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Parents to FDA: ‘Get Your Hands Off Our Children’

Summary:

  • Without strong evidence to support their decisions, the FDA has begun a campaign to use an emergency use authorization (EUA) that will subject the most vulnerable to unnecessary risks from a genetic experiment
  • The FDA has also proposed a “Future Framework” to approve all future COVID formulations without clinical trials if they are “biologically similar”; there is still time to take action against the proposal
  • The FDA amended the Pfizer EUA to allow a booster shot in children ages 5 to 11 based on a study of 400 children. The EUA they propose for children 6 months to under 5 years is based on 10 children, a number which even outspoken vaccine advocate Dr. Paul Offit finds difficult to comment on
  • Approval of the shot in children is critical to protecting the pharmaceutical industry’s financial interests. Once fully licensed, the company is liable for injuries so the shot must be added to the children’s vaccine schedule to allow the government to mandate the shot
  • Surveys show many pediatricians are willing to refuse treatment if a family refuses vaccination and state legislatures are changing the rules, so parents are not informed. Over 17,000 doctors and scientists believe healthy children should not be force vaccinated and offer this evidence to parents


By Dr Joseph Mercola

This short video is a poignant illustration of the children who have been injured or killed by the mRNA jab. Some have died, while others are living in chronic pain, with seizures, tics and an inability to walk or eat independently.

According to data from the CDC1 there were 1,086 deaths in children aged birth to 17 years from 2020 to June 2, 2022, involving COVID-19. This was 1.33% of deaths from all causes in the same age group. According to the American Academy of Pediatrics,2 the cumulative hospitalization rate in children by February 3, 2022, was 0.7% and the cumulative death rate was 0.01%.

Although any death is tragic, it’s apparent from these numbers that COVID-19 has not affected the pediatric population to any great extent. Studies3 have also shown that most healthy children either have mild symptoms or no symptoms. Symptoms in healthy children are like those of a cold or flu-like illness.

Taking this one step further, a study4 published in July 2021 by the Department of Pediatrics at Duke University School of Medicine found children who had mild or asymptomatic cases of COVID-19 also developed a robust antibody response.

The jab is not innocuous. According to an analysis by Steve Kirsch, an engineering graduate from MIT who is himself doubled vaxxed with the Moderna shot,5 as of December 12, 2021, the jab had killed nearly twice as many children as the illness.6

The FDA Has Declared War on Children

In this three-minute video Mary Holland, president and general counsel of Children’s Health Defense, makes an impassioned plea to the public and the U.S. Food and Drug Administration to stop the war against our children.7 Without strong evidence to support the attack, the FDA has begun a campaign to use emergency use authorizations (EUAs) that will subject the most vulnerable in our population to unnecessary risks from a genetic experiment.

The FDA scheduled four meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss — and potentially approve — EUAs that would cover the population from cradle to grave in COVID shots. The itinerary began June 7, 2022, and is scheduled to end June 28, 2022.

The planned discussions include adding the Novavax COVID shot for adults and amending Moderna’s EUA for the primary series in children and adolescents aged 6 through 17 and children 6 months to 5 years. The meetings also include an amendment to Pfizer’s primary series to include children 4 months to 4 years.

Toby Rogers Ph.D.,8 has a master of public policy degree. He’s called the June meetings a “blitzkrieg” designed to “create psychological shock and demoralizing chaos.”9

Children’s Health Defense10 mobilized a grassroots effort to inform the FDA and CDC officials, elected representatives and VRBPAC members that the public wants them to reject proposals from Pfizer and Moderna, and requests that government agencies follow science to protect public health. It is possible to make a difference when consumers are armed with real data and take action. The main points Children’s Health Defense makes for consumers include:11

There is no COVID emergency for children — Children younger than 18 without comorbidities have a 99.995% recovery rate and the CDC data show over 74% of all children birth to 17 years have robust natural immunity.

mRNA shots offer little protection — In 2020, regulators set a minimum standard effectiveness for EUA approval — vaccines must meet a threshold of 50% effectiveness. However, preliminary data show the jab was only 44% effective in the youngest children and 37% effective in children up to 5 years.

In addition to failing the minimum standard, the effectiveness of the vaccine against the Omicron variant dropped to 12% after seven weeks in children 5 to 11 years.

Jab injuries in children are catastrophic — The Defender points out that as of May 20, 2022, the Vaccine Adverse Event Reporting System (VAERS) recorded over 48,500 reports of adverse events in children. In 14 days, as of June 3, 2022,12 this number jumped dramatically to a total of 49,283 adverse events.

This included 114 deaths, 457 children who are permanently disabled and 8,811 who have not recovered from their vaccine injury. Vaccine injuries have included encephalitis, Bell’s palsy, new onset diabetes, aneurysms or cerebral hemorrhage and Guillain Barre or transverse myelitis resulting in paralysis.

