>> We're going to move right on
to Public Comments Session,
without a break.
So, let me begin by
stating the following.
So, I'd like to welcome
and thank our Public
Comment speakers
for addressing the
Committee today.
All the speakers today
submitted a request in advance
of the meeting, and
the final list
of public commenters was
determined by lottery.
We want you to know that you
are very important to us,
that your thoughts
and concerns are taken
into consideration,
and we welcome them.
For the speakers, it's
important to keep in mind
that we have a limited Public
Comment period, and in order
to make it through all
of the listed speakers,
it is extremely important
that each speaker limits his
or her remarks to three minutes.
We will be displaying
a timer on the screen,
so that you know how
much time is left.
And again, I want to emphasize
that we really appreciate
you taking the time
and volunteering to do this.
I want you to know that
when your time is up,
I will thank you -- I will say,
"Thank you for your comment.
Your time is expired."
Fifteen seconds afterwards,
I will say, "As a courtesy
to other speakers, we ask that
you conclude your comment",
and if you are still speaking
at 30 seconds after that,
then I will say the following:
"Your comment time has ended.
Thank you," and your
microphone will be terminated.
So, we'll begin, and Mr. Del
Bigtree, would you please come
to the microphone,
state your name,
and your affiliated
organization.
>> And I just want to --
>> My name is Del Bigtree.
I speak for the Informed
Consent Action Network,
which is my non-profit.
I would like to address our
concerns about the safety trials
that are taking place, on all
of the vaccines for COVID-19.
Specifically, I want to point
out that I think the ASHP
Committee, that you sit
in an unprecedented moment of
the potential of having one
of the greatest accidents
in science
that has ever taken place,
and that would be
rushing this vaccine,
given what we know
about the science.
Of course, I'm talking
about the possibility
for antibody-dependent
enhancement,
compliment mediated
antibody-dependent enhancement,
cellular mediated
enhancement, TH2.
All of these problems, which
have appeared in Dengue Vaxs,
which killed over 100 people
in the Dengue Vax Campaign
in the Philippines, the
RSV vaccine program,
which was discontinued, because
of the death of children,
and this is occurring in
virtually every animal trial
over the last 20 years.
This is not any other vaccine.
This is one of the
most dangerous vaccines
ever attempted.
And to know that we
are using warp speed,
and that we have governors
around this country and leaders
around the world, saying they
will immediately mandate this
product upon all of
their population.
It means that we
could have a vaccine
that could potentially kill
unknown, untold amounts
of people, because their
bodies don't protect them
after this vaccine, but in
fact, enhance the problem.
And I when I look at the
trials that are taking place,
when we look at the
Moderna trials,
we are not doing challenged
studies on human beings,
but the challenge that is being
done on the Macaque monkeys,
which are known to have
a very mild reaction,
which is not the way, you
know, to weed out a problem.
We're using the young monkeys,
and even then, we
did not test them.
We did not challenge
them in the first --
after the first vaccine, which
only created binding antibodies,
which is one of the theories
that creates the
immune enhancement.
We've only tested after they
knew they had neutralizing
antibodies, which only
took place two weeks
after the booster shot,
which means we are allowing
the pharmaceutical industry
to cherry-pick their
moments of research,
to make their vaccine look good.
Of course, they're going to
try and make it look good.
They stand to make potentially
hundreds of billions of dollars,
if not trillions of
dollars, off of the vaccine,
should they be selected.
Under these circumstances, I
would like to see more rigorous,
from the CDC, demanding
more constant testing.
The United States of America
is putting billions of dollars
into these vaccine trials.
We should be having all
sorts of animal trials,
on a constant basis, truly
challenge them, and make sure
that we have overcome
immune enhancement.
If we have not, we could
seriously put our species
at risk, and the only
conversations I hear going
on is how quickly can
we get it to everybody,
and the risk of the disease.
What about the risk
of this vaccine?
That is in your hands, and you
will be remembered in history,
should you make a diabolical,
catastrophic mistake.
Thank you very much.
>> Thank you for your comments.
Next, is Dr. Montoya Barthelemy.
Please, state your name
and your affiliation.
>> My name is Andre
Montoya Barthelemy.
First of all, all of those
held in -- my name's -- okay.
Thank you.
All of those held
in jails, prisons,
and detention centers really
must be included in Tier One
of the ACIP recommendations
for COVID vaccination.
As I said, I'm Andre
Montoya Barthelemy,
a physician with specific
training in Public Health
and Epidemiology, and I lead
a task force investigating the
hazards of the correctional
environment.
