I received a request this morning for a short-form summary of the history of US government non-regulation of vaccines.
My reply:
I don't have a short version of it yet.
Writing the series
to make the long version is part of the process of getting a good
enough grasp on the material to be able to explain it in short form.
Best entry-level, overview posts so far are these three:
Two key legal records confirming or corroborating that there
are no standards for vaccines (for product identity, stability, purity,
effectiveness, safety, potency or any other characteristic), are —
One, 2011 Bruesewitz SCOTUS decision:
Scalia opinion at p. 13:
“Design defects…do not merit a single mention in the [1986 National Childhood Vaccine Injury Act] or the FDA’s regulations.
Indeed, the
FDA has never even spelled out in regulations the criteria it uses to
decide whether a vaccine is safe and effective for its intended use.”
Scalia
doesn't mention it, but FDA has also never spelled out in regulations
the criteria it uses to decide whether any vaccine's contents have the
identity, quantity, stability or purity claimed by the manufacturer.
No
such criteria exist, and no such criteria can ever be established,
because of the inherent heterogeneity and instability of biological
material.
and
Two, 2018 ICAN v. HHS stipulation:
Quoting from the first Bailiwick post in the list of three above:
"…One
of the justifications used to exempt manufacturers from liability was
that the US government, through the Department of Health and Human
Services, would monitor the childhood vaccine program, collect safety
data, report the data to Congress to provide oversight, and take harmful
vaccines off the market.
Safety monitoring and reporting as called for in the 1986 law did not occur.
In August 2017, the Informed Consent Action Network
(ICAN) filed a FOIA request with HHS, requesting copies of the biennial
reports that should have been prepared and submitted to House and
Senate committees between 1987 and 2018.
In June 2018, HHS responded to ICAN's request:
"The [Department]'s searches for records did not locate any records responsive to your request. The
[HHS] Immediate Office of the Secretary (IOS) conducted a thorough
search of its document tracking systems. The Department also conducted a
comprehensive review of all relevant indexes of HHS Secretarial
Correspondence maintained at Federal Records Centers that remain in the
custody of HHS. These searches did not locate records responsive to your
request, or indications that records responsive to your request and in
the custody of HHS are located at Federal Records Centers."
Informed Consent Action Network v. US-HHS, (1:18-cv-03215-JMF), resulted in a July 9, 2018 stipulation signed by Attorney Robert F. Kennedy Jr.
The stipulation quoted the June 2018 acknowledgement, by HHS, that HHS had no record of any safety monitoring activity or public, Congressional reporting of the childhood vaccination program, under the 1986 law, between 1986 and 2018.
Later two reports were located, filed on May 4, 1988 and July 21, 1989
(partial, no appendices). The 1988 and 1989 reports addressed vaccine
promotion, vaccine supply, vaccine research activity (see, for example,
pp. 67-78 of 1988 report), and set-up of reporting and data analysis
programs.
Since 1989: nothing.
HHS
has never systematically collected or reported information from
parents, pediatricians, toxicologists, manufacturers, or anyone else
about harms caused by childhood vaccines administered in single doses,
combined doses (i.e. measles-mumps-rubella), or cumulative doses (the
childhood schedule), and HHS has never collected or reported information
about the harmful effects of biological components, chemical adjuvants,
preservatives or any other ingredients...
The
July 2018 ICAN-HHS stipulation supports the conclusion that none of
those regulatory functions have been performed, no records of vaccine
manufacturing regulation have been produced by FDA or regulated
manufacturers, and no records have been collected, assessed or used by
HHS…"
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