>> Thank you, everyone.
It's now 2 p.m., and we'll now reconvene the meeting
to begin oral public comment.
I'd like to welcome and thank our public comment speakers
for addressing the committee today.
All the speakers submitted a request in advance
of the meeting, and the final list
of public commenters was determined via a lottery.
For our speakers today, we have a limited public comment period
and in order to make it through all of the listed speakers,
it's extremely important each speaker limits his, her,
or their remarks to three minutes.
We are displaying a timer on the screen,
so you'll know how much time you have left.
As a gentle reminder,
our committee appreciates diverse viewpoints
that are respectful in nature and focused
on the issues being discussed in our three-day meeting.
Thank you again to our speakers,
and we look forward to your comments.
Our first public speaker is Mr. Jack Baker.
>> Good afternoon.
I'm Jack Baker with the National Foundation
for Infectious Diseases or NFID.
As NFID commemorates its 50th anniversary during 2023,
we celebrate the remarkable impact that vaccines have had
in protecting public health and saving lives.
As a long-standing partner of CDC,
NFID appreciates the valuable work of ACIP
in guiding U.S. immunization policy to protect public health
to the ongoing review and analysis
of vaccine safety and advocacy data.
Our comments today focus on two respiratory viruses
of concern: influenza and RSV.
Now influenza or flu is not just a cold
but can cause potentially life-threatening complications,
even in healthy children and adults.
During the current flu season, estimates show
that at least 25 million people in the U.S. have become sick
with flu, 280,000 have been hospitalized,
and 17,000 have died from flu and related complications,
including more than 100 children.
Those affected are far more than just numbers,
as clearly illustrated by the dozens of personal stories
that NFID has collected
of people whose lives have been impacted
by vaccine-preventable diseases.
Data also show that flu has a disproportionate impact
on communities of color.
Black adults are more likely to be hospitalized
with flu-related complications and are less likely
to get vaccinated against flu than White and Asian adults.
In fact, during most flu seasons in the past decade,
hospitalization rates among Black adults have been
about two times higher than among White adults.
To help address these disparities, NFID is working
with partner organizations to increase awareness
of the importance of annual flu vaccination through the Show Up
and Fight Flu campaign.
Another respiratory virus of concern in the U.S., RSV,
also has a substantial impact on individuals of all ages.
Each year in the U.S.,
RSV causes an estimated 58,000 hospitalizations and 100
to 500 deaths among children younger than age five years,
as well as 177,000 hospitalizations
and 14,000 deaths in adults age 65 years and older.
In 2022, NFID issued a call to action on reducing the burden
of RSV across the lifespan
which outlined key strategic priorities to drive progress
in RSV surveillance, diagnosis, prevention, and treatment.
Like flu, RSV also has a disproportionate impact
on communities of color.
As the ACIP evaluates new interventions
to protect both infants and older adults against RSV,
swift action will be essential to ensure equitable access
through private and public payors,
including the Vaccines for Children program.
Additionally, developing clear,
consistent communications will be critical
in building public confidence and ensuring
that these potentially life-saving new tools are
available to all who need them.
NFID values its long-standing partnership with CDC,
and we look forward to continued collaboration
to raise awareness about the importance
of disease prevention through vaccination.
On behalf of NFID, thank you for your dedicated service.
>> Thank you for your comment.
Next, we have Mrs. Angie Bluford [phonetic spelling].
>> Thank you.
Good afternoon.
I'm Angie Bluford, a 49-year-old mom of two.
And at the beginning of 2021, I was in the best shape
of my life due to a recent found love of kickboxing.
On April 15th of 2021, I gladly took my second Moderna vaccine
to protect my family, friends, and return to the gym.
Since that day, I feel like I'm wearing a lead suit.
The migraines, excruciating head pressure, and bone pain keep me
from smiling as much as I used to.
The shortness of breath, fatigue, cognitive
and speech issues have forced my second leave
of absence since the vaccine.
I've been denied short-term disability,
and most likely will again, considering that no one wants
to acknowledge our injuries.
The mRNA vaccine has put me and my family in financial,
emotional, and physical strain.
It robs the injured of our families, friends,
employment, and hobbies.
Why would we, the injured, choose to make this up?
Per the CDC's website, verified again today,
the mRNA from the vaccines is broken down within a few days
after vaccination and discarded from the body.
I have a test result showing
that the spike protein was still present and wreaking havoc
in my body 603 days after my last Moderna vaccine,
and I've never had COVID.
