On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) gave full approval to a Biologics License Application (BLA) submitted by BioNTech Manufacturing GmbH of Mainz, Germany on May 18, 2021 for a biologic drug called COVID Vaccine, mRNA. The FDA gave permission to BioNTech to label the product “Comirnaty” and market it in 2.0 milliliter (mL) glass vials, in packages of 25 and 195 vials.1
According to the FDA:
Comirnaty is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.2
The FDA states that Comirnaty has the same formulation as the experimental mRNA biologic produced by Pfizer and known as the “Pfizer-BioNTech COVID-19 Vaccine” or by its research name “BNT162b2.” The Pfizer-BioNTech COVID-19 Vaccine has been marketed and sold jointly by Pfizer and BioNTech since it received Emergency Use Authorization (EUA) from the FDA on Dec. 11, 2020.3
EUA for Pfizer-BioNTech COVID-19 Vaccine Reissued
The FDA reissued its letter of authorization for the Pfizer-BioNTech COVID-19 Vaccine on Dec. 23, 2020; Feb. 25, 2021; May 10, 2021; June 25, 2021 and Aug. 12, 2021. On the same day the FDA approved Comirnaty, the agency once again reissued its letter of authorization Pfizer-BioNTech COVID-19 Vaccine “in its entirety with revisions incorporated to clarify that the EUA will remain in place” for that product.4
In its Aug. 23 letter to Pfizer notifying the company of the reissuance of the EUA for the Pfizer-BioNTech COVID-19 Vaccine, FDA stated:
Pfizer-BioNTech COVID‑19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.4
The FDA’s letter to Pfizer also stated clearly that the Pfizer-BioNTech COVID-19 Vaccine has “not been approved or licensed by FDA, but has been authorized for emergency use by FDA… “4
Comirnaty and Pfizer-BioNTech COVID-19 Vaccine are Similar But Separate Products
It is a little confusing but, essentially, the FDA is saying that Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine have the same ingredients, the same recipe and are manufactured based on the same “processes and procedures.” While the FDA states that the two products are identical and may be used interchangeably, the FDA also declares that these two products are “legally distinct” without disclosing information or explaining how these products are legally distinct.4
Comirnaty, which is given as two injections into the arm at least 21 days apart, has been marketed in European Union (EU) since it received conditional market authorization from the European Medicines Agency (EMA) on Dec. 21, 2020. According to the EMA, the most common side effects of Comirnaty include “pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever.”5 The government of India has decided against granting emergency authorization for Comirnaty for use in that country. On Feb. 3, 2021, India’s COVID-19 Subject Expert Committee (SEC) rejected an EUA application for Comirnaty. The SEC reportedly cited “serious adverse events including anaphylaxis and palsy as well as the companies’ lack of safety and immunogenicity studies in the Indian population.”6
Full Liability Shield for Pfizer-BioNTech COVID-19 Vaccine and Comirnaty
By the FDA issuing a license to a Comirnaty and granting it EUA status on the same day, the FDA has created uncertainty surrounding liability for Comirnaty. Many are wondering whether Comirnaty has a different liability status than other EUA products now that it is licensed by the FDA. Under the PREP Act, Covered Countermeasures have liability protection except in cases of willful misconduct and any qualifying claims for serious injury or death as a result of the administration of an EUA product are heard by the Countermeasures Injury Compensation Program (CICP).7
On Dec. 3, 2020, a Fourth Amendment to the Prep Act declaration was issued which clearly states that a countermeasure that is licensed, approved, cleared or authorized by the FDA in response to COVID-19 will fall under PREP Act for purposes of liability.7
The day after the FDA licensed and provided EUA status to Comirnaty, as well as reissuing the EUA status for the experimental Pfizer-BioNTech COVID-19 Vaccine, the National Vaccine Information Center (NVIC) contacted the U.S. Health Resources and Services Administration (HRSA) to seek clarification about the legal liability of Comirnaty. HRSA administers the Vaccine Injury Compensation Program (VICP) that awards compensation for injuries arising from routinely recommended vaccines for children and pregnant women, and the Countermeasures Injury Compensation Program (CICP) that awards compensation for vaccine injuries sustained by vaccines that are in use as countermeasures and have EUA status.
NVIC received clarification from HRSA on Aug. 26, 2021, which stated:
Your question relates to which Program provides coverage, the CICP or the Vaccine Injury Compensation Program (VICP), for injuries alleged to have been caused by the newly licensed Pfizer COVID-19 vaccine.
As noted, the COVID-19 vaccines currently authorized through Food and Drug Administration (FDA) Emergency Use Authorizations or approved by the FDA are covered countermeasures under the Public Readiness and Emergency Preparedness Act and, therefore, individuals who allege injury as a result of the administration or use of such vaccines are eligible to apply for benefits under the CICP. Full FDA approval of the Pfizer COVID-19 vaccine does not remove its coverage from the CICP or provide coverage under the VICP.
