. Engler, Chief, Allergy/Immunology Department, Walter Reed Medical Center, Department of Defense (DoD)
Dr. Geoffrey Evans, Medical Director, Division of Vaccine Injury Compensation Program, Health Resources and Services Administration (HRSA)
Dr. James Randolph Farris, Regional Administrator, Region VI, Centers for Medicare and Medicaid Services (CMS)
Emily Marcus Levine, Senior Attorney, Office of the General Counsel, DHHS

Committee Members Absent
Neal Brandes, U.S. Agency for International Development (USAID)
Dr. Myron Levin, Chair, Advisory Committee on Immunization Practices (ACIP)
Dr. William Schaffner, Professor and Chair, Department of Preventive Medicine, Vanderbilt School of Medicine

Welcome from Chair

Dr. Peter welcomed the meeting attendees asked NVAC members to introduce themselves. He explained that Dr. Schaffner could not attend the meeting for personal reasons. NVAC has two unfilled positions that Dr. Gellin is working to fill, but new liaison and ex officio members have joined the committee, including Dr. Overturf and Dr. Levin. He welcomed Dr. Cochi, the new Acting Director of NIP, and noted that Dr. Walt Orenstein, the program's previous director, was also in attendance. He introduced Dr. Baylor as the new CBER representative and Dr. Farris as the new CMS representative and noted that Dr. Brandes is the new USAID representative. Dr. Peter then asked all of the guests in the audience to introduce themselves.Dr. Peter asked NVAC members to declare conflicts of interest as they arise, noting that they rarely occur given the general issues they discuss.

Welcome from the Acting Assistant Secretary for Health - Dr. Cristina Beato

Dr. Beato welcomed meeting attendees and expressed her appreciation for NVAC. She acknowledged the critical work NVAC does for DHHS and the nation. She explained that DHHS is the largest department in the federal government, noting that the budget is over $120 billion more than the DOD's.

Budget Overview
Dr. Beato provided an overview of the President's budget for FY 2005 for vaccines and immunizations. The President has requested $1.5 billion for the Vaccines for Children (VFC) program and a series of improvements in financing childhood vaccines. The proposed budget would improve access to VFC vaccines for uninsured children entitled to these vaccines and enable underinsured children to be vaccinated at state and local public health departments. All VFC children would have record access to all new and improved vaccines. Access to pneumococcal conjugate vaccine for these children has been unsteady. The proposed budget restores tetanus and diphtheria toxoid vaccines to the VFC program and repeals the price caps that have excluded them from the program. The private sector price is $7.91 and VFC is capped at $.32 per dose. DHHS is building a national stockpile of childhood vaccines in preparation for part of the Bioterrorism Program in Public Health Preparedness. An investment of $751 million will be made between FY03 and FY06 to build a vendor-managed, 6-month supply of all childhood vaccines by 2006. Dr. Beato highlighted the inclusion of approximately $73 million for the influenza vaccine in the VFC Program. There is a routine purchase of $33 million for children at high risk for complications of influenza: children aged 6 to 23 months and aged 2 to 18 years with medical conditions that put them at risk for influenza complications. The proposal also includes $40 million for the 2004-2005 influenza season and $40 million for the 2005-2006 season. Vaccines would be stockpiled to meet exceptional demand for each season. Furthermore, DHHS is seeking to increase the $50 million investment in 2004 with a $100 million investment in 2005 to enhance our capacity to respond to an influenza pandemic. These funds would accelerate the development of cell culture influenza vaccine and provide year round availability of raw materials needed to produce egg-based vaccines until the cell culture technology is ready. She noted that the President is very committed and that the Secretary has been in the forefront of influenza preparation issues.

Request for NVAC Assessment of Influenza System
Dr. Beato asked that NVAC take a step back and critically look at the current national influenza program as a whole to see if it is still on track. She noted that the current system is very complex and every day a new facet comes up. The meeting agenda allows NVAC to hear from DHHS agencies, vaccine manufacturers, and other key stakeholders. She asked the committee to consult with NVPO, the agencies within DHHS, and their advisory committees, as appropriate, to thoroughly review the national influenza program and report their insights and recommendations. She acknowledged that this is a big task and requires assistance from the national principal advisory committee.

Overview of NVPO - Dr. Gellin

Dr. Gellin then provided a "preface" to today's meeting. He noted that the message is finally out about the seriousness of influenza as a disease. The season started early this year, and the media highlighted children's deaths, which helped reinforce the concern about influenza and what it is. Headlines about vaccine shortages appeared around the release of the CDC influenza-like illnesses study. He noted however that when we look the entire population of 185 million, we still fall short in broad coverage; the US demand is only about 50% to 60% of this number every year. As Dr. Beato discussed, Dr. Gellin explained the need to look at how the situation can be improved. With regard to the budget, from his perspective, Dr. Gellin wanted to underscore the issue of pandemic influenza preparedness and exploring other approaches to producing influenza vaccines, noting that two pre-solicitations had been announced on FedBizOpps

Influenza 2003-2004: Review and Lessons Learned for Next Year and the Future

The Current Season: Virus/Disease/Vaccine and Efficacy - Dr. Nancy Cox

Dr. Cox discussed the influenza disease that occurred last year by examining national morbidity and mortality data, the disease compared with other influenza seasons, mortality in children, and the circulating viruses. Influenza received a lot of attention in the 2003-2004 season from the media and others. This attention was caused by four factors:
Sustained increases in influenza activity were reported unusually early.
Influenza-related pediatric deaths were prominently reported by the national media.
Vaccine manufacturers had sold all vaccines by mid-December as demand continued.
A less than optimal match between the predominant circulating viruses (A/Fujian/411/02-like) and the corresponding vaccine component (A/Panama/2007/99).
She provided an overview of the season's virologic surveillance, which is based on the number of isolates collected by collaborating laboratories.
The majority of the viruses were influenza A viruses, and for those that were subtyped, 99% were Influenza A H3N2 viruses. She then showed a graph representing the percentage of respiratory specimens testing positive for influenza by week. She compared the 2003-2004 season data to the 1999-2000 and 2002-2003 seasons to show how much earlier it occurred. The 1999-2000 season was the last large influenza A H3N2 epidemic in the U.S., and 2002-2003 season was a relatively milder season. Dr. Cox reviewed the percentage of visits from influenza-like illness for the same seasons based on reports by sentinel providers. The 2003-2004 season began early, had a rapid rise, and peaked and finished earlier than the 1999-2000 and 2002-2003 seasons. Again, she noted how much milder the 2002-2003 season was in comparison to the H3N2 seasons. Dr. Cox showed the pneumonia and influenza mortality data for 122 U.S. cities from 2000 to the week ending January 24, 2004. There was a substantial peak in mortality this season, which is now declining. This peak, however, was not as high as the 1999-2000 season, which reached approximately 11.3% of deaths. In addition, she noted that influenza death rates first rose above the "epidemic threshold" during week 51 and remained there for five consecutive weeks; the highest influenza-like illness attack rates were among children and young adults.
Dr. Cox then discussed influenza-associated deaths among children under 18 years of age. To date, there have been 121 lab-confirmed, influenza-associated deaths reported to CDC. The age of these children ranged from 2 weeks to 17 years, with a median age of 3.8 years. Of these children, 72 (60%) were under 5 years old, and 33 (27%) were aged 6 to 23 months. There were 26 (21%) children who had underlying medical conditions. Although the CDC does not have complete vaccination records for these children, for the 57 children with available records, only two were vaccinated according to recommendations. She noted that the estimates of vaccine effectiveness for the 2003-2004 season are still unknown. NIP/CDC conducted a study among healthcare workers in a Denver, Colorado hospital, but the endpoint to the study was vaccine effectiveness against influenza-like illness-not against the more specific endpoint of laboratory-confirmed influenza. The endpoint was also not vaccine effectiveness against more serious outcomes, such as hospitalization or death, which would have been too rare in this population. This study was unable to demonstrate vaccine effectiveness. Other studies are being undertaken in the U.S. and will be announced when the results become available. Though she has not reviewed the methodology, there was a study reported in France that estimated that vaccine effectiveness was 60% for this past season.

