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Blue Ribbon Panel Meeting
Summary Report
June 3 and 4, 2004
In March 2004, Dr. Julie Gerberding, Director of the Centers for
Disease Control and Prevention (CDC) requested that a diverse group of
individuals be convened to review the vaccine safety monitoring and
research activities at CDC. At a two-day meeting in June 2004, the
participants engaged in frank and wide-ranging discussion of current
vaccine safety programs and perceptions about the safety of
immunizations. The participants accepted Dr. Gerberding’s charge to
report back on CDC’s longstanding commitments in vaccine safety
monitoring, research and communication. The discussion highlighted that
vaccine safety is a subject that requires much broader governmental and
public involvement in keeping with the evolving epidemiology of disease
and expanding clinical and laboratory science. In addition, community
expectation for vaccine safety standards increases as the burden of
disease decreases as a result of successful immunization programs.
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CDC
Background
Objectives for the Meeting Participants
Summary of
Meeting
Conclusion
CDC BACKGROUND
Rationale for convening this meeting:
Vaccines are cited as one of the greatest achievements of biomedical
science and public health in the 20th century. This achievement is based
on the remarkable success in controlling numerous infectious diseases
which used to be widely prevalent in the United States. While there has
been great progress in reducing the number of cases of
vaccine-preventable diseases such as polio, measles, rubella and
meningitis, the threats posed by these diseases remain because the
organisms that cause them have not been eliminated.
The public health importance of immunizations cannot be disputed;
however, an equally important aspect of the immunization program is
ensuring the safety of all vaccines, particularly because they are
sometimes administered to entire populations and are often mandatory.
CDC recognizes its role in collaboration with FDA and other partners in
ascertaining the risks involved in vaccinations as well as its
responsibility to communicate these risks to the public. Public
confidence in the immunization program is essential and must be based on
understanding and communicating the benefits and risks of immunization.
At the same time, it is critical that public health officials listen to
and understand concerns that are expressed by the public around vaccine
safety.
Although CDC is not solely responsible for the complex issue of
vaccine safety, it has a unique role in surveillance, monitoring and
engaging in and supporting research on immunization. Respect and
confidence in the quality and integrity of these scientific efforts is
an essential component of our national immunization program. CDC is
actively involved in detecting and investigating vaccine safety concerns
and supporting a wide range of vaccine safety research to address safety
questions. Given this role, CDC is deeply committed to ensuring that
vaccine safety monitoring and research is undertaken with the highest
degree of integrity and scientific quality. CDC recognizes its dual
roles in promoting immunization to prevent disease and ongoing
assessment of vaccine safety. In addition, given the concerns some have
expressed about potential conflicts of interest in fulfilling these
roles, CDC appreciates that the assessment of immunization risk warrants
both adequate resources and appropriate oversight.
Therefore, Dr. Gerberding made the important decision to convene a
group of individuals who have been engaged in the area of vaccine safety
and who could provide individual opinions on a variety of issues related
to the vaccine safety program at CDC. By holding this meeting and
encouraging an open and honest exchange of ideas on vaccine safety, CDC
hoped to demonstrate its commitment to strengthen the collaboration
between public health agencies, public interest, professional and
advocacy groups, industry and the general public. Furthermore, CDC hoped
the discussion among the participants will continue to provide a
foundation upon which further trust and confidence can be established on
these very important public health issues.
Meeting Participants:
The group consisted of 17 individuals (see
Appendix
1, Meeting Participants) from a variety of professional
organizations, public interest and advocacy groups, government advisory
committees, and government agencies. In an effort to create balance
among the participants, including complementary skill sets, diverse
points of view, and general interest in safety issues (specifically in
area of vaccine safety) while maintaining a size that would promote
productive and manageable discussion, the following guidelines were
utilized to choose participants:
- Broad understanding and knowledge of risk assessment, risk
management, and quality assurance and/or,
- Interest and/or knowledge of vaccine safety issues and/or,
- Partners with diverse perspectives who work with CDC on vaccine
safety issues and its research agenda and/or,
- Partners with diverse perspectives who work with CDC in an
advocacy role for public health issues and/or have engaged CDC in
discussions on this issue and/or,
- Individuals who actively seek credible vaccine safety
information which include healthcare providers, consumers, other
federal agencies, industry, professional groups and others.