Per Dr. David Wiseman, Moderna disclosed at September's ACIP,
that their bivalents produced non-natural spiked
heterotrimers, something acknowledged
to react 19 by FDA's Dr. Marks.
EMA papers reveal Pfizer's bivalents likely do the same.
Since this is new chemistry and new immunology,
how can you recommend tetravalent vaccines
with new, untested toxicology?
Dr. Wiseman also shared that the CDC and FDA's statement
at January's VRBPAC that an ischemic stroke signal was only
found in one database, FSD, is incorrect.
Highly significant values for the PRR safety signals
in VAERS emerge from CDC's recent FOI disclosure
and an NIH-sponsored calculator.
How can CDC hold this infor--
withhold this information
from unsuspecting seniors it is studying
without informed consent?
Last year, the German Ministry
of Health publicly acknowledged post-vac syndrome,
a disease like long COVID that occurs after COVID vaccination.
Post COVID vaccine syndrome is most certainly happening
to Americans, too.
Why is the CDC silent with these important side effects?
I implore you to remove the COVID vaccines from the schedule
of recommended vaccinations for children
until further study of adverse effects.
Please hear, acknowledge, and help us.
Thank you.
>> Thank you for your comment.
Next, we have Miss Sarah Regginstan [phonetic spelling].
>> Hello. Thank you very much to the committee
for the opportunity to speak, and I acknowledge
that I didn't have the time to be as prepared
as the, our previous speaker.
I was also injured by the COVID vaccine.
I took my third Pfizer vaccine on January 7th, 2022,
and within hours I developed burning chest pain
and called my primary care doctor.
I've never been hospitalized, but I was diagnosed
by a cardiologist with vaccine-induced pericarditis
and over 13 months later, I am still suffering from symptoms
that are preventing me from exercising normally
and having a normal quality of life.
My cardiologist has told me
that they don't know why I'm still experiencing symptoms
and that they have no more help to offer me.
My primary care doctor says the same, although I'm very lucky
that I have providers who do believe that this--
that this is a vaccine-induced injury.
I made a VAERS report.
I've applied to the Counter Measures Injury
Compensation Program.
I would be happy to submit my medical records and proof
of those filings to any members of the committee here
who would like to see them.
And I just want to point out that even vaccine injuries
that do not result
in hospitalization are extremely traumatic and lead
to a great loss of quality of life.
And there are no answers being provided for people like me.
And I would really love to see the CDC
and this committee offer some support to those
in the community like me who rolled up our sleeves
and took not one, not two, but three of these vaccines
because we were told it was for the greater good.
And we wanted to be of service to the community.
I've now spent close to $25,000 of my own money and gone
into credit card debt doing experimental treatments to try
to recover, as traditional cardiology medications have not
solved the problem for me.
So, this has been an extremely painful
and traumatic time in my life.
It's been a very, very lonely journey.
And it's disappointing to not see more, more support
from government entities like the CDC.
And my worry is that it is going to continue
to produce resistance to public health measures in the future,
as friends and family of those who are injured see
that we are getting no support and no options
for medical treatment and no acknowledgement from the CDC.
So, I really would urge you to look into these injuries
and take them seriously so that, so that the public will trust
and be part of public health measures in the future.
Thank you.
>> Thank you for your comment.
Next, we have Christina LaBette [phonetic spelling].
>> Good afternoon.
My name is Christina LaBette.
On April 21st, 2021, I freely received my second dose
of the Pfizer COVID vaccine.
Within 36 hours my nightmare began, being rushed
to the hospital experiencing stroke symptoms.
Today marks my 22-month anniversary of my injury,
and I wish for you to please listen to my story.
Prior to my injury, I traveled, did many outdoor activities.
I was the mom who volunteered at school whenever needed,
a cheer mom, a devoted wife, an active person who was free
to do what I needed without assistance.
Now, 22 months later, my life has forever changed,
struggling to live with debilitating cardiac
and neurological symptoms,
having to take multiple medications,
and needing assistance with daily basic needs.
Not only has my health deteriorated; I'm no longer able
to be the mother or the wife that I was prior
to the Pfizer injection.
I have accrued over $35,000 in traditional medical bills,
and I have no improvement.
I am begging for help to heal from these injuries.
I now suffer from over 30 new diagnoses, with conditions
such as blood-clotting issues, tachycardia, dysautonomia,
hemiplegic migraine disorder, diastolic dysfunction,
small fiber neuropathy.