Vaccine Strain Selection Process and Regulatory Issues - Dr. Jerry P. Weir

Dr. Weir reviewed the influenza vaccines that are licensed in the U.S.:
A trivalent inactivated influenza vaccine produced by Aventis Pasteur, Inc. and Evans Vaccines Ltd. For the 2003-2004 season, production is estimated at 83 million doses. A live attenuated influenza vaccine produced by MedImmune Vaccines Inc. was licensed in June 2003. This is a cold-adapted, intranasal vaccine, and approximately 4 million doses were produced for the 2003-2004 season.
Dr. Weir then shared a schematic of the timeline for vaccine production and use. The Northern hemisphere vaccine is issued in the fall from September to late December or early January. The support and the preparation work for the vaccine, however, occur throughout the year. Surveillance is done globally year round, and they monitor for new and predominant strains. There are constantly new reference strains and reagents that are being updated. He added that the recommendations are made at different times of the year for the Northern and Southern Hemispheres and that recommendations would be made over the next several weeks for the 2004-2005 season.
Dr. Weir then reviewed the strain selection process. He explained that vaccine efficacy depends on the vaccine's immunogenicity (potency) and the match of vaccine with wild-type viruses that are in circulation. Strain selection is necessary because the antigenic shift of influenza A and B viruses is continuous. Dr. Weir explained that there are questions that everyone involved must ask every year for strain selection. These questions are generally examined in January and February of each year, are:
Are new (drifted or shifted) influenza viruses present?
Are these new viruses spreading in people?
Do current vaccines induce antibodies against the new viruses (with a focus on HA)?
Are strains suitable for vaccines available?
Based on these questions, Dr. Weir described the context for strain selection for the 2003-2004 season. There were no new strains present for influenza A/H1N1 or for influenza B. He noted that there were new strains for influenza A/H3N2, although the HA of most strains were similar to the current vaccine strain. However, a proportion of the strain, approximately 10% to 20% , was antigenically different. He noted that these virus isolates had signature amino acid changes that suggested a potential emerging variant cluster. New influenza A/H3N2 viruses were spreading. New variants, now termed A/Fujian-like, were found in Asia, Europe, and North America. They were first identified in late January and late February 2003. For the third question, influenza A/H3N2 viruses were only partially inhibited by the current vaccines. The majority of the strains was A/Panama/2007/99-like and well inhibited; for the A/Fujian-like strains, some were well inhibited while others were poorly inhibited. These data did not provide a clear picture of what to do with strain selection.
For the final strain selection question, there were no suitable strains available for manufacture last winter, because of timing. The first H3N2 variants were identified in February 2003, and there were no H3N2 variant egg isolates until April 2003. High growth reassortants were not available in June 2003. Dr. Weir noted that manufacturing depends on the egg-adapted strain and the selected virus strain must grow well for production.
The vaccine composition for the 2003-2004 season was based on data available in early March 2003. Both WHO and VRBPAC recommended that the strains selected for the previous year be used again: A/New Caledonian/20/99, B/Hong Kong/330/01-like, and A/Moscow/10/199 (H3N2)-like. As the season started in Northern Hemisphere and a new variant H3N2 began to predominate, however, reports of associated morbidity significantly increased demand. Effectiveness of the vaccine to provide protection against A/Fujian-like H3N2 became an important issue. Dr. Weir then discussed what they are looking at for the 2004-2005 season. Global surveillance remains ongoing, and the spread of Avian H5/N1 is being watched carefully. WHO recommendations for strain selection will be made on February 11 to 13, and the VRBPAC recommendations will be made at their meeting the following week on February 18 to 19. VRBPAC recommendations will depend on the current surveillance, and their meeting will also include discussions of effectiveness studies and strategies for use of non-egg virus isolates as reference strains for manufacturing. In summary, Dr. Weir explained that changes in vaccines generally occur yearly to remain current with circulating viruses. Though the timelines are somewhat inflexible, they have already been streamlined as much as possible to accommodate surveillance, timing of influenza appearance, and manufacturing.

Public Perception of Influenza/Influenza Vaccine - Dr. Glen Nowak

Dr. Nowak provided findings from studies on public perception and influenza. He discussed several influenza vaccination communication studies. The studies were the HealthStyles panel survey, the RoperASW/NFID telephone survey, the HealthStyles Recontact Panel survey, the Associated Pres-Ipsos Poll, the Harvard telephone surveys, and the Harris Interactive/Wall Street Journal online surveys. Most of the studies were conducted in December (AP poll, Harvard telephone surveys, Harris interactive studies) as the season was unfolding and, with the exception of the second Harris study, before there were reports about the actual efficacy of the vaccine.
Findings from these studies are counter to expectations that experts have assumed about the public and influenza. These assumptions have typically been: most people over 65 are not well informed; most Americans are not aware that flu can be prevented with vaccination; most Americans do not believe that flu can be a very serious illness; most Americans think that the vaccine protects against a wide variety of illnesses and germs; and it is relatively easy to persuade more Americans to get vaccinated by using the word "influenza" instead of "flu" by telling them that it is a serious disease, or by getting celebrities to tell people to get vaccinated. Data from the influenza studies challenge many of these assumptions. Key findings of the RoperASW study showed that 84% of respondents said they were aware that the flu could be prevented by vaccination and 82% of those over 65 get the vaccination. The studies also showed that respondents were generally well-informed about influenza: 94% were aware that flu can lead to hospitalization and possibly death; 77% of people are aware that healthy people should get vaccinated; 75% were aware that December was not too late to get a flu shot; and only 1% said that SARS is a reason to get the flu vaccination. The findings also showed that 42% believed that someone in their home would catch the flu, so people were aware that this could be a real threat to their health or their family's health. People, however, did generally underestimate the number who would suffer serious complications from influenza-they estimated that about 5,000 people per year die versus the actual 36,000. About 90% of people said they wash their hands, dress warmly, ate healthy, and took vitamins to help prevent the flu.
Dr. Nowak then discussed the HealthStyles Fall Survey done in October. Key findings showed that overall, 48% indicated that they had already received a flu vaccination or planned to get one. Most respondents said they were "well-informed" about who should receive an annual flu vaccination and about the vaccine's benefits and risks. About two-thirds (63%) said they had recently read or heard something about flu shots or vaccine in the media. The study also showed that about 47% were vaccinated at a doctor's office or HMO, which is consistent with other studies. People who did not receive the flu shot were asked the primary reasons why they did not get one, and most people gave more than one reason. These reasons were that 26% said they did not need it; 24% cited allergic or other reactions; 23% said that no health professional had recommended one; 22% did not believe they were likely to get the flu; 18% did not think the illness caused by the flu was serious enough to get vaccinated; 15% did not believe the flu vaccine was effective; and, 9% were not sure if they needed it.
Dr. Nowak then discussed the first of the two Harvard studies. Again, results show that a large percentage of people aged 65 years and older (71%) indicated that they received a flu shot this season. However, 47% of people with chronic illnesses said they did not get a flu vaccination. The study also looked at people who chose not to get the flu shot (about 50% of respondents). Although many had more than one reason for not getting vaccinated, there were three primary reasons: 54% did not believe they were at risk of getting a serious case of the flu; 45% did not believe the vaccine was effective in preventing them from getting the flu; and, 42% were concerned about the side effects or reactions to the flu shot.
Dr. Nowak noted that there is evidence from the studies that the collective efforts of CDC, healthcare professionals, and other partners, through education and outreach, appear to have made a significant impact. For example, a large majority of the public is well informed about influenza vaccination and has a relatively accurate understanding of influenza illness, especially people aged 65 years and older, and many can recall the key messages. Furthermore, more people appear to have received or sought a flu vaccination this year than in previous years, up to a 10% increase. The studies also suggest, along with the experience in the last couple of months, that realities and perceptions regarding disease/virus prevalence and severity do matter and that they quickly and strongly affect interest, motivation, and behavior regarding to vaccination. For people who choose not to be vaccinated, the perception that they will not experience severe complications from the flu is strong, and for the most part, this is in line with experienced and statistical realities. For the vast majority, influenza is not life threatening. Furthermore, people know from experience and experts that some seasons/strains of influenza are more virulent and harmful than others, and interest and demand will vary annually based on how severe the season appears to be. The variance could be significant even as we try to convince more people to get an annual vaccination.
In conclusion, Dr. Nowak noted that generating additional significant increases in consumer demand for the influenza vaccine will be challenging. Barriers, such as doubts about the efficacy or value of the vaccine, will need to be addressed. Furthermore, it will require persuading and motivating people other than those aged 65 years and older, particularly parents, people aged 50 to 64 years, and people with chronic illnesses that place them at risk of serious complications.

Perspectives of Influenza Vaccine Manufacturer, Aventis Pasteur - Ms. Christine Grant

