The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel today voted unanimously to recommend Moderna’s COVID-19 vaccine for children ages 6 to 17 after determining the benefits of the vaccine outweigh the risks for use.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 22 to 0 to recommend Moderna’s two-dose vaccine for 6- to 11-year-olds at half the strength of the adult version, and 22 to 0 in favor of authorizing the shot for 12- to 17-year-olds at the same strength as adults.
The FDA’s vaccine advisors will meet again on Wednesday to discuss amending Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine to include the “administration of the primary series to infants and children 6 months through 5 years of age.”
The committee tomorrow also will discuss amending EUA of the Pfizer-BioNTech vaccine to “include the administration of the primary series to infants and children 6 months through 4 years of age.”
After VRBPAC makes its recommendations, the FDA will then decide whether to authorize Moderna and Pfizer’s vaccines for the suggested age groups.
During the public comment session of the meeting, individuals expressed concern over recommending a vaccine for an age group that has an almost zero risk of experiencing severe illness or death from COVID-19 and has already acquired a high level of natural immunity.
Dr. Harvey Klein, orthopedic surgeon, mechanical engineer and rocket scientist said he is appalled at the FDA’s arrogance in even “thinking of vaccinating healthy children with outdated, highly toxic COVID vaccines.”
“Children have a “99.998% recovery rate with no sequelae if they get COVID. Vaccine Adverse Event Reporting System (VAERS) statistics show children ages birth to 18 who have been vaccinated with Pfizer-BioNTech and Moderna’s so-called vaccines have had severe life-threatening adverse reactions, such as myocarditis, Guillain-Barré Syndrome and many more severe adverse reactions [including] death.
Klein said the risks don’t outweigh the benefits as children from birth up to age 18 have a survival rate of 99.9% and virtually zero risk of death.
“Why in the world would you want to try to improve on perfection by exposing them to significant chances of being permanently severely injured or dead?” Klein asked. “The risk is infinite, the benefits are non-existent and the efficacy is extremely negative.”
Dr. David Gortler is a pharmacologist, pharmacist, FDA and healthcare policy oversight fellow and FDA reform advocate at the Ethics and Public Policy Center in Washington, D.C.
In a public comment published on the Ethics and Public Policy Center’s website, Gortler said the FDA and its advisory panel have “maintained a highly non-scientific and casual attitude toward approving a vaccine whose short- and long-term effects on children are unclear.”
Gortler said the FDA has failed to address genotoxicity, teratogenicity, oncogenicity of COVID-19 vaccines and cardiovascular risk following vaccination, potential fertility issues and clinical effects of spike proteins in donated or transfused blood.
“Before parents consent to vaccinate their children against COVID, basic medical ethics requires that they be informed of exactly how safe that vaccine is,” Gortler said.
Four million doses must be administered to children 5 to 11 years of age to prevent a single ICU admission in the same age group, Gortler said.
“Assuming two doses per child, that means two million children must risk potentially serious side effects to prevent a single child from requiring intensive care due to COVID-19.”
Another analysis, by Kathy Dopp and Stephanie Seneff, Ph.D., shows COVID-19 vaccination increases a child’s risk of dying from infection.
“Children under 18 are also 51 times more likely to die from the vaccine than they are to die from COVID infection if not vaccinated,” Gortler said, citing the analysis. “In other words, there is no clinical or epidemiological justification for vaccination in this particular group.”
“Vaccinating young children against a virus that poses no harm to them is unethical and dangerous.
“However, it does bring Pharma closer to its ultimate goal of getting COVID shots added to the recommended childhood vaccine schedule, which means Pfizer and other COVID vaccine manufacturers will have a captive market in perpetuity and likely never be held accountable for harm or even death to young children caused by their products.”