These are just to name a few.
I have been suffering unimaginable symptoms.
These conditions are without question from my COVID vaccine.
My life is consumed
by appointments, testing, treatments.
I'm just trying to survive this nightmare.
It is a full-time job managing all of my health issues
from the Pfizer vaccine.
During our infertility journey in 2020,
I had extensive clotting workups prior to starting treatment.
All indicated I had no clotting genetics or factors.
And now, my labs are riddled with clotting issues
and worse yet, my husband and I can no longer pursue our dream
of having another child due to the Pfizer vaccine.
I am mostly bedridden and housebound now.
I can't garden or provide for my family
as I did previous to my injection.
I just can't up and go, as my body now dictates
if I am capable of doing anything, including driving.
I live in fear if I'm going to live or die,
as well as my child fears losing her mother, so terrified,
she is in counseling now.
I did my job getting the vaccine, so I ask you,
why aren't you doing your job to help us get better?
Why aren't you giving us a chance
to recover from these injuries?
We know you know this is happening.
Why aren't you helping us?
Here is a question for you all: what if this was your child?
Your parent?
Your loved one?
What would you be doing to help them
if they were injured by these vaccines?
Why aren't you doing that to help me?
To help us?
We are real.
We matter.
And we need your help.
The German government has even acknowledged
that these reactions as post-vax COVID syndrome,
like a long COVID-like disease after COVID vaccination.
So, I ask you again, why aren't you helping us?
>> Thank you for your comment.
I want to thank all of our public comment speakers today
for taking the time to share their comments with us.
We will now move on to the next section
of the agenda which is votes.
We have one vote on the table for monkey pox vaccine.
I'm going to ask if we can please pull
up the vote slide text, so we can review it one last time.
Thank you.
Dr. Rao, would you mind just reading the proposed wording
for the committee.
And then, I'll just ask if there's any additional questions
or issues the committee would like to discuss before the vote.
>> ACIP recommends the two-dose JYNNEOS vaccine series
for persons aged 18 years and older at risk
of Mpox during an Mpox outbreak.
And then the footnotes there.
So, for two dose, dose two is administered one month
after dose one.
And then the second footnote about an Mpox outbreak says
that public health authorities determine whether there is an
Mpox outbreak.
A single case may be considered an Mpox outbreak
at the discretion of public health authorities.
Other circumstances in which a public health response may be
indicated include on-going risk of introduction of Mpox
into a community and disease activity
in another geographic area.
>> Thank you very much.
Are there any questions or clarifications needed
from the committee members?
Okay, I don't see any hands raised,
so I'll assume the committee has no objections
to proceeding with the vote.
ACIP members, if you're able, please turn your video on.
And I will go around and ask you to state your name,
whether you have a conflict of interest, and then your vote.
Thank you, I'm going to start to my right.
Dr. Talbot.
>> Keipp Talbot.
No conflicts.
Yes.
>> Dr. Chen.
>> Wilbur Chen.
No conflicts.
Yes.
>> Dr. Loehr.
>> Jamie Loehr.
No conflicts.
Yes.
>> Ms. Bahta.
>> Lynn Bahta.
No conflicts.
Yes.
>> Dr. Daley.
>> Matt Daley.
No conflicts.
Yes.
>> Dr. Brooks.
>> Oliver Brooks.
No conflicts.
Yes.
>> Ms. McNally.
>> McNally.
No conflicts.
Yes.
>> Dr. Bell.
>> Bell. No conflicts.
Yes.
>> Dr. Sanchez.
>> Sanchez.
No conflict.
Yes.
>> Dr. Long.
>> Long. No conflict.
Yes.
>> Thank you.
Dr. Kotton.
>> Camille Kotton.
No conflicts.
Yes.
>> Dr. Cineas.
>> Sybil Cineas.
No conflicts.
Yes.
>> Dr. Poehling.
>> Poehling.
No conflict.
Yes.
>> And Lee.
No conflicts.
Yes. So, Dr. Wharton, can you give us a final count?
>> It was unanimous.
Fourteen yes.
No nos. No abstentions.
>> Thank you.
And the motion passes.
You can turn off your cameras now.
And I want to thank everybody for a robust discussion
around monkey pox and for the vote.
At this point, we are just going to take a very short break.
And we are going to reconvene early.
We'll reconvene at 30 minutes after the hour
to begin our pneumococcal vaccine session.
Thank you.