Ms. Grant thanked Dr. Gellin, Dr. Beato, and Dr. Peter for inviting the manufacturers to the meeting, which she believes is a best practice. She explained that she would discuss lessons learned about vaccine supply and demand, the experience in this past season, and some recommendations. Ms. Grant emphasized that from a manufacturer's perspective with 30 years of experience, demand has driven the doubling of supply and will continue to drive increases in the future.
Aventis Pasteur accounts for 50% of the world's influenza vaccine supply. Their plant in Swiftwater, PA produces 50% of influenza vaccines sold in the U.S. The company has plans for additional manufacturing and is well on its way on increasing its filling and packaging capacity. She announced a new partnership with the Crucell Organization after extensive research on an optimal cell culture/cell line approach. They looked at characteristics such as potential yield and the fact that cell line can be grown in suspension. She cautioned that Aventis Pasteur believes that while they are hopeful for innovative technology, it will be a multi-year project before a product that meets everyone's expectations, including licensing requirements, can be brought into the U.S. and commercialized in Europe.
In the 2003-2004 season, Aventis Pasteur shipped approximately 43 million doses of influenza vaccine in the U.S.
Ms. Grant discussed the three phases of the influenza season. They work very interactively, pre-season and throughout the season, with FDA and CDC as the vaccine goes through the manufacturing process. Beginning with the January to May phase, she explained that it is not unusual for manufacturers to go at risk before the new year starts and the final strain has been approved. They make a best judgment in consultation with others (though it is ultimately the manufacturer's choice) to start with one strain to further compress the timeline, wherever possible. The first step is seed preparation. The virus is then grown in millions of fertilized eggs, which are required for the activation process. The next phase is June to August, when the strains go through a company and FDA testing process. Each lot is released-based sequentially on good tests. The vaccine starts to flow into the market in the August to December timeframe. This year, distribution was completed by November 1.
Ms. Grant presented another perspective on the manufacturing timeline since people always ask where the timeline can be compressed and what can be done differently. This perspective shows a 10-week process, beginning after spring decisions are made and starting with the preparation of the monovalent concentrate. CBER is periodically involved and provides a quick turnaround in the review. Aventis Pasteur believes they manage the process well on their end, considering that the variables every year depend on yield. The quality assurance process cannot be compressed since it is a human vaccine.
She then discussed the projected supply to the U.S. market. The industry estimated capacity for the upcoming year is 83 to 100 million doses of trivalent vaccine. Since they do not share information with competitors, they rely heavily on the government projections. The goal is to distribute vaccine by the first week of November, but this depends on public announcement, final decisions about the strain, and strain yield. The vaccine supply in the U.S. has more than doubled in the last 10 years to meet or exceed the market demand. Supply has, over the past 10 years, tended to increase demand-"demand" being the actual vaccine produced and sold. She noted that the vaccine return policies have changed over the past years, and it was not unusual for unused vaccines to be returned. Capacity could expand further, but demand drives the supply.
Another way to increase supply is to work together to extend the immunization system, and manufacturers can, in turn, discuss increasing production. Ms. Grant moved on to discuss recent trends in the supply/demand environment. In 2002, 12 million doses intended for the U.S. market were discarded due to insufficient demand. This is likely an underestimate since reportedly several million doses of unsold vaccines were not returned. In 2003, the vaccine orders were down significantly, indicating that demand would be less than in the prior season. The company has 30 years of experience with people in the production, scientific, regulatory, and commercial operations areas. They look at pre-ordering, which started on December 1 for the upcoming season. They routinely factor in a cushion in case demand is underestimated, though they are also concerned with the inefficiencies and costs associated with wasted vaccines. She noted that in the past year, the boost in demand occurred after their production had ended. With the influenza outbreak occurring earlier than usual this year, there was an end-of-the-season unanticipated demand after production was completed. In the third quarter, it appeared that there would again be several millions of doses of unused vaccines. However, they began receiving several calls from private sector clients who were seeing a surge in demand based on media reports of outbreaks and pediatric deaths. Aventis Pasteur proactively notified CDC of the late surge and worked with them to reserve and allocate any small amounts of unused vaccines for use by the states (100,000 additional doses of Fluzone and 150,000 doses of pediatric P-Free influenza vaccine).
Ms. Grant then discussed preparation for the 2004-2005 influenza season. Pre-orders drive vaccine production, considering that demand drives supply over time and that this will be the first season experiencing pediatric recommendations. The pre-order process began on December 1, 2003, and in general, does not appear overwhelming. Since they do not see anything unusual, everyone will have to work together to plan. They are giving a targeted notice to those who plan on ordering the vaccine (both public and private) to remind them that this pre-ordering period is the time to think about plans for September and October, despite the fact that they educate the public in the fall.
Aventis Pasteur has developed an equitable allocation and distribution policy in coordination with public health and medical authorities in discussions of the Flu Summit Group. They make every effort and have been successful in ensuring that everyone affected (e.g. state, county, public health clinics, private sector, larger organizations) gets a share of their orders as the vaccines are distributed, the season progresses, and until all orders are filled. Most people do not realize that 85% of influenza vaccine doses sold in the U.S. are actually distributed and administered in the private sector. Aventis Pasteur provides about 70% of the remaining 15% of doses that are purchased by the public sector.
Ms. Grant discussed the influenza vaccine market, which is increasingly a private purchase system. Private sector demand has double since 1991 but has plateaued over the past few years. She noted that the adult vaccine system, unlike the children's vaccine system, is very heavily dependent on the private sector for delivery and administration. Aventis reinforced the need to promote provider and consumer education on influenza immunization recommendations and to encourage healthcare providers to order the vaccine early. Innovative and sustainable initiatives would help drive demand. Lastly, the medical community needs to set an example by urging healthcare workers to routinely get immunized.
She acknowledged the synergy of DHHS agencies and a great opportunity to forge partnerships among private sector stakeholders and public agencies. She suggested that CDC gather and publish annual influenza rates by risk group, since people tend to look at this information state by state, and noted the importance of CDC's continued work to increase public confidence. CMS has also worked hard in the last couple of years to see that reimbursement for physician administration did not decline. They are sitting on a wealth of access to information for Medicare and Medicaid providers and have a routine way of communicating with them. This is an opportunity to remind them that at the front end of the season is the time to start thinking about their immunization program. Similarly, CMS has access to information by zip code on who is and is not being immunized. Aventis Pasteur is confident that CMS will publish timely reimbursement notices regarding fees since clinicians are clearly concerned about this. Finally, FDA should continue working to ensure public confidence on safety and efficacy.
Ms. Grant referred back to her discussion of extending the immunization season and increasing immunization rates among healthcare professionals. She suggested that there are also ways that the insurers and managed caregivers can work on an immunization campaign to cover tens of millions of Americans.
Ms. Grant discussed what Dr. Beato called "stockpiles," which Aventis Pasteur refers to as "strategic reserves." Manufacturers understands that there may be a need for the government, at the front end of season, to negotiate with manufacturers to ensure that vaccines are available in the event of unanticipated demand or outbreaks. Aventis Pasteur looks forward to working with CDC and DHHS on this issue. This does not, however, substitute for the difficult job of seeing that demand is increased over time.
In conclusion, the optimal solution to achieve the Healthy People 2010 goal and pandemic preparedness is to increase annual immunization rates. Increased demand will, in turn, increase supply and capacity in a market that is becoming exciting and competitive. Aventis Pasteur plans to expand egg-based capacity and is working on innovative cell culture approaches. They encourage immediate attention to "strategic reserves." They need to immediately begin planning for shared-risk reserves for surges to ensure availability for the 2004-2005 season.

Chiron Vaccines - Dr. Clem Lewin

Dr. Lewin noted that Chiron is a part of Chiron Corporation, a biotechnology company located in Emeryville, California. He thanked Dr. Peter and Dr. Gellin for the opportunity to present to NVAC. He welcomed this and continued opportunities for dialogue and feedback.
Dr. Lewin explained that his presentation would provide an overview of Chiron, their 2003 production, a view of the future, lessons learned in 2003, and preliminary recommendations on how the supply shortage can be addressed in the future.
Chiron Vaccines is the fifth largest vaccine producer in world, producing both pediatric and adult vaccines. They are one of the leading producers of the oral polio vaccine and distribute more than 8 million doses annually. Despite only being 25 years old, Chiron Vaccines has a rich heritage based on the companies they have acquired, mainly European vaccine companies that have up to a 100-year history. In July, they purchased PowderJect, which produces Fluvirin, and are now the second largest flu vaccine producer with a global presence. They have manufacturing facilities in Liverpool, United Kingdom; Marburg, Germany; and Siena, Italy. They provide Fluvirin, RabAvert, and tetanus and diphtheria bulks in the U.S. and have a vaccine for meningitis C currently in Phase III trials in the U.S.
In 2003, Chiron supplied approximately 38 million doses of Fluvirin, a 50% increase from 2002, and made them available to distributors from August to early November. The supply of Fluvirin to the U.S. more than tripled from 2000 (12 million doses) to 2003. At CDC's request for additional influenza vaccines, Chiron estimated that they had 360,000 vaccines in bulk to provide, which were FDA-licensed and delivered in early January. In 2004, Chiron plans to produce approximately 50 million doses. The exact volume of the doses depends each year on factors such as yield and assumes that all plans go as anticipated. They plan to deliver the vaccines in the same time frame as 2003. Plans are in place to expand production further if demand for vaccine exists, since supply tends to follow demand. Finally, Chiron is currently in discussions with FDA about a cell culture vaccine using an MDCK cell mine. The product has completed Phase II for European approval, and a scaled up production process is available. However, Dr. Lewin provided the same caution as other speakers regarding the longer timeframe required to obtain FDA approval and license for new products.
Dr. Lewin shared Chiron's lessons learned in 2003. He explained that the only thing that is predictable about influenza season is that it is completely unpredictable. A severe epidemic can cause surge in demand, as can media attention. However, it is difficult, if not impossible, to adjust the supply. By the time the severity of the epidemic is known, it is too late to increase production. They also learned the importance of open channels of communication between the manufacturers, CDC, and DHHS about the ability to respond with additional doses and to coordinate activities. He noted Dr. Nowak's point that they achieved the highest immunization rates for influenza, so this season was both a challenge and an accomplishment from a public health perspective.
There have been many discussions by Congress and others about a guaranteed purchase program for the influenza vaccine in the U.S. Chiron is prepared to extend the production season to deliver additional doses in late November and December. They do not currently do this since the demand for influenza vaccine tends to drop after Thanksgiving, and they do not know if there is going to be increased demand unless there is severe disease. The result could mean unused vaccines that would have to be destroyed. A decision to increase the supply must be made by January to ensure an adequate supply of eggs to produce the vaccine, and the vaccine purchases must be placed prior to this decision with no knowledge of the severity of the season. To maximize the benefits of the program, Chiron believes that any purchase program should be distributed among all vaccine manufacturers rather than having a "winner takes all" situation.
Dr. Lewin added that Chiron has concerns about the long-term viability of a purchase program where vaccines are destroyed. While a purchase program may meet short-term goals, the demand for the vaccine must increase in the long-term. While government involvement may be appropriate and necessary, there could be unintended consequences that they must be cognizant of and manage properly. A lot of the manufacturing is in the private sector, and therefore, large-scale government purchases have the potential of destroying the current private sector distribution system for influenza vaccines. Chiron does believe that it is possible to create and manage a program that has no negative consequences and does not destroy the current system.
Chiron believes that increasing influenza vaccine demand under routine circumstance is the best market efficiency solution for the episodic surges in demand since it can balance client demand in a severe upswing. He noted that previous presentations showed that outreach has increased immunization coverage in the age group over 65 years old. Chiron believes that the same efforts must be made for other recommended groups to raise demand. There is a need to raise awareness of influenza immunization recommendations, develop innovative programs to highlight the benefit of the vaccine and to facilitate access, and extend the immunization season into December.
Dr. Lewin noted that the findings on attitudes towards immunization are encouraging. People are aware of vaccines and other issues, so the best way to build on the lessons learned must be determined for both elderly and pediatric populations to increase the coverage rates. Again, he noted that the best way to increase supply is to increase demand under routine circumstance and referred to an editorial in the recent January 15 issue the New England Journal of Medicine that makes the same recommendation.

