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Members of Congress today demanded answers from Dr. Robert M. Califf, commissioner of the U.S. Food and Drug Administration (FDA), as the agency reviews Emergency Use Authorization (EUA) for COVID-19 shots in children age 5 and under.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting on four separate occasions in June to discuss additional EUAs that would provide cradle-to-grave COVID-19 shots — and to consider a “Future Framework” that will permanently lower the bar for safety and efficacy, according to Toby Rogers, Ph.D.
A letter signed by Sen. Ted Cruz (R-Texas), Rep. Bill Posey (R-Fla.) and 16 other members of Congress today asked Commissioner Califf 19 questions about the safety of COVID-19 vaccines for young children.
The questions focused on the youngest children (6 months to 5 years) due to the Congress members’ concerns about what they called the FDA’s “one-size-fits-all” approach to the vaccines.
“The data show that the risks of serious adverse outcomes for COVID for children five and under is very low and as such the standard for evaluating EUA interventions must be very high,” the letter states.
“We believe it is prudent and necessary that the FDA provide answers to a number of questions before approving EUA vaccines for children under age 5, including more than 70% of whom are already seropositive for COVID-19.”
The VRBPAC meetings began Tuesday. The meeting schedule is:
- June 7 — EUA for Novavax’s COVID-19 shot for adults.
- June 14 — Amendment to Moderna’s EUA to include primary series to children and adolescents 6 through 17 years of age.
- June 15 — Amendment to Moderna’s EUA to include primary series for children 6 months to 5 years and amendment to Pfizer’s EUA to include the primary series to children 6 months through 4 years of age.
- June 28 — Proposed “Future Framework” for COVID-19 shots.
The Congress members’ letter presses the FDA to address unanswered questions regarding the risks and benefits of administering COVID-19 vaccines to children.
They ask the FDA to explain, among many other things:
- What the cardiac risk factor is for children who receive EUA COVID-19 vaccines.
- Why the FDA recently lowered the efficacy bar for COVID-19 vaccines for the youngest children.
- When the FDA and the Centers for Disease Control and Prevention (CDC) will provide the public with more details on children’s serious adverse outcomes from COVID-19 infections.
- If it is possible that administering the vaccines in young children could predispose them to increased risk from future novel COVID-19 variants.
- How many children ages 5 and under with and without pre-existing medical conditions have died from COVID-19 or its variants.
Finally, the letter asks Commissioner Califf to “please list the medical emergencies [among] children 0 to 4 years old that enables the FDA to approve the COVID vaccine for children using its EUA.”
Children’s Health Defense calls for action
Mary Holland, Children’s Health Defense (CHD) president and general counsel, called the FDA’s Future Framework proposal “quite possibly the worst idea in the history of public health.”
In a video, Holland asked viewers to send a message to FDA and CDC officials, VRBPAC members and elected representatives demanding they reject the EUAs for children and ensure government agencies follow the science:
Children under 18 with no comorbidities have virtually no risk of death from COVID-19, according to a November 2021 study published in Nature.
A July 2021 preprint paper found children have a 99.995% recovery rate, and the vast majority of children have minimal symptoms.
The Nature study described how children between 3 and 11 years of age mount effective, robust and sustained immune responses to COVID-19.
There is no clinically significant health benefit from the mRNA vaccines, according to Moderna. Reporting on its Phase 2/3 KidCOVE study, the company said, “the absence of any severe disease, hospitalization or death in the study precludes the assessment of vaccine efficacy against these endpoints.”
Preliminary data showed the shots were only about 44% effective at preventing symptomatic infection in children 6 months to 2 years old, and 37% effective in children ages 2 to 5 — both below the 50% level that regulators generally called the minimum level for EUA approval in 2020.
In New York, officials observed that Pfizer’s efficacy against Omicron plummeted from 68% to 12% after 7 weeks in children ages 5 to 11.
“These shots are dangerous and carry very real risks,” Holland said.
Studies show vaccinated children face a substantial risk of myocarditis. Moderna’s EUA application, originally filed in June 2021, has already been held up because of a clear safety signal for myocarditis, which prompted a number of European countries to prohibit its use in young people.
Additionally, the Vaccine Adverse Events Reporting System or VAERS has more than 48,500 reports of adverse events in children, including 112 deaths (as of May 27), and a growing number of reports of encephalopathies, clotting issues, diabetes and neurological problems in children following COVID-19 shots.