Today, I represent leaders
of the American College
of Correctional Physicians
and the American Association
of Public Health Physicians.
And together, we've reviewed
the ACIP's current plan
for COVID vaccination.
We have to recommend
modification of your criteria,
based on a fundamental
public health principle,
that individuals are high risk
for COVID, based on structural
and environmental forces,
which promote transmission
of the virus, as well as
their individual high risk
health condition.
Increased risk is
increased risk, and it leads
to disease, regardless.
Let me be more specific though.
Individuals who live
in congregant settings,
including group homes, shelters,
long-term care facilities,
prisons, jails, and
detention centers,
must be provided the protection
against the very environment
in which they live.
In these settings,
vaccinations can do more.
Today, our group advocates
specifically for prisoners.
We look at their environment,
possibly overcrowded facilities,
where social distancing
is extremely challenging,
where masks, hand
sanitizer, cleaning supplies
and even soap is rationed
and restricted, where a visit
to a clinic can cost a full
week of your prison wages.
Recent research demonstrates
death rates
up to three times higher, and
case rates up to five times --
more than five times higher
than the general population.
Vaccination here
will go farther.
It will save lives.
And as we look at our windows,
many of the COVID hot spots
in our country are in prisons.
Although often considered
isolated,
inmates are regularly
released from prisons and jails
and correctional staff daily
travel home to their families.
Without a damper
on the transmission
inside the facility,
they'll act as incubators,
during and releasing financial,
legal, and public
health burden back
into the general population.
The solution is what in medicine
we call, source control.
Without it, transmission
will continue,
as long as the hot spots
remain uncontrolled.
As a physician, I care for the
individuals who live and work
under the constant and invisible
threat of this pandemic.
As a public health
professional, I'm obligated
to apply the fundamental
principles
to arrest spread
in the community.
As our government-appointed
advisors,
you have a very difficult
position, a responsibility
to balance both of
those imperatives.
It is terrible difficult,
but vaccination
of inmates accomplishes
all three.
It's good medicine,
it's good public health,
and it's good governance.
So, I'm imploring you to
protect those individuals living
in congregant settings,
especially those in jails,
prisons, and detention centers.
Include them in Tier One of
your COVID vaccination schedule.
Thank you.
>> Thank you for your comments.
The next speaker is
Ms. LeeAnn Ducet.
Oops, we're skipping
that one, I'm sorry.
Our next speaker is Mr. Erwin.
>> Thank you.
Not since the depths
of the Great Depression
or the darkest hours of World
War II, have so many sane
and sober adults
wondered out loud,
whether America may be facing
a year without Christmas.
Every professional Santa has
a story or 20, about the kid
who asks nothing for himself,
but wants Daddy to get a job,
or an Abuela to get better, or
a sibling to be safe overseas,
or -- insert personal
favorite here.
This is because, to the young at
heart, Santa is the very image
of faith, hope, and charity, and
that's during the good times.
For most, times ain't good.
I'm Santa Ric Erwin, Chairman
of the Board of Directors
for the Fraternal Order
of Real-Bearded Santas,
the nation's original
Santa Fraternity.
We're a 5.01(c)(7), dedicated
to the professional cause,
and we've successfully
lobbied on behalf
of the Christmas
Community, to various state
and federal agencies, whenever
significant issues have called
for it.
Today, I'd like to call
your attention to one
of our more successful efforts.
The 2009 Christmas season
was under serious threat
by the H1N1 epidemic, and with
a vaccine approved, but not
yet publicly available,
[inaudible] led the industry
in petitioning for early
access to the vaccine,
on behalf of America's
front line seasonal workers.
Our efforts were admittedly
reliant on media support
and public pressure,
but you know what?
It worked.
Armed only with our letter to
CDC, FDA, HHS, and [inaudible].
I went to Kaiser on November 18,
and received my H1N1
vaccination, during or shortly
after Tier One relief,
and nearly a full month
before Tier Three.
Following my example,
members in other parts
of the country were
able to do the same.
And, cumulatively, we were able
to provide vaccinated Santas
to nearly all major events
and locations that year,
not to mention, the countless
private parties that were saved.
This year, Christmas
will be more important
to the American psyche
than ever before.
Our country is enduring an
historic disaster trifecta,
and nearly all Americans
endure unparallel suffering.
But we are still America,
and if passed this prologue,
families will do
everything possible
to end the bad year
on a good note.
Promising vaccines are
in phase testing already,
and remaining social
restrictions may be easing
by Christmas.