MedImmune/Wyeth -Dr. Peter Paradiso

Dr. Paradiso noted that he is representing MedImmune and Wyeth, though he works for Wyeth.
Dr. Paradiso began by explaining that they introduced a new vaccine in the U.S. this year. They learned a lot about launching a new product in an environment where there is already a known product on the market and wanted to share on their experience with FluMist. Buyers are not quick to move to new things and innovations. They did a significant media blitz and believe it contributed to the increased awareness about influenza vaccination. The message needs, however, to be repeated.
Dr. Paradiso stated that it is obvious that we are driving demand up for a number of reasons and in a number of ways. The CDC net Healthy People 2010 goals have been suggested. In order to be prepared for a pandemic, annual vaccine use is critical. Forecasting demand is also critical. There are risks involved in trying to forecast demand and matching supply to goals. In, 2002, over 90 million doses were produced and over 20% were discarded, while fewer than 90 million doses were produced in 2003 and there was a vaccine shortage. Dr. Paradiso noted that this was the first year with a shortage. In the previous few years, there was a vaccine shortage in October and November, but vaccines were being thrown away in December. There are lessons to be learned from this year and how demand is driven.
In general, vaccination campaigns begin in October and end in November, regardless of the timing of the supply, and the month of peak influenza activity varies from year to year. Ordinarily, flu activity begins and vaccination stops, so the concept of vaccinating into the influenza season does not seem to catch on. In 2002, the vaccine has been late arriving, and although the epidemic did not occur until January and February, there was essentially no vaccination occurring in February. In 2004, influenza activity began while vaccination was still occurring, so the connection between the influenza activity and the availability of the vaccine came at the same time. As a result, demand for the vaccine went beyond November into December. To his knowledge, this is the first real vaccine shortage because we vaccinated into the epidemic, and in his opinion, they should vaccinate into the epidemic, every year regardless of when the epidemic occurs.
In early December, there was an announcement about the widespread disease especially among children and the limited vaccine supply. Wyeth, in an attempt to make it easier to supply the vaccine, decreased the cost of FluMist to $20 per dose. The result, however, was disappointing with only about 75,000 doses of FluMist distributed and millions of doses remaining unused. While the aging patients and the population for which the vaccine is indicated are limited, most of the illnesses and deaths occurred in populations that could have been vaccinated.
Dr. Paradiso presented data on influenza-associated deaths in children less than 18 years of age for the 2003-2004 influenza season. FluMist is recommended for children between the ages of 5 and 18 years, and the data show that about 40% of deaths occurred among children in this age group. In terms of FluMist eligibility, there is a fair percent of the population who was not part of the recommended population and a high percentage of these people get and spread influenza.
In looking back at the track record for influenza vaccination, Dr. Paradiso referred to Dr. Beato's remarks and questioned if we have the correct paradigm for influenza vaccination. We have heard that 60% to 70% of the elderly (over 65 years of age) are vaccinated annually. Although this is a good rate, it may be possible to raise this by 10% to meet the Health People 2010 goals of 90%. Many patients value the vaccination because of its efficacy, and all major high-risk groups are targeted. Significant epidemics still occur annually even though 80 million doses are distributed each year. A new way of managing influenza is needed.
Dr. Paradiso commented that the broad population should be vaccinated, especially children. Protecting the elderly requires protecting the infectors. He used the strep pneumococcal vaccine as an example. If we broadly vaccinate children against infectious agents such as pneumococcus, for example, many populations outside of those vaccinated will be protected because children are infectors. A similar effect would occur with broad vaccination of children, especially school age children, against influenza.
Vaccination campaigns need to begin as soon as the vaccine is available and continue until the epidemic is over. Because the literature state that October and November are the best months. The message needs to be changed to let people know that while there are good months to be vaccinated, people can be vaccinated at other times as well. New and improved vaccines need to be introduced, if and when possible, and vaccinations should be stockpiled to meet goals. Dr. Paradiso expressed some doubt with regard to increasing the number of vaccine suppliers as a solution. The trend in demand may be more useful in alleviating the problem.
He noted that the current regulatory environment has made it difficult to introduce innovative, new vaccines. New vaccines are very expensive and regulatory hurdles are very high. The FluMist investment has been very substantial $1 billion over a large number of years. The companies had to introduce the vaccine with a very conservative label that indicates use in healthy children aged 5 to 17 years of age and healthy adults 18-49 years of age as a first step. This is expected to broaden over the coming years, but it is very difficult to sustain a business while doing this. The reticence on the part of physicians, the public health community and the government to promote the use of new products and distinguish between old and new products has also made it difficult to introduce new products. There were many barriers in health clinics, and misinterpretations of some of the precautions to the vaccine hurt its use.
Dr. Paradiso concluded by emphasizing the need for a new paradigm to control influenza disease. Innovation must be encouraged and rewarded whether it be cell culture, other vaccines, or another technology. Risk, especially of producing supply, must be shared.

Baxter - Dr. Joan Fusco

Dr. Fusco thanked NVAC for the invitation to present and explained that she would be providing a glimpse into what Baxter Vaccines hopes is in the not-too-distant future. She noted that they were the only non-U.S.-licensed vaccine manufacturer represented at the meeting. Her presentation focused on an overview of Baxter Vaccines and Vero cell culture platform technology, its application to influenza, how it can be complementary to existing egg-based vaccines, and some of the benefits and problems with cell-based vaccines.
Baxter Vaccines is a part of the bioscience division of Baxter International, global healthcare company. Their vision is to be leader in infectious disease vaccines and to focus on next generation products and technology for influenza, bio-defense, meningococcal disease, and insect-born diseases. Baxter currently has two licensed products: an encephalitis vaccine licensed in Europe and a meningococcal C vaccine licensed in 35 countries around the world.
Dr. Fusco explained that Baxter Vaccines has partnerships with companies, such as Acambis, to produce small pox and other vaccines. It is also working with the U.S. government to develop a SARS vaccine.
Dr. Fusco provided background on Vero cell technology. Baxter can create master cell banks and working cell banks, and these banks have been tested for absence of tumorigenicity, absence of adventitious agents, and identity/genetic stability. They grow cells in microcarriers in fermenters and have expanded their capacity over the last few years. She noted it is a fairly permissive system for multiple viruses. Some of the benefits of using this microcarrier Vero technology include a continuous cell line, acceptance for production of licensed vaccines, a serum protein free medium, high yield of virus antigens, high purity of virus vaccine preparations, and high safety of virus vaccines. It is also permissive for a multitude of viruses and wild-type viruses.Dr. Fusco then described the Vero cell-derived pandemic influenza vaccine formulation, which they have completed and tested in Europe. They grow the virus on a qualified continuous cell line and use an egg-derived wild-type seed virus provided by WHO. There is no requirement for high growth reassortants; they naturally get the virus to grow in a reproducible way in the cell culture. This whole virus inactivated vaccine is free of preservatives, antibiotics, and egg protein.
She noted that some clinical data are available. These data show that the majority of local reactions observed, in seven studies with nine different vaccine lots, over four influenza seasons in Europe were mild, very few moderate, and none severe. Systemic adverse events were minimal. The frequency and severity of the local systemic reactions to the Vero derived whole virus influenza vaccine are comparable with licensed egg derived split influenza vaccines. Baxter has applied for a product license for European Community-wide registration in a Mutual Recognition Procedure (MRP) this year and received First National Licensure in the Reference Member State (RMS) in February 2002. They are also working with the FDA to begin U.S.-phase clinical trials this year.
Dr. Fusco then shared Baxter's view on how cell culture influenza vaccine complements current efforts. With wild-type viruses, they do not have to wait for reassortants. Hypothetically, they could provide a vaccine earlier in the season and could continue to supply vaccine by turning to their on-demand subsidiary. Depending on what is reported, they could also make course direction changes, if necessary. She noted that for a pandemic, they have the flexibility to grow wild-type viruses. Again, there is no need for attenuated reassortant that requires time to generate and may be unstable. They could begin delivery within 7 weeks of identifying the virus. Dr. Fusco explained that they are in the process of bringing Vero cell influenza vaccine into the U.S. from Europe. A Vero cell influenza vaccine is an alternative in the not-too-distant future and provides flexibility during both the season and a pandemic.

