Comirnaty & The Legal Conundrum
Today’s critical thinking question:
Is the Pfizer-BioNTech (Pfizer) COVID-19 vaccine the same as the Pfizer Comirnaty (Comirnaty) vaccine and is the Emergency Use Authorization (EUA) for Pfizer still in effect?
With the vaccine topic being so polarized and political, there are so many views about the authorization versus approval of the Comirnaty licensed vaccine. Let’s breakdown some of the U.S. Food and Drug Administration (FDA) language.
"Authorization" or "EUA" means the product is authorized for emergency use during a declared national emergency (Emergency Use Authorization, EUA).
"Approval", "Approved" or "Licensed" means the FDA has approved the use of the product without the stipulation of a national emergency.
Currently, in the United States, there is one "approved" vaccine product and that is the licensed Pfizer Comirnaty product.
I know you are thinking "but, Dr. Jill, they are the exact same product!"
To that, I say, "I challenge you to read carefully and think critically."
According to the FDA Biologics License Application (BLA) Approval letter dated August 23, 2021, Comirnaty is the same as the Pfizer-BioNTech COVID-19 Vaccine with small differences that do not change the safety or effectiveness, however, both the Comirnaty and Pfizer-BioNTech vaccines are “legally distinct”.
The major point here is that the population at large believes the Pfizer product (licensed or not) is fully approved by the FDA and they feel safer to choose to take the jab versus lose their careers and livelihood.
So, what does “legally distinct” mean?
According to powerthesarus.org,
“legally. adverb. by law; conforming to the law. distinct. adjective. (often followed by `from') not alike; different in nature or quality.” So, according to the laws that restrict the use and perhaps authorization/approval for the vaccine products are not alike or different in nature or quality.
Interesting…
The statement from the Q&A for Comirnaty (10/1/21) has a whole new meaning, now doesn’t it?
“Comirnaty has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”
When compared to the statement that was published the day the FDA approved the Comirnaty product, you have to question, "why did they add the 'legally distinct' statement? "
Let's read that again, shall we?
“The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed or approved vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine.”
And why did they remove the statement about using the doses distributed under the EUA to administer the vaccination series as if the doses were the licensed vaccine?
Now you are thinking, "Dr. Jill, you are making this more than it is, who cares if the licensed product is not what I get, they are both the same formulation".
Are they? Are you sure about that?
The initial Q&A statement (8/23/21) stated that the only population that the EUA covered was the ages that did not get approval for the two-shot series. At the time of approval of Comirnaty, people 16 and older were able to receive the 2 dose vaccination series. So, the EUA doses covered ages 12-15 and the third dose for immunocompromised.
Okay, seems legit, I suppose. But, why do they make a point to make the statement about logistics and the EUA covering the Pfizer BioNTech for all individuals 16 and older?
“The EUA will continue to cover adolescents 12 through 15 years of age and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. Additionally, for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years of age and older; this use is also now approved.”
Now you are saying, "Dr. Jill, you are making me wonder what the heck is going on here!"
Good!
I am glad we got to this point. Now, you tell me why the updated Q&A document says this:
“Yes. The EUA remains in effect for the two dose primary series in individuals 12 years of age and older and as a third primary dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromised. Additionally, the FDA authorized the vaccine for emergency use to allow for a single booster dose administered at least 6 months after completion of the vaccination primary series in certain populations.”
The FDA is telling you that the Pfizer BioNTech vaccine is still fully covered by the EUA which means they have "legal indemnity." You think you are taking the same exact product as the Pfizer Comirnaty and it is safe and effective and while you probably are taking the same product,
LEGALLY. THEY. ARE. DISTINCT.
If you are a visual person, see the table below.
The Pfizer EUA fact sheet for recipients and caregivers also notes that the vaccines are legally distinct, (see page 1 at the bottom of the page). If you want to read the in initial and updated EUA for Pfizer BioNTech vaccine, the document which shows the product is still under an EUA currently. In the Evil Over Profit w/ Dr. Jill & Broken (10/11/21) podcast episode, we mentioned, there is no law or executive order for the mandating of the vaccine for companies with 100 or more employees.
But don't take my word for it. Take a look at the Federal Registrar and see if you can find it.
IT.DOES.NOT.EXIST!
The only "vaccine mandates" are:
EO 14043: Requiring Coronavirus Disease 2019 Vaccination for Federal Employees
EO 14042: Ensuring Adequate COVID Safety Protocols for Federal Contractors
If and when the time comes for the government to enforce a monetary penalty on a company, they have no law to cite or reference!
We need to hold the line and request the law, ask for how we go about ensuring that if we are harmed by an experimental vaccine the company is taking responsibility since they are requiring it. Our medical freedom is severely at risk, and we need to act. Stand up, refuse, and do not quit!
Call Pfizer and question them, call the FDA and question them.
WE DEMAND TRANSPARENCY!
Call your representatives and demand a law prohibiting medical mandates, there is no precedent on forced vaccination!
Signed,
Dr. Jill
References:
Q&A for Comirnaty (COVID-19 Vaccine, mRNA) updated 10/1/21 https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
Q&A for Comirnaty (COVID-19 Vaccine, mRNA) From the day the FDA approved Comirnaty 8/23/21 Using Wayback archive https://web.archive.org/web/20210823233744/https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