We're asking that
professional Santas
and other front line seasonal
workers be granted early access
to the COVID-19 vaccine,
as soon as practicable
after Tier One relief,
for the following reasons.
Number one, traditionally
professional Santas place
themselves in close personal
contact, with anywhere
between five and 15,000 family
members each holiday season.
Number two, our target
demographic, our clients,
if you will, are young children,
notorious distribution vectors
for all things infectious.
Number three, most
professional Santas are
in the most at-risk
category, due to advanced age
or underlying medical
issues, and number four,
despite all of this, Americans
are going to want Santa
to be at Christmas, 2020.
I await your questions
or comments.
Thank you.
>> On behalf of the voting
members of the ACIP Santas
in America, we want to
thank you for your comments,
and really enjoyed
hearing from you.
Thank you again.
>> Thank you.
>> And I really did
believe in you all my life.
The next speaker is Ms. Dorret
Reece [assumed spelling].
>> Well, even as a Jew, I
realize that Santa is a hard act
to follow, but I'll try.
I appreciate the Committee's
[inaudible] careful work
in overseeing a [inaudible]
COVID-19 vaccine.
The presentation showed how much
attention you put into safety,
and how many mechanisms
are already
in place, and more to be added.
We really need this oversite,
and I also appreciate
the transparency
which you presented
to the public.
We also need the transparency
of seeing the oversight --
of seeing what's going on.
It is critical that any decision
about COVID-19 vaccines are made
in the public eye,
just as you provide,
through this publicly
available web guide.
And this is just as important
for the emergency [inaudible],
for licensing or
recommending the vaccine,
which is why I sincerely hope
that they are exceeding
related, [inaudible].
FDA will review the data
for the vaccine candidates
and welcome public input
before approving a NOAA,
and ASHP will have from rolling
the NOAA process as well.
I also want to remind everyone
that it is not only important
to exercise oversight over the
vaccine list-making process,
but it is important that
the oversight be known.
I think speaking to the public
is not intrinsic to many
of the scientists, and do
they have a listing in ASHP,
in their one group of
the Committee itself?
But you work to oversee the
vaccine list to be visible,
in order to create trust.
This public meeting is
great, but it's not enough.
I hope that ASHP will make
visible to the public their role
in overseeing vaccine's
extensive work they do.
For example, it would be
useful to have fact sheets,
explaining your role in
oversight, generally,
a fact sheet about the wonderful
many systems of monitoring
that were presented here,
and maybe a fact
sheet highlighting the
COVID-19 workgroup.
We have a group of [inaudible]
of independent experts,
many with established
careers, extensive experience,
and know they're at stake.
Looking closely at the
data, discussing it openly
and critically, making sure
it meets the high standards.
The public should
know that it's them,
and I hope you make an effort
to bring that information
to the public, in
multiple forms.
Finally, as I said in my
previous comment, you --
I really hope ASHP considers
adding a legal expert
that has experience with equal
protection to the workgroup.
I am not an expert in legal
protection, but I know enough
to know that, when you start
considering race, as a standard
for allocation, you're
touching on issues
that can have real
legal pitfalls,
and a legal expert can
help you avoid this.
Thank you.
>> Thank you very much
for your comments.
Our next speaker will
be Ms. Grace Whiting.
>> Hi. Good afternoon.
I'm Grace Whiting.
I'm the President and CEO
at the National Alliance
for Caregiving, and I just
wanted to thank all of you
for the great work you're doing
and for giving us the chance,
just to speak and say
hello and weigh in.
So, the National Alliance
for Caregiving is a 501(c)(3)
non-profit organization.
We're based in the Washington
D.C. area, and our mission is
to build partnerships and
research advocacy and innovation
that can make life better
for family caregivers.
We just have two brief
comments today, to share.
First, that family caregivers
can be valuable partners
in improving adult
vaccination rates.
And second, that preventative
care models should incentivize
providers, to include caregivers
and shared decision-making.
We know that there's
roughly 53 million people
in the United States, which
is about one in five Americans
who care for a friend
or family member
because of a healthcare need
or functional disability.
And while we think about
caring for another person
as an intimate activity, in the
aggregate, it's foundational
to our health and
social care system.
In fact, AARP estimates
that the economic value
of unpaid caregiving is
roughly $470 billion, each year.
That's how much it
would cost, if we wanted
to replace each caregiver with
a paid worker, and it's someone
to help with activities
of daily living,
such as grocery shopping,
managing finances,
every thing to high touch
activities, like bathing
and toileting, medical
nursing tasks,
such as wound care
or colostomy care.
