FDA Records Show Skeletal Deformations In Newborn mRNA Test Rats

12-15-2022  (Washington, DC) – Judicial Watch announced earlier this week that it received almost 700 pages of records from the Department of Health and Human Services (HHS) regarding data Moderna submitted to the Food and Drug Administration (FDA) on its mRNA COVID-19 vaccine, which indicate a “statistically significant” number of rats were born with skeletal deformations after their mothers were injected with the vaccine.

The documents also reveal Moderna elected not to conduct a number of standard pharmacological studies on the laboratory test animals.

The records include a “Nonclinical Overview” (available here) prepared by Moderna and submitted to the FDA for approval of its vaccine revealing that a number of rats were born with skeletal deformations, known as “wavy ribs” and “rib nodules,” to mothers injected with the mRNA vaccine. Moderna dismissed the anomalies as “not considered adverse.”

The “Summary” indicates:

• No absorption studies with mRNA-1273 [used in Moderna’s COVID vaccine] have been performed.
• No metabolism studies with mRNA-1273 have been performed.
• No excretion studies with mRNA-1273 have been performed.
• No PK [pharmacokinetic] studies with mRNA-1273 have been performed.
• No other PK studies with mRNA-1273 have been performed.

According to PubMed.gov, “Pharmacokinetics studies are performed to clarify the absorption, distribution, metabolism, and excretion of drug candidates" and therefore are "are required for establishing the efficacy and safety in humans.” 

Since these studies have not been done, Moderna's mRNA COVID-19 vaccine cannot yet be considered effective and safe in humans according to previously established scientific standards. 

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