From LifeSiteNews

By Ray L. Flores II, Esq. and Suzanne Burdick Ph.D., The Defender

“This is an insult to people’s intelligence,” she said, “I pray that parents will have the good sense to say no to these dangerous and unnecessary shots for babies.”

Nine-month-old babies must receive multiple doses of an unlicensed mRNA COVID-19 vaccine to be considered “up to date” with their COVID-19 vaccination, according to the Centers for Disease Control and Prevention (CDC).

The CDC’s updated guidance, issued August 30, states that children – as young as 6 months old – should get either two doses of the 2024-2025 Moderna vaccine or three doses of the 2024-2025 Pfizer-BioNTech vaccine.

If getting the new Pfizer shot, the baby is supposed to receive the first dose at 6 months, the second dose three weeks later and the third dose at least eight weeks after the second dose – meaning, that by 9 months old, babies are supposed to have received three Pfizer shots.

If getting the latest Moderna shot, the CDC recommends babies get the first dose at age 6 months and the second dose a month later.

The latest Pfizer and Moderna COVID-19 shots for children under 12 are unlicensed in the U.S. The U.S. Food and Drug Administration (FDA) has granted only emergency use authorization (EUA) for the vaccines.

Children’s Health Defense (CHD) CEO Mary Holland told The Defender, “The earlier COVID shots have been proven unsafe and ineffective. Now we’re asked to believe that newer versions are miraculously safe and effective?”

“This is an insult to people’s intelligence,” she said, “I pray that parents will have the good sense to say no to these dangerous and unnecessary shots for babies.”

As of July 28, 37,814 deaths following COVID-19 vaccination had been reported to VAERS, the Vaccine Adverse Event Reporting System, run by the FDA and CDC.

Of those, 187 reports were for children and teens under 18. Nearly 13,000 reports listed the age as “unknown.”

VAERS analyst and expert Albert Benavides recently told The Defender he believes VAERS is “throttling” and underreporting deaths of all ages following COVID-19 vaccination.

Meanwhile, the CDC continues to tell the public that COVID-19 vaccines are “safe and effective.”

CDC ‘absolutely misleading’ public on safety of EUA vaccines

Holland said the CDC is “absolutely misleading” the public by asserting that COVID-19 EUA vaccines are safe and effective because EUA vaccines are not held to the same safety or efficacy standards as licensed vaccines.

“By law,” she explained, “EUA products ‘may be effective,’ and they have not undergone the safety testing required to permit licensing.”

“This is one more horrific example of the CDC putting profits before people and acting as an unethical arm of Big Pharma’s marketing operation,” Holland added.

CHD Chief Scientific Officer Brian Hooker agreed. “It is criminal that these untested vaccines are being recommended to infants and children, especially given the fraudulent tactics to market them to an unsuspecting public,” Hooker told The Defender.

There’s no licensed COVID vaccine for kids under 12

There are still no licensed COVID-19 vaccines available for children under 12, Hooker said – so all COVID-19 vaccines given to young kids are EUA products.

The FDA’s website on EUA for medical products states that EUA vaccines only have to meet the standard of “may be effective” as long as if, “based on the totality of the scientific evidence, it is reasonable to believe that the product may be effective for the specified use.”

“The ‘may be effective’ standard for EUAs provides for a lower level of evidence than the ‘effectiveness’ standard that FDA uses for product approvals,” the website states.

Before a vaccine can be fully licensed, the vaccine maker typically is required to conduct numerous clinical trials to demonstrate that the product is safe. However, the safety requirements for EUA are more flexible.

According to the FDA:

The amount and type(s) of safety information that FDA recommends be submitted as part of a request for an EUA will differ depending upon a number of factors, including whether the product is approved for another indication and, in the case of an unapproved product, the product’s stage of development.

Despite this, the first statement on the CDC’s “6 Things to Know about COVID-19 Vaccination for Children” says, “COVID-19 vaccination for children is safe.”

Risks outweigh benefits for kids

Hooker said the CDC’s actions are especially problematic as, historically, the meaning of “safe” has been interpreted by regulatory authorities as meaning that the benefits of a drug outweigh its risks.

“With the risk to children of dying from a COVID-19 infection being statistically zero, it is unclear if there is any benefit,” he said.

Meanwhile, the CDC still claims that “while adverse reactions are rare, the benefits of COVID-19 vaccination outweigh the known risks of COVID-19 and possible severe complications.”

Pfizer fact sheet more forthcoming about risks

For licensed vaccines, the CDC typically provides an official vaccine information statement (VIS) that describes the vaccine’s risks and potential benefits.

According to the CDC website, “Federal law requires that healthcare staff provide a VIS to a patient, parent, or legal representative before each dose of certain vaccines.”

However, for EUA COVID-19 vaccines, the CDC directs people to “fact sheets” – produced by the vaccine manufacturer, not the CDC, and authorized by the FDA – which detail the product’s risks and benefits.

There is no federal law requiring healthcare providers to share these fact sheets with patients, or parents of minors, before a COVID-19 vaccination.

“Pfizer’s own ‘fact sheet’ for its latest COVID-19 vaccine appears to give a more accurate picture [of the vaccine’s risks] than the CDC’s own websites,” Hooker said. “Shouldn’t the CDC be more a watchdog than Pfizer?”

For example, Pfizer’s fact sheet states, “A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product.”

The Pfizer fact sheet also acknowledges that its vaccine “may not protect everyone” and that reported side effects associated with the Pfizer vaccines include myocarditis and pericarditis.

Hooker pointed out that research has shown that vaccine-induced myocarditis, inflammation of the heart, and pericarditis, inflammation of the tissue surrounding the heart, can be fatal.

He urged parents to “read between the lines” when assessing the CDC’s COVID-19 vaccination recommendation for babies and children.

“Most of all,” he added, “use common sense to decide if the CDC’s and the FDA’s logic is sound.”

This article was originally published by The Defender – Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

From LifeSiteNews

By Calvin Freiburger

Two Republicans and two Democrats in the House of Representatives have leveled stunning allegations against two pharmaceutical companies, calling on the U.S. Food and Drug Administration to investigate potential testing of drugs on prisoners of Communist China.

A bipartisan group of Congress members has leveled stunning allegations against pharmaceutical companies Pfizer and Eli Lilly, calling on the U.S. Food & Drug Administration (FDA) to investigate the potential testing of new drugs on prisoners of Communist China.

The letter was sent August 19 to FDA Commissioner Dr. Robert Calf and signed by Select Committee on the Chinese Communist Party (CCP) Chair Rep. John Moolenaar, a Republican from Florida and ranking member and Illinois Democratic Rep. Raja Krishnamoorthi, Health Energy & Commerce Subcommittee ranking member and California Democratic Rep. Anna Eshoo, and Florida Republican Rep. Neal Dunn.

“For over a decade, it appears that U.S. biopharmaceutical companies conducted clinical trials with China’s military organizations, and specifically with medical centers and hospitals affiliated with the People’s Liberation Army’s (PLA), to determine the safety and effectiveness of new drug candidates prior to approval,” the letter reads. “ … we are also concerned that U.S. biopharmaceutical companies have conducted clinical trials with hospital infrastructure located in the Xinjiang Uyghur Autonomous Region (XUAR), where the Chinese Communist Party (CCP) is engaged in genocide of the Uyghur population.”

The lawmakers’ review of publicly available data found that over the last decade major American Pharma companies have conducted “hundreds of clinical trials in China that included at least one entity with PLA in the name as a research trial partner.”

“Even today, one major U.S. biopharmaceutical entity is actively recruiting patients for an advanced Alzheimer drug trial and is partnered with the PLA’s General Hospital and Medical School … and the PLA’s Air Force Medical University. … Previously, another U.S. biopharmaceutical entity used the 307 Hospital of the PLA (307 医院) as the setting for a cancer therapeutic clinical trial.”

Such work not only carries risks of sensitive technology falling into the CCP’s hands, “there are also U.S. biopharmaceutical trials listed on clinicaltrials.gov that were conducted with hospitals located in the XUAR, where credible investigative reports have shown that ethnic minorities in the region are repeatedly forced by the CCP to surrender their body autonomy. As we know, there is simply no ability for firms to conduct due diligence to ensure that clinical trials done in XUAR are voluntary.”

Axios noted that the trials in question concern Pfizer’s kidney cancer drug axitinib (brand name Inlyta), and Eli Lilly’s Alzheimer’s drug donanemab (brand name Kisunla).

The lawmakers asked the FDA to answer several questions related to its knowledge and oversight of such trials and called on the agency to “take on a greater role in protecting U.S. national security interests. With this data, it is clear that the FDA should play a greater role in analyzing U.S. biopharma entities (sic) clinical trial operations in the PRC.”

Pfizer responded that it “is committed to conducting business in an ethical and responsible manner. This includes respecting internationally recognized human rights throughout our operations,” Straight News reported. Eli Lilly claimed that it is “committed to IP protections, and we conduct robust assessments of our partners to ensure they meet Lilly standards for research and data privacy. Further, we oversee their activities when conducting clinical trials to ensure quality and data integrity.”

The allegations come amid a strained public reputation for Big Pharma given its role in the COVID-19 pandemic response.

A large body of evidence has found that mass restrictions on personal and economic activity undertaken in 2020 and part of 2021 caused far more harm than good in terms of personal freedom and economics as well as public health, particularly through the controversial COVID vaccines rushed through development by Pfizer, Moderna, Johnson & Johnson, and the Trump administration.

Yet, so far Big Pharma has largely escaped accountability thanks to the federal Public Readiness and Emergency Preparedness (PREP) Act of 2005. According to the Congressional Research Service (CRS), the PREP Act empowers the federal government to “limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines.” Near the beginning of the 2020 COVID-19 outbreak, the Trump administration invoked the Act in declaring the virus a “public health emergency.”

Under this “sweeping” immunity, CRS explained, the federal government, state governments, “manufacturers and distributors of covered countermeasures,” and licensed or otherwise-authorized health professionals distributing those countermeasures are shielded from “all claims of loss” stemming from those countermeasures, with the exception of “death or serious physical injury” brought about through “willful misconduct,” a standard that, among other hurdles, requires the offender to have acted “intentionally to achieve a wrongful purpose.”

A handful of states are currently making efforts to hold Pharma companies accountable despite this hurdle, such as Florida’s ongoing grand jury investigation into the vaccines’ manufacturers, and a Kansas lawsuit accusing Pfizer of misrepresentation for calling the shots “safe and effective.”