And despite broad support
from this Committee
and from other leaders
in this space,
adult vaccination remains low.
We know from pediatrics that
caregivers, when included
in shared decision-making
by formal care providers,
can be critical partners,
and the same is true
of adult partners in care.
In the national research that
we do with AARP, most caregivers
who seek outside information
preferred to talk to a doctor
or a healthcare professional.
And the next most trusted
source is friends and family.
Here, the Medicare program
can provide some insight,
into how to incentivize
shared design-making,
between providers, patients,
and family caregivers.
Currently, the Medicare
program can reimburse providers
for family support related to
transitional care evaluation
and management, chronic
care management,
education to a family
member, patient monitoring,
comprehensive clinical visits
and a written care plan,
the annual Wellness Visit
and advanced care planning.
We would encourage this
Committee to consider models
of care delivery that can
likewise incentivize providers,
to have early, often, and
open conversations to families
about preventing
infectious disease.
And finally, as we heard
this morning on COVID-19,
the needs of older adults
are front and center.
There's an opportunity
to meet the moment
and recruit additional
experts with expertise
in adult and geriatric care.
Thank you.
>> Thank you very much
for your comments.
Our next speaker is Dr. Maria
Garay [assumed spelling].
>> My name is Maria
Garay,and I'm a Doctor
of Nursing Practice,
board-certified
as a family nurse practitioner.
I speak on behalf of the
patients I provide care for.
We have a crisis of
vaccine confidence,
and I fully understand why.
I have personally
cared for patients
who have suffered a vaccine
injury and has seen an increase
in vaccine hesitancy
and distrust
over the last six months.
My patients are questioning
the safety
of the new Corona Virus vaccine.
They know it's being
rushed to market,
with a lack of long-term
safety studies.
They are concerned there will
be no liability or recourse
for injuries they may sustain.
They are concerned about
the risk of autoimmunity,
impairment infertility,
and the possibility
of this causing cancer,
because of the nature
of an mRNA vaccine.
In some studies, safety will
only be monitored for one month.
It is unethical to
monitor efficacy
for two years, but not safety.
All studies should be
similar, for safety monitoring.
Inclusion criteria for
the mRNA-1273 vaccine,
shows evidence that
their concerns
about these risks are
completely rational.
Female participants must have
non-child bearing potential,
not be pregnant at the start
of the trial, and must abstain
from all activities in which
they can become pregnant,
from 28 days prior
to the first dose,
and three months following
the second dose at day 29.
Male participants engaging
in activity that could result
in pregnancy of sexual partners,
must agree to practice adequate
contraception and refrain
from sperm donation from
the time of the first dose
and through three months
after the second dose.
Given the specific
inclusion criteria,
what is the specific
mechanism of this vaccine,
and are you concerned
about it getting
into the germ line cells?
After its approval, will
this specific recommendation
regarding fertility
continue to apply
to those receiving the vaccine?
Clearly, those conducting
the studies are fully aware
of the risk it poses
to fertility
and the potential to affect DNA.
How can I instill
confidence in my patients
when we will have zero
data about the impact
of this vaccine, on fertility,
and the long-term consequences
the vaccine may have?
Real-time monitoring will
not pick up fertility
or autoimmune conditions
in VAERS.
Mortality for COVID-19 is .26
percent, for those infected,
and a small fraction
of that for children.
The HPV Vaccine had
an autoimmunity rate
of 2.3 percent, in the
pre-licensed trials.
If we translate that number
to the U.S. population,
and assume this new
vaccine has a similar rate,
that would equal nine million
new cases of autoimmunity.
Can our healthcare
system withstand that?
Can you justify recommending
a vaccine
with a potential serious
adverse event rate,
that is significantly higher
than the disease's
morbidity or mortality rates?
And how can we, as
medical providers,
possibly instill confidence in
our patient with these numbers?
Patients are paying attention.
My hope is, you are, too,
as your recommendations will
become mandates, forced on all
of us, to participate in --
>> Thank you.
Your comment time has expired.
Our next speaker is
Ms. Lindsay Clarke.
>> Good afternoon.
I'm Lindsay Clarke,
Vice-President
of Health Education and Advocacy
at the Alliance for
Aging Research.
For the past four years,
the Alliance has led the
Our Best Shot Campaign,
which encourages older adults
to play an influential role
in our families and
communities to be about myths,
and make sure they're own
vaccinations are up-to-date.
The CDC includes campaigns,
educational film on its website,
and we thank you for
featuring this resource.
We appreciate the important
work that ASHP is doing.
However, we urge you to make
some changes to better respond
to the needs of the
older adult population,
especially in the face of
the double threat of COVID-19
and influenza outbreaks
this fall.
First, while the
2020-2021 influenza season
recommendations, go into
more detail on the evidence
for enhanced influenza products.
They continue to avoid
recommending them
over standard dose flu shots
for people ages 65 and older.
This is a clear missed
opportunity,
to encourage older adults to
seek out enhanced vaccines,
to protect themselves during one
of the worst pandemics the
U.S. has ever experienced.
Yes, any flu shot is
better than no flu shot,
but older adults are going
to need all the protection
they can get this year.
Please take a stand on that.
Second, we urge you to
immediately add more experts
in geriatrics and older
adult vaccination research,
building better expertise on
the ASHP and its Working Groups,
on how to care for older
adults, including those
with additional risk
factors and those living
in congregant settings,
will be critical
to assessing potential COVID-19
vaccines in the near term,
and other promising adult
vaccines in the future.
Third, we believe that
the Committee's current
interpretation of conflict of
interests, or ASHP nominees,
is more restrictive
than intended
by the Federal Advisory
Committee Act,
and that this overly strict
interpretation may have
dissuaded or even
prevented experts
in older adult vaccinations
from ASHP participation.
We recommend that
CDC develops clear
and publicly available guidance
on COAA, like the FDA has done.
Please see our written
comments for more on this.
Lastly, we strongly urge ASHP
to immediately eliminate
economic considerations
from its charter.
We remind the Committee that
U.S. Federal Civil Right Laws,
including the ADA, the
Rehabilitation Act, and the ACA,
prohibit the use of
quality adjusted life years,
and similar cost-effectiveness
assessments,
and covers every
reimbursement decision-making
in both the Medicare
and Medicaid programs.
The reason for this is
that quality assessments assign
a discriminatory financial value
to the patients from whom are
given treatment as intended.
Under qualities of the
group is sicker, older,
and/or disabled,
their value is less.
When applied to healthcare
decision-making,
the results can mean
that some patients --
people with disabilities,
Veterans, older adults,
are deemed too expensive
to receive care.
Effectiveness should be
measured by improvements
to a patient's condition
and quality of life,
rather than personal
characteristics
for health status.
Thank you for the opportunity.
>> Thank you very much
for those comments.
The next speaker is Ms. Shoshona
Fishfine [assumed spelling],
please.
>> Thank you.
My name is Shoshona Fishfine,
and I represent Families
Fighting Flu.
Many people use personal
stories to convey
that vaccines are
harmful or dangerous.
But it's also important
to personal stories,
to demonstrate why
vaccines are crucial
to preventing a potentially
eradicating deadly
and debilitating diseases.
I use an anecdote to explain
why vaccines are necessary,
both in my personal
and professional lives.
Personally, my sister
had a cerebral seizure
after receiving the
Tdap vaccine at age 13.
It's impossible to know if the
vaccine was truly responsible
for her seizure, but thankfully,
this was an isolated event.
We rely on science, that
shows that the benefits
of vaccinating outweigh
the risks,
and this event has not
stopped my family or myself
from getting vaccinated.
I know that sharing a story like
this one allows people to begin
to see the other side
of the vaccine argument.
That's why I started for
Families Fighting Flu,
a patient advocacy organization
that highlights the stories
of people who have died or
suffered from influenza.
These stories show that
not vaccinating is not a
risk-free choice.
Forgoing an annual flu
vaccine comes with the risk
of some being hospitalized,
having lasting complications,
or even dying from flu.
Our stories include people
like Allison Miller [assumed
spelling], a 33-year-old woman
who survived a flu illness,
but was hospitalized
for three months and suffered
an amputation above the knee,
as a result of the flu.
We also share the
story of [inaudible],
who was a 10-week-old
premature baby as a result
of his mother contracting
influenza while pregnant.
He now suffers from
chronic lung disease.
We use these stories
to encourage evidence-based
practices,
like annual flu vaccination for
everyone six months and older.
Story-telling is not
just a method to be used
by opponents of vaccine.
Sharing stories of the benefits
of vaccination allows us
to help individuals understand
the seriousness of influenza
and the importance of
annual flu vaccination.
I implore you to share
stories about the benefits
of all vaccines, to both
individuals and communities,
and emphasize the risk of
not getting vaccinated.
We know that anecdotes
are emotional,
and emotions can motivate
people to protect themselves
and their loved ones against
vaccine-preventable diseases.
