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July 28, 2021 (Children’s Health Defense) – Pfizer and Moderna will increase the number of children in their COVID vaccine clinical trials prior to seeking Emergency Use Authorization (EUA), after the U.S. Food and Drug Administration (FDA) told the vaccine makers the size and scope of their pediatric studies, as initially envisioned, were inadequate to detect rare side effects.
The rare side effects cited by the FDA include myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart, multiple people familiar with the trials told The New York Times.
Moderna’s shot is authorized for emergency use in people 18 and up, and Pfizer’s vaccine is authorized for children as young as 12. No COVID vaccines have yet received EUA approval for children younger than 12.
Expanding the pediatric trials means thousands more children as young as 6 months old may soon be recruited and enrolled in COVID vaccine trials.
According to the Times, the FDA asked the companies to include 3,000 children in the 5- to 11-year-old group, the group for whom results were expected first.
One person, granted anonymity by the Times to speak freely, described that figure as double the original number of study participants.
Moderna researchers had intended to test the vaccine in about 7,000 children, with some as young as 6 months, according to ABC News, but the company told the news outlet today in an email they never decided on how many kids would be added to the trial.
Pfizer began testing its vaccine in children ages 5 to 11 on June 8, with those younger than 5 being included as of June 21. The study will involve up to 4,500 subjects from the U.S., Finland, Poland and Spain, according to the Wall Street Journal, which also reported the company declined to say whether the recent request from the FDA will change the timing of any authorization submissions.
Last month, Pfizer and Moderna said their vaccines for children 5 through 11 could be ready as early as September. Pfizer, which is on a faster timetable than Moderna, may be able to meet the FDA’s expectations on a bigger trial size and still file a request for expanded EUA by the end of September, the Times reported.
A federal official, who spoke to the Washington Post on the condition of anonymity because they were not authorized to speak publicly, predicted authorization of a COVID vaccine for children 5 through 11 might come by late October or early November.
The government is not expecting it will be a big problem to enroll more children because so many parents are eager to get their children vaccinated, the official said.
Heart inflammation in teens raises red flag
Moderna spokesman Ray Jordan told the Post the goal is “to enroll a larger safety database which increases the likelihood of detecting rarer events.”
According The Washington Post:
“The FDA wants to be particularly careful about the possibility of children developing myocarditis, or heart inflammation, after receiving a coronavirus vaccine. Adolescents who receive the vaccines are more likely to develop myocarditis than adults — though the risk remains small — and officials want to increase the chances that the trials will indicate whether there is increased incidence of heart inflammation in children.”
The Centers for Disease Control and Prevention in June acknowledged 1,200 cases of heart inflammation in 16- to 24-year-olds, and said mRNA COVID vaccines should carry a warning statement. The FDA followed by adding the warning.
According to the latest data available, the CDC’s Vaccine Adverse Event Reporting System has received 383 reports of myocarditis and pericarditis in vaccine recipients between the ages of 12 and 17 years old, with 379 cases attributed to Pfizer’s vaccine.
For all age groups during the same period, 1,848 cases of myocarditis and pericarditis were reported to VAERS, with 1,176 cases attributed to Pfizer, 606 cases to Moderna and 62 cases to J&J’s COVID vaccine.
The data reflects reports received between Dec. 14, 2020 and July 16, 2021. The FDA first authorized Pfizer’s vaccine for 12- to 15-year-olds in May of this year.
In 2019, LifePetitions launched a similar petition on behalf of Jeff Younger (the father) and his son James, asking for support and for the Texas state authorities to intervene in a unbelievable case in which the Dallas courts keep flip-flopping over which parent has parental rights and, ultimately, whether or not James must be forced to live as a girl and suffer the trauma of so-called gender "transitioning," as his mom believes he is a girl.
Incredibly, we now seem to be back at square one.
Jeff Younger currently has a gag order put on him, which prohibits him to speak out in defense of his son. But, because he has recently decided to ignore that order, to save his son from irreversible surgery, this brave Dad now faces possible arrest.
Please SIGN and SHARE this urgent petition which does two things: 1) Supports Jeff Younger (again, the Dad) in his fight to save his son, James, from so-called gender "transitioning;" and, 2) Calls on Texas' Attorney General to intervene in this case and quash the gag order against Mr. Younger.
CLICK HERE to WATCH the latest LifeSite interview with Jeff Younger. Hear about the latest developments with his son, as well as the real dangers of gender reassignment surgery and other “transititioning” methods.
Currently, even though he shares 50/50 parental rights to James, which has allowed him to stop the chemical castration of his son, Jeff’s ex-wife recently sued to have full parental rights and to "give her sole medical and psychological decision making."
Jeff is also being threatened with jail time from the gag order, which he believes was intentionally done to stop him from helping pass legislation in Texas to ban sex-change surgeries for minors.
Jeff says that the gag order "prohibits me from speaking on all manner of political topics. And I’m not even allowed to tell you in that gag order whether my son’s a boy or girl."
But Jeff is speaking out, no matter what, because of the real danger that his son is in if he undergoes "transition" surgery.
Indeed, so-called gender "transitions" present many unsafe effects, some desired, some undesired, though all dangerous for one's physical and mental health.
Puberty-blocking drugs and cross-sex hormones have not been proven safe. For example, the FDA has NOT approved Lupron and GnRH analogues for use in blocking puberty.
Risks associated with these pharmaceuticals include: low bone density, high blood pressure, weight gain, abnormal glucose tolerance, breast cancer, liver disease, thrombosis, and cardiovascular disease.
And, additional risks and potential harms include:
For Males: Stunting of penile and testicular growth, sexual dysfunction, prevention of spermatogenesis, and disruption of normal brain and bone development.