Public Sector Roles in Adult and Childhood Influenza Vaccination - Dr. Lance E. Rodewald

Dr. Rodewald provided an overview of the public sector role in influenza vaccination. He began by explaining that the differences between public sector roles for childhood and adult are not upstream. He noted that for childhood public purchases, the CDC uses a vaccine replacement model. The VFC program allows vaccine purchases using federal and state funds and is used to provide government-purchased vaccines to providers for administration to patients. Unlike the adult program, this program has stockpile authority and funding, which is a major asset.
For adult vaccine public purchase, a vaccine reimbursement model is used. This fee-for-service model reimburses the provider after the vaccine is administered and is primarily administered through Medicare and Medicaid. The differences between the programs for providers are the up-front purchase costs and the financial risk. He noted that manufacturers do not offer vaccine return policies.
Dr. Rodewald explained that the childhood public delivery system has approximately 100,000 public health providers operating at 45,000 vaccination sites. The latest data from the 2002 immunization survey show that the VFC program reaches more than 90% of preschool children. He added that children's immunization is integrated into primary care, which is a very important concept because immunization is one of many services that need to be delivered. VFC promoted the program heavily.
The adult public delivery system has approximately 3,000 vaccination sites, which are primarily the local health department clinics. He noted that these are the public sector sites and do not include all of the public-purchased vaccines.
There are several evidence-based childhood public interventions to sustain and improve coverage rates. The first intervention is to minimize the cost barrier. The Section 317 discretionary program and state purchase help minimize costs for both parents and providers who purchase the vaccine. VFC has a provider quality improvement aspect to the program that allows states to work with VFC-involved private sector immunization providers to improve their immunization coverage practices according to NVAC standards published last fall. In addition, school and day care laws are a potential intervention for influenza, depending on how the vaccination paradigm shifts. He noted that surveillance for coverage and safety is very similar for children and adults.
Dr. Rodewald then discussed immunization policies and finances. For childhood vaccines, ACIP is a powerful organization that recommends the schedule and target population for influenza vaccination. It also has the authority to raise the funds for VFC-eligible children, which is very unusual for an advisory committee. For adults, ACIP recommends the schedule and target populations, but has no real authority to finance vaccines. Since the intent of discretionary 317 funds is to immunize children, only an estimated 5% of are used for adults. States also raise funds for adult immunization.
He also noted that the CDC and states control the vaccine for routine childhood, but there is very little public sector control for routine adult and minimal control for targeted, high-risk adults. In addition, the burden of vaccination assurance lies with CDC and states for routine childhood but that there is no clear public sector lead for assuring vaccination for high-risk adults.
Dr. Rodewald noted that the childhood program is very effective and explained that there has been a rapid increase in coverage with new vaccines. Among adults, influenza vaccination coverage rates have experienced a plateau. There is, however, a disturbing discrepancy among racial/ethnic adults.
In conclusion, Dr. Rodewald explained that the public sector routine childhood program is almost fully funded, delivers more than 50% of childhood vaccines, and is highly effective with new vaccines. The public sector adult program administers about 6% of influenza vaccine through local health department clinics and has a relatively small public health infrastructure.

CMS: Financing and Quality Improvement Organizations Efforts - Dr. James Randolph Farris

Dr. Farris discussed recent efforts by CMS to increase immunization rates among Medicare beneficiaries. He learned a lot today and heard many comments that he would not have heard a couple of years ago at a meeting like this. There is recognition of the efforts that CMS has made to improve immunization rates and to work with groups such as NVAC to come up with a viable solution to the problems.
About 39 years ago, the Medicare program had no preventive services. In 1981, they began coverage of pneumococcal immunizations and in 1993 added coverage of influenza immunizations. Those familiar with the Medicare Modernization Act (MMA) and its phases are aware of the fact that there will be opportunities to increase preventive services. Under MMA, Medicare will begin covering physical exams, and this will provide an opportune setting to talk to Medicare patients about the need for preventive services including, as specifically mentioned in the bill, influenza. This will in turn be an opportunity to increase the level of influenza immunization coverage, as well as pneumococcal immunizations, among Medicare recipients.
CMS is committed to the goal of increasing coverage of Medicare beneficiaries for influenza and pneumococcal vaccines, and has included it as one its GPRA goals. Dr. Farris discussed working with Quality Insurance Organizations (QIOs), once called peer review organizations. QIOs make certain that CMS provides good, reasonable services to Medicare beneficiaries. They see to it that services are provided in a timely manner, are given in appropriate setting, meet medical necessity, and meet quality standards. A QIO exists in each state and part of their charge is to reduce mortality due to pneumonia. They are charged with a task of increasing influenza and pneumococcal immunizations in each state. They are also required to screen patients in hospitals to see that those patients have been offered or have received influenza and pneumococcal vaccines. This gives them the opportunity to work with physicians. Part of QIO duties is to work with physicians in office and hospital settings to talk about current trends and methods to make certain that physicians know what is appropriate in terms of provision of quality services.
He noted some CMS special project, though not specifically for influenza, that involve working to increase pneumococcal immunizations through faith-based organizations, schools, and pharmacies.
Dr. Farris noted that immunization in institutional settings offers a unique opportunity to improve immunization rates. Many Medicare beneficiaries spend time in hospitals and nursing homes and many receive home healthcare services. Since healthcare needs are greater for these individuals, standing order programs for vaccine administration went into effect in October 2002.
Finally, he noted that there has been an increase in the administration fee for influenza and pneumococcal vaccinations that increased an average of 94% (related to physician fee schedule). Dr. Farris reassured the committee that CMS will work with QIO and regional office coordinators to make sure that the exact price Medicare will pay for influenza and pneumococcal immunizations and physician fees are on their websites. This will solve a number of problems.

Perspective of Health Plans and Insurers - Mr. Bob Rehm

Mr. Rehm began his presentation by thanking Dr. Peter, Dr. Gellin, and Dr. Black. He explained that AAHP-HIAA is the national trade association representing the private sector in healthcare. It has nearly 1,300 member companies that provide health, long-term care, dental, disability, and supplemental coverage to more than 200 million Americans.
Dr. Rehm focused his presentation on coverage policies, public reporting on performance, targeted organizational initiatives, community outreach efforts by both AAHP-HIAA and health plan members, and challenges and opportunities.
AAHP-HIAA's latest data collection on coverage policies was done in 2001. The study was an exhaustive assessment where the primary respondents were chief medical offices (CMOs). The survey was sent to 280 health plans, representing about 70% of the total health plan membership. The results showed that health plans cover vaccines recommended by ACIP. This year included other preventive services such as breast cancer screenings and colorectal cancer screenings.
AAHP-HIAA is planning a vaccination and immunization survey for Q3 2004. They will be looking at different types of health insurers and are hoping to get both health plan and insurer perspectives on many of the questions that have been raised. The questions expected to be seen will be included, and Dr. Rehm said that anyone interested in adding questions can contact him.
He reviewed data from AAHP-HIAA's 2001 annual industry survey in which results showed that close to 95% of health plans cover pneumococcal and influenza vaccines for people at high risk.
Dr. Rehm commented that immunization rates, at least among health plan members, continue to improve. He presented data showing improvements demonstrated by health plans in childhood immunization. The data show that health plans are, over time, effective in reaching out to their membership and that providers are committed to improving rates. The data show the percent of health plan members receiving childhood immunization services in 2000 through 2003. Chicken pox/varicella vaccine has the lowest rates but the steepest slope. Many are performing in the 90th percentile but some are performing at 25th percentile.
Dr. Rehm discussed AAHP-HIAA immunization initiatives, which are guided by their Immunization Task Force. The Task Force is comprised of 12 to 15 immunization experts within health plans. AAHP-HIAA shares immunization updates regularly with its members and the public via the Immunization Newsletter. They also have a monthly magazine that, last year, featured three articles specifically addressing immunization issues.
AAHP highlights and promotes health plans' models that work in the field of immunization. Their Grant for Innovation in Immunization Practices Program supports future programs to improve immunization rates. This is the second year where grants were given to a particular health plan to support its effort to improve immunization rates in terms of a population or target vaccine.
Dr. Rehm discussed the AAHP-HIAA 10-year contract with CDC to manage the Vaccine Safety Datalink (VSD) project and the Clinical Immunizations Safety Assessment (CISA) project. VSD is a large database project that looks at the adverse effects of vaccines, and CISA is a more patient-centered clinical assessment of vaccines. Dr. Rehm noted AAHP-HIAA representation on national committees. He mentioned Dr. Black as the NVAC liaison and DR. Robert Scalettar Blue Cross/Blue Shield as the ACIP liaison.
Dr. Rehm discussed a community outreach program on influenza immunization called the PARTNERS Project. This is a unique partnership with CDC that began in 2000 and ended in 2002. The partnership was formed to promote evidence-based preventive health services to health plan members, employees, and their dependents.

Influenza Vaccine R&D - Dr. Cristina Cassetti

Dr. Cassetti explained that NIAID supports a wide range of research activities from basic research to the clinical evaluation of the vaccines, therapies, and diagnostics. This research involves industry and academia. She noted that over the years, NIAID has supported several research programs for the development of improved influenza vaccines. One of the major goals of these programs is to develop vaccines that have enhanced immunogenicity or are broadly protective against widely divergent virus strains. Ideally, the goal is to produce a vaccine that does not need to be updated each year.
Many of the research programs aim to improve TIV with adjuvants, mucosal delivery, or increased dose. To develop a vaccine that does not need to be updated, there are also programs that are developing new vaccines that target conserved proteins, such as NP and M2. Ongoing clinical trials, such as Dr. Arvin's, are elucidating the immune responses to LAIV compared to TIV and natural infections.
Dr. Yoshihiro Kawaoka at the University of Wisconsin at Madison developed reversed genetics technology in 1999 with NIAID support. This powerful technology allows an understanding of the virus from a research standpoint, provides a potentially faster and easier method to generate the vaccine reference strains, and eliminates the need for working directly with the clinical isolate. It allows the engineering of the HA of pandemic virus strains without the basic amino acids at the cleavage site which are associated with high virulence.
NIAID is also supporting research on new technologies that could more rapidly produce influenza vaccines. This research includes a tissue culture-based system as an alternative to eggs, DNA-based vaccines, and recombinant baculovirus-expressed protein vaccines. They are also supporting projects exploring new methods for vaccine delivery, such as a skin patch and a gene gun.

