US FDA and CDC Delayed Health Advisory on COVID-19 mRNA Vaccine Myocarditis for Months, Failed to Issue Black Box Warning for Years
Upcoming Senate Hearing Will Probe Agency Delay, Refusal to Black Box Label, Costing American Lives
By Peter A. McCullough, MD, MPH
Ever since the FDA on one of its internal slides dated October 22, 2020 indicated that heart damage or myopericarditis was an expected side effect of mRNA vaccines, I have been concerned about this side effect as a cardiologist who would be expected the handle the problem potentially on a mass scale.
We know in hindsight that COVID-19 vaccination and not the infection is the major risk for heart damage, cardiac arrest, and heart failure especially in young persons during the pandemic years.
A US Senate Hearing scheduled for Wednesday May 21, 2025 at 2 PM is set to investigate the US FDA and CDC delay in issuing a health advisory on COVID-19 mRNA vaccine myocarditis.
By April 23, 2021, the Times of Israel reported the Israeli health ministry had recorded 62 cases, two of which were fatal. Shortly afterwards, Albert et al from University of Massachusetts submitted a manuscript on May 6, 2021, documenting MRI confirmed myocarditis having ruled out SARS-CoV-2 infection.
With 226 cases of vaccine myocarditis in hand on June 10, 2021, the FDA waited until June 25, 2021 to warn Americans on the vaccine information sheets that the products cause heart damage.
The first fatal case beyond the two from Israel was reported by Verma et al in the New England Journal of Medicine, August 18, 2021. At this point the FDA and CDC should have immediately updated the product information to indicate vaccine myocarditis could be fatal. Instead they did nothing to warn the public.
To this day, fatal COVID-19 vaccine myopericarditis occurs many times with sudden cardiac arrest as the very first sign. Autopsies have proven the COVID-19 vaccine is the cause of myocarditis not the infection. At the hearing we plan to explore the delay in issuing the myocarditis health advisory and more importantly, the continued failure to fairly inform patients that myocarditis can be fatal.
The January 1, 2025, FDA package insert for SPIKEVAX the Moderna COVID-19 mRNA booster lists myocarditis, but does not have a black box warning indicating the myocarditis can be and is lethal in some victims. Failure to “black box” Pfizer and Moderna will certainly be under discussion in the US Senate.
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Peter A. McCullough, MD, MPH
President, McCullough Foundation
Thank you in advance, Dr. McCullough, for your upcoming testimony on Wednesday.
Though I’m sure you’re aware, as many/most of your readers are, when the FDA provided to the Biden Administration the Pfizer “Cumulative Analysis of Post-Authorization Adverse Event Reports…Received through February 28, 2021” (report dated April 30, 2021) beginning on page 16, the AESI Table 7 detailed the Adverse Events of Special Interest for each ‘health’ outcome category. At the end of *each* of these categories it states: “Conclusion: This cumulative case review does NOT raise new safety issues. Surveillance will continue.”
So, yes, all of the documented AESI’s were *expected* as your October 2020 FDA slide shows/lists. By February 28, 2021, Pfizer reported to the FDA via this document that they had already noted 1,403 Cardiovascular AESI’s; 136 of those Cardiovascular outcomes were fatal. Death was the result and death DID NOT raise a NEW safety issue, so surveillance - distribution & injection - would continue.
That needs to sink in folks. It cannot be underscored enough. The outcomes were known to our FDA *BEFORE* mass distribution of these shots began in December 2020, the outcomes were expected during the first months of roll out, and purposefully allowed to continue.
Speak with confidence this week Dr. McCollough. We need you in this fight. The fraud here is staggering.