Unfortunately, many key stakeholders who have been deeply involved
and dedicated to issues around vaccine safety were not invited to
participate in the meeting. The primary reason for not inviting
additional groups and/or individuals was not to exclude any particular
points of view but simply to maintain a smaller group of individuals to
allow for productive discussion. This summary report will be posted on
the CDC website for public comment and we invite those who were not able
or invited to participate in this meeting to provide their comments. The
public comments along with the summary report will be provided to the
Director of CDC.
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OBJECTIVES FOR THE MEETING PARTICIPANTS:
The meeting participants were asked to review and discuss three
objectives during their two-day meeting. The purpose of providing
objectives for the participants was to assist them in discussing the
vaccine safety program at CDC on a broader level; therefore, they were
not convened to discuss specific vaccine safety studies such as the
thimerosal issues, the recent IOM report or other more specific details
of the vaccine safety program.
Individuals were asked to provide individual opinions on the
following three objectives:
- Review the structure, function, credibility, effectiveness,
efficiency and support of CDC’s vaccine safety program and assess
how it can be maximized and sustained.
- Assess the program’s ability to detect emerging or rare
adverse events.
- Assess the capacity of the program to provide comprehensive
monitoring of the growing number of vaccines.
- Review the intramural and extramural collaborative activities of
the vaccine safety program and determine their effectiveness and
efficiency.
- Assess additional steps CDC can institute to enhance
coordination with other federal agencies and partners, including
consumer and advocacy groups.
- Determine the optimal organizational location for vaccine safety
activities within the CDC to ensure scientific objectivity,
transparency and oversight while at the same time ensuring that
program priorities are appropriately established and are relevant to
the immunization program and other stakeholder needs.
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SUMMARY OF MEETING:
The two-day meeting took place in Atlanta, Georgia on June 3 and 4,
2004. Prior to the meeting, the participants were provided with a
notebook of informational materials and an agenda for the meeting. To
ensure a productive meeting, the participants were asked to review the
materials prior to the meeting. Specifically, the notebook consisted of
supplemental materials and recommended sources for other information on
vaccine safety. While the meeting was not open to the public, the
discussions of the meeting were transcribed.
June 3, 2004:
On the first day of the meeting, the Chair, Dr. Louis Cooper as well
as CDC’s Chief of Science, Dr. Dixie Snider, provided opening remarks to
the participants. Then, each individual present, including CDC staff
attendees, offered a personal introduction. Finally, the objectives for
consideration by the participants were reviewed and the meeting
continued with presentations given by CDC and other Department of Health
and Human Services (DHHS) staff.
The presentations by the staff ranged in topic, beginning with a
broad overview of the vaccine safety activities in the DHHS coordinated
through the National Vaccine Program Office (NVPO). There were
presentations on CDC’s overall activities in vaccine safety and then the
focus of the presentations narrowed to specific overviews of the
National Immunization Program (NIP) and its activities in vaccine
safety. The Immunization Safety staff presented on specific functions
and activities within the immunization program which involve
surveillance, monitoring and research in vaccine safety. Specifically,
activities such as the Vaccine Adverse Event Reporting System (VAERS)
and the Vaccine Safety Datalink (VSD) Project were outlined and there
was background given on other efforts such as the Clinical Immunization
Safety Assessment (CISA) Network and the Brighton Collaboration. There
was a presentation on CDC’s Data Sharing Program and finally, to
stimulate thinking and further discussion, options were presented
regarding the current and potential organizational location for vaccine
safety activities within CDC.
The range of topics presented was intended to give the participants a
sense of the depth and complexity of the issues that CDC and
specifically, the Immunization Safety staff tackle on a daily basis.
Throughout the day, while presentations were given, the participants
were encouraged to ask questions of the staff. The questions and
comments from the participants were direct and at times constructively
critical of the vaccine safety monitoring and research activities at
CDC. The immunization staff’s honest and direct answers stimulated
additional substantive and productive discussion.
The discussion demonstrated the complexity of the issues and often
revealed sources of tension between CDC and some members of the public
as well as among CDC staff. At times, it was clear that some of the
staff have experienced a great deal of stress and frustration, including
personal harassment, while dealing with the vaccine safety issues and
allegations by some of loss of public trust in CDC’s work. However, the
pride and dedication that the immunization staff have regarding their
effort in vaccine safety was equally clear and impressive to the
participants.
Overall, the presentations given by the staff and questions asked by
the participants generated frank dialogue on important and challenging
aspects of vaccine safety by a unique, diverse group of individuals,
including the CDC and NIP staff, representatives from parental and
advocacy groups, vaccine manufacturers, professional organizations,
advisory committees and government officials. Although disagreement was
clear on some issues, the interaction underscored a common theme, a
clear dedication to the safety of vaccines and the importance of broad
public and professional understanding about the benefits and risks of
immunization.
