Why the FDA tried to bury studies showing vaccines are safe
Jake Scott, MD
A spokesman for the Department of Health and Human Services
(HHS) confirmed the withdrawals on the record, saying the studies were
withdrawn because "the authors drew broad conclusions that were not
supported by the underlying data" and that "the F.D.A. acted to
protect the integrity of its scientific process and ensure that any work
associated with the agency meets its high standards."
The studies are public. Anyone can read them. The FDA's own
scientists, working with the active surveillance system Congress mandated after
the withdrawal of Vioxx, an anti-inflammatory pain reliever, in 2004 after it
was tied to increased heart attacks and strokes, produced findings consistent
with every major post-market analysis of these vaccines published worldwide
since 2023.
The work was buried for reasons that have nothing to do with
the underlying data.
What the studies actually found
One of the COVID vaccine studies, involving US adults 65 and
older, was withdrawn from the
journal Drug Safety after acceptance. It analyzed more
than 7 million Medicare beneficiaries who received the 2023-24 vaccine. The
investigators evaluated 14 specific health outcomes, ranging from heart attacks
and strokes to Guillain-Barré syndrome (GBS), an autoimmune condition that has been
linked to certain vaccines.
They identified one statistically meaningful signal: a small
elevation in anaphylaxis (a severe allergic reaction) following the
Pfizer-BioNTech vaccine. After they adjusted for the possibility that some
"anaphylaxis" billing codes did not represent true cases, the signal
disappeared. The attributable risk, before that adjustment, was less than one
excess case of anaphylaxis per million doses administered. The investigators
concluded that no new safety signals had been identified.









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