Despite Letter From CCHF, Full Approval Has Been Granted To A Pfizer-BioNTech COVID Vaccine By FDA


Citizens’ Council for Health Freedom



Despite Letter From Citizens’ Council For Health Freedom, Full Approval Has

Been Granted To A Pfizer-BioNTech COVID Vaccine By FDA

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, 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, an online directory of direct-pay practices ( In 2018, CCHF published “Big Brother in the Exam Room: The Dangerous Truth About Electronic Health Records.”


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