‘Future Framework’ Doubles Down on a Failed Strategy

The final meeting is scheduled for June 28, 2022. Its focus will be a proposed “Future Framework” for COVID-19 jabs.13 According to The Defender, by June 1, 2022, over 500 million doses of the jab had been distributed and injected during a 17-month period. Unfortunately, there has been no discernible impact and far more people have died since the shots were introduced.

According to CDC data,14 at the end of 2020 there were 385,666 people whose deaths were recorded involving COVID-19. The jab was introduced in December 2020. By the end of 2021, the jab had been distributed for 12 months. People had also begun successfully treating COVID at home with a variety of protocols, including those from Dr. Vladimir Zelenko15 or the Front Line COVID-19 Critical Care Alliance.16

Despite knowing more about the virus after 12 months and successful at-home treatment protocols, 77,103 more people died in 2021 than in 2020 for a total of 462,769 deaths in 2021.17

The proposed Future Framework is a way for pharmaceutical companies to use information captured by regulatory agencies to get reformulated shots approved without undertaking new clinical trials. The Defender calls this “doubling down on a failed strategy.”18

In a slide presentation19 produced for the April 2022 VRBPAC meeting, the selection process for the influenza vaccine strain was reviewed and called successful. However, as The Defender reported,20

“Lisa Grohskopf from the CDC’s Influenza Division reports that last year the flu shot was somewhere between 8% and 14% effective (based on data from seven sites that participate in the U.S. Flu Vaccine Effectiveness Network).”

These abysmal effectiveness percentages are what the FDA and CDC call success. The presentation goes on to identify several challenges to adapting the influenza model to new COVID-19 vaccines.21 The answer to these problems appears to be the Future Framework.

Proposed changes would allow the regulatory process to approve future COVID-19 shots without clinical trials, regardless of how drastically the formulation changes. If the changes are implemented, they will only need to meet the standard of being “biologically similar.”22

The meeting is scheduled for June 28, 2022, so there is still time to tell the FDA to get their #HandsOffOurChildren by using the Children’s Health Defense action page, where you can quickly and easily send emails to the FDA, VRBPAC committee, CDC officials and elected representative.

FDA Reviewed Pfizer’s Test Results Based on 10 Children

The U.S. Food and Drug Administration amended its EUA for the Pfizer-BioNTech COVID-19 shot to allow a booster dose for children ages 5 to 11.23 The FDA’s “evaluation of safety” for the booster dose in young children was based on a study of only about 400 children, and although that number is exceedingly low, it’s far greater than the 10 children in the test for children 6 months to 5 years.24

In a press release, Pfizer announced the EUA they were seeking from the FDA for children 6 months to under 5 years is “based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022.”25

The study included 1,678 children who received three doses of the formulation. However, the 80.3% efficacy that Pfizer announced is based on just 10 cases. The number is so low that even outspoken vaccine advocate Dr. Paul Offit expressed dismay, saying:26

“I mean, 10 children — you’re talking about 10 children. It’s a small number, so it’s really hard to comment o[n] this as something more general since you don’t know because the numbers are so small.”

The trial reportedly evaluated “the safety, tolerability and immunogenicity of three doses of the Pfizer-BioNTech COVID-19 Vaccine.”27 This claim of 80.3% effectiveness in children came on the heels of data released by the New York state Department of Health study28 that showed efficacy in children ages 5 to 11 years fell to 12% in two months after vaccination.

These data are consistent with a report29 from Britain that showed effectiveness against symptomatic infection dropped 22.6% after two months in adolescents aged 16 to 17 years. In the press release, Pfizer wrote the shot was “well-tolerated among 1,678 children under 5 years of age with a safety profile similar to placebo.”30

However, according to the American Academy of Pediatrics,31 as of June 8, 2022, 36% of 5- to 11-year-olds had received at least one dose and 29% had received two doses and, according to VAERS, there were 11,773 total reports of adverse events in children 5 to 11 years through June 3, 2022.

If you extrapolate the adverse event numbers using 36% of the pediatric population that received at least one dose, there would be 32,702 adverse events reported in children aged 5 to 11 if 100% were given the shot.

It seems highly unlikely, based on the number of adverse events in children reported to VAERS after at least one injection, that shots in children aged 6 months to under 5 years would have resulted in only “mild or moderate”32 events, or that the shot could have “a safety profile similar to placebo.”

Children’s Vaccine Approval Crucial to Protect Big Pharma

It is crucial to understand what is driving the push behind getting children vaccinated when there appears to be no scientific reason to do it. In this interview with Alix Mayer, we discuss the nefarious reasons why children are being aggressively targeted. Even though VAERS33 has shown many vaccines have a questionable safety profile, data collected from 2021 and 2022 demonstrate the COVID jab presents a more serious risk than all the previous vaccines combined.