For additional details, the presentations and discussions can be
reviewed in the official transcript.
June 4, 2004:
The second day of the meeting was reserved for discussion among the
participants regarding the three objectives (mentioned earlier) as well
as specific considerations dealing with vaccine safety activities at
CDC. With the exception of senior staff who were asked to remain as
resources, other CDC staff were excused from this session, allowing the
participants the entire day to engage in thorough and open discussion
regarding the objectives as well as the issues presented the previous
day.
To begin the discussion, Dr. Cooper asked all participants to share
their most important impressions and views following the June 3rd
session. The participants each provided insightful and direct remarks
concerning, but not limited to the presentations and the interactions
with the immunization staff. An emphasis was placed on vaccine safety
issues where improvement is feasible and critical.
Following the opening remarks, the participants continued the
discussion on the three objectives but also considered some other
specific questions/issues regarding vaccine safety. Again, the
participants were encouraged to speak freely and openly regarding their
views and as a result, the discussion was extremely thoughtful. The
comments made during both the opening remarks and the remaining session
seemed to revolve around very specific themes. As a result, even though
the participants were not convened to come to a consensus and/or make
recommendations as a group regarding what CDC should do to improve the
vaccine safety activities at CDC, these themes seemed to resonate
throughout the day. Individuals did not restrict their comments solely
to the role of CDC, but directly mentioned other governmental entities,
industry, the provider community and the public. Some of the themes are
highlighted in this report as a framework for moving forward to make
improvements in the area of vaccine safety. (These themes are not
prioritized.)
There is a tremendous need for strategic planning for vaccine
safety research and for greater coordination and collaboration among
federal agencies and community leaders.
Vaccine safety research and monitoring is not just an activity at
CDC. Therefore, collaboration is considered critical if the activities
around vaccine safety are going to be improved and strengthened. The
collaboration, however, must occur on many levels. It is important to
harness the strengths of all stakeholders in the vaccine safety arena
which translates into not only involving the federal government agencies
such as FDA, CDC, National Institutes of Health (NIH), Health Resource
and Services Administration (HRSA), Department of Defense (DOD), and
others but allowing for public and community leaders and/or key
advocates to be an integral part of the process. Additionally, the
advisory committees, manufacturers, and other partners who have
important stakes in vaccine safety need more clearly defined roles in
this process.
There is a need for a more formalized process to coordinate
activities and promote collaboration and priority setting among all
federal agencies working in vaccines, specifically CDC, FDA, NIH, HRSA,
DOD, and others. Some of the participants mentioned that NVPO could
assist a great deal more in the coordination of vaccine safety
activities, particularly among the federal government agencies; however,
it was acknowledged that NVPO lacks the resources and the authority to
drive such activity. Some participants expressed the need for creating
an interagency coordinating group to review the vaccine safety
activities and/or a scientific advisory board for research. Others
suggested that a Task Force on vaccine safety to include NIH, CDC, FDA,
HRSA, and others should be formalized. The participants were reminded
that at one time, there was a Task Force on Childhood Vaccines that
could be reactivated with clear definition of its role in vaccine
safety. Currently, it should be noted that there is an Interagency Group
on Vaccines (IAVG) comprised of senior staff from many of the agencies
noted above; and it convenes via teleconference every two weeks.
Overall, participants expressed the tremendous need to strengthen
coordination on vaccine safety activities. More importantly, the
discussion highlighted the need for defined roles of responsibility and
accountability for resource allocation and plan implementation across
the various federal government agencies. These activities must be
accompanied by an ongoing review of results to ensure further
responsibility and accountability.
The discussion around collaboration revealed that a strategy for
setting the agenda on vaccine safety research is critical but that it
must be done in a way that is coordinated and incorporates the strengths
of each participating agency and/or partner. Again, NVPO, with
additional resources and a clearer definition of authority was mentioned
as an appropriate key player in the process of providing more formal
collaboration on the development of a strategy for looking at vaccine
safety issues.
When speaking to the strengths of the various agencies, CDC’s
strengths in epidemiological studies and outbreak investigations were
acknowledged. However, it was emphasized by many that epidemiology is
not the only scientific research that should occur around vaccine
safety. There was a discussion about NIH and its’ focus and strength in
basic and clinical research. Additionally, there was acknowledgment that
the genetic component of any chronic disease must be studied as well as
the genetic predisposition to any serious adverse event (acute or
chronic). Again, NIH has the potential to bring additional strength and
expertise to conduct such research.
