Please submit comment to FDA by 10/25 on plans to vaccinate 5 - 11 year-old children

On October 26, the FDA will hold a meeting of the public advisory committee of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss authorization of Covid shots for children aged 5 – 11. The meeting will be open to the public.

FDA has a docket for public comment on this document. The FDA Comment Period Ends This Monday, 10/25.

Please take 2 minutes to send in your written public comment before the end of Monday, even if one sentence. There are now 1.4 K comments.  Although it feels like a done deal, let’s flood them so they know there is formidable opposition. This is the least we can do. It is a simple way to exercise your freedom of expression. 

Here is the link to post comments and browse other comments:  

https://www.regulations.gov/document/FDA-2021-N-1088-0001

Please forward this request to your networks.

Risk/Benefit Analysis

This is not one size fits all. Risks and benefits vary with age. Those most likely to die from Covid are older with an average of 2.6 co-morbidities like diabetes, heart disease and obesity, with low vitamin D levels and deprived of effective early treatments. Compared with children, older people with health problems have a high risk from Covid and a lower risk from the “vaccines.”

Children have statistically no risk from Covid and a higher risk from the DNA and mRNA shots. Children from 0 - 19 years of age have a 99.9973% survival rate from Covid. The very few who died had serious illnesses. Children do have increased risk of adverse reactions to the Covid “vaccines,” including blood clots, myocarditis, seizures, paralysis, neurological problems, and death. Long term consequences, including potential infertility (spike proteins lodge in highest concentrations in the ovaries, testes, spleen, brain) will not be known for decades.

Most children who get Covid have no or very mild symptoms. Their innate immune systems are well equipped to handle the virus. They acquire enduring natural immunity, robust against variants and then provide herd immunity.

For example, the expected incidence of myocarditis in 12 - 17 year-old males is 0 - 4. 128 cases were observed within 7 days following the second dose of mRNA. (https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.056135)

For more information see:

This Is Politics, Not Science’: White House, CDC Prepare to Vaccinate 5- to 11-Year-Olds Prior to FDA Authorization

The Race Is on to Get Experimental COVID Shots Into Little Kids — Why?

White House Details Plan To "Quickly" Vaccinate 28 Million Children Age 5-11

Here is a sample comment you can copy or change. More samples below.

"I strongly oppose giving mRNA and DNA shots to children, 5 - 11 who have no risk from Covid and high risks of adverse reactions including injuries like blood clots, heart problems, neurological, seizures, paralysis, infertility and death. Please do not approve of these shots for children. 

You can browse comments from people on the site

https://www.regulations.gov/document/FDA-2021-N-1088-0001

Here are a few examples.

PUBLIC SUBMISSION

Comment from JOHNSON MARCIA

Posted by the Food and Drug Administration on Oct 21, 2021 

I AM HORRIFIED WATCHING THE EXTREME PUSH FOR CHILD VACCINES. NONE OF THESE "VACCINES" HAVE BEEN TESTED FOR ANY AGE. PLEASE BE HUMAN,PLEASE DO NOT PERMIT THE EXPERIMENTAL TESTING ON OUR CHILDRENPUBLIC SUBMISSION

PUBLIC SUBMISSION

Comment from Danice Hertz MD

Posted by the Food and Drug Administration on Oct 15, 2021

FDA meeting 10/26/21 to approve COVID vaccine for children

I am a physician who had a severe reaction to the Pfizer Covid vaccine starting 30 minutes after I received my first dose. I developed agonizing burning pain and numbness in my face, scalp, tongue, eyes, limbs as well as tinnitus, blurred vision, tremors, twitching, dizziness and imbalance, trouble speaking and thinking, internal vibrations, severe weakness, a very tight constricting band around my chest, chest pains and shortness of breath. I thought I was dying. I have spent the last 10 months trying to survive this unbearable illness, trying to get medical care that doesn’t exist because the medical community knows nothing about these reactions and trying to plead with the FDA, CDC, NIH and Pfizer to acknowledge these reactions, educate the medical community and research what has happened to us and how to treat us. I am part of a group of many thousands who have had similar neurological reactions. We are being completely ignored despite our efforts. We desperately need help.
In addition to these devastating neurological reactions, there are other life threatening reactions to the covid vaccines that involve the heart, kidneys, liver, blood clotting system etc.. There are serious gynecological reactions. We do not yet know the long term health implications that these vaccines may cause.
Now, can you imagine this vaccine reaction happening to a child who will suffer excruciating symptoms and perhaps not survive. This child will have trouble communicating his/her symptoms, trouble coping with the pain, trouble adjusting to the profound changes in his/her life. There will no doubt be serious impact on his/her future life. This is an unimaginable thought. It will happen to many children. Statistically, children have a greater chance of having a severe Covid vaccine reaction than having a severe case of Covid.
Please hear me. One child who is profoundly injured or dies from a Covid vaccine is one child too many. Please hear my words. I know first hand what a devastating impact these vaccines can have on a person’s life.

PUBLIC SUBMISSION

Comment from Fred V. Cook

Posted by the Food and Drug Administration on Oct 24, 2021 

Dear FDA,
I will be very surprised and pleased if you do in fact base your decision on logical reasoning, sound scientific evidence, and the precautionary principle.

The Biden administration is pushing to begin vaccinating children before the FDA-approved version of the Comirnaty vaccine is expected to be available.  Hence, giving approval to vaccinate 5 to 11 year old children is opening the door to an extension of the uncontrolled experiment being carried out on the American public.

