ST.
PAUL, Minn. — The
FDA just announced last Monday that a COVID vaccination
produced by Pfizer-BioNTech called "Comirnaty" has been fully
approved. This makes the Pfizer-BioNTech vaccine the first to move beyond
emergency use authorization— although the announcement seems to make it clear
that the current Pfizer vaccine has not been approved and remains under
emergency use authorization:
"[1] The licensed vaccine has the same formulation as the EUA-authorized vaccine
and the products can be used interchangeably to provide the vaccination series
without presenting any safety or effectiveness concerns. The products are legally distinct
with certain differences that do not impact safety
or effectiveness."
Citizens' Council for Health Freedom (CCHF) says any assurances
of safety and effectiveness are premature, including for the "Comirnaty"
vaccine: "The FDA letter to Pfizer requires 13 studies, including six studies related to heart inflammation and one on exposure during pregnancy.
How is it that the Covid shots are being mandated despite
these clear concerns? The public
should not be comforted by the approval of this Pfizer vaccine," said Twila Brase,
President and Co-founder of CCHF.
To the
dismay of the many Americans who have chosen not to get the vaccination, the approval will likely pave the way for corporations, colleges, and other organizations to mandate the vaccination as a condition of employment or as
a requirement for education. This will further hamper the individual's right to make an informed
choice about what they put in their
body without penalty.
Back in
June, CCHF sent the Acting Commissioner of the FDA, Janet Woodcock,
a letter asking that the approval
requests for both Moderna and Pfizer be "promptly and fully denied." Of the many reasons given in the letter for the denial,
a major one is that this is the first-ever mRNA
(messenger Ribonucleic Acid) vaccine to be considered for full approval, which means
it's never been used before and
"should not be rushed into approval," as its long- term effects are unknown.
Another key
concern stated in the CCHF letter is the issue of calling it a vaccine.
By categorizing it as a vaccine, "the manufacturers are exempt from liability
for the already more than 200,000 injuries and at least 4,863 deaths reported
from the injection." These numbers have only increased. According to the CDC, as of August 23, there
have been 6,986 deaths reported after vaccination. According
to openVAERS.com, 623,341 adverse events to COVID- 19 vaccines have been reported as of August
20, 2021.
Brase
further stated, regarding the letter: "The FDA should recognize publicly
the right of Americans to make a real choice, not a coercive choice. Coercion is not consent." She said, "The FDA must acknowledge the dangers to freedom and the
possible adverse reactions such premature
approval may cause many Americans to face in a nation
where employers, colleges,
schools, and businesses just want to "get back to normal."
About Citizens'
Council for Health Freedom:
CCHF maintains a patient-centered, privacy-focused, free-market perspective. CCHF has worked in its home state of Minnesota
and at the national level for more than 20 years to protect health care
choices, individualized patient care, and medical and genetic privacy
rights. CCHF airs the "Health Freedom Minute" on more than 850 radio stations
each weekday. In 2016, CCHF launched The Wedge of Health Freedom,
a national online directory
of direct-pay practices
(JointheWedge.com). In 2018,
CCHF published "Big Brother in the Exam
Room: The Dangerous Truth About Electronic Health Records."
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