Thursday, September 3, 2009

CDC's H1N1 public engagement dialogue, day 2

On August 31 and September 1, the CDC in conjunction with the Keystone Center and WestEd held a web based discussion centering around implementation of and communication about H1N1 vaccination efforts. In addition to the sponsors, over 150 members of the public from different regions of the US participated. The discussions were structured around 3 distinct approaches to vaccination:

1. With the "go easy" approach a few extra sites for vaccination are planned. The goal is to meet an expected low public demand for vaccine and to do so throughout the flu season without rushing to vaccinate early on. 

2. The goal of the "moderate effort" approach is to raise the expected low public demand for vaccine by promoting vaccination to eligible groups, setting up extra vaccination sites, and vaccinating relatively quickly a large number of the eligible groups. 

3. The goal of a "full throttle" approach is to create and respond fully and speedily to significant public demand for vaccination even if the severity of the illness is initially perceived to be low.

The discussions were guided by the following questions/points:
--What are your questions and concerns about each approach? 

--As you weigh the pros and cons for this approach what values influence your thinking? 
--What additional pros/cons do you think should be considered? 
--If you feel this option is the best for the assumptions and circumstances, talk about why. 
--If this option is not acceptable to you, share why not.
Here is the summary of day 1 as kindly provided by the conference organizers.

Day 1 notes can be found here.


Anthony Fiore, Medical Epidemiologist, MD, MPH, Captain, Public
Health Service, Influenza Division , Centers for Disease Control and
John Iskander, Senior Medical Consultant, CDC
Frank Malinoski, President and Principal Partner, TD Consultancy, LLC
Martin Meltzer, Senior Economist and Distinguished Consultant,
Division of Emerging Infections and Surveillance Serv, CDC


Exploration of Poll Results

Participants will explore the preferences registered through the
poll. The goal is to explore the reasons behind the choices made and
the underlying values and assumptions that may have influenced those
choices. This conversation will provide a richer, deeper view into
participants' choices and will help the CDC better understand the
reasons behind the numeric poll results.

Now that you have completed the poll and can view the results so far,
what are your initial responses? If you liked them, why do you like
them? If you favored an alternative that didn't get majority support,
what are the most serious difficulties that you would face if the CDC
didn't adopt your favored alternative? Can you live with the results
even if you disagree with them? If the CDC takes the approach chosen
by the majority of participants, what important perspectives will
they be missing? If the pandemic were more or less severe than you
had expected, how would that change your perspective on the poll

While poll results do not reflect a statistical representative sample
of the US population, they provide insights into the views and
preferences of individuals who choose to participate in the online
discussion and polling process. Like the comments in the previous
days' discussions, the polling data provides additional information
and perspectives for CDC to consider as it plans its approach to H1N1
vaccination. It also allows participants to learn what one another
might be thinking and toward what approach they might be more or less
inclined, which may help us to explore implementation challenges and

Highlights of participants' comments on the Exploration of Poll
Responses discussion follow.

* The Moderate Effort approach was favored because it has a timeline
that permits the flexibility to ramp up or down as the situation
changes (more or less severe flu). Since the current H1N1 strain is
less severe, the moderate approach allows us to complete additional
testing and monitor how the virus changes.

* The Moderate Effort was preferred because it is aimed to lower the
public need for vaccine.

* The Full Throttle approach was favored because the majority of
Americans are uninformed about why this virus is a problem and how
widespread it will be. The crush of "worried well" or mildly ill
people who will break our already broken health care system is

* Taking a Full Throttle approach is troubling because it is going to
cause people to panic. Those who thought they had a choice not to
vaccinate will have to get vaccinated to protect themselves from
those who receive live vaccine.

* One participant advocated: (1) intensive education about the
pandemic, including the evolving risks, (2) a low threshold for
social containment actions, and (3) intensive education on the
vaccine, including full disclosure of what we do not yet know.

* Participants noted the strong preferences of individuals who seek a
flexible, balanced approach that prevents the maximum number of
deaths and hospitalizations and that preserving life is more
important than the costs associated with it. Additionally, the
preference for wanting "more time for educating the population and
raising awareness about H1N1 virus" would be nice, but the disease
itself may not allow for that.

* A discussion of the vaccine and whether or not it is "experimental"
led to an explanation of the two sets of trials that are underway
being conducted by the manufacturers and the National Institute of
Allergy and Infectious Diseases. The trials comply with Good Clinical
Practices, which includes many provisions to prevent results from
being "invented". While the H1N1 vaccines are not experimental and
will be licensed like all strain changes, it was noted that H1N1 is a
novel strain and there is a risk that the vaccine may need two shots
in older people.

