The COMIRNATY Package Insert

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  • Source: UncoverDC
  • 09/19/2023

As the Biden Administration continues its relentless push to vaccinate every man, woman, and child in the United States, the FDA just released the package insert prescribing information for the Pfizer-BioNTech mRNA "vaccine" COMIRNATY. The insert reveals in distressing detail that—as the ongoing clinical trial continues—there is no safety or efficacy data for individuals 16 years and younger. And except for "postmarketing" data facilitating the need to add a section on myocarditis, pericarditis, and fainting, the insert is remarkably similar to the Emergency Use Authorization (EUA) prescribing information distributed in Dec. 2020 with the "Pfizer-BioNTech BNT 162b2 mRNA COVID-19 "vaccine." 

COMIRNATY and Pfizer-BioNTech: Continued Confusion

The release of COMIRNATY's package insert does little to clarify the confusion surrounding the "approved" COMIRNATY jab and the EUA Pfizer-BioNTech shot that is now being given as if it was COMIRNATY. While a Sept. 13, 2021 announcement on the National Institutes of Health (NIH) Daily Med database is a little more forthcoming on the two jabs, ultimately, it does little for clarification. The announcement states:

Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.

At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.

The above announcement from the NIH Daily Med database says, while the Pfizer-BioNTech EUA product is still available, the company will not produce the approved COMIRNATY vaccine. The FDA also reports the two are interchangeable, despite declaring the two are legally distinguishable from each other. Making matters even more complicated, revised (Oct. 29, 2021) label information for the Pfizer-BioNTech COVID-19 vaccine implies that EUA is in place for not just the Pfizer-BioNTech "vaccine," but for the COMIRNATY shot as well, stating:

"This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed."

Screenshot / Official Label Information

Screenshot / Official Label Information for Pfizer-BioNTech COVID-19 Vaccine-bnt162b2 injection, suspension

The "Official Label Information" datasheet, upon closer look, highlights the "Product Information" referenced in the above screenshot for the Pfizer-BioNTech/COMIRNATY COVID-19 vaccine, lists "TOZINAMERAN" as the active ingredient. On a global scale, the World Health Organization's (WHO) "COVID-19 Vaccine Explainer" (last updated Sept. 21, 2021) indicates the "COMIRNATY® (Tozinameran), COVID-19 mRNA vaccine (nucleoside modified)—Pfizer-BioNTech COVID-19 vaccine" is being administered by the organization under an "Emergency Use Listing" (EUL) since Dec. 30, 2020, with an updated EUL recommendation on Apr. 27, 2021.

For efficacy, the 9-page WHO fact sheet notes that those fully vaccinated with two doses showed efficacy of 95% based on a median follow-up of just two months. Notably, while declaring no post-introduction pharmacovigilance, when recommending the mRNA "vaccine" to pregnant women, the guidance reveals:

"Data from small studies have demonstrated that COVID-19 mRNA vaccines are immunogenic in pregnant women and that vaccine-elicited antibodies are transported to infant cord blood and breast milk, suggesting possible neonatal as well as maternal protection."

Screenshot / WHO COVID-19 Vaccine Explainer for COMIRNATY (Tozinameran)

Addition of Myocarditis and Pericarditis

COMIRNATY's insert includes a warning stating that postmarketing data of its mRNA inoculation discovered increased risks of myocarditis and pericarditis, "particularly within 7 days following the second dose." The FDA states the risk exists in males under the age of 40 and is highest among young men 12 through 17 years of age. The warning points out that there is currently no information on the likely long-term consequences of this condition. Yet, it says that "most individuals have had resolution of symptoms with conservative management."

The FDA's heart damage notice links to clinical considerations from the Centers for Disease Control and Prevention (CDC), which indicates the serious adverse events are specific to the two mRNA "vaccines" from Pfizer and Moderna. While acknowledging the mRNA products are at times triggering the body's immune system to cause inflammation of the heart muscle and the lining outside the heart, the CDC continues to promote COVID-19 experimental "vaccines" for everyone five years of age and older. Despite being in the midst of an ongoing clinical trial with unknown outcomes, the agency maintains the risk of COVID-19 illness and related, possible severe complications, including hospitalization and death, are behind the recommendation.

Adverse Reactions and Instructions for VAERS

Notably, while the EUA fact sheet for the Pfizer-BioNTech jab states it is MANDATORY for vaccination providers to report all vaccine errors and all serious adverse events to the Vaccine Adverse Events (VAERS), COMIRNATY's insert says "advise vaccine recipient to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System."

Screenshots of FDA Instructions for VAERS with Comirnaty and Pfizer EUA

FDA Package Insert Prescribing Information VAERS for COMIRNATY Vaccine

FDA Prescribing Information for VAERS for Pfizer-BioNTech EUA Vaccine, last updated 12/2020

Screenshots of FDA Listed Adverse Reactions for Comirnaty and Pfizer EUA

FDA's Adverse Reactions for Comirnaty Vaccine

FDA's Adverse Reactions for Pfizer-BioNTech EUA Vaccine

In addition to the underused VAERS for adverse events reporting, it is well known that it is not possible to sue vaccine manufacturers since the enactment in 1986 of the National Childhood Vaccine Injury Act. The act created the Vaccine Injury Compensation Program (VICP), which, since its inception and through Nov. 1, 2021, has compensated 8,369 claims, totaling $4,689,096,485.22.

