Tuesday, September 1, 2009

CDC's H1N1 public engagement dialogue, day 1

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.

PANELISTS:

Roger Bernier, Senior Advisor For Scientific Strategy and Innovation,
National Center for Immunization and Respirat, CDC
Anthony Fiore, Medical Epidemiologist, MD, MPH, Captain, Public
Health Service, Influenza Division , Centers for Disease Control and
Prevention
Frank Malinoski, President and Principal Partner, TD Consultancy, LLC
Martin Meltzer, Senior Economist and Distinguished Consultant,
Division of Emerging Infections and Surveillance Serv, CDC
Eleanor Peters, Epidemiology Specialist, St. Louis County Department
of Health
............................................................

FOCUS POINT DISCUSSION SUMMARIES:

Pros and cons of a "GO EASY" approach to a vaccination program

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. Program activities in the areas of communication,
volunteer involvement, partnerships, safety, disease, and coverage
monitoring will be slightly increased over those undertaken during a
regular flu season.

What are your questions and concerns about the "go easy" 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
consider? If you feel this option is the best for the assumptions and
circumstances, described in the Discussion Guidelines, talk about
why. If this option is not acceptable to you, share why not.

Some pros of the Go Easy approach

* Given the fairly low complication and case fatality rates in New
Zealand, perhaps the "go easy" approach is the most rational one.
This seems sensible particularly because the vaccine development and
approval are such a rush job, and we will be learning about their
efficacy and safety once they are on the market.

* We need to be developing risk stratification schemes for who is
likely to develop complications. If we can risk-stratify, we may not
need to have a shotgun approach to vaccination.

Some cons of the Go Easy approach

* It's just a matter of time before a severe pandemic will happen. If
we fail to respond appropriately to this, it could have far more
lasting, more adverse effects.

* Although a pandemic of some sort is a foregone conclusion, it's not
clear if this is the one. In looking at the Southern hemisphere, so
far it is not as bad as predicted. If the second wave does not
materialize this season, this may give us time to test the vaccines
more extensively for both efficacy and safety before advocating the
full throttle vaccination approach.

* Other effective, inexpensive health strategies have been overlooked
as we have a medical system that seems focused solely on the idea of
vaccination to deal with disease. I would suggest the CDC look at the
research on the use of probiotics and Vitamin D supplementation to
enhance immunity and incorporate that into any level of approach to
the H1N1 response.

* I believe the time has passed for Go Easy approach. The Go Easy
approach gave way to the Moderate Effort approach over the summer. If
we fail to respond Moderately now, we may not be able to respond more
aggressively later, say in October when we will have a clearer
picture of what we are dealing with.

* The Go Easy plan would make it too hard to find and get the flu
shot, even for those who would really like to get it.

* If the Go Easy approach were applied, there is no possible way to
provide vaccination to those who would want it, or in time to
minimize hospitalization and death. Resources would be stretched
beyond their capacity and fatalities would increase.

* I prefer the Go Slow option where everyone that wants a vaccine can
have it, and people who do not want it do not have to take it. I do
not feel any schools should be centers for administering the vaccine
(if the live form) because of possible shedding to the unvaccinated
children.

* A public health crisis is not the time for our government to "Go
Easy." We have had the benefit of buying time since H1N1 showed in
May to learn about the virus and of watching the Southern hemisphere
go through their influenza season. If we Go Easy and wait, I think
there will be a devastating impact.

* The government has already committed so much to the study and
development of the vaccine that to treat this virus as if it's a step
above a seasonal influenza will undercut the government's perceived
competence. Truth be told, this isn't the same as seasonal influenza
nor are all the parameters known--it could end up being much ado
about nothing.


Pros and cons of a "MODERATE EFFORT" approach to a vaccination
program

The goal of a "moderate effort" approach is to promote vaccination to
eligible groups, set up extra vaccination sites beyond those used in
a regular flu year, and to vaccinate relatively quickly a large
number of the eligible groups. An aim of the program is to raise the
expected low public demand for vaccine. Regular program activities
are considerably enhanced to accomplish this especially in the area
of communication, but other program areas such as volunteer
involvement, partnerships, and program monitoring are also
intensified.

What are your questions and concerns about the "moderate effort"
approach? As you weigh the pros and cons for this approach what
values influence your thinking? What additional pros and cons for do
you think should be considered? If you feel this option is the best
for the assumptions and circumstances, described in the Discussion
Guidelines, talk about why. If this option is not acceptable to you,
share why not.

