FDA Committee Pushes mRNA COVID Shots for Infants and Toddlers

Jun 16, 2022

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted unanimously yesterday to recommend that the agency authorize the mRNA COVID injections for children under five years of age and as young as six months.
The FDA’s briefing document released earlier claimed that the vaccine efficacy in children under five years is 80.3 percent. However, even though the study to “determine” this included 1,678 children who received three doses of the formulation, the stated 80.3 percent efficacy claim is based only on “10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022.” (emphasis added)
Pfizer announced these results after delaying the EUA application process to gather more data. Initially, children in the study did not produce a significant immune response after two doses, so the company delayed the request until they could give the children a third dose. The trial reportedly was evaluating “the safety, tolerability and immunogenicity of three doses of the Pfizer-BioNTech COVID-19 Vaccine.”
Recent studies also suggest that the effectiveness of COVID-19 shots in children is low in the beginning and wanes rapidly to statistical insignificance. Moreover, the data suggests that vaccine effectiveness in children actually becomes negative within several months after the second dose.
Researchers from the New York State Department of Health published a study on February 28 noting that the evidence for COVID vaccine effectiveness in children, particularly those aged five to eleven, was “limited.” The authors concluded, “During Omicron variant predominance, vaccine effectiveness against infection declined rapidly for young children in the state of New York, with low protection by one month following full vaccination.”
Comparing COVID-19 cases during January between unvaccinated and vaccinated children, they estimated initial vaccine effectiveness (VE) for children aged twelve to seventeen to be 76 percent, but this dropped to below 50 percent after just five weeks after the second dose. In addition, they observed a drop in effectiveness in children ages five to eleven from 65 percent to just 12 percent after only one month.

Another study by CDC researchers published in JAMA on May 13, 2022, concluded that “Among children and adolescents, estimated VE for 2 doses of BNT162b2 [the Pfizer-BioNTech COVID-19 vaccine] was modest and decreased rapidly.” The CDC authors also noted that estimates of vaccine effectiveness against the Omicron variant, which became predominant during December 2021, “are lacking.” 

The CDC researchers estimated initial vaccine effectiveness for children aged five to eleven to be 60 percent. However, within two months (the limit of the duration of follow-up for this age group), effectiveness dropped to just 29 percent. 

The FDA’s briefing document also claims that the majority of adverse events in Pfizer’s clinical trial were non-serious. However, an analysis by two Israeli researchers shows that at least 58 life-threatening adverse events from the shots in infants and toddlers under three years old were reported to VAERS. The most common serious adverse events were life-threatening bleeding, anaphylactic shock, anticholinergic syndrome, encephalitis, hypoglycemia and neuroleptic syndrome. In most of the reported cases, these children had multiple injuries. During the analysis, cases were removed in which it was stated that the exposure to the COVID shot was through breastfeeding. 

Even though children under five were not considered eligible for these COVID shots unless they were part of a clinical trial, in some of the cases the VAERS report states the children were not part of a clinical trial. In other cases, it is not clear whether they participated in a clinical trial or were vaccinated in other unknown circumstances. Apparently, there was not any follow-up on the medical condition of babies who suffered from severe and life-threatening adverse events, so it is uncertain whether they survived and recovered or died. 

A summary of the findings of the analysis of the 58 life-threatening adverse events according to age is as follows: 

  • In the age group of 0-6 months, 28 reports include nine suffered an anticholinergic syndrome, nine had an anaphylactic shock, eight suffered Neuroleptic syndrome, five suffered from heart rhythm irregularities, and five had hypoglycemia. 
  • In the age group of 6-12 months, five cases had adverse reactions which included anaphylactic shock, anticholinergic syndrome, and Neuroleptic syndrome. 
  • In the age group of one - three-year-olds, 25 cases were reported, six of the babies had an anaphylactic shock, six suffered anticholinergic syndrome, five suffered from Neuroleptic syndrome, four suffered encephalitis, three had irregular heartbeats, one baby was hemorrhaging, and one suffered from hypoglycemia. 

Several specific examples of the adverse events in these children include: 

  • A one-year-old baby received a Pfizer shot on January 19, 2021 and developed a pain in her left ear that escalated to full paralysis, which was diagnosed as Guillain Barre syndrome, face paralysis, non-infectious encephalitis, non-infectious meningitis, earaches and hearing disorders. The report specified she was not a participant in a trial.
  • A 43-day-old female baby received Pfizer’s COVID shot on January 30, 2021 and suffered a variety of life-threatening multi-system injuries, such as anaphylactic reaction, asthma/bronchospasm,  Anticholinergic syndrome, acute central respiratory depression, pulmonary hypertension, cardiomyopathy, eosinophilic pneumonia, vestibular disorders, hypersensitivity, respiratory failure, drug reaction with eosinophilia and systemic symptoms syndrome. The report does not specify whether the baby survived though it states she has not recovered.
  • A two-month-old baby suffered a cardiac arrest one hour after receiving a Pfizer COVID-19 injection on February 2, 2021. 
  • A one-month-old baby suffered “vaginal bleeding with chunks of clots” the following day after receiving the Pfizer-BioNTech vaccine on May 19, 2021. 
  • A six-month-old baby who received the COVID-19 Pfizer shot on December 29, 2021 experienced anaphylactic shock, anticholinergic syndrome, Neuroleptic syndrome, infectious pneumonia, other infections, and multi-system symptoms. 

Liberty Counsel Founder and Chairman Mat Staver said, “Our precious children should not be the guinea pigs of pharmaceutical companies. There is no significant benefit and all risk to inject a child with an experimental COVID shot. Common sense and science seems to be rare these days at the FDA.” 

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