HRSA’s response affirms findings in a report issued by the Congressional Research Service7 and federal law,8 which note that the FDA may grant EUA status to licensed products. As such, under the 2005 Public Readiness and Preparedness Act, “entities and individuals involved in the development, manufacture, testing, distribution, administration, and use” EUA-approved COVID-19 vaccines are immune from liability.
Accordingly, it appears that Comirnaty, despite being licensed and approved by the FDA, remains under EUA status and is considered a Covered Countermeasure under the PREP Act and any claims for injuries arising from its use will be covered by the CICP.
Lack of Transparency in FDA Licensure of Comirnaty and Public Access to Data
The FDA’s actions of licensing Comirnaty, determining that its use is interchangeable with the experimental Pfizer-BioNTech COVID-19 Vaccine, and granting it EUA status was all done on the same day and was accomplished without convening the FDA’s federal advisory panel to evaluate the data generated since their last meeting in December 2020.
The failure of the FDA to hold a public meeting of the Vaccine and Related Biological Products Advisory Committee (VRBPAC) prior to approving BioNTech’s Comirnaty deprived the committee of the opportunity to provide independent oversight and exercising their duty to make recommendations to the FDA based on their review and evaluation of the safety and efficacy data, including post-marketing surveillance safety and efficacy data as it relates to circulating COVID-19 variants.
On Aug. 30, NVIC requested that the FDA release data to the public that would have been released to VRBPAC, disclose what was meant by stating that the two products were legally distinct, and the impact of the interchangeability of these vaccines.
Notably, without a release of data from the FDA in this regard, it is unknown if the FDA’s June 2020 Guidance for Industry document, Development and Licensure of Vaccines to Prevent COVID-19, in which the FDA recommended that vaccine manufacturers be required to meet a minimal primary efficacy endpoint of at least 50 percent in preventing severe COVID-19 disease is currently being met.9 At the time of publication of this article, the FDA had yet to respond to NVIC’s request.10
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Click here to view References:
1 U.S. Food and Drug Administration. Approval Letter – Comirnaty. Aug. 23, 2021.
2 FDA. Comirnaty. Aug. 24, 2021.
3 Press release. FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine. FDA Dec. 11, 2020.
4 FDA. Letter of Authorization (reissued). Aug. 23, 2021.
5 European Medicines Agency. EMA recommends first COVID-19 vaccine for authorisation in the EU Share. Dec. 21, 2020.
6 Taylor NP. Asia-Pacific Roundup: India rejects Comirnaty EUA. Regulatory Affairs Professionals Society Feb. 9, 2021.
7 Congressional Research Service. The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures. Mar. 19, 2021.
8 21 U.S. Code § 360bbb–3(a)(2)(B) – Authorization for medical products for use in emergencies – Approval Status of Product. Cornell Law School.
9 U.S. Department of Health and Human Services – Food and Drug Administration (DHHS – FDA). Statistical Considerations. Development and Licensure of Vaccines to Prevent COVID-19 – Guidance for Industry. FDA June 2020; Pg 14.
10 National Vaccine Information Center. Letter to RADM Denise M. Hinton, Chief Scientist. Aug. 30, 2021.
September 2, 2021 60% of Those Older than 50 “Who Die from COVID” Are Double Vaxxed
STORY AT-A-GLANCE: “TrustWHO,” a documentary film produced by Lilian Franck, reveals the clandestine influences that are controlling the World Health Organization, to the peril of public health
What’s needed here are some good savvy lawyers who can pull apart this bait and switch scam that the FDA/CDC/HHS are part of. The regulatory agencies in the US needs a thoroughly house cleaning. Starting with Fauci
So if both products are covered under cicp, how are they legally distinct?
Rochelle P. Walensky of the CDC believes the shot is not experimental. Lying again from a regulatory agency. Imagine that!
Kaiser Permente mandating the rnma vaccines for all employees, or lose your job. There are no clear stats but it appears most religious exemptions are being denied. So we’re going to lose our 10 year job, lose our medical coverage, and have to hit the job market with disabilities we coincidentally picked up during this working period. We have done nothing wrong, have hurt nobody, and have good employment record. But to lose our jobs for not getting a vaccine, even though we are remote work from home permanent basis? The injustice imposed by these mandates appears worse than the disease itself. We have not gone out. We have not infected other people. We have followed cdc guidance on distancing, hygiene, and masks. And now we’ll have to take tremendous financial losses because the state of Colorado and this corporation need someone to blame. Because by using the force of government, that somehow eliminates diseases in the wild? We’re more likely to acquire and transmit this with weekly and bi weekly testing nonsense. The Kaiser SEIU workers union has failed us miserably. Nobody even is asking or testing for antibodies with these blanket policies.