Thank you for your time.
>> Thank you for your comments.
Our next speaker is
Dr. Deborah Wexler.
>> Hi. My name is
Dr. Deborah Wexler.
I am the Founder and
Executive Director
of the Immunization
Action Coalition,
a 30-year-old national
non-profit organization,
and thank you for this
opportunity to speak today.
All of us are seriously
concerned
about the upcoming flu season
and how we will be able
to take care of our
nation's people
with two different
contagious diseases, influenza
and COVID-19, circulating
concurrently across our country.
Your deliberations on COVID-19
vaccines will help lead the way
to our ultimate control
of that disease.
But in the meantime,
we must remember
that we currently have
the ability to provide
and promote a critical
public health intervention,
with readily available
influenza vaccines.
This fall, we must expand our
influenza vaccination coverage
to as many people as possible,
reducing the likelihood
of hospitalizations due to flu
or, of even greater concern,
hospitalizations resulting
from dual infections,
with both influenza
and COVID-19.
Recently, IAC has learned
of several colleges
and universities that are
putting influenza prevention
into practice, by making
the policy decision
to require flu vaccination
for their students,
faculty, and staff.
And on a larger scale, two
university-wide systems,
the University of Tennessee
at its four campuses,
and the University of
California at its 10 campuses,
have implemented flu
vaccination requirements.
All of this is quite impressive,
but the flu vaccination
policy decision
that took center stage just last
week, was from Massachusetts.
For the upcoming season,
the state of Massachusetts will
require influenza vaccination,
not only at all the state's
colleges and universities,
but also for all children and
students who attend daycare,
childcare, and kindergarten
through 12th grade.
These types of decisions
are the direct result
of ACIP leadership.
Ten years ago, you made your
age-based influenza vaccination
recommendations, to vaccinate
everyone six months of age
and older, which was an
easy to understand guidance
for providers to carry out.
Thank you, ACIP, for
making these straightforward
recommendations.
And thank you to the colleges,
universities, and the state
of Massachusetts
that are following --
that are leading the way,
by thoroughly following
ACIP's guidance.
I hope many more will
follow in their footsteps.
Thank you.
>> Thank you for those comments.
Our next speaker will
be Ms. Nissa Shaffi.
>> Good afternoon.
My name is Nissa Shaffi,
and I'm here today on behalf
of the National Consumers
League.
Since the league was founded in
1899, we have educated consumers
about the vital role of vaccines
in society, and continue
to dispel myths about
vaccine safety.
Today, we extend our gratitude
to the Advisory Committee
on Immunization Practices,
for all that you do
to protect public health,
and for the opportunity
to speak here today.
NCL strongly urges
ACIP to increase
and enhance infrastructure,
regarding vaccine confidence,
as the nation navigates
the COVID-19 pandemic.
COVID-19 has spread at
an alarming velocity,
and we need to ensure that we
are utilizing our full reservoir
of preventive services,
like vaccine.
A small but vocal minority have
politicized preventive health
measures, as perceived
destructions
in personal liberty.
We need to ensure that vaccine
hesitancy does not spoil
critical public health
intervention,
especially within the
context of a pandemic.
The American public should feel
safe, informed, and empowered
in their decisions to
vaccinate, once a vaccine
for COVID-19 becomes available.
Due to COVID-19 imposed
lockdowns, routine vaccinations
across all age groups have
declined by over 30 percent,
with 2019, with the largest
decline observed among ages 19
to 49, at over 60 percent.
Medically underserved
communities and people
with underlying health
conditions are more vulnerable
to adverse outcomes, should
they developed COVID-19.
A decline in vaccination rates
will further compromise heart
immunity and endanger
public health.
Minority communities are
among the hardest hit,
during this pandemic.
Additionally, we request
that clinical trials
for the potential COVID-19
vaccine are inclusive
and consists of diverse
subjects,
the current vaccine
hesitation regarding efficacy.
The vaccine must be
safe, and effective,
and an ample outreach
must be conducted,
to ensure optimal heart
immunity and vaccine confidence
across all demographics.
In closing, to stem
the tide of deaths
from these vaccine-preventable
diseases.
NCL urges the Committee
to maintain
and encourage strong
vaccine recommendations
and infrastructure.
This recommendation
serves to ensure
that we fortify health
providers,
public health leaders,
an advocate,
with evidence-based medical
intervention, to help protect
and advance the health
of our nation,
during this pandemic and beyond.
Thank you for your
consideration of our views
on this important
public health issue.
>> Thank you very much
for your comments.
