All three major Covid-19 ‘vaccine’ manufacturers have unveiled new names for their ‘fully authorized’ jabs, even as two pharmaceutical companies await FDA approval for their products. Following the lead of Pfizer/BioNTech, which branded its ‘fully authorized’ (and oddly, unavailable) vaccine “Comirnaty,” the second and third largest manufacturers for Europe and Canada, Moderna and AstraZeneca, are also relabeling their Covid shots.
“The Pfizer-BioNTech vaccine is Comirnaty, the Moderna vaccine will be named SpikeVax, and the AstraZeneca vaccine will be named Vaxzevria,” Health Canada said in a tweet Thursday. “These are only name changes. There are no changes to the vaccines themselves,” Health Canada added in an attempt to quell confusion. But even vaccine supporters were confused by the name changes.
I don't understand WHY this is being done, I fully support vaccines and wish everybody would get vaccinated…. but I assure you, whoever made the decision made a bad one. Antivaxxers are going to have a field day with this change, and that's very sad.
— JB 🍁 (@Parapraxis1980) September 16, 2021
Why? Why further confuse/intimidate those who are vaccine hesitant? I understand these vaccines need actual trade names but seems this should be low priority. Send vaccines where they are needed and work to curb hesitancy. https://t.co/wxzN5Mftgw
— MJ Rafanan (@ehmjayraf) September 16, 2021
That wasn’t the only thing that is raising questions, however. Despite Pfizer having a ‘fully authorized’ vaccine, the vaccine manufacturer admitted that it was still sending the Covid ‘vaccine’ under the label that was initially produced under Emergency Use Authorization in the United States and under Interim Order Authorization in Canada. On Thursday, Pfizer received ‘full authorization’ in Canada, as it stated in a release.
“Pfizer Canada ULC and BioNTech SE today announced that Health Canada has granted full approval (Notice of Compliance or NOC) for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older,” Pfizer said.
“The vaccine was initially authorized for use in Canada under an Interim Order Authorization on December 9, 2020 and has been referred to as the Pfizer-BioNTech COVID-19 Vaccine,” the release said. “The authorization permitted essential rollout of vaccine doses across Canada to help provide protection during the COVID-19 pandemic, based on preclinical and clinical data, including initial data from the Phase 3 clinical trial.”
“Although the vaccine’s brand name will be COMIRNATY following this approval, Canada will continue to receive vials of the vaccine labeled as Pfizer-BioNTech COVID-19 Vaccine.,” Pfizer continued. “The formulation for Pfizer-BioNTech COVID-19 Vaccine is the same formulation as COMIRNATY and they are considered interchangeable by Health Canada to provide the COVID-19 vaccination series. Given the current ongoing pandemic, a gradual transition to new labeling with the COMIRNATY brand name will occur at a later date.”
All three of the vaccine makers’ name changes have been approved for European Union distribution.
“Spikevax it is. Moderna has earned European Medicine Association approval for the brand name of its COVID-19 vaccine, even as it awaits an FDA decision,” Fierce Pharma noted.
“With last week’s official nod in the EU, Moderna’s Spikevax joins Pfizer and BioNTech’s Comirnaty and AstraZeneca’s Vaxzevria with European brand-name approvals,” the report continued. “None of the names is approved in the U.S., though, because the vaccines are still under emergency use authorization rather than bearing full FDA approval.”
“Still, it’s likely the companies are fielding the same brand names in their vaccine applications filed or soon-to-be-filed with the FDA,” the report added.
It is additonally interesting to note how these ‘vaccines’ are described by the European Medicines Agency.
“Spikevax contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19,” EMA said. “Spikevax does not contain the virus itself and cannot cause COVID-19.”
“Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2,” the EMA also said. “Vaxzevria does not contain the virus itself and cannot cause COVID-19.”
A closer examination of the documents issued by Pfizer/BioNTech after FDA approval provides some potential insight into why the vaccine makers want a new label for their ‘fully authorized’ vaccines.
“On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the Act,” the FDA stated in a letter to the Global Senior Director of Pfizer Ms. Elaine Harkins. “FDA reissued the letter of authorization on: December 23, 2020, February 25, 2021, May 10, 2021, June 25, 2021, and August 12, 2021.”
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
PhD. biochemistry and molecular biology student Kathleen Lee picked up on the change in language and decided to press further.
I called the Pfizer BioNtech number 1-800-666-7248. The recording clearly states that it has not been approved by the FDA. Pfizer BNT162B2 is still under EUA. This clears up that messy FDA authorization between Comirnaty and Pfizer BioNtech
— DrKatPhD🐭 typer of typos (@KathMLee1) August 25, 2021
“I called the Pfizer BioNtech number 1-800-666-7248,” she said. “The recording clearly states that it has not been approved by the FDA. Pfizer BNT162B2 is still under EUA. This clears up that messy FDA authorization between Comirnaty and Pfizer BioNtech.”
“It’s deceitful,” Lee claimed. “If the vial says Comirnaty- It’s FDA approved. It the vial says Pfizer BioNtech- it’s under EUA and they’re not subject to liability. There’s millions of doses to get rid of first.”
Yet if the next batch of vaccines being dispensed were being produced under the Cominarty label, then that would appear to reconcile the issue.
Except that isn’t the case. Buried deep within the footnotes of the Pfizer-BioNTech documents is one footnote that puts into rather jolting perspective that the currently labeled vaccines are still under Emergency Use Authorization (EUA).
“Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in this EUA.”
The profound implications of this admission was mentioned by notable vaccine critic Alex Berenson, formerly of the New York Times and a best-selling author on the subject.
“So now that Come-Here-Naughty is approved (ish), the [Moderna] and [Johnson & Johnson] lose their Emergency Use Authorizations, right?” Berenson asked. “Because there’s an approved alternative and you can’t have an EUA when there are ‘adequate, approved, and available alternatives’.”
“Or is this another reason [the FDA] is going out of its way to say Comirnaty is not available?” Berenson continued. “[A]lthough COMIRNATY (COVID-19 Vaccine, mRNA) is approved… there is not sufficient approved vaccine available for distribution to this population.”
Attorney Robert Barnes also addressed the perplexing matter.
There is no *available* FDA approved licensed vaccine. Here's what is happening. If FDA approved & licensed COVID19 vaccine, it would have to revoke the EUA vaccines & subject the vaccine maker to more liability risk. So it only approved a future vaccine that isn't "available".
— Robert Barnes (@barnes_law) August 25, 2021
“There is no *available* FDA approved licensed vaccine,” Barnes said. “Here’s what is happening. If FDA approved & licensed COVID19 vaccine, it would have to revoke the EUA vaccines & subject the vaccine maker to more liability risk. So it only approved a future vaccine that isn’t ‘available’.”
When a user questioned his analysis, Barnes countered with an indisputable legal point.
Did you fail to read the part of the FDA letter where it said the licensed vaccine isn't "available" yet? How is there ANY EUA vaccines when the law does not allow them if there is a licensed vaccine available?
— Robert Barnes (@barnes_law) August 25, 2021
“Did you fail to read the part of the FDA letter where it said the licensed vaccine isn’t ‘available’ yet?” Barnes asked. “How is there ANY EUA vaccines when the law does not allow them if there is a licensed vaccine available?”
If the Pfizer-BioNTech vaccine is a ‘fully authorized’ vaccine, then it should no longer be afforded the liability protections offered by the EUA. The other vaccines should also cease being distributed under an EUA. However, since this is not the case, we can only assume that it continues to be one giant sham.
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OPINION: This article contains commentary which reflects the author's opinion.