Regarding vaccine safety monitoring, there was a strong support
for CDC’s role in surveillance and epidemiology; however, there was less
clarity regarding differentiation of CDC’s role and FDA’s role in
vaccine safety research matters such as post-licensure trials.
Once it was recognized that a need exists for a formalized
collaboration across the agencies and beyond, another theme emerged
which demonstrated that the specific roles of each agency within the
federal government are not as clearly defined when it comes to vaccine
safety research. It is certainly a cross-cutting issue with tremendous
overlap and at the same time, some gaps.
FDA is responsible for the regulatory oversight and review of
pre-licensure studies conducted by manufacturers and the question came
up as to who is responsible for post-licensure studies? Currently,
within the federal government, both CDC and FDA are involved in these
types of studies. As part of a post-licensure commitment, FDA may
request that a manufacturer conduct certain post-licensure studies, and
FDA is also responsible for the regulatory oversight and review of these
studies. Although this process seems to be working and must continue, it
can also be improved. There was a sense among the participants that
there is real need for improvement in post-licensure research. It was
mentioned that some manufacturers have an active role in conducting
post-marketing trials, both on their own initiative as well as in
response to agreements with FDA.
CDC and FDA have important functions in surveillance and some
participants emphasized that the performance has generally been strong
in this area. However, concern was expressed that most
monitoring/surveillance systems are not specific to a particular vaccine
and there are not enough studies of possible adverse effects of new
vaccines in combination with existing vaccines. Therefore, as the number
of vaccines increases, the number of unresolved hypotheses which need
new studies might also increase. Who will be responsible for
prioritizing and doing these studies? Another point raised was that
post-marketing research results may not necessarily be included in the
vaccine package insert unless they are submitted for FDA review by the
manufacturer.
Additional questions focused on the perceived increase in national
morbidity from chronic diseases—and the role, if any, that vaccines may
play regarding such conditions as asthma, neuro-developmental and
learning disabilities, diabetes and autoimmune disorders. While CDC does
conduct research on chronic diseases, it was not completely clear what
the roles are for the agencies in conducting research on chronic
diseases that could be linked to a vaccine and/or drug (i.e.
product/drug-induced disease) and whether this type of research should
fall only within the purview of FDA, since it is a regulatory agency.
The challenge of determining whether a chronic disease is
product-induced was recognized. There is great difficulty in determining
whether a valid signal exists for a relationship between vaccines and
chronic conditions. Some participants questioned the sensitivity of
existing vaccine safety tools, such as VAERS and VSD in picking up
signals around chronic diseases.
There is a need for external oversight and community/public
involvement in setting the research agenda.
Another key theme that emerged is the underlying need to involve the
public to a greater extent in the decision-making process on vaccine
safety research. The public has a critical stake in the vaccine safety
research agenda and therefore, could play a larger role in this process.
Some participants stated that in the current environment, there is
controversy about vaccine safety research and some of this may stem from
the lack of trust that some members of the public have towards those
setting and monitoring the research agenda. If coordination of vaccine
safety activities could be improved and public participation could be
enhanced in this process, the trust could be strengthened between the
government and the public. Some individuals felt strongly that the
process whereby the Advisory Committee on Immunization Practices (ACIP)
and the Institute of Medicine (IOM) make recommendations for research
priorities is working well and must continue, but might be strengthened
with the addition of greater public participation. Others believed more
substantive changes within and outside these existing relationships
would be necessary to reduce what some perceive as inherent conflicts of
interest.
A consistent message in the discussion supported the value of an
integrated research effort to answer research questions. Some views were
expressed that highlighted the desire by independent researchers to
conduct research different from that research which the government is
funding. For example, while there have been some changes implemented in
the past several years (i.e. movement from whole cell pertussis to
acellular pertussis as well as from oral polio to inactivated polio),
there is a feeling among some participants that CDC can sometimes seem
unaware of some concerns among the public and even at times dismissive
of new ideas. This was another key reason why some participants believe
that more public participation in setting research priorities will be a
step towards additional collaboration and trust around these issues. The
biases mentioned included:
- Extramural investigators whose hypotheses or initial findings
raised questions about the safety of certain vaccines did not get a
fair review of grant applications from any government agency.
- Vaccine safety research, in general, has no strong advocates
involved in prioritization and allocation of resources and thus,
does not seem to be a priority at NIH, the major source for
biomedical research within the federal government.
- An exception has been made for funds related to vaccines
considered to be useful for protection against bio-terrorism.
Anthrax and Smallpox are examples, including National Institute of
Allergy and Infectious Disease’s recent creation of centers to study
atopic disease associated with smallpox vaccine.
- Funding for long-term studies of vaccine safety is very limited
or not available.
- Clear mechanisms are too limited for rapid responses to new
concerns around vaccine safety. The public’s role in evaluating the
level of concern and prioritization for limited resources has been
even more limited.
Additionally, the peer review process for government-funded research
was questioned and there were suggestions that the research needs to be
more results-oriented and customer-directed. An external prior peer
review process is critical to evaluate the technical merit of proposed
research protocols and also to assess the competence of the
investigators to perform the research. Some participants believe that an
additional external peer review process to assess research results
should include people with different disciplines than the “usual
suspects” with the technical expertise. Other members encouraged
external peer review for both intramural and extramural research.
Some participants felt that the public should be involved throughout
the process. Whereas, others felt that the technical review should be
left to those scientists with the expertise and the public can
contribute with the scientific community in recommending vaccine policy.
Furthermore, it was mentioned that different patterns of review are
needed. When new issues arise around vaccine safety, it should be
possible to re-evaluate and do additional follow-up research as needed.
Some suggested that while the CDC has demonstrated the ability to
respond to signals, sometimes the response does not appear to be
appropriate to the significance of the signal. Some believe that this
demonstrates peer review of research results alone does not represent a
final answer on a scientific issue. If there were more public
participation in the process of setting research priorities, some felt
that that this would reduce the risk of research being terminated
“prematurely” in areas viewed as problematic.
Finally, once a research agenda has been set, there needs to be an
external oversight process in place to monitor the research being
conducted by the various agencies and others to ensure that ideas raised
by members of the public are being addressed and the scientific
integrity of the research is maintained. Additionally, and some believed
most importantly, external oversight is needed to protect the science.
While there are currently oversight mechanisms in place, some
participants who noted that there is a need for improvement around the
quality of the oversight. Others expressed concern that if an
independent advisory board is set up to provide oversight to management,
there is a risk that decision-making could effectively come to a halt.
It was apparent that external oversight was essential if the results are
to have the high credibility that the modern era of consumerism and
evidence-based medicine demands.
There is a need for greater transparency in terms of how
research priorities are set, how research designs are developed, how and
what research is being conducted, how data are being analyzed, and how
those data are used for policy making. This transparency could help the
public understand what research is being done and why it is being done –
this knowledge may help create a greater sense of participation in the
process itself.
As the participants discussed the need for increased participation by
the public in the process of setting the research agenda for vaccine
safety, there seemed to be a sense that almost as important is the need
for greater transparency into the research being done within the federal
government. It was expressed by some that in the current environment, it
is unclear who decides the priorities of vaccine safety research, how
this research is funded and who ultimately does it. These are
fundamental issues into which some members of the public would like to
have more insight.
There were some concerns raised that it already seems as if some of
the research being done in vaccine safety has been in response to
political pressures, inaccurate public perception of the vaccine safety
issues and other external factors. Given these issues, some of the
participants believe that many of the research priorities are being set
in a reactive versus proactive mode. There was concern expressed by some
participants that research is being determined in response to external
criticisms that are not based on science. These criticisms pose serious
risks to priority-setting for use of limited resources. Responsiveness
to public concern is important, but a mechanism must be implemented to
balance these concerns with protection of science and the scientists.
Some comments supported the importance of allowing science to drive the
research agenda. While it was also expressed that the government
research agenda should be driven by the health needs of the general
public, the driving force for the research agenda should be based upon
the “best science.” Oversight, regardless of where it is based, should
utilize measurable objectives that are consonant with the needs of the
general public. Otherwise, oversight alone tends to lead to
micro-management and stifles creative outreach for solutions.
There were also comments regarding the need for the peer review
process to have increased transparency. Overall, transparency in the
governmental planning and implementation process in setting our nation’s
vaccine safety agenda could potentially lead to increased public
confidence.
Data access for external review and research is critical.
Recommendations were varied as to how public access could be increased
safely but there was agreement that data access needs to be increased.
Additionally, this access would allow for increased extramural research.