Contained within the "Pfizer-BioNTech COVID-19 Vaccine- bnt162b2 injection, suspension" official label insert, is the question "What is the Countermeasures Injury Compensation Program (CICP)?" As of Oct. 1, 2021, the CICP has received 3,158 COVID-19 countermeasure claims. 1,357 allege injuries/death from the "vaccines," and 1,801 allege injuries/deaths from other COVID-19 countermeasures (such as ventilator). Still, the CICP is the payer of last resort and can only reimburse or pay for medical expenses or lost employment income not covered by other third-party payers. Paying just 29 claims totaling over $6 million since its first claim in 2010, the CICP has not compensated any COVID-19 countermeasure claims.

Explaining 'Clinical Trials Experience'

The "Clinical Trials Experience" information provided for the Pfizer-BioNTech EUA vaccine and COMIRNATY is very similar. Limiting the scope of information, both studies excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnoses of COVID-19. Interestingly, when speaking of the issuance of the FDA's emergency use authorization on Dec. 11, 2020, for the Pfizer-BioNTech "vaccine," as the two clinical trials were underway for that product, the recent COMIRNATY package insert from the agency states:

"Upon issuance of the Emergency Use Authorization (Dec. 11, 2020) for COMIRNATY, participants were unblinded to offer placebo participants COMIRNATY. Participants were unblinded in a phased manner over a period of months to offer placebo participants COMIRNATY."

Unblinding of the Clinical Trial

As previously reported, following the EUA for Pfizer-BioNTech COVID-19 shot—despite pleas for a placebo-controlled trial—during the middle of the phase 3 trial (intended to measure long-term side effects), the FDA allowed the drug manufacturer to turn the trial study from a placebo-controlled, blinded study into an open, observational study. Unblinded, the two cohorts were given the opportunity to take the experimental vaccine if they wanted to, and many chose to get the vaccine.

A May 18, 2021 article in the BMJ pointed out that it was unclear how the FDA would compensate for not having blinding and placebo-controlled follow-up, adding that "just months ago the agency said these trials were vital." Nonetheless, the article noted, "there is a growing gap of unknown size between any expectation of blinded placebo-controlled data, and the reality that within weeks of the vaccines receiving an EUA the unblinding of trials commenced as placebo recipients were offered the chance to get vaccinated." Stressing the importance of placebo-controlled data, the FDA's Philip Krause—who has pushed back against rapid COVID vaccine development and recently announced his departure from the FDA—and explained last December:

"Very often, it's the fact that we have that placebo-controlled follow-up over time, that gives us the ability to say that the vaccine didn't cause something at a longer period of time after vaccination."

Significantly, COMIRNATY's clinical trials information expands on the trial data initially offered by the FDA in Dec. 2020. The updated Pfizer trial data reveals that "study 2" in the clinical trials included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. As recently reported by UncoverDC, Dr. John Mascola, director of the Vaccine Research Center (VRC) at the National Institutes of Allergy and Infectious Disease (NIAID), has spent thirty years on HIV drug development attempting, unsuccessfully, to isolate a neutralizing antibody for the ailment.

However, with the SARS-CoV-2 outbreak, Mascola and fellow researchers switched gears from HIV to COVID-19 vaccines. As a by-product of the warp-speed vaccine operation, they were able to isolate a neutralizing antibody for COVID-19, and HIV vaccines based on Mascola's research became available for the first time. Although not highlighted in the news, Mascola and the National Institutes of Health (NIH) are admittedly "celebrating the gift of COVID-19 vaccines."

Pregnancy, Lactation and Pediatric Use

The FDA's information on pregnancy for both the Pfizer-BioNTech EUA shot and COMIRNATY report there is insufficient data on the "vaccines" to inform of vaccine-associated risks in pregnancy. Yet, the CDC insists, without question, "COVID-19 vaccination is recommended for people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future. There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems in women or men." 

Referencing a study in rats, the COMIRNAY insert from the FDA shares that a single human dose of COMIRNATY (to scale) was administered to female rats by the intramuscular route on four occasions: 21 and 14 days before mating and on gestation days 9 and 20. The study reported no vaccine-related adverse events on female rat fertility, fetal development, or postnatal development. Still, COMIRNATY's insert urges women who are vaccinated during pregnancy to enroll in a pregnancy exposure registry that monitors pregnancy outcomes in women "exposed to COMIRNATY during pregnancy."

Despite the WHO's previously mentioned suggestion that vaccine-elicited antibodies have been found in human breast milk, both Pfizer-BioNTech and COMIRNATY immediately state that it is unknown if the vaccine product is excreted in human breast milk. COMIRNATY's insert adds, "The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COMIRNATY and any potential adverse effects on the breastfed child from COMIRNATY or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine."

Both inserts confirm that the safety and effectiveness of Pfizer-BioNTech's "vaccines" in individuals 16 years and younger have not been established.


With mass clinical trials of COMIRNATY underway for the next few years, the name has substantial thought behind it. A Dec. 23, 2020 report in Fierce Pharma explains that when the Pfizer and BioNTech COVID-19 "vaccine" was rolling out in the U.S. under emergency use authorization (EUA), the name COMIRNATY had already been chosen. Indeed, in Dec. 2020, COMIRNATY was approved by Swiss and European regulators under a conditional marketing authorization. At the same time, its proprietary name, Tozinameran, was approved by the WHO.

To come up with the name, the heavyweight naming agency Brand Institute began working with BioNTech in April 2020, and Pfizer joined the effort soon after. Pronounced phonetically as "koe mir' na tee," Scott Piergrossi, Brand Institute president of operations and communications, said he was "humbled by the scale of the project and implications of the name." He added:

"The name is coined from Covid-19 immunity and then embeds the mRNA in the middle, which is the platform technology, and as a whole, the name is meant to evoke the word community. It was a challenging project relative to other projects because there's so much invested in this product—from a global economy standpoint, from a health and emotion standpoint."

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