[ExI] etymology of just a piece of paper

[John Clark]

On Tue, Aug 18, 2026 at 11:10 AM <spike at rainier66.com> wrote:

*>there was a known elevated risk of myocarditis and endocarditis in young
> people who took the vaccine*


*The misinformation never ends! *

*ME: Somebody told me that before the Covid vaccine was approved for wide
scale use there was already a known elevated risk of myocarditis and
endocarditis in young people who took the vaccine. Is that true?*


*GROK**: "No.* The elevated risk of myocarditis (inflammation of the heart
muscle) and pericarditis associated with mRNA COVID-19 vaccines in young
people—particularly adolescent and young adult males, most often after the
second dose—was not known before the vaccines received emergency use
authorization (EUA) for wide-scale use. It emerged as a post-authorization
safety signal after millions of doses had already been administered.

Pfizer-BioNTech (BNT162b2) received FDA EUA on December 11, 2020 (initially
for ages ≥16), and Moderna (mRNA-1273) on December 18, 2020 (for ages ≥18).
Clinical trial data supporting these authorizations *did not identify
myocarditis or pericarditis as safety concerns*. The trials were large but
still underpowered for very rare events, and no associated cases were
reported in the pre-EUA clinical development for Moderna; similar findings
held for Pfizer in the main adult trials.

Reports of higher-than-expected myocarditis/pericarditis cases first
appeared in early 2021 after widespread rollout:

   - Initial signals came from Israel (around February–April 2021, with
   investigation of cases in Pfizer recipients noted by April), the U.S.
   Department of Defense (military members), and other surveillance systems.
   - Broader recognition and investigation accelerated in May–June 2021 as
   more data accumulated from VAERS, other countries, and active surveillance.
   The CDC’s ACIP and FDA reviewed evidence showing a likely association,
   concentrated in younger males shortly after dose 2.
   - FDA *updated EUA fact sheets with warnings about myocarditis and
   pericarditis in late June 2021 (around June 24–25). CDC/ACIP affirmed that
   benefits still outweighed risks* in recommended populations while
   emphasizing awareness and monitoring.

This timeline aligns with how rare adverse events are typically detected:*
clinical trials catch common or moderately rare issues, but very rare ones
(on the order of tens of cases per million doses in the highest-risk
subgroups) often require large-scale post-authorization monitoring*.
Subsequent observational studies confirmed an elevated risk relative to
background rates, highest in males roughly 12–29 years old (especially
after dose 2 of mRNA vaccines), *usually mild/resolving with supportive
care* in most cases, though still a genuine and labeled risk.

Note that “endocarditis” (infection/inflammation of the heart
valves/lining) is distinct and was not the primary signal; the documented
association is with myocarditis and pericarditis. COVID-19 infection itself
carries a substantially higher risk of myocarditis than vaccination in
comparative data.

In short, the claim that an elevated risk was already known *before*
approval/EUA for wide-scale use is not supported by the regulatory and
scientific record. The signal was identified and acted upon after rollout,
leading to label updates and ongoing surveillance".


* John K Clark*
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