Our next speaker is Dr.
Sherry Cohen, please.
>> Yes. Thank you very much for
this opportunity to speak today.
My name is Dr. Sherry Cohen.
I'm the Senior Vice President
for the Hepatitis B Foundation,
a national, non-profit
organization dedicated
to finding a cure and improving
the quality of life for those
with Hepatitis B.
Today, we urge ACIP
to consider our recommendations
for universal adult
Hepatitis B vaccination.
Despite being one of the
world's leading causes
of primary liver cancer,
only 25 percent of adults
in the country are
fully protected
against Hepatitis B. Most
of the virus burden falls
upon Asian American,
Specific Islander, and
African immigrant communities.
When you add up the 17
separate groups recommended
for either Hepatitis B testing
or screening due to risk,
including those who
have diabetes
and fatty liver disease.
Up to 84 percent of adults
in the U.S. are at risk
and should be vaccinated.
Recent projections show that
several high risk categories,
including people living with
diabetes and those diagnosed
with sexually-transmitted
infections, are expected
to continue rising
over the next 20 years.
With such a large proportion
of adults needing or expected
to develop at least
one risk factor,
the universal Hep B vaccine
recommendation would improve the
number of adults who are
vaccinated and protected,
preventing new infections
in thousands of people.
A universal adult Hepatitis B
recommendation simplifies the
vaccine process for providers,
makes it easier for everyone
to understand who
needs to be vaccinated,
and can eliminate a major
barrier to vaccine uptakes.
Additionally, current
guidelines are primarily focused
on occupational exposure
in healthcare settings.
But increases in
self-administered treatment
and the opioid crisis,
has expanded occupational
groups who may be at risk.
Sanitation workers,
cleaning service workers,
and food service workers have
all reported being accidentally
stuck by a needle while on
the job, and the CDC estimates
that the average risk for
contracting Hepatitis B
from a needle-stick is
between six and 30 percent.
While there are national
and state protocols
for safe needle disposal,
an estimated 95 percent
of needles are still
discarded in municipal waste.
Implements -- the implementation
of the Hepatitis B vaccine
is currently limited
by many logistical barriers.
A universal adult vaccine
recommendation is one large
hurdle that we can jump,
to improve vaccine rates.
We can't eliminate Hep B if
we ignore key opportunities
to protect vulnerable
populations.
History shows that universal
vaccine recommendations help
increase vaccine rates,
and can open the doors
for state-supervised more aid.
With increased awareness
and support,
we can reduce health disparities
related to Hepatitis B
and protect our communities.
Thank you very much
for your time.
>> Thank you for those comments.
Our next speaker is Mrs. Pam
Wright [assumed spelling],
please.
>> Thank you very much.
I appreciate the opportunity.
I will focus on the dangers
of becoming fast-tracked
COVID-19 vaccines,
pointing out the
following facts:
a healthy American has less
than a .03 percent chance
of dying from COVID-19.
That is not a pandemic
and actually less
than annual influenza
season deaths.
I will quote Dr. Peter
Hotez, testifying in front
of the Health Science
Committee this March, quote,
"One of the things
we're not hearing a lot
about is the unique
potential safety problems
of Corona Virus vaccines.
This was first felt,
in the early 1960s,
with the RSV vaccines, that
some of these kids that got
that vaccine actually did worse,
and I believe there were
two deaths as a consequence
of that study," end quote.
This was actually
a human trial court
of 2,200 [inaudible]
performed in Washington,
D.C. Can we trust Moderna or
Pfizer to develop a vaccine
in only a short period of time,
that is safe and effective
on SARS [inaudible], when it
hasn't been done on the 18 years
since the first outbreak
of SARS.
On March 15, 2020, HHS Secretary
Alex Azar invoked the Public
Readiness and Emergency
Preparedness Act of 2005.
This gave complete immunity
to vaccine developers.
Fast-tracking has allowed
vaccine developers,
such as Moderna, to bypass
clinical animal trials
and go directly to
phase one human trials,
and passing a critical
safety step.
Despite hospitalizations
in phase one,
due to severe adverse
events, up to 20 percent
in the high dose group, they
are moving ahead with phase two
and three trials, and
making two billion doses.
In human trials, the
vaccine is being given
to perfectly healthy
individuals,
with exclusionary criteria of
like -- could not be pregnant,
overweight, never
smoked, no family history
of respiratory problems,
seizures,
or any autoimmune diseases.
What is going to happen
when they give this vaccine
to the average American?
We're not only going to
see 20 percent incidents
of serious adverse events,
but likely much, much higher.
