The U.S. FDA’s vaccine advisory panel on Tuesday (June 14) 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.
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and rocket scientist said he is appalled at the FDA’s arrogance in even “thinking of vaccinating healthy children with outdated, highly toxic COVID vaccines.”
In a public comment published on the Ethics and Public Policy Center’s website, Dr. David Gortler— a pharmacologist, pharmacist, FDA and healthcare policy oversight fellow and FDA reform advocate at the Ethics and Public Policy Center in Washington, D.C.—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.”
“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 warned.
The FDA’s vaccine advisors will meet again on Wednesday (June 15) 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 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.