* It was noted that poll results appeared inconsistent. For example,
even though the moderate approach was favored in question #7, the
opposition to vaccination program came in first at 31% on question

* Disapproval was expressed about CDC's "in-humane" vaccination
program. Concern was voiced for innocent individuals who could die,
become chronically ill, or acquire a lifelong neurological disorder
as a result of unstudied vaccine.

Implementation issues -- a look into the future

The H1N1 vaccination program that is ultimately chosen will involve
specific features (e.g., resources, number of vaccination sites,
speed of vaccination, recall methods for the second dose) and
activities (e.g., communication, volunteer involvement, partnerships,
safety monitoring, disease surveillance, coverage monitoring,
security). The level of effort for these features and activities will
vary depending on which program approach is implemented.

When considering the poll results, what thoughts or issues come up
for you regarding implementation of the vaccination program? What do
you think implementation will look like? How do you think the
vaccination program will really work? What implementation issues do
you foresee given the poll results? What concerns do you have?

Highlights of the discussion of implementation issues follow.

* The dominant theme of the implementation discussion covered
elements of a Public Information Campaign: audience, media, and
content. Overall, participants advocated for a communication program
that is based in fact and repeats the same message clearly and
consistently in easy-to-understand language. The goal of the campaign
would be to raise awareness of the H1N1 virus and to promote
prevention and containment of the disease. Other considerations:
employ images for visual learners, use multiple languages, and
provide information so that people can make an informed decision
based on facts. Vaccination education needs to be implemented full
throttle, talking about the risks of the virus as well as the
unknowns of the vaccine.

* The target audience includes, among others, seniors/over 64 years
old, young adults (the "bullet proof" generation), parents, pregnant
women, adolescents, those at risk for complications, employers,
health care workers, families, etc.

* Media should be selected based on the target audience's typical
preferences for receiving information. For example, seniors are
likely to listen to the radio and watch TV, while young adults are
inclined to use FaceBook, Twitter, and cell phones. Other media
outlets included billboards, signage in public places like airports,
the Internet (reputable sources), newspapers, posters, text
messaging, MTV, YouTube, MySpace. Community organizations such as
schools, PTAs, church groups, senior centers, and libraries were also
suggested as forums for disseminating the H1N1 message. Public
service announcements, commercials, infomercials, peer-to-peer
discussions, and word-of-mouth could be used to broadcast the H1N1

Concerns were expressed about using live vaccine particularly in
schools, potential for disease spread by shedding, risks of
thimerosal and adjuvants, how well patients are being informed, lack
information about vaccine ingredients (e.g., on VIS pages),
absenteeism due to illness, unsafe vaccines, harming our healthcare
and other priority groups with an unsafe vaccine, and more. The
Public Information Campaign plan needs to address these concerns in a
straightforward, factual way. Some examples of the type of content
participants want include the following.

* Explain to seniors why they are not in the initial priority group:
one of the benefits of their age is that they have some immunity to
H1N1. However, they are still susceptible to seasonal flu and need a
seasonal flu vaccine.

* Explain the types of vaccines (live and killed, preservative-free
and preservative-containing vaccines), reasons for having multiple
types (e.g., greater supply), and the target population for each
vaccine. Spell out the risks and benefits of the vaccine and its
ingredients. Include warnings about side-effects, adjuvants,
preservatives, and shedding. Note availability of thimerosal-free

* List the ingredients contained in the vaccine including their

* Explain the reasons why the CDC is following the approach it is
following. Spell it out: (1) Pregnant women are at X times more
likely to be hospitalized and X times more likely to die from this
virus. (2) If 30% of the population is ill, these are the
ramifications (detail the impact on the health care system, the
impact on the economy, lost opportunity to protect the public).

* Explain practices for good hygiene (cough into your elbow, don't
share drinking glasses and eating utensils). Provide personal
preparedness information: necessary supplies, how to care for loved
ones, how to care for children when schools close, utilize "tribes of
three" for high-risk children, describe disease prevention tactics.
Include information on the serious complications, hospitalizations,
and deaths that have occurred in children with certain chronic
medical conditions. Inform parents of the danger signals that mean
their child needs medical attention.

* Describe the relative risks and benefits of getting the vaccine
versus not getting it.

* Clarify the rationale regarding the prioritization of groups and

Additional implementation issues included the following.

* If the outbreak is more severe than anticipated and the "full
throttle" approach is chosen, then health care workers will be in
greater demand. Strengthening existing volunteer networks and
encouraging volunteer participation through communication campaigns
might help. Recently retired health care workers might be an
excellent group to target for assistance since that age group is less
susceptible to the H1N1.

* To effect containment, there should be very low thresholds for
closing schools and work places. This will test our distance learning
and working capabilities, and could serve as a pilot public health
measure. Travel should also be limited; business travel may be
effectively replaced by web-enabled communications.

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