WASHINGTON, D.C. (LifeSiteNews) — The U.S. Food & Drug Administration (FDA) is approving booster doses of Pfizer’s COVID-19 shot for children as young as six months based on a trial of just 24 patients.
The FDA announced March 14 that it is amending its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, Bivalent, to allow a single booster dose for children between six months and four years, at least two months after being initially vaccinated.
“Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine,” claimed Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Buried in the press release, however, was the revelation that “among individuals 6 months of age and older, safety was assessed in participants in two clinical studies,” and that for the 6-23 months age group there were only 24 participants. The 2-4 year age group had 36.
For the first group, “most common side effects included irritability, drowsiness, injection site redness, pain and swelling, decreased appetite, fatigue, and fever,” according to the agency. For the second group, effects included “fatigue, injection site pain, redness and swelling, diarrhea, vomiting, headache, joint pain, and chills.”
Medical freedom attorney and COVID vaccine critic Aaron Siri called it a “new low” for the FDA to make its decision based on such limited data.
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
Many Americans continue to harbor safety concerns about the COVID shots, which were developed and released in a fraction of the time vaccines usually take under former President Donald Trump’s Operation Warp Speed initiative. The federal Vaccine Adverse Events Reporting system (VAERS) reports 34,653 deaths, 193,913 hospitalizations, 18,766 heart attacks, and 26,584 myocarditis and pericarditis cases as of March 3. An April 2022 study out of Israel indicates that COVID infection itself cannot fully account for the myocarditis numbers, despite common insistence to the contrary.
Jab defenders are quick to stress that reports submitted to VAERS are unconfirmed, as anyone can submit one, but U.S. Centers for Disease Control & Prevention (CDC) researchers have recognized a “high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination,” leading to the conclusion that “under-reporting is more likely” than over-reporting.
Further, VAERS is not the only data source containing red flags. Data from the U.S. Pentagon’s Defense Medical Epidemiology Database (DMED) shows that 2021 saw drastic spikes in a variety of diagnoses for serious medical issues over the previous five-year average, including hypertension (2,181%), neurological disorders (1,048%), multiple sclerosis (680%), Guillain-Barre syndrome (551%), breast cancer, (487%), female infertility (472%), pulmonary embolism (468%), migraines (452%), ovarian dysfunction (437%), testicular cancer (369%), and tachycardia (302%).
Last September, the Japanese Society for Vaccinology published a peer-reviewed study conducted by researchers from Stanford, UCLA, and the University of Maryland, which found that the “Pfizer trial exhibited a 36% higher risk of serious adverse events in the vaccine group” while the “Moderna trial exhibited a 6% higher risk of serious adverse events in the vaccine group,” for a combined “16% higher risk of serious adverse events in mRNA vaccine recipients.”
In December 2022, U.S. Sen. Ron Johnson (R-WI) hosted a roundtable discussion during which civil rights attorney Aaron Siri detailed data from the CDC’s V-Safe reporting system revealing that 800,000 of the system’s 10 million participants, or approximately 7.7 percent, reported needing medical care after COVID injection. “25 percent of those people needed emergency care or were hospitalized, and another 48 percent sought urgent care,” Siri added. “Also, another 25 percent on top of the 7.7 percent reported being unable to work or go to school.”
Another study by a team of American, British, and Canadian researchers, published last December by the in the Journal of Medical Ethics, found that COVID booster mandates for university students – a relatively healthy group at relatively low risk from the virus – do far more harm than good: “per COVID-19 hospitalisation prevented, we anticipate at least 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation).”
COVID vaccination is most controversial for the young, as data shows that children are at little-to-no risk from the virus itself.
In summer 2021, a team of researchers with Johns Hopkins School of Medicine “analyze[d] approximately 48,000 children under 18 diagnosed with Covid in health-insurance data from April to August 2020,” and found a “mortality rate of zero among children without a pre-existing medical condition such as leukemia.” The lead researcher, Dr. Marty Makary, accused the CDC of basing its advocacy of school COVID vaccination on “flimsy data.”
Meanwhile, even experts otherwise friendly to the new shots — as acknowledged by the left-leaning publication Wired — argue that the potential for vaccine-related myocarditis among young males undermines the public health establishment’s persistent refrain that “the benefits of [COVID-19] vaccination far outweigh any harm.”
The FDA’s latest decision echoes previous accusations that the agency is not doing due diligence in approving the shots for children. In late 2021, when the FDA first approved the Pfizer shot for children as young as five years, Dr. Eric Rubin, a member of the FDA’s Vaccines & Related Biological Products Advisory Committee, drew alarm by stating that “we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes.”