Some pros for the Moderate Effort approach

* Given history, and the events that have transpired since the Novel
H1N1 appeared last Spring, the most logical and practical approach is
the moderate approach. The current virus, appears to resemble the
effects of the 1957 Asian Bird Flu Pandemic rather than the 1918
Swine Flu Pandemic. The Moderate approach provides a balanced,
credible avenue for dealing with a mild to moderate pandemic.

* The moderate effort could be the best approach. Getting the
infrastructure in place and working at some capacity will allow
either scaling back or ramping up as the situation unfolds. According
to the Discussion Guide, enhanced communication is part of the
Moderate approach. Providing sufficient, accurate and timely
information so that the public, government, and health care providers
can make informed decisions should be a fundamental activity,
regardless of the approach taken.

* I am advocating the Moderate Effort approach. People who are
staunchly against vaccination won't agree to be vaccinated (or have
their kids vaccinated), no matter how much time is put into studying
the safety and efficacy of a vaccine. The vast majority of people
will want to know the costs/benefits of the vaccination and will
weigh if it's worth taking the risk in a situation where everything
can't be known. A moderate approach communicates the seriousness of
the H1N1 threat without suggesting that people should be panicked.

* Moderate effort is the best choice overall for the reasons already
indicated. Additionally, it places you in the middle of preparedness
making it easiest to respond appropriately to developments, which can
result in de-escalation or escalation. Flexibility in the plan is a
must.

There were no cons for the Moderate Effort approach.


Pros and cons of a "FULL THROTTLE" approach to a vaccination program

Significant additional federal, state, and local funds are invested
in creating numerous extra vaccination sites in both the public and
private sectors. The aim of a "full throttle" approach is to create
and to respond fully and speedily to significant public demand for
vaccination even if the severity of the illness is initially
perceived to be low. Extensive communication activities are
undertaken to stimulate public demand, and extensive networks of
volunteers and partners are identified and ready to spring into
action. Monitoring of the program activities is carried out
aggressively to collect timely data and take any corrective actions
needed to improve the ongoing program or to protect public safety.

What are your questions and concerns about the "full throttle"
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, described in the Discussion
Guidelines, talk about why. If this option is not acceptable to you,
share why not.

Some pros of the Full Throttle approach

* The only real positive for the Full Throttle approach seems to be
the Rapid Response feature to vaccinate the population quickly should
the severity increase.

* I favor the Full Throttle approach. The H1N1 virus is here to stay.
Those who want to vaccinate will, those who don't, won't. Another
consideration to the vaccination strategy is the economy. If 40% of
the population is sick, how is this country going to continue to get
out of this economic recession?

Some cons of the Full Throttle approach

* A full throttle approach that would inject mercury into pregnant
women and young children is not safe. Any approach that fails to warn
the general public about these hazards is not taking into
consideration the health and welfare of the whole person.

* We shouldn't go full throttle unless we have the vaccine supply to
cover the top tier.

* Use of resources during an economic hardship. Given the resources
are for the safety of the people and the fact that they have spent
far more bailing out businesses elsewhere - this is a non-issue for
me. The people of the United States of America are worth the
investment.

* Less possible for the U.S. to donate vaccine elsewhere. Not
necessarily true. If it turns out to be less severe here and more
severe elsewhere, we will of course send what we have.

* Risk of reaction. This is a legitimate concern - expressed
emotionally and at length by others here. I would prefer to have
factual studies cited to read for myself, however. This is too
serious a subject to be laced with subjective opinion and conjecture.

* If we go full throttle, and it turns out to be a mild flu season,
we will have lost a lot of public credibility by "crying wolf" and
people will be less willing to gear up the next time there is the
possibility of a pandemic.

* I am not in favor of a full-throttle response because increased
subjective demand for a vaccine is not necessarily correlated to
increased objective need for a vaccine in order to protect vulnerable
people. As long as the media reports on H1N1 in the sensationalized
and alarmist way it did this spring, people will not get the
information they need to know whether they should be demanding a
vaccine. Therefore, I am in favor of the CDC going slow and using
their expertise to decide whether to ramp up the response.

* I am dis-inclined to support the Full-Throttle approach for the US
because of our recent experience with non-severe symptoms, low
mortality rate, and last swine flu episode. I agree with a strong
readiness posture concerning health education, vaccine production,
and vaccination for high-risk individuals, but would caution against
a Full Throttle initiative for the Nation at this time.

* I'm not sure that we need to start with the "full throttle" mode of
operation as the availability of the vaccine doesn't appear to be
able to keep up with the demand in this mode of operation.  

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