And yet, with inadequate
testing,
we're going to mandate the
vaccine to be administered
to the 18 million Americans with
chronic diseases, including HIV,
AIDS, autism, and
autoimmune disease, cancer,
often immune diseases associated
with animal viruses acquired
from vaccines contaminated with
animal viruses, from birds,
dogs, cows, six live monkeys,
and aborted fetal tissue.
When recipients of
the flu vaccine
and Corona Virus vaccine
are subsequently exposed
to the Corona Virus, this is
when we will see the spike
in serious adverse events.
The flu vaccine has been
around for 90 years,
and is ineffective.
Each year, it causes far
more injury than benefit,
as evidenced by [inaudible],
which are almost exclusively
from flu vaccines in
the past several years,
including death in the elderly.
Why would the Corona Virus
vaccine be different?
[inaudible] has performed
three huge systematic reviews
on the flu vaccine
in 2010, 14, and 17,
and concludes there
is little evidence
that flu vaccine prevents
hospitalization or deaths.
Given the above, moving forward
and administering the
Corona Virus vaccines
to the general population
would constitute human
experimentation, and thus,
informed consent must be
given by all Americans.
In conclusion, these COVID-19
vaccines cannot be made
mandatory to a general
public, not healthcare workers,
military, or first responders,
we the people will not consent.
We have constitutional
and basic God-given rights
to decide what's
injected into our bodies
and those of our children.
Thank you.
>> Thank you for your comments.
Our final speaker of today
is Ms. LeAnn Ducat, please.
Is Ms. Ducat on the line?
>> Oh, I'm sorry.
Are you there?
I forgot to hit the mute.
>> That is fine.
Thank you.
Go ahead, please.
>> Thank you so much
for having me.
I'll get right to it.
Recent lawsuits have
uncovered truth that the CDC,
specifically this panel,
recommended mandated vaccines
to children that were never
placebo safety tested.
Without inert placebo testing,
no one can point to any vaccine,
even a COVID one, and say that
it is more or less dangerous
than the infection itself.
My point is, is that we're
already at warped speed,
with these children's vaccines,
and now we're going even faster
to approve a COVID one, when we
should be pumping the brakes.
Rushing products to market in
the name of the greater good
and using active
placebos instead
of inert ones, is playing God.
Dr. Fauci even told us
that hydroxychloroquine
couldn't be given
to dying COVID patients, because
of no placebo control studies.
By that logic, why on earth
would anyone recommend
that healthy people
receive a product
that has not been held
to the same standard?
Is this really about public
health, or profitability?
Because if you really
cared about public health,
why is this panel not
recommending sunshine, exercise,
organic food, vitamins,
and adequate sleep?
Because your current
recommendations have created the
sickest generation
of kids ever, ever.
You have shut down
the entire country
and caused massive
spikes in suicides,
addiction, abuse, and hardship.
Well, a day of reckoning
is coming.
The truth cannot be
suppressed forever.
Even with censorship, no matter
how much Ms. Dorret Reece calls
for it, government health
authorities are rapidly losing
credibility, due to
blatant inconsistencies,
half truth, and lies.
The false narrative about
vaccine safety is crumbling.
Even the Cross-Fit
guy sued you and won.
They said, and I agree, the
CDC prioritizes industry
partnerships over its
charter, to protect
and inform the American public.
They also said that the CDC
and the HHS have
spontaneously failed
to address the chronic disease
epidemic, and they're not alone.
These complaints span
from every racial
and socioeconomic demographic.
We want answers.
We want accountability, and
we want immediate change.
The blunders made by the CDC
surrounding vaccines in general,
and COVID-19 have recruited
more activists at warp speed,
faster than I could
have ever imagined.
So, really, I'm here
to thank you.
You're doing my job for me,
just by being yourselves,
warp speeding the
American public to justice
for the lives we
lost to big pharma.
Your charade is almost over.
There is honor in
admitting when you're wrong.
It's time to stand up
for truth, and it's time
to pick people over profits.
Thank you for your time,
and thank you for having me.
>> Thank you very much.
On behalf of the ACIP, I wish
to thank all of the speakers
for giving their time today,
and for their comments.
In closing, let me
thank the Workgroup,
members of the leagues
and members of the CDC
for all the efforts
that they put into making
this meeting successful and providing us with information.
Our next open public meeting will be September 22nd,
tentatively.
And with that,
I wish you all a Good Afternoon.
And safe travels if you're traveling.
I gavel this meeting to and end.
Thank you. [Adjourned]