Providing additional access to vaccine safety data to external
researchers for the purpose of conducting vaccine safety research was
another recurring theme. Some participants believe that the data must be
publicly posted as this would increase public confidence in CDC’s
credibility and accountability in these issues, while others place
greater emphasis on audits. While a data sharing mechanism to allow
access to the Vaccine Safety Datalink (VSD) Project data has been in
place at CDC since 2002, some expressed their continued interest in
having broader access to the VSD database to allow outside researchers
to replicate and validate the studies that have already been done by
CDC. However, others emphasized that CDC should more fully assess the
current mechanism before expanding access. Some participants felt that
in providing transparency and public participation in the research
process, access to data is a key aspect of strengthening the trust
around these issues.
Adequate safeguards for data must be in place to ensure the health
plans’ willingness to continue participating, and to protect the privacy
of both patients and the participating health plans. It was recognized
that the health plans involved in the VSD Project can choose at anytime
to discontinue participation and this would be an irreplaceable loss to
vaccine safety research. During the discussion, it was emphasized that
CDC and HHS must define conditions that protect the health plans and
their patients, maintain the integrity of the science and continue to
allow public access to the data. The participants all recognized that
achieving these objectives was technically, legally and logistically
challenging.
The Vaccine Adverse Event Reporting System (VAERS) is not
sufficient to detect signals due to underreporting and doesn’t have the
granularity needed to identify who is affected. There is a need to
bolster and improve VAERS.
In reviewing some of the specific processes in place dealing with
vaccine safety, concerns were raised regarding VAERS, a system
collaboratively managed by both CDC and FDA. It was not clear to all
participants that VAERS was designed only to identify signals, not
respond to them. Nevertheless, several participants expressed little
confidence in VAERS. Even if CDC can respond rapidly to signals, some
participants perceive that CDC cannot respond adequately. Others
expressed that VAERS has been sensitive in detecting signals and that
CDC has demonstrated the ability to respond rapidly and decisively to
clear-cut signals of vaccine adverse events. There was considerable
discussion around what constitutes a signal and what represents a
reasonable response. Intussusception following vaccination with the
rotavirus vaccine was reviewed as an illustrative example.
Concerns were expressed that there may be important signals missed
due to under-reporting; and therefore some participants questioned
whether VAERS has the breadth and depth of signal reporting to allow for
an appropriate response. Some expressed the opinion that in order to
have a system that is truly effective, there would need to be mandatory
reporting of adverse effects to VAERS by those who administer vaccines.
Others discussed the importance in determining who does not report to
VAERS and why they are not reporting. This latter concern was related to
special or under-represented populations that may be at differential
risk, due to genetic and/or environmental factors. Examples mentioned
were racial and ethnic minorities, immigrants and the poor. Some thought
that there may be additional ways to encourage reporting to VAERS and
that this is another area where external input can be beneficial.
Programs to educate the public and professionals about the importance of
VAERS were proposed as potential ways to improve the sensitivity of
signal detection by VAERS.
There were recommendations for structural changes at CDC (i.e.
where to locate vaccine safety activities), ranging from very specific
to very diffuse.
One question which continued to be discussed throughout both days of
the meeting had to do with the placement of vaccine safety programs–
both within CDC as well as outside of CDC. Opinions varied on where
vaccine safety activities should be placed within CDC and how vaccine
safety activities should be organized. Although options were presented
by Dr. Wharton as to where vaccine safety might be placed within CDC,
including pros and cons provided for each option, there seemed to be a
tacit understanding by the participants that the placement of vaccine
safety activities is largely a management decision. It was hoped that
the tone of discussion would be useful to management as it reviews
options for placement of vaccine safety activities.
One overarching issue that was raised had to do with CDC’s expertise
in outbreak investigation and the necessity to continue to have the best
science. Opinions were expressed by some that the vaccine safety
activities must remain within the purview of skilled scientists and not
be distorted by passions of the moment, current public trends or
perceived conflict of interest. It was acknowledged that all individuals
have biases and that conflicts of interest are inherent. Oversight
structures, which can include external participation, may offer helpful
approaches for managing and balancing these conflicts.
Strong sentiment was expressed to “do no harm” to the good work
currently being done in any decision regarding where vaccine safety will
be placed organizationally. CDC has a different role than NIH or FDA in
responding to emergencies and there was an expressed desire to not
jeopardize this ability with any changes that are instituted.
Recognition of the need for CDC to maintain a workforce both interested
in and desirous of responding to emergencies as well as doing safety
research was also discussed. It was also noted that currently little
support exists for only a small cadre of scientists with particular
skills in the pharmaco-epidemiology of vaccines and the nascent field of
pharmaco-genetics.
