CDC Deputy Director Acknowledges Significantly Elevated Risks & Long-Term Effects Associated with COVID-19 mRNA Vaccines at FDA VRBPAC Meeting

The U.S. Food and Drug Administration (FDA) now shares information more openly about the risks associated with the COVID-19 vaccines. In the recent FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) June 7th meeting, Tom Shimabukuro, MD, MPH, Deputy Director of the H1N1 Vaccine Task Force at the U.S. Centers for Disease Control and Prevention (CDC) acknowledged at 1:15.57 that based on reviews from the Vaccine Adverse Event Reporting System (VAERS) and other sources, including the pharmaceutical companies, there is “significantly elevated risks” associated with the COVID-19 mRNA vaccines. These include both Pfizer-BioNTech (BNT162b2) and Moderna’s (mRNA-1273) vaccine products. While the question-and-answer session opened up a dialogue about the problem, including deaths, perhaps for the first time in such a public manner, an accompanying presentation emphasized the incidence is rare.  

TrialSite includes the entire VRBPAC meeting video as well as the specific myocarditis question and answer session with the CDC deputy director starting at 7:21.43.  

The session titled,  “June 2022 video: FDA Q&A, FDA mRNA vaccines Cause 'Significantly Elevated Risk' of Myocarditis with 'Long Term Effects'" suggests that the FDA and CDC are starting to publicly acknowledge that there are risks with the COVID-19 mRNA vaccines. Based on TrialSite’s tracking of safety incidence, more than likely the FDA will be compelled to disclose more risks to the public over time. 

Zeroing in on the data, deputy director Shimabukuro presents information from a table titled, “VAERS Reporting Rates of myocarditis (per 1 million doses administered) after mRNA COVID-19 vaccination, days 0-7 and 8-21 post-vaccination.”

He shared that the data reveals an elevated risk of myocarditis with data from 0-7 and 8-21 days. Shimabukuro shows a table with peach-colored cells depicting higher risk cohorts associated with myocarditis and the mRNA COVID-19 vaccines, including the highest risk cluster of males aged 12 to 29. This, of course, is not new information for a sizeable sample of the American population. TrialSite and a handful of media, as well as independent journalists, continue often at their own expense to report on the risks associated with the mRNA vaccines. This is a task that should have been funded and managed from the start by the agencies under the U.S. Department of Health and Human Services.

The CDC deputy director goes on to acknowledge that with certain cohorts, a rate of 40 to 60 incidents of myocarditis per million doses administered contributed to risk analysis. The CDC analyst also shared, perhaps for the first time in such a public way, deaths associated with the mRNA vaccines. According to the analyst, the CDC and FDA acknowledge  21 reported deaths associated with the COVID-19 mRNA vaccines.  A brief review of VAERS finds a total of 14,980 deaths reported by various parties in association with the COVID-19 vaccines. Both the CDC and FDA have been quick to suggest that most of these cannot be proven to be linked to the vaccines. They also point out that based on the total number of vaccine doses administered, the deaths equal 0.0025%.

Shimabukuro shared that a summary of the cases reveals that myocarditis cases recover between 3 to 8 months. However, when asked pointed questions about long-term effects, the CDC deputy director stated, “I think there can be long-term residual effects of myocarditis.”

During the June 7 VBRPAC meeting, the FDA also recently shared a presentation titled, “Update on Myocarditis following mRNA COVID-19 Vaccination” also presented by Tom Shimabukuro. In this presentation, the CDC analyst introduces the epidemiology of myocarditis, shares the distribution of cases across age groups, and compares characteristics of myocarditis via a viral source and the COVID-19 mRNA vaccines.

The presentation moved on to the topic of VAERS, a description of the safety system, and a breakdown of analyzed myocarditis cases associated with the COVID-19 mRNA vaccines. According to the CDC deputy director, out of an estimated 491.9 million primary series and 1st booster mRNA COVID-19 vaccine doses administered in the United States among people ages 18 years and older, only a total of 1321 cases of myocarditis fit into the CDC definition.

In addition to other information, the CDC analyst in the summary acknowledges a causal association between mRNA COVID-19 vaccination and myocarditis and pericarditis. They note that cases cluster in the first week of vaccination and that the risk is greatest in adolescents and young adults. Furthermore, the risk for myocarditis is higher after the second dose of the mRNA vaccine when compared to the first dose of the primary series (first two jabs) while males, as TrialSite has reported for nearly a year, face a higher risk than females. They also report that rates reported in VAERS are higher after the second dose of the vaccine administration. Shimabukuro reports the risk of myocarditis during the booster dose is higher for a “minority of the age strata" (e.g., males aged 16-17 years). While again the CDC and FDA declare that based on their review a majority of the cases recover between 3- and 8-months post-diagnosis, they don’t address what happens to those that don’t recover. That’s a concern.

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