by Angelo DePalma, Ph.D., John-Michael Dumais, Childrens Health Defense:
The U.S. Food and Drug Administration said it “has become aware that some healthcare providers may not recognize that the single dose vial of Moderna COVID-19 Vaccine (2023-2024 Formula) for use in individuals 6 months through 11 years of age contains notably more than 0.25 mL of the vaccine.”
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Young children may be getting double the authorized dose of Moderna’s COVID-19 vaccine — a mistake that could have serious consequences, medical professionals told The Defender.
According to a Nov. 1 U.S. Food and Drug Administration (FDA) advisory, the agency “has become aware that some healthcare providers may not recognize that the single dose vial of Moderna COVID-19 Vaccine (2023-2024 Formula) for use in individuals 6 months through 11 years of age contains notably more than 0.25 mL [milliliters] of the vaccine.”
The FDA said some healthcare providers “may be withdrawing the entire contents of the vial to administer to an individual.” Adults receive a dose of 0.50 mL.
The FDA did not elaborate on how it came by the information on dosing errors. However, according to the advisory, the agency had “not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age” and “no serious adverse events were identified related to a dosing error for the vaccine.”
Dr. Elizabeth Mumper, a pediatrician and president and CEO of The Rimland Center for Integrative Medicine, told The Defender she had concerns about the mistaken doses.
Mumper said a child who receives more than the recommended amount “will have more exposure to synthetic modified RNA, lipid nanoparticles and potentially DNA plasmid contamination.”
Even with the appropriate dose, Mumper said, there is no guarantee that the baby or child will make the “just right” amount of spike protein to induce just the right amount of immune response.
“I worry about over-producing the spike protein and getting side effects,” Mumper said.
Dr. Renata Moon, also a pediatrician, told The Defender:
“The only appropriate dose of this mRNA shot for children is no dose. Children shouldn’t be injected with it at all. We have an avalanche of highly concerning data regarding the risks of this product.
“Experienced, frontline physicians are being censored, silenced and threatened for speaking out. Our nation’s children deserve better.”
Vaccine packaging unclear
The Moderna product is packaged in four main formats: a 0.25-milliliter pediatric single-dose vial, a 0.50-milliliter adult dose vial, a 0.50-milliliter prefilled syringe and a 2.5-milliliter vial containing five adult doses (primary or booster).
Vaccinators are instructed to draw no more than one dose from single-use vials and not to combine the leftovers from one vial with those from another to create a larger dose.
Mumper said she called the Moderna helpline, as the package insert and FDA documents do not indicate the amount of vaccine in the vials. She said Moderna told her, “There is overfill to assure sufficient volume, but there is no quantity listed.”
“Hopefully, nurses are conscientious about following the directions to only give 0.25 mL,” Mumper said. “Administration errors vary depending on the setting or experience of the nurse or medical assistant.”
The advisory instructed healthcare providers, parents and caregivers with questions to email the agency’s Center for Biologics Evaluation and Research at ocod@fda.hhs.gov.
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