FDA Admits Administration of Double Dose of Moderna’s COVID Vaccine to Children as Young as 6 Months
Concerns have been raised as it comes to light that some children and babies may have inadvertently received double the authorized dose of Moderna’s COVID-19 vaccine. Medical professionals emphasize that such errors could lead to serious consequences.
The US Food and Drug Administration (FDA) issued an advisory on November 1, stating that some healthcare providers may not be recognizing that the single-dose vial of Moderna’s COVID-19 vaccine for individuals aged 6 months through 11 years contains more than the intended 0.25 mL of the vaccine. The advisory mentioned that some providers might be withdrawing the entire contents of the vial for administration, which is double the recommended dose for adults.
The Defender reports:
While the FDA did not provide details on how it obtained information about dosing errors, it assured that no safety risks had been identified for the higher dose in individuals within the specified age group, and no serious adverse events related to dosing errors had been reported.
Dr. Elizabeth Mumper, a pediatrician and CEO of The Rimland Center for Integrative Medicine, expressed concerns about the potential consequences of children receiving more than the recommended dose. She highlighted that an increased dose could result in higher exposure to synthetic modified RNA, lipid nanoparticles, and potential DNA plasmid contamination. Dr. Mumper also voiced worries about over-producing the spike protein and the associated risk of side effects, even with the correct dose.
Another pediatrician, Dr. Renata Moon, argued against administering the mRNA shot to children altogether. She raised concerns about the risks associated with the product and expressed frustration about the censorship and silencing of frontline physicians who speak out against it.
Moderna’s COVID-19 vaccine is available in various formats, including pediatric single-dose vials, adult dose vials, prefilled syringes, and multi-dose vials. The advisory emphasizes the importance of adhering to the specified doses and instructs vaccinators not to draw more than one dose from single-use vials or combine leftovers from different vials to create a larger dose.
Dr. Mumper highlighted the lack of information on the vaccine vials regarding the quantity of the vaccine, prompting her to contact the Moderna helpline. According to her, Moderna acknowledged the presence of overfill to ensure sufficient volume but did not provide a specific quantity.
Healthcare providers, parents, and caregivers with questions are advised to contact the FDA’s Center for Biologics Evaluation and Research via email at ocod@fda.hhs.gov, as stated in the advisory.
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