Lack of transparency has been a chronic issue within the industry, but the current challenges with the COVID shots have highlighted the issue. The jabs were released under EUA to give the pharmaceutical companies legal immunity against liability for vaccine injury.34

As Mayer points out in the interview, what you may not realize is that although the FDA appeared to approve and license BioNTech’s Comirnaty,35 the shot is still administered under the EUA.

One significant reason is that once the product is fully licensed, the company is liable for injuries.36 For a vaccine and the manufacturer to have immunity that is not administered under an EUA, it must be placed on the childhood vaccination schedule.37,38 This allows state governments to mandate the shot (the federal government only makes recommendations; states issue the mandates). Mayer notes:39

“This is the holy grail if you’re a vaccine manufacturer of a COVID vaccine right now. You want it to be fully licensed, but not put it on the market until you get it on the children’s schedule.”

Will Pediatricians Refuse Care if Parents Refuse the Jab?

Parental concerns over vaccinations are not a new issue. A study40 published in 2005 found “many” pediatricians said they would discontinue care if a family refused vaccination. Another study41,42 published in 2020 surveyed U.S. pediatricians and found 51% said they would dismiss a family if they refused vaccinations.

Medical trade associations and several states have also stepped in to pull parental rights out from under families who want to exercise informed consent on behalf of their children.

In 2020,43,44 the District of Columbia passed a allowing minors as young as 11 to consent to a federally-recommendation vaccination without their parents’ consent or knowledge. Since then,45 Alabama, Oregon, South Carolina, North Carolina and Rhode Island have passed legislation specifically for the COVID shots. The laws allow doctors to persuade children from 14 to 16 years to take the jab without telling their parents.

In May 2022, California, which already has a law permitting minors as young as 12 to get an HPV or hepatitis B vaccination without their parents’ knowledge consent, filed a bill adding the COVID shot to it.46

17,000 Doctors and Scientists Warn Parents

In his interview with podcaster Joe Rogan,47 Dr. Robert Malone gives a historical perspective on the credentials that make him uniquely qualified to understand and speak about the mRNA technology used in the current COVID-19 genetic jabs.

Rogan’s podcast is hosted exclusively on Spotify48 but you can see this particular one and read the transcript on the website of Texas Congressman Troy Nehls’, R-Texas, without downloading the Spotify app.49

Malone is the primary inventor of the mRNA gene transfer technology that underpins the jab. The very nature of the technology used to create the jab transfers genetic material from the shot into your cells, creating genetic therapy.

The information Malone shared during the three-hour interview was so damaging to the COVID narrative that Google manipulated the search results50 and just days before the interview Twitter banned Malone.51

References:

1 Centers for Disease Control and Prevention, June 6, 2022, Table 1 Total page, top line
2 American Academy of Pediatrics, Children and COVID-19: State Data Report, February 3, 2022 Page 19 and 25
3 JAMA Pediatrics, 2022;176(1) Abstract/Results/Conclusion
4 Duke University School of Medicine, July 16, 2021
5 Steven Kirsch, About
6 Steve Kirsch, December 12, 2021
7 Rumble, June 6, 2022
8 The Defender, Toby Rogers
9, 13 The Defender, June 6, 2022
10 The Defender, #HandsOffOurChildren
11 The Defender, June 6, 2022, Bold points at the bottom
12 Open VAERS, COVID Vaccine Reports in Children
14, 17 Centers for Disease Control and Prevention, June 6, 2022 Table 1 Yearly
15 Vladimir Zelenko
16 Front Line COVID-19 Critical Care Alliance
18, 20 The Defender, June 1, 2022
19 U.S. FDA, April 6, 2022
21 U.S. FDA, April 6, 2022, page 9-11
22 FDA, October 20, 2017
23 U.S. FDA May 17, 2022
24, 25, 27, 30 Pfizer, May 23, 2022
26 NPR, May 23, 2022
28 The New York Times, February 28, 2022
29 The Lancet, 2022;22(5)
31 American Academy of Pediatrics, June 8, 2022
32 Pfizer, May 23, 2022, para 6 under the bullets
33 OpenVAERS
34 CNBC, December 17, 2020
35 FDA, May 20, 2022
36 BitChute, December 22, 2021, Minute 21:50
37 History of Vaccines, Vaccine Injury Compensation Programs Subhead 3
38 Legal Information Institute
39 BitChute, December 22, 2021, Minute 22:55
40 JAMA Pediatrics, 2005; 159(10)
41 JAMA, 2020; 324 (11) Results
42 CNN Health, September 15, 2020
43 Council of the District of Columbia, B23-0171 Minor Consent for Vaccinations Amendment Act of 2019
44 National Vaccine Information Center, June 28, 2021
45 KFF, October 11, 2021
46 CBS Bay Area May 5, 2022
47 Spotify, Podcast #1757- Robert Malone MD
48 Spotify, The Joe Rogan Experience
49 Congressman Troy Nehls, January 3, 2022
50 Steve Kirsch Substack January 2, 2022
51 Twitter, January 3, 2022

 

 

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