Colorado, I’m sorry to hear that they’ve gone total commie on you. This is happening more and more, there are a lot of protests that are not being covered in the media, but apparently health care workers who won’t take the shot, some are working for private companies that don’t force a potentially lethal vaccine on their employees. It’s better to not take the shot, IMO because if one does take it and dies, there are no repercussions from any agency.
I wonder if anyone has tried to sue Fauci, Gates or Biden personally for this destruction of our remaining “liberties”.
I note no one (except for communist controlled NPR) is saying Ben Franklin’s quote:
“Those who would give up essential liberty to purchase a little temporary safety, deserve neither liberty nor safety.”
Never ever take these vaccines. Don’t take ANY vaccines. You submit yourself to experimentation via injection day. Don’t do that.
@Redpill: The efforts of lawyers (even phenomenally brilliant ones) will have no effect or make any progress against FDA/CDC/HHS.. as the Financial Liability Immunity Clause that was slipped into a 1986 Spending Bill (under Reagan’s watch) protects all vaccine manufacturers against any and all claims for compensation due to damages suffered after receiving one of the vaccine products. Recently, Robert F. Kennedy Jr litigated a landmark case in US Supreme Court against US vaccine manufacturers (and won). Among the points proven were failure by the manufacturers to provide results of safety studies of the vaccines produced, which they had agreed to as part of the immunity clause.
If Cominarty has”virtually the same formula” and is meant to “PREVENT” Covid this is a lie because either it is different formula or they are lying about the Prevent part because the current Pzfizer biontech shot clearly states on the PPI that it neither prevents infection or transmission but only makes symptoms milder. Also when did they study this new shot; or have they been giving it all along without our knowledge? Since Pfizer unblinded the original study after only 3 months; maybe they continued the study by giving different kinds of vaccines according to region or race or religion according to batch numbers. They certainly know & can track who took which batches and could get away with it unless samples were obtained & analyzed by experts. Why would anyone trust any of these serial convicted felons with their lives?
Your job or your life is the choice we are given.
SARS CoV2 aka ‘covid-19, CDC, FDA even A Toenail Faucci etc are each & every one full-blown deceitfully dishonest. Should anyone-everyone eventually ask why….
This alleged ‘virus’ has not and never will be scientifically-medically isolated. It’s all fake as the day is long.
Last but more important than all the others combined:
Ephesians chapter 6 verses 12-13: “For we wrestle not against flesh and blood, but against principalities, against powers, against the rulers of the darkness of this world, against spiritual wickedness in high places. Wherefore take unto you the whole armour of God, that ye may be able to withstand in the evil day, and having done all, to stand.”
What a disappointment yet not surprising the FDA has failed to respond to NVIC’s request. I see it as a red flag.
The fraudsters at the FDA are pathetic along with being dangerous. All part of MIMMAC. The Military Industrial Media Medical Academic Complex. The goal is total control over your lives from cradle to grave and one world government. Welcome to the world of the United Nations Agenda 21 and 2030
What is COVID other than a scam, its your Certificate of Vaccination ID. Take your jab and die. These people don’t care.
“If I were reincarnated I would wish to be returned to earth as a killer virus to lower human population levels.”
Prince Phillip, Queen Elizabeth’s husband, Duke of Edinburgh, leader of the World Wildlife Fund
Sep 5, 2016 Suzanne Humphries, MD, speaking on Polio at the Association of Natural Health Conference edit 5 2015
Medical Doctor Susan Humphries speaks on Polio at the Association of Natural Health Conference. Original posting 2/2013, edited for time with emphasis on the talking points regarding toxicology and statistical redefinition, reposted 5/2015
EUA’s are authorized when there are no other effective treatments (yeah, CDC et al does noconsider Hydrocloriquine and Ivermectin effective). So now that we have an authorized product in Corminaty (say that one 5 times fast …), shouldn’t the CDC then revoke the EUA’s for Moderna, Johnson and Johnson and the original Pfizer vaccine?
Lets hope that this is the start of unraveling, we need more brave people like this on e to step up……….https://worldfreedomalliance.org/au/news/india-charges-who-scientist-soumya-swaminathan-for-mass-murder-the-beginning-of-accountability/
I wonder too that the health insurance companies should be sued as well, because I get so many emails saying to get vaccinated from them, however, they will not cover any vaccine injuries… this is a crime for them to push you to do something that could cause harm for life.
Also one more thought, how do we stand up together, because to sue the criminals, with judges that are paid off, won’t work, the media is paid off, To do marches and fight against this on the streets, the black lives matter last year, no cops, I think has silenced more people, even more, to stand up. It has been very well orchestrated, and it is crazy that people don’t see it.