Pandemic Influenza Preparedness - Dr. Ben Schwartz

Dr Schwartz provided an overview of the draft National Influenza Pandemic Plan. The goals of the pandemic influenza response are to decrease the burden of the disease, minimize the social disruption, and reduce economic impacts.
Dr. Schwartz presented recent developments that have affected the planning process, which started over 10 years ago. These developments include increased focus on influenza and other health threats, such as the avian influenza outbreaks (1997, 1999, 2003, 2004) and the global spread of SARS. There have also been improved infrastructures and technologies, including improved vaccine development technologies, new antiviral medications, and new communications systems. The 2003-2004 influenza season also provided lessons-learned in vaccine supply and demand.
The plan is divided into several different components. The core plan describes national coordination and decision-making, provides an overview of key preparedness issues, and outlines response actions at national, state, and local levels. In addition to the core plan, there are two guide documents. One provides guidance for state and local health departments' planning process; the other provides guidance for the healthcare system's planning process. There are also ten annexes that will provide more detailed and technical information on key preparedness and response issues. The key intervention in a pandemic is vaccination. The vaccine and vaccination preparedness goals are to assure surge production capacity, shorten timelines to availability, and ensure effective distribution and administration to achieve pandemic response goals. To approach these goals, the first step is to assure year-round egg supply. Additionally, U.S. manufacturing capacity must be increased, vaccine pilot lots for strains with pandemic potential must be developed and tested, and research to improve the ability to rapidly develop reference strains that grow well in production systems must be conducted. A lot of thinking is ongoing about the best way to deliver vaccine, especially to traditionally underserved racial and ethnic communities.
Before vaccines will become available during a pandemic, antiviral drugs are likely to be the most important intervention.
He noted that state and local preparedness is key because these are the levels in which interventions are implemented. State and local health departments are being supported with pandemic, bio-terrorism, other preparedness planning. HRSA is providing grants to coordinate medical care and enhance capacity in local communities, and CDC is providing support for surveillance and public health laboratories. Another activity involves developing tabletop and field exercises so that states can look at the effectiveness of their plans. In the healthcare system, there is also a need for planning and education, especially for interventions that may be implemented at that level, such as triage and infection control. HIPAC has recently revised the infection control guidelines for influenza.
Dr. Schwartz presented the next steps in influenza pandemic preparedness. The first step is to finalize the national plan. The second step is to promote and support planning at state and local levels, with testing of plans in tabletop and field exercises. The third step is to address key issues to enhance preparedness improving response capacity. The last step is to monitor the progress of the plan and revise it accordingly.

New Business Discussion

Dr. Hinman made a motion to adopt a resolution that recognizes the contributions of Dr. Orenstein. Dr. Hinman read the resolution, which was passed out to the committee. The motion was seconded by Dr. Fast and several others, and all voted in favor. Dr. Peter commented that NVAC would not have been able to reach this point without Dr. Orenstein's leadership. He thanked him on behalf of NVAC. - ACTION - NVAC RESOLUTION RECOGNIZING DR. WALT ORENSTEIN

WORKING GROUP UPDATES AND REPORTS

Laboratory Containment of Wild Poliovirus in the United States, Phase I: National Survey and Inventory Final Report - Dr. Ann Margaret Arvin and Dr. Walter R. Dowdle

Needs and Recommendations for the U.S. Polio Vaccine Stockpile
Dr. Charles M. Helms

Dr. Helms explained that in 1999, the ACIP recommended that inactivated poliovirus vaccine (IPV) be used for reaching the mitigation of the U.S. population, while oral poliovirus vaccine (OPV) be reserved for "mass vaccination campaigns to control outbreaks." The sole U.S. manufacturer of OPV has withdrawn from the market, making it difficult to implement ACIP's recommendation. In February 1993, the NVAC/ACIP joint work group was charged with creating a report that looked at this problem. ACTION - THE NVAC COMMITTEE MEMBERS ALL VOTED IN FAVOR OF APPROVING THE REPORT AND SUBMITTING IT TO THE ACIP.

Public Health Options for Implementing Vaccine Recommendations: A Framework for State Decision Making - Dr. Donald Williamson

Dr. Williamson began by explaining the factors that the workgroup discussed. There were growing numbers of recommendations from ACIP and an increase in scope and complexity of the schedule. There is an increase in cost, while resources remain fixed. There is a growing public cynicism about immunization and immunization requirements. Expectations about total disease elimination and protection is increasing. There is an increased international commitment to interrupt transmission and achieve eradication. The final factor was the use of school immunization requirements as a strategy to control transmission and increase immunization coverage. The problem is that state officials are faced with increased challenges as they implement newly recommended vaccines. The strategy of the workgroup is to help state policy makers develop guidance around this issue. The process involved literature reviews, regional stakeholder meetings, and workgroup deliberations. The literature reviews included surveys on how immunization policies are currently made. Dr. Williamson presented the conclusions of the stakeholder meetings. First, immunizations are a benefit, not only to the individual, but also to society as a whole. Thus, immunization requirements for entry into daycare, school, and colleges have been repeatedly affirmed by society in general. Second and most important, the process for state decision-making regarding implementation of vaccine recommendations has been effective. Finally, immunization requirements that do not consider financial constraints will not be optimally effective. These requirements need to be prioritized and the economic barriers include more than payment of vaccines. Dr. Williamson provided four general areas of recommendations. These include guidelines for states to address national immunization recommendations, effective implementation of state immunization recommendations and requirements, monitoring implementation of state immunization requirements, and development of new knowledge. These recommendations are intended to be broad in application, though the language is specific to school systems.

Public Participation in Vaccine Decision Making - Ms. Ruth Katz

Ms. Katz noted that the purpose of the Wingspread Group was to explore how the immunization community might enhance public engagement in decision-making about vaccine policy. The group was made up of representatives from health professional organizations, government agencies, academia, industry, NGOs, and private consultants. The group developed a proposal to the Vaccine Policy Analysis Collaborative (VPACE) that explored actions to further engage the public in vaccine policy. NVAC has been asked to review the proposal and to recommend additional activities. An NVAC workgroup was formed to do the homework behind this request and to make its recommendations to the whole committee. The workgroup was formed over the last few months and includes Ms. Koslap-Petraco, Dr. Kline, Dr. Schaffner. Both Dr. Gellin and Dr. Peter have served in an ex officio capacity.
The workgroup is now in the process of identifying individuals and organizations who have been directly involved in engaging the public in policy-making activities. The plan is to bring them or representatives from those organizations, along with the Wingspread Group, to meet with the workgroup in Washington, DC over the next several months. The WB will report back to the committee on these meetings. The purpose of these activities is not an attempt to identify mechanisms for addressing issues of conflict resolution. Rather, it is about identifying ways to go beyond the traditional stakeholders and to find ways to engage them. Towards that goal, the workgroup hopes to be as creative and thoughtful as those who have developed the VPACE proposal.

Vaccine Financing -Dr. Hinman

Dr. Hinman explained that the charge of the workgroup was to recommend a process for systematic evaluation of the Institute of Medicine (IOM) report. The IOM report contained three recommendations. The first recommendation was the implementation of a new insurance mandate confined with the government subsidy and doctorate plan for vaccines recommended by ACIP. The second recommendation was DHHS should propose changes in the ACIP membership procedures so that its recommendations can associate vaccine coverage decisions with social benefits and costs, including consideration of the impact of the price of vaccines on recommendations for its use. The third recommendation is NVOP should convene a series of stakeholder deliberations on the administrative, technical, and legislative issues associated with the shift from a vaccine purchase to a vaccine mandate, subsidy, and voucher finance strategy. The members of the workgroup are Dr. Hinman, Dr. Arvin, Dr. Black, Dr. Williamson, Dr. Klein, and Dr. Whitley-Williams.
He noted that the workgroup is seeking industry perspective on the IOM options. NVAC currently has no industry members and industry will be heavily affected by the option that is ultimately chosen. Consequently, the workgroup recommends the following steps. First, solicit representation and participation to serve on the workgroup from major manufacturers in the pharmaceuticals and biotech industries. Second, convene a stakeholder meeting in Spring 2004 to discuss the IOM options in detail. Third, using the results from that meeting, the summary of the NPI forum, the workgroup's surveys, as well as ongoing discussions and consultations, begin to draft the NVAC report and present an outline of that report at the next meeting.

Monitoring Anthrax Vaccine Adverse Events Defense Medical Surveillance System -
Dr. Jeff Davis and Dr. Michael McNeil

Dr. Davis noted that NVAC was asked for input on the process of using the Defense Medical Surveillance System (DMSS), which is a composite of several different databases, and to probe the potential of adverse events occurring as a result of using anthrax vaccine. The workgroup met to work out a mechanism to evaluate a variety of different proposals for using DMSS. They undertook a rigorous process to understand the protocol, weighing the proposals based on standard criteria, and ultimately selecting several proposals for further investigation.
The proposed high-ranking topics for full protocols include arthritis, erythema multiforme, optic neuritis, systemic lupus erythematosus, and multiple immunizations. The workgroup is not sure of any particular pathogenic mechanism for contributing to adverse events, but felt that arthritis was a good topic. Erythema multiforme is a rare and severe adverse event, and is also autoimmune-related. There is also strength in the database, which would allow examination of optic neuritis in the Air Force.
Dr. McNeil presented the timeline for the NVAC Vaccine Analytic Unit Workgroup. The workgroup was formed in June 2003. They prioritized their topics between July 2003 and February 2004, and will be launching a protocol review by the June 2004 meeting. One of the next steps is to continue DMSS data validation, which is a learning process that will take a couple of months to finish. The second step is for CDC to award a contract for chart abstraction. This is an important step for data validation and specific protocols for particular adverse events. A third step is to draft full protocols for selected topics for IRB approval. The final next step is to continue the NVAC workgroup review.
Dr. Davis added that the workgroup did not formulate a formal recommendation, but rather helped to evaluate the proposals. He also noted that the potential for this database is extraordinary.

