The U.S. Food and Drug Administration’s decision Tuesday to allow infants and children 6 months through age 4 to get Pfizer’s bivalent booster shot drew harsh criticism from pediatricians and others who said children don’t need any COVID-19 vaccines, let alone four doses.
Infants and children 6 months through age 4 who received the three-dose primary series of the Pfizer-BioNTech COVID-19 vaccine are now eligible for a fourth dose — Pfizer’s bivalent booster shot.
The U.S. Food and Drug Administration (FDA) on Tuesday amended the Emergency Use Authorization (EUA) of Pfizer bivalent COVID-19 booster vaccine for the younger age group, but only for those children who received the three-dose series before the FDA authorized Pfizer’s bivalent Omicron booster as the third shot in the primary series.
Under the amended authorization, children can receive their fourth shot two months after completing the three-dose primary series.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said the authorization gave parents the opportunity to “update their children’s protection.”
But critics including Peter McCullough, M.D., MPH, an internist and cardiologist, said the shots pose long-term safety concerns for children.
“I am greatly concerned about the long-term safety of accumulating novel mRNA and Wuhan spike protein in previously healthy children,” McCullough told The Defender. “Continued shots are not natural and cannot make their bodies healthier.”
Mary Holland, president and general counsel of Children’s Health Defense said:
“If one ever needed proof of which side the FDA is on, Pharma’s or the people’s, one need look no further than its authorization of a fourth COVID shot for children under 5.
“With knowledge that these shots don’t work and that they can cause severe harm, including death, this decision is simply obscene.”
Dr. Michelle Perro, a pediatrician with more than 40 years of experience in acute and integrative medicine, told The Defender, “Medical logic and reason have taken a back seat to an unfathomable policy based on fiction.”
Perro added:
“With the steady stream of information now available on VAERS [Vaccine Adverse Event Reporting System] and other global vaccine reporting systems, the harm caused to children from this unnecessary ‘vaccine’ is nothing short of pediacide.”
Perro pointed out that according to some researchers’ estimates, children under 18 are 51 times more likely to die from the mRNA vaccines than from COVID-19 if unvaccinated.
Perro, who said she will deliver a conference lecture in April on how to help children who have been harmed by the COVID-19 vaccines, said:
“The time is now for parents to do what’s best for their children and refuse this experimental technology.”
Muriel Blaive, Ph.D., tweeted:
Children under 5 don’t need this vaccine, let alone four doses of it. In the age of universal education and global information you can still manipulate a country with ease. Critical mind and access to competing information don’t seem to change a thing. 1/https://t.co/D9HfsXzRFF
— Muriel Blaive, PhD (@MurielBlaivePhD) March 15, 2023
Aaron Siri, a civil rights attorney who sued the Centers for Disease Control to release its V-Safe vaccine injury data, tweeted:
Breaking: This may be a new low, even for FDA. It just authorized new bivalent C19-V for babies/toddlers and only trial of this vaccine for those ages had “24 participants 6 months through 23 months” and “36 participants 2 years through 4 years of age.” https://t.co/FwbAd136rv
— Aaron Siri (@AaronSiriSG) March 15, 2023
New clinical trial had ‘no published results’
The agency said it based its decision to authorize the fourth shot on previous analyses of earlier Pfizer COVID-19 vaccine efficacy data and on new clinical trial data from 60 children ages 6 months through 4 who, after completing the three-dose primary vaccination and receiving the booster shot, “demonstrated an immune response” to both the original COVID-19 virus strain and the Omicron subvariants.
The new clinical trial “had no published results” but was presented to the FDA in a Jan. 26 meeting slide show, said blogger Igor Chudov.
According to Chudov’s analysis, the data included “the strangest count of participants.”
Slide 16 of the presentation showed there were 21 babies in the clinical trial before the fourth shot — and 23 babies after the shot, he pointed out.
“How is that even possible? And why did no one present at the FDA meeting ask questions?” Chudov asked.
Chudov pointed out that under the new authorization, the four-dose vaccination sequence could be completed within four months after starting at age 6 months.
“Therefore, a 10-month-old infant could have four mRNA Covid vaccine doses,” he said.
Dr. Meryl Nass, an internist and epidemiologist and member of the Children’s Health Defense scientific advisory committee, said the official data released by the U.K. and German governments suggest you are 20 times as likely to injure a child with an mRNA vaccine than to benefit them.
In a Substack post today, Nass said Dr. Scott Jensen, a family physician and former Minnesota State Senator, noted that the number of mRNA vaccine doses needed to vaccinate young children to prevent one hospitalization for severe illness is more than 224,000 doses.
Assuming the risk of injury due to the COVID-19 vaccine is similar for children to the overall risk the German health minister disclosed, you would have to vaccinate more than 112,000 5- to 11-year-old children with two shots and seriously injure 22 of them as a result, in order to prevent one COVID-19 hospitalization.
“Anyone who is cognizant of these data and recommends mRNA COVID vaccines for children is in my view guilty of professional malfeasance, a crime and needs to immediately be brought to justice,” said Nass.