For Females: A menopause-like state, blockade of normal breast development, decreased blood flow to vagina and vulva, sexual dysfunction, thinning of vaginal epithelium, vaginal atrophy, prevention of menses/ovulation, and disruption of normal brain and bone development.
In other words, these medications can sterilize and cause medical harm to vulnerable, confused children.
And, the stunning part about this: studies show that 85% of gender confused children eventually become comfortable with the sex of their bodies.
Please SIGN and SHARE this urgent petition which supports Jeff Younger, a Texas Dad, who is fighting to prevent his son, James, from being "turned into a girl." At the same time, we appeal to Texas State Attorney General, to intervene in this case and quash the gag order against Jeff.
FOR MORE INFORMATION:
'Save James: Father risks arrest to save 9-year-old son from forced gender-transition': https://www.lifesitenews.com/blogs/save-james-father-risks-arrest-to-save-9-year-old-son-from-forced-gender-transition
FOR MORE INFORMATION ON THE DANGERS OF PUSHING GENDER IDEOLOGY ON CHILDREN:
Many eminent psychiatrists are now speaking against the faulty notion that sex is fluid and a matter of choice. In particular, they are concerned about the welfare of children and young people in this regard.
Dr Paul McHugh, former psychiatrist-in-chief at Johns Hopkins University, who has researched the occurrence of gender dysphoria for 40 years, has stated that the notion of gender fluidity "is doing much damage to families, adolescents, and children and should be confronted as an opinion without biological foundation wherever it emerges". [See more below.]
And, the American College of Pediatricians (ACP) is definite about the promotion of transgenderism as being harmful public policy:
"Human sexuality is an objective biological binary trait: 'XY' and 'XX' are genetic markers of health – not genetic markers of a disorder. The norm for human design is to be conceived, either male or female…Conditioning children into believing that a lifetime of chemical and surgical impersonation of the opposite sex is normal and healthful is child abuse. Endorsing gender discordance as normal via public education and legal policies will confuse children and parents…” [Read more below.]
Here is what Dr Paul McHugh said on this topic: https://www.cnsnews.com/blog/michael-w-chapman/johns-hopkins-psychiatrist-transgendered-men-dont-become-women-they-become
This is the ACP statement on Gender Ideology: http://www.acpeds.org/the-college-speaks/position-statements/gender-ideology-harms-children
About the medical risks associated with medical interventions to attempt to change the sex of the body: https://www.thepublicdiscourse.com/2020/01/59422/
About some of the unconscionable practices some medical professionals are engaged in:
Despite the known cases and the FDA warning, the CDC said the benefits of the vaccine outweigh the risk.
Doctors weigh in on ill-advised rush to vaccinate kids
The authors of an op-ed published earlier this month in The BMJ argued that even if one assumes the vaccine provides protection against severe COVID, given its “very low incidence in children,” an extremely high number would need to be vaccinated in order to prevent one severe case.
Meanwhile, a large number of children with very low risk for severe disease would be exposed to vaccine risks, known and unknown, they said.
“In the clinical trial underlying the authorization of Pfizer-BioNTech’s mRNA vaccine in children aged 12 to 15, of the close to 1000 children who received placebo, 16 tested positive for COVID-19, compared to none in the fully vaccinated group.
“Given this low incidence, the fact that COVID-19 is generally asymptomatic or mild in children, and the high rate of adverse events in those vaccinated (e.g. in Pfizer’s trial of 12-15 year olds, 3 in 4 kids had fatigue and headaches, around half had chills and muscle pain, and around 1 in 4 to 5 had a fever and joint pain), a comparison of quality-adjusted life-years in the trial would very much favor the placebo group.”
Doctors for COVID Ethics, an EU-based international alliance of hundreds of concerned doctors and scientists, said COVID vaccines are not only “unnecessary and ineffective,” but also “dangerous for children and adolescents.”
Three of the group’s founding signatories — Dr. Michael Palmer (Canada), Dr. Sucharit Bhakdi, (Germany) and Stefan Hockertz, Ph.D. (Germany) — assembled in one document powerful expert evidence that highlights the Pfizer vaccine’s “catastrophically bad” safety profile in both adults and adolescents.
In an open letter to the EU’s Medicines and Healthcare Products Regulatory Agency, more than 40 doctors, medics and scientists in the U.K. said children are more vulnerable to the potential long-term effects of COVID vaccines.
In an open letter to the Medicines and Healthcare Products Regulatory Agency, more than 40 doctors, medics and scientists in the UK say children are more vulnerable to the potential long-term effects of COVID vaccines. #TheDefender https://t.co/kkgIp6jFsv
— Robert F. Kennedy Jr (@RobertKennedyJr) June 1, 2021
Vaccinating kids for COVID is “irresponsible, unethical and unnecessary,” they said.
The letter warned against vaccinating people under 18 because evidence shows the virus poses almost no risk to healthy children. The risk of death from COVID in healthy children is 1 in 1.25 million, the authors wrote.
COVID vaccines, however, are linked to strokes due to cerebral venous thromboses in people under 40 — a finding that “led to the suspension of the Oxford-AstraZeneca children’s trial,” the authors said.
The doctors wrote:
“Children have a lifetime ahead of them, and their immunological and neurological systems are still in development, making them potentially more vulnerable to adverse effects than adults.”
According to the latest available data for 12- to 17-year-olds, between Dec. 14, 2020 and July 16, 2021, VAERS received a total of 14,494 reports of adverse events related to COVID vaccines, including 871 rated as serious and 17 deaths.
© July 27, 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.