SUBCOMMITTEE UPDATES AND REPORTS

Subcommittee on Immunization Coverage - Dr. Patricia N. Whitley-Williams

Dr. Whitley-Williams noted that the first topic discussed in the subcommittee has been covered by the Polio Vaccine Stockpile presentation. The second topic involves developing a white paper on adult immunization, which has been discussed at a SC meeting prior to the influenza season. As a result of their experience with influenza, a proposal was made to have the white paper focus on influenza, as well as barriers and strategies to improve adult immunization coverage. As a rationale for this proposal, Dr. Whitley-Williams noted the 1991 NVAC measles white paper, which put forth recommendations to overcome the measles outbreak. However, there is only one recommendation that deals specifically with measles. The other recommendations and strategies actually look at the immunization delivery program and vaccine development for the childhood immunization program. The subcommittee hopes to mirror those efforts for the adult immunization program.

Subcommittee on Future Vaccines - Dr. Patricia Fast

Dr. Fast noted that the subcommittee reviewed the progress of three different workshops in their report. The report on the CMV workshop has been accepted by Clinical Infectious Disease and will be sent to Dr. Beato for his final review. The pneumococcal vaccine workshop was called September 2003. The workshop was to identify the extent of protection against pneumococcal disease and to consider how existing and future vaccines can be tested in clinical trials. The workshop was successful in bringing together representatives from industry, government, and academic research. Almost all of the presentations are available on the NVPO website and a brief summary is being prepared for publication.
Dr. Fast highlighted the First International Neonatal Vaccination Workshop (INVW), scheduled for March 2-4 in McLean, VA. The workshop is coordinated by the National Vaccine Advisory Committee's Future Vaccines Subcommittee, CDC, the U.S. Food and Drug Administration, the National Institutes of Health, and the Task Force for Child Survival and Development, and is supported by a grant from the DHHS National Vaccine Program Office. A steering group led by Trudy Murphy, CDC, planned the workshop, and Dr. Fast noted that Dr. Murphy did a stellar job planning the workshop.
INVW will explore the feasibility and safety of strategies to expand protection of young infants against vaccine-preventable diseases, including a variety of viral agents, diphtheria/tetanus/pertussis, haemophilus influenzae type b, and pneumococcus. Presentations by national and international experts will focus on the immune responses of the neonate to vaccine antigens, review clinical experience, consider expanded use of vaccines in the neonate from industry and regulatory perspectives, and explore other strategies to protect neonates, such as maternal immunization. There will be a broad spectrum of people coming, including the national scientific press, public organizations, and a number of scientists.
Dr. Fast noted that another topic was how the SC could contribute to the report Dr. Beato has requested. The SC supports this request and volunteers have been identified to work on this report. They believe research focusing on the goal of improving influenza vaccine needs to be on the agenda. The research would identify the epidemiology, laboratory, clinical, and operational research gaps. They also believe that some consideration should be given to possible organizational, structural, or policy impediments to this research.

Subcommittee on Vaccine Safety and Communication -Dr. Jerome Klein and Dr. Christine Casey

Dr. Klein noted that they discussed three areas: an update on the CDC Thimerosal studies, an update on the Clinical Immunization Safety Assessment Network, and an update from the ACIP/AFEB Smallpox Vaccine Safety workgroup. He first presented highlights of the smallpox presentation. According to the BMG January 2004 report, 650,000 military personnel were screened and 566,900 were vaccinated. Seventy-one percent were primary and 88% were male.
Dr. Klein noted the screening technique must have been very successful in the absence of eczema vaccinatum or progressive vaccinia. There were zero cases in the military, which shows the success of the screening program. For the DHHS Smallpox Vaccination Program, the number screened is not available.
Dr. Casey presented an update on the Clinical Immunization Safety Assessment (CISA) network. The CISA network is a vaccine safety initiative under contract with CDC. There are seven centers and they aim to clarify hypotheses of clinical syndromes following vaccination by addressing some of the challenging clinical vaccine safety questions at the individual patient level for all ages.
The main focus of the network is to provide real-time clinical consultation for complex vaccine safety queries from the medical community. The goal is to increase understanding of the underlying pathophysiology of vaccine associated adverse events and identify genetic or risk factors for predisposed groups. For example, ADEM (Acute Disseminated Encephalomyelitis) has been known to occur after vaccination. CISA was able to have their commissioned researchers from the Boston Medical Center staff a case prospectively in one of the states. They connected with the primary care provider and with the patient to review clinical scenarios and make recommendations.
They are planning a gradual rollout of the program in Summer 2004, but have some scientific and nonscientific barriers. Dr. Casey noted the nonscientific barriers to the CISA project. There are inherent challenges since this is an innovative and complex project. There are medico-legal concerns, most notably liability on distant consultation. Another concern is reimbursement variability. There are Data Privacy 308(d) and HIPAA requirements to protect the patients. They have to build a functional informatics system. They have to effectively communicate their goals to the public, providers, and partners. Finally, the process will involve complex project coordination and logistics. To learn from their international partners, CISA will be holding an international risk management workshop this summer.
Dr. Klein continued by providing an update on the CDC Thimerosal studies. The Vaccine Safety Datalink Screening Analysis was published in Pediatrics in November 2003. The analysis showed there was no increase in risk for autism or ADD. The subsequent studies will include a follow-up neuropsychological testing study of children, a follow-up study of vaccine trial participants, and a case-control study of thimerosal and autism, which is currently being planned.

Vaccine Management Business Improvement Project - Ms. Kimberly S. Lane

Ms. Lane presented background information on NIP. NIP administers $1.2 billion in childhood vaccines and covers vaccine purchase funds and all associated costs, such as vaccine ordering, vaccine order approval, distribution, inventory management, and funds management. This is all done through a combination of the VFC program and the 317 program. One of the overarching goals of the program is to drive high levels of childhood vaccination by ensuring an adequate vaccine supply, efficient distribution, and emergency stockpiles.
The program has been very successful, but there are shortcomings. There is minimal integration among supply chain partners (e.g., manufacturers, NIP, states), which limits inventory visibility and reduces our ability to manage it. An example of this is in vaccine shortage. There are 44,000 sites receiving vaccines through the program and trying to find where we spot shortages has to be a manual process.
Ms. Lane added that the administrative processes are largely manual and overly complex. There are 64 unique accounts set up at CDC based on a really old 317-legacy system. One grantee receives 600 faxes per week while another receives 200 per week, which is very burdensome and duplicates many efforts.
NIP will partner with Booz Allen Hamilton, a private company with commercial expertise in supply chains, distribution, as well as government operations. They will be looking for ways to improve operations, with the overall goal of developing and implementing an automated, seamless VFC vaccine management system. The project deliverables include an overview of the existing distribution system and administrative processes. Second and third would be a diagnostic of performance "gaps" and improvements for the shared vision. The fourth deliverable will be a recommendation on alternatives and an agenda for moving forward, including initiatives to implement and manage work streams.
Ms. Lane noted that this is an opportunity to improve the program and perhaps free up some funding that can be redirected to other core public health functions.
Mr. Hutchins presented data showing that the majority of vaccines under the VFC program are distributed through private third-party providers. Mr. Hutchins noted that 5% (fewer than 2,500) of the 44,000 providers account for a third of the vaccines. This makes it difficult to take a "one-size fits-all" approach, since there are a few providers with a very large volume and several providers with a small volume.
The second set of data Mr. Hutchins presented showed that if stockpiles were all in place, the system would be operating with 9 to 10 months of inventory under the VFC program, representing an investment of over $875 million. Mr. Hutchins noted that he hopes to have the first set of recommendations by the end of March and then turned the presentation over to Ms. Lane.

Project BioShield - Dr. Philip K. Russell

Dr. Russell provide an update of the progress on Project BioShield since last year. The proposal for the administration had three phases. One was to provide official authority to the Secretary and Commissioner of FDA for emergency use authorization of products that are in IND status at the time of the emergency. Congressional action will determine the execution of this proposal. The second component is to give additional acquisition authority to NIH and NIAID to change the hiring authority and some of the contractual capabilities that would give NIH more flexibility for contracting for the R&D aspect of the bio-terrorism approach. The third part is within the Office of Assistant Secretary for Public Health Emergency Preparedness and is the acquisition phase. The proposed legislation has been redrafted and has been passed in the House, but not in the Senate. The Administration is working with Senate leadership to get it passed. Dr. Russell commented that the legislation is being held up by legislative obstacles.
Dr. Russell then addressed the potential procurements under consideration. First is the rPA anthrax vaccine, because there is very little of the vaccine in inventory. The next consideration is the smallpox vaccine for high-risk individuals. There are 30 million to 50 million people in the U.S. for which the smallpox vaccine is contraindicated, so a safer smallpox vaccine is a high priority. Botulinum antitoxin (Equine) is a high priority because, of the threat of the botulinum toxins in the milk/food supply. This is a familiar program because according to CDC, the antitoxin can be processed from immunized horses. Also under consideration are anthrax immune globulin products, recombinant plague vaccine, replacement botulinum vaccine, as well as a short list of anti-radiation drugs and chemical antidotes. The legislation was extended beyond biological hazards and vaccines to include chemical and anti-radiation antidotes.
Potential future candidates for BioShield procurement include the Ebola-Marburg vaccine, Rift Valley Fever Vaccine, novel antibiotic/anti-infective, novel antiviral, human anthrax and botulinum antitoxins from transgenic animals, and possibly a third generation anthrax vaccine. The need for an efficient vaccination against anthrax is a very high priority. There needs to be a better way to deliver that vaccine. Thimerosal/Autism Litigation

