Why Aren’t The FDA And CDC Informing The Public About Documented Adverse Events After mRNA Injections? BY: DAVID GORTLER for The Federalist
Properly evaluating any kind of drug safety — let alone that of presidentially mandated vaccines— involves carefully examining all of the available data. While Americans still haven’t been given full access to the full Pfizer “Comirnaty” license application, we do have access to the Food and Drug Administration’s medical officer review.
This comparatively spartan 107-page FDA review document purportedly contained everything the FDA believed was important to release to the public from the original Pfizer application of 329,000 pages. The FDA review conspicuously notes “clinically important serious adverse reactions [included] anaphylaxis and myocarditis/pericarditis”— that is, severe allergic reactions and inflammation of the heart and or the sac containing the heart, respectively.
Likewise, Moderna’s “Spikevax” vaccine was given its Emergency Use Authorization in late 2020, and was fully approved by the FDA on January 31, 2022. Following approximately a month of time to redact its review from “trade secrets,” the FDA released an even leaner 30-page review. Like the Pfizer vaccine, there were clear indications of myocarditis and pericarditis in the initial study, demonstrating the potential for risk going forward.
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Specifically, the review states: “post-authorization safety surveillance has identified serious risks of myocarditis and pericarditis, particularly within 7 days following the second dose of Moderna COVID-19 Vaccine. The observed risk is higher in males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age… An increased risk for thrombosis with thrombocytopenia syndrome (TTS) has been identified following administration of adenovirus-vectored COVID-19 vaccines.”
Bottom line: The FDA, Centers for Disease Control, Pfizer, and Moderna knew about myocarditis and pericarditis risks from the mRNA vaccines since day one, yet made no formal warnings to Americans in the form of recommending labeling changes or any other warnings, such as letters to warn physicians, pharmacists, or the American public.