CDC must be able to detect potential safety problems quickly and
address them systematically and effectively. Some believe that CDC
should maintain leadership of the vaccine safety program while others
felt the vaccine safety program should be moved outside of CDC. It was
also noted that criticism of some study results will still exist
regardless of where vaccine safety programs are placed. Other
participants believe that the vaccine safety activities are best located
where they are within the NIP and that additionally, there must be a
formal enhancement of coordination of activities.
Comments were expressed concerning strong, positive interactions
between policy, surveillance and research, thus making a case for
continuing to house these activities together. There were comments that
moving the vaccine safety monitoring outside of NIP could create more
problems and there was a question of how public health benefits by
moving the vaccine safety activities. Specifically, there were several
remarks on the placement of the risk management, risk assessment and
risk communication activities at CDC. Some participants questioned
whether risk management for vaccine safety belongs in FDA (or outside of
CDC) but they felt that it should not remain in NIP. Some noted that
public perception must be considered and that generally, maintaining the
management of risk and assessment of risk in same location would
continue to raise questions. Some believe that while these two areas
dealing with the assessment of risk and the management of risk should be
separated, there are other ways to achieve this separation other than
reorganization. There were suggestions that risk communication should be
moved outside the Immunization Safety Branch or the NIP.
Strong concern was expressed that the CDC scientists and their
research work need to be protected from undue outside influences. From
the presentations, it was clear that there are many personnel issues
around vaccine safety. One issue includes high levels of stress due to
increased public criticisms of CDC’s vaccine safety research and other
vaccine safety activities. Another issue is the number of people with
the expertise to do this type of work is limited and the incentives to
keep people in the field are limited. Other personnel issues of concern
included recruitment, training and retention and the career ladders for
personnel with appropriate training and skill sets in vaccine safety. It
was further noted that regardless of the placement of vaccine safety
activities, the staff in the broader immunization program and in the
Immunization Safety Branch must have the support of the Director of CDC.
Overall, there seemed to be a sense among some that the work CDC and
the immunization safety staff have been doing in this area has been very
good. Some participants were extremely impressed with the breadth and
depth of accomplishments presented by the staff. It was noted that there
is tremendous respect for the Immunization safety staff. On the other
hand, some noted that while the staff presented accomplishments with
great pride, this expression of pride can often be misinterpreted by
some in the public as arrogance and/or a lack of openness to listening.
There was a clear sense that vaccine safety activities are
under-funded within the federal government.
The lack of funding dedicated to vaccine safety may have been the
most common theme expressed. Some expressed the need for a protected
source of dedicated funding for vaccine safety research activities. In
order to do some of the research that is needed, such as genomics and
more longitudinal studies, more resources must be devoted to vaccine
safety.
Some participants commented on chronic under-funding of the public
health infrastructure in general (at less than 3% of the overall health
budget) and that the funding currently dedicated to vaccine safety is
miniscule. Inadequacies in data systems and surveillance largely reflect
the modesty of fiscal resources. Some believe that there is a real
disconnect in the money spent to purchase vaccines versus the amount
spent on vaccine safety activities. Vaccine safety issues demand a
culture of continuous quality assurance. While it was agreed that
additional resources dedicated to vaccine safety are warranted, it was
equally clear that assuring a culture of continuous quality improvement
is also necessary. This demands improvement in the area of
self-examination as well as willingness to listen to concerns from
external sources. The mindset of “circling the wagons” in response to
external criticism must be avoided in reality and external perception.
There was significant discussion of the importance of true
informed consent regarding vaccination, public confidence and public
acceptance of vaccination. State mandates were recognized as adding
complexity to the informed consent process.
While the discussion among participants primarily focused on issues
of vaccine safety monitoring and research, another theme came up dealing
with overall public confidence in and acceptance of the vaccination
program. Although the complex issues brought up by “mandates” were not
explored in detail, some of the feelings expressed by participants
provided insight into an area that often contributes to the
controversies surrounding vaccine safety. Vaccines are accepted as one
of the greatest accomplishments in public health. Yet along with the
benefit comes a cost, because no vaccine is 100% risk free.
There was discussion about the need for more informed decision-making
between the parent and provider. Informed consent should be based on
sound science that characterizes acute, long-term and cumulative effects
of vaccines. In some states, the state law for mandating vaccines has
been placed as a rule-making authority under the public health
department. While CDC encourages informed consent through the use of the
Vaccine Information Statement (VIS), several participants suggested that
CDC could further promote informed consent and informed refusal as a
modification of “mandates.”
The issue was raised that some healthcare providers may not give full
and balanced views about the risks of adverse reactions as well as the
benefits of specific vaccines. Some parents who raise questions or
concerns around vaccine safety report that they are not treated with
sensitivity and respect but are dismissed as “anti-vaccine.” Some
parents would like the healthcare provider to be as concerned about the
adverse effects of vaccines as they are in giving the vaccines and focus
on individual risks. While most parents want vaccines for their
children, all parents want the truth about the safety of vaccines. Most
people have confidence in vaccines; yet when questions are raised by
some parents, there is often an assumption that they are anti-vaccine.
The confidence in the vaccination program can be enhanced if there is
improvement around risk communication. It was suggested that it may be
more helpful to some parents for providers to communicate the risks and
unknowns of vaccination rather than simply mandating and/or requiring
vaccination. While the VIS does include information about possible risks
associated with vaccines, these sheets are not always used by all
physicians. There seemed to be a general sense that parents want to be
treated as equal partners in the decision-making process around
vaccination of their children. However, it was emphasized that public
concerns about vaccine safety go beyond just “improving communication
between clinicians and parents.”
People overall felt that this meeting was very positive and an
important step for CDC to have taken. A good beginning…
Many positive remarks were made by the participants at the end of the
meeting regarding the importance of holding the meeting. In substance
and tone, there seemed to be a common sense of moving forward on many of
the key issues discussed.
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CONCLUSION:
Immunization programs play a special role in national health and
security. Program success requires a high level of public trust because
in the United States parents are asked to immunize their children.
Vaccine safety is just one component of a national effort to provide the
safest possible healthcare, but because it heavily involves children and
places tremendous pressure on parents to assure that their children are
immunized, vaccine safety issues deserve a special commitment from the
government and the private health industry. Convening a diverse group of
citizens to seek perceptions about vaccine safety is an expression of
openness and courage on the part of CDC.
Overall, there was an encouraging sense of a common purpose among the
participants that demonstrated the benefit of broad public participation
in discussion of vaccine policy including the special concerns around
safety. As noted throughout the report, even though a consensus was not
sought, some common themes resonated throughout the meeting. This report
is an effort to describe these general themes and to provide an overview
of the two-day meeting.
Among issues identified and discussed at length, as expected, many
differing opinions were expressed, regarding the meeting objectives. For
example, while some felt the vaccine safety monitoring activities were
appropriately placed and had a good track record, others felt that
vaccine safety monitoring activities did not have a good track record
and needed to be moved completely outside of CDC. Some believed vaccine
safety monitoring activities need to stay within CDC, but that
relocation to another organizational unit within CDC would offer
important advantages. Nevertheless, the participants believe the
discussion around these divergent views will be useful to the Director
of CDC and to others within government as they fulfill their
responsibility to optimize immunization programs that play a unique role
in preventing disease and maintaining health.
We have chosen to ignore our instructions from Dr. Gerberding
regarding any "voting" and unanimously express to the CDC staff our
thanks for their candor in the meeting and their generous courtesy to
each of us.
Respectively submitted for the participants,
Louis Z. Cooper, MD
July 19, 2004
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Appendix 1
External Review Committee Members and Organizations
| Government
advisory committees |
| Non-government
professional groups |
| Past President
|
| Advocacy
groups |
Invitees who were not able to participate:
National Aeronautics and Space Administration - Douglass E. Lyons
Associate Editor, Pediatrics; Baylor College of Medicine,
President and C.E.O. – Ralph Feigin, M.D.
Advisory Commission on Childhood Vaccines – John Schreiber, M.D. and
Kathryn Edwards, M.D.
IOM Recommendations – June Osborne, M.D. and Jo Ivey Boufford, M.D.
American College of Physicians – Kathleen Neuzil, M.D. and Kristin
Nichol, M.D.
Health Policy/Program Consultant – Amy Fine
Federal Aviation Administration - Nancy Shelton (Dorothy Davis is
serving on the Panel)
Public Citizen’s Health Research Group, Director – Sidney Wolfe, M.D.
(Deputy Director, Peter Lurie, M.D., M.P.H. is serving on the Panel)
Advisory Committee on Immunization Practices – Myron Levin, M.D. (Jon
Abramson, M.D. is serving on the Panel)
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Notification of
posting
Summary Report on
Public Comments (PDF-75K) |