National Vaccine Injury Compensation Program -Ms. Elizabeth Saindon

Ms. Saindon began by providing a background on the National Vaccine Injury Compensation Program (NVICP). Established in 1986, it was developed as a no-fault compensation scheme whereby persons allegedly suffering injury or death as a result of the administration of certain compulsory childhood vaccines may petition the federal government for monetary damages. Congress intended that the Vaccine Program provide individuals a swift, flexible, and less adversarial alternative to the often costly and lengthy civil arena of traditional tort litigation.
Settlements are based on the Vaccine Injury Table, which summarizes the adverse events caused by vaccines. Individuals and their families can qualify for compensation in three ways. First is to show that an injury found on the Vaccine Injury Table occurred in the appropriate time interval following immunization. For injuries outside of the table, the other two ways to qualify include proving that the vaccine caused the condition or demonstrating that the vaccine worsened or aggravated a pre-existing condition.
NVICP is jointly administered by DHHS, the United States Court of Federal Claims, and DOJ. At the beginning of the program, almost all of the claims were table claims. However, as the vaccine supply has improved and become safer, the newer vaccine caused injuries are from vaccines taken off the market. As a result, almost all of the cases are now based on the foundation of fact. This has caused backlog in the program.
In the middle of 1999, manufacturers began making certain vaccines without thimerosal. In reaction to this, beginning in late 1999 and 2000, people began to sue the vaccine manufactures, alleging that the mercury in the vaccine was causing autism. Because of the jurisdictional issue, the civil courts first looked at the jurisdiction laagering claim. The decision was made that all of the claims should go through NVICP first because it was the vaccine itself that was at issue. Beginning in July 2002, there were approximately 400 autism cases filed with the NVICP. As of today, there are more than 3,500 cases, with more being filed everyday.
In order to respond to this influx of cases, DOJ proposed a way of dealing with the caseload. First, there is to be an inquiry into the general causation issue, which looks at whether the vaccine caused autism and under what circumstances. The second phase is to apply the results of the first phase to the individual cases. That permits the petitioners to come into the program by filing a one-page sheet of paper saying that they want to join the autism proceedings; they are not required to supply medical records. This short-form petition has caused some litigation within the litigation.
A rigid schedule for discovery was imposed, with an end date of August 2003. Causation hearings are to be conducted March 2004, and a ruling on causation is scheduled for July 2004. The discovery has been very burdensome and as a result, the litigation is behind schedule. The Office of Special Masters has permitted petitioners to seek discovery from the department and there have been productions for essentially every operating division. For the most part, the document discovery is complete, but the product licensing agreements from FDA is still an issue.
Although almost all of the discovery has been completed from the initial set of interrogatories, petitioners are now in a position to expand the scope of discovery. They are also seeking third-party discovery from manufacturers, and there will be a hearing on this issue. Due to these discovery disputes, the hearing has been indefinitely postponed.
For updates, she encouraged NVAC to visit the Office of Special Masters section in the U.S. Court of Federal Claims at www.uscfc.uscourts.gov.

Civil Litigation Update - Mr. Randolph Moss

Mr. Moss noted that he is not counsel on record on any of these cases and is not representing any official position on behalf of any of the litigants. In the 1980s there was crisis relating to vaccines and vaccine litigation. There were 200 lawsuits that were brought against vaccine manufactures relating to DTP. In the face of that escalating litigation, all but four manufacturers left the market. This created a shortage of vaccines, prices went up, and compensation was haphazard. As a result, Congress created NVICP. The goals of the program were to provide prompt, efficient, and fair compensation to individuals who were injured by vaccines, and to protect the vaccine supply by minimizing litigation.
Over the past few years, the thimerosal litigation has raised questions about those goals. The litigation is proceeding through various stages. The first phase of the litigation was jurisdictional disputes, specifically whether claims needed to be processed through the program. The core operative feature of the program is that if an individual alleges injury from vaccines, that individual must file a claim under the program. If the results of the program as undesirable, that individual can then go to the courts.
The first phase of the litigation raised the issue of whether individuals had to file a claim under the program. As of the end of 2003, there were more than 350 lawsuits and 11 class action suits. Many of the individual cases have been dismissed but many continue to be filed. There is one unique case, the California Proposition 65 case, dealing with warnings to consumers of certain chemicals used in vaccines.
There have been different attempts to circumvent the NVICP. Under the National Childhood Vaccine Injury Act, all claims of $1,000 or more had to be filed with through the program. To undermine this provision, class actions were filed that contained millions of people, each with $999 claims. Another issue is that there is an argument made that thimerosal, which is a preservative added to vaccines, is an adulterant, since the program does not cover adulterants. There has been a range of derivative cases brought by parents or grandparents of children who are alleging vaccine-related injury. Their argument is that the child has to file a claim under the program, but that parents and grandparents do not. The final class of cases has been medical monitoring cases where the argument has been that they do not have to file with the program because they have not sustained an injury yet.
Largely, the courts have rejected each of these theories. There have been 36 separate cases, as well as a decision of the Special Masters, concluding that the adulterant theory does not work, since thimerosal is not an adulterant. Despite this, these cases continue to be filed. For derivative cases, the courts have held that, to the extent that someone is seeking compensation for medical expenses, these cases must be filed under the program first. The $1000-claims have been dismissed and all of the class actions have been dismissed, though some are in appeal. The California Proposition 65 case has been dismissed with prejudice on the basis that federal law preempts state laws relating to the labeling of vaccines. This case is on appeal.
There are many thousands of claims that are pending in the program and the delay in discovery is a very serious issue. However, the real question about the interaction between the program and litigation is what is going to happen next. A major issue to come is whether the claimants in the program will decide whether they want to accept the judgment under the program or whether they will decide to opt out of that process and decide to litigate. This process is already developing, with 11 cases that are currently pending back in court. In general, the courts have done a good job of sending these cases back to the program, but there are still questions about what the next steps will be in light of the breathtaking expenses.

DHHS AGENCIES AND COMMITTEES REPORTS

ACCV/DVIC Report - Ms. Jackie Noyes and Dr. Geoffrey Evans

Ms. Noyes noted that they have been short on committee members and have about two years of catch up to do. As a result, their March meeting will consist of almost all new members. She is concerned about the viability of the program and what its survival means to the childhood immunization program. She noted there is legislation in Congress that will correct many of the gaps in NVICP that has not yet moved. Congress was to get to it in June of 2003 but did not. Additionally, influenza vaccine will be added to NVICP in the future.

VRPBAC/FDA Report -Dr. Norman Baylor

Dr. Baylor shared that the VRPBAC meeting will be on February 18 and 19 at the Sheraton Four Points Hotel in Bethesda, Maryland. They will be selecting the influenza vaccine strains for 2004-2005. They will also discuss the use of tissue cultures in the manufacturing process of vaccines. He announced that Dr. Overturf will be taking over the chair of VRPBAC.

ACIP/NIP Report - Dr. Stephen Cochi

Dr. Cochi provided an overview of the NIP activities. He noted that despite the challenges with vaccine supply shortages of Td, DTaP, PCV-7, MMR, and varicella, the overall coverage levels have been the highest the program has ever attained. Every one of the coverage levels is a record high.
He then noted that the National Infant Immunization Week (NIIW), from April 25 to May 1, 2004, will include all 38 countries in the Western Hemisphere. CDC and the department are working with PAHO and the Mexican government to support these advocacy events, including cross-border activities in San Diego and El Paso. There is also some discussion of doing this worldwide, perhaps as early as 2005. As part of NIIW, on April 23, CDC will be participating with the March of Dimes in a media event to celebrate the start of the 50th Anniversary of the Start of Polio Clinical Trials.
Dr. Cochi presented NIP's global GPRA targets. These include the eradication of polio by 2005, the reduction of the annual global measles-related mortality (compared with 1999 estimates of 875,000 deaths), and the elimination of ongoing indigenous measles transmission in all 47 countries and territories of the Americas by 2005. The last target was achieved in November 2002. There is also a new target to eliminate rubella in the Americas by 2010.

NIH - Dr. George Curlin

Dr. Curlin mentioned two international clinical trials. One is just getting started and one has just finished. They have completed the immunizations in Gambia. They are just starting clinical trials in India on bovine vaccine strains, which should be completed in 3 years. It is a rigorous program and they will have a more detailed report in the future.

PUBLIC COMMENT

Clare Hannon reiterated some ASTA and state concerns about the 317 funding cuts. She acknowledged that NVAC has been supportive. The infrastructure funding is being cut by a little more than $1 million, as well as the vaccine purchasing funding. There is a movement towards a two-tiered system where vaccines are covered by VFC and insurance, but there is no funding in 317 to provide vaccines to the 12% served by 317. On the infrastructure side, there is a good children's program that needs to be sustained, but many states have only part-time coordinators in adult programs. They are concerned that states are grappling with budget deficits themselves. Down the road, the states may have problems with their coverage and it may be hitting a certain group of children.
Dr. Peter suggested putting on the agenda for the next meeting a review of the implications of 317 cuts.

Adjournment

Dr. Peter thanked all of the speakers and noted that he has never been at a meeting with so much information. He thanked Carolin Commodore for her support of the meeting and Dr. Gellin who put together the agenda. Dr. Hinman noted that this is Dr. Peter's last meeting as chair and thanked him for his leadership.
Dr. Peter adjourned the meeting.

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