Manufacturers and the delivery chain have been indemnified. So far, the Countermeasures Injury Compensation Program has proven extremely difficult for vaccine-injured persons to use.  The costs of vaccine injuries from EUA injections will fall predominantly on the families of the injured. The manufacturers tests have not been completed and, at this point, have been compromised by the injection of mRNA materials into what WAS the control group.  The collection of data to evaluate the safety and effectiveness of the COVID-19 vaccines being used under EUA is not, so far as I can tell, being monitored in any systematic and responsible way.  

There are three problems of which I am aware at this time.

The reports of vaccine injury come in through a VOLUNTARY reporting system which a Harvard study suggests may capture 1/10 of the actual results  Health care workers have reported a number of instances in which they have received institutional pressure NOT to report vaccine injuries, and even deaths.

The CDC has determined that they want to capture only those cases of post-vaccination COVID infection that result in hospitalization.  This will predictably result in a substantial undercount of the number of breakthrough infections.

The effectiveness of the RT-PCR tests has been legitimately called into question for (a) failing to distinguish between seasonal flu and CoViD-19, and (b) inconsistency of reporting based on variations in the number of amplification cycles used to achieve a "positive" result.  Furthermore, it has been alleged and not disproven that the criteria for determining that a post-vaccination patient is "positive" were set to 25 to 28 cycles, whereas the criterion for deciding that a non-vaccinated person was "positive" could go up to 35, 40, and even 45 amplification cycles. This leads to comparing apples to oranges and "data" that is so corrupted as to be not just misleading but fraudulent.

The adverse events from exposure to the mRNA injection and the resulting COVID-19 spike proteins range from immediate to effects that don't show for longer periods.  One of the worrisome effects that we seem to be seeing - and systematic data gathering has not addressed - is the frequency of “antibody-dependent enhancement,”.The occurence of Multisystem Inflammatory Syndrome (MIS) may indicate Antibody Dependent Enhancement.  There seem to be cases of  myocarditis and pericarditis, as well as neuro-degenerative disease in young people (16 to 30 years old) following mRNA injections. The FDA's own advice says, "Information is not yet available about potential long-term sequelae."  

Are there any systematic studies of the frequency and severity of these problems?  Having concluded some adequately powered and well-controlled medium term (3 to 5 years) studies of these kinds of vaccine injuries would be prudent BEFORE subjecting children 5 to 11 to the injections.  Remember the Hippocratic Oath, please.

I strongly oppose giving mRNA and DNA shots to children, 5 - 11 who have a vanishingly small risk from Covid-19 and high risks of adverse reactions, deaths injuries like blood clots, heart problems, neurological, seizures, paralysis, infertility. 

The protection of people who are at high risk of serious illness and death from COVID-19 can be managed in other, much safer ways, including isolation, prophylaxis, and early outpatient treatment.
Please do not approve of these shots for children.

Thank you,
Fred V. Cook

PUBLIC SUBMISSION

Comment from Angela Griffiths

Posted by the Food and Drug Administration on Oct 15, 2021

To Whom It May Concern:

Please accept this as a comment AGAINST the 5-11 year old EUA and I pray you hear my heart. Please do NOT use our children as an experiment. We will not even have final data on the impacts of these COVID vaccines on adults until late 2022 (end of current stage 3 trial). Many Nordic countries have paused the vaccines for their children because they saw early warning signs. Thus far, the US had ignored several critical warning signs: 
•All three available vaccines in the U.S. have killed more people than they have saved have for all age ranges (https://www.skirsch.com/covid/VCage.pdf).
•Based on the research of Steve Kirsch and team, it appears that these vaccines have killed more than 150,000 Americans thus far.
•Original research offered towards current COVID EUAs stated that the spike protein (S1) would remain localized in the shoulder. Researchers in the US have found S1 proteins in circulation beyond the injection site (https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab465/6279075). German postmortem study of a deceased individual showed that the spike proteins migrated to all organs examined (oropharynx, olfactory mucosa, trachea, lungs, heart, kidney and cerebrum) except for the liver and olfactory bulb (https://pubmed.ncbi.nlm.nih.gov/33872783/).

Data on pediatric COVID-19 cases in children show, for the vast majority, infection is asymptomatic or mildly symptomatic, and is self-limiting. Of the very few children who develop more severe illness requiring hospital attendance, the majority have had underlying health conditions.

Of the 73 million children in the U.S., fewer than 700 have died of COVID-19 during the course of the pandemic, according to the Centers for Disease Control and Prevention. Comparatively, about 50,000 children under 14 have died of all causes since the start of the pandemic, according to the CDC. 

Children who have recovered from COIVD-19 should NOT be mandated to get a vaccine. Recent evidence indicates that mRNA vaccines may induce more severe adverse events in those with known previous COVID-19 infections.

The therapies offered and approved under EUA as vaccines for COVID do not meet the threshold of a vaccine (prevent contraction and spread of a particular pathogen), induce immunogenicity but not sterile immunity, and they do not offer sufficient benefit to warrant a mandate.

Children, in particular, seem to be impacted by very serious health effects from the COVID-19 vaccines, such as life-threatening myocarditis. 

I believe, at this time, the risk to children outweighs any benefit. The current, available evidence clearly shows that the risk versus benefit calculation does NOT support administering rushed and experimental COVID-19 vaccines to children, who have virtually no risk from COVID-19, yet face known and unknown risks from the vaccines. 

Please HALT the experiments on our children and prevent generations of suffering. Please vote NO on the EUA for 5-11 year olds and wait for further adult data.