Vaccines: Full Approval – where, how?
How could the FDA recent letter, Letter of Authorization [1], be considered FULL APPROVAL when the document clearly and repeatedly uses the term EUA (Emergency Use Authorization)?
The document ends with a statement,
“This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.”
Further, the document states that:
“On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.”
“The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.”
“The Pfizer-BioNTech COVID‑19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders …”
“ Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that:
- This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older;
“I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals.”
For all practical purposes, this letter relates to the renaming of the Pfizer-BioNTech product as COMIRNATY. The following statement in the letter clearly explain this situation
“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.”
It is not uncommon that manufacturers of original products relabel their products for marketing or price advantages to sell them as generics. In such cases, regulatory authorities, including the FDA, grant them approval with minimal filing and administrative requirements, and the product approval is directly linked to the original product (safety, efficacy, and quality) data.
A similar situation is happening here, i.e., COMIRNATY is a generic version of the Pfizer-BioNTech vaccine. Therefore, if the original product is not approved yet and remains under EUA, how could a generic version be considered approved or fully approved? It cannot be.
The newly named product (COMIRNATY) is a version of the Pfizer-BioNTech vaccine, which is not approved and will go through the standard approval process in due course. Hence it will automatically follow the fate of the Pfizer-BioNTech vaccine.
On the other hand, it is to be noted that one of the conditions for EUA is the lack of availability of alternatives. For example [2]:
“Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”
Therefore, if COMIRNATY vaccine is considered APPROVED or FULLY APPROVED, then authorization of other vaccines would become null and void. As a result, those vaccines have to be withdrawn from the market. However, this does not appear to be the case. Therefore, all vaccines would remain in the EUA status.
In short, it could be argued that the assumption of FULLY APPROVED status is a false interpretation and conclusion. The status of vaccine use remains under EUA and is highly unlikely to be changed soon from EUA to approval because of the lack of scientific/experimental data supporting effectiveness against the virus [3].
[1] Letter of Authorization (Reissued), August 23, 2021 (https://www.fda.gov/media/150386/download)
[2] Emergency Use Authorization for Vaccines Explained. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained.
[3] The FDA Committee’s Review of Pfizer-BioNTech COVID-19 Vaccine: Unscientific, False and Deceitful. https://bioanalyticx.com/the-fda-committees-review-of-pfizer-biontech-covid-19-vaccine-unscientific-false-and-deceitful/
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JaKo
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Great interpretation, Saeed!
Why all the lawyers and MSM editors don’t get the facts straight?
Why it always have to be an honest / unaligned person (and in your case a true expert in this filed) to chop through the rubbish and come up with the facts as they are?
Isn’t it because all the “others” give more weight to their agendas than to the subject at hand?
Thank you!
Cheers, JaKo
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Saeed Qureshi
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Wow!
Thank you, JaKo, for your kind words. Very happy to know that you find my views/articles scientific and informative. Appreciate the feedback.
Regards
Saeed
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Howdy
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“Full approval could help overcome vaccine hesitancy, Eric Topol, director of the Scripps Research Translational Institute, wrote”
https://www.sciencemag.org/news/2021/07/when-will-covid-19-vaccines-be-fully-approved-and-does-it-matter-if-they-are
Sounds like a good ploy to me.
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Lunatictoctarian
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Or retards being retarded.
“We’re not just going to shoot the bastards…we’re going to murder…”
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Lunatictoctarian
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It’s funny shit that.
A black guy opening a song with “I murder your whole Sidhe…”
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richard
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It seems these vaccines have full approval in Europe according to someone I know from Germany. I find this quite bizarre.
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Carbon Bigfoot
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One of the aspects of the Pharmaceutical Industry manufacturing in 70s was good manufacturing procedures, (CMPs) which morphed into, best manufacturing procedures, (BMPs). I participated in these developments with a panoply of S&P Pharma Clients for 35 years. As a Licensed Professional ChE it was important to follow FDA guidelines primitive as they were “back in the day”. Rarely was I involved the chemistry of reactions (proprietary) my focus was on mirror polished 316SS reactors and process piping design & construction. More importantly installation of double osmosis water for injection (WFI) units and clean-in-place (CIP) process systems, to name a few.
As a backdrop being married to my engineering business cost me my first marriage.
In my second marriage my wife landed a position as an IT Enterprise Software Specialist that developed into a NA/European IT Director responsible for a 20 person department. In that position she was intimately involved with the whole FDA drug approval process, quality control, batch records, supporting documentation, etc.. As such she has a different take about this article and interpretation. Her unedited comment follow as a separate comment.
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Carbon Bigfoot's Wife
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I am retired after 15 years in Pharmaceutical industry. I have experienced the processes and regulations from Clinical Trial thru Commercial approval via the BLA. Even so, it is beyond challenging and no less than tedious to read through FDA materials. So, I found myself reading the August 23rd letter over and over until if could figure out what was being said. It appears it is a letter that not only confirms the approval of the BLA, but also a history of the EUA, and the impact into the near future. As such, I have a few items that I interpret differently than your summarization.
• The BLA approval was given to the product called COMIRNATY, as defined in the BLA for individuals 16 years and older. As you noted in your extractions from the letter, this product is the ‘same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably…..’. It is not generic.
o I have also lived through an approval process that was given after Phase2 clinical trials because the efficacy for the advanced disease was so compelling, the FDA authorized conditional use under its clinical name. Once the product completed Phase 3 Trials and the full submission was made for the BLA, the product was also given a “commercial brand name”, but it was still the same clinical product. Not generic.
• Now going forward you have to read the letter in context of Pfizer-BioNTech COVID 19 Vaccine and/or COMIRNATY. Most of the rest of this letter is discussing the original EUA rules, regulations and guidelines for this extension for the original Pfizer-Biontech COVID 19 Vaccine.
• On Page 12 is a separate section related to COMIRNATY – Use of Licensed Product. Sec AA clearly states COMIRNATY approval for use in individuals 16 years of age and older. It discusses the remaining original product produced under the EUA, and this EUA will remain in place for that previously authorized indication. This addresses your mention of “This product has not been approved or licensed by FDA…..” This statement is addressed to the labeling on the remainder of the original Pfizer-BioNTech COVID-19 Vaccine, not the COMIRNATY.
Sec BB addresses “authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals *(you left out this next part) 12 thru 15 years or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromised”. As I understand, this is the “certain uses not included in the approved BLA”, which are being covered now as part of the EUA.
Whew! To be clear, I am not condoning or condemning the vaccines. I am, like most everyone else, frustrated with the complexity of the landscape and trying to understand what is going on.
Thank you for your continued focus and insight on these issues.
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Qureshi
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Thank you very much for reading my article and providing feedback.
I do not think that your interpretation is correct. Unfortunately, you are reading the FDA document as they like people to read it, i.e., incorrectly.
I did not mean that COMIRNATY is a generic product. Sorry if it gave this impression. I meant the application (BLA) got approval like a generic version of an innovator product by the innovator, i.e., approved based on fulfilling minimal filing requirements.
You seem to be considering the same thing, i.e., the old product being given a commercial name (COMIRNATY). It means that it (COMIRNATY) is the Pfizer-BioNTech vaccine that is authorized under EUA. How could a product change the status from EUA to APPROVED just by giving a commercial name? It cannot be.
On the other hand, if you consider COMIRNATY a new or different product, then where is its safety and efficacy study (clinical trial) data. I do not see anything different, but references/links are made to the clinical trials conducted for the Pfizer-BioNTech vaccine. If I missed the trial details of another or new product, then please provide supporting information. I will be happy to reconsider my view.
To me, COMIRNATY’s “approval” is based on the same data on which Pfizer-NTech is granted EUA, so COMIRNATY should not be granted different status than that of Pfizer-NTech vaccine.
Please note that the FDA is a public agency working to protect the public interest/health, which is generally not well informed on the technical and linguistic aspects. Therefore, the agency should be straightforward in describing what the public should understand and follow easily and clearly.
For example, the agency should be direct in saying that COMIRNATY is approved for treating COVID, with no if or buts or thirteen pages of explanation describing differences between COMIRNATY and Pfizer-NTech.
If COMIRNATY is approved and exists (as you are saying as well – commercial name), then Pfizer-NTech does not exist. In fact, as I noted in my article, if COMIRNATY has been approved, then not only the Pfizer-NTech vaccine but all others must also be withdrawn because EUA cannot be granted to any treatment if an approved product is available.
In short, there is no approved vaccine available for COVID at present. So, unfortunately, scientifically, the FDA and others are making a false claim.
I hope this would clarify my view.
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Carbon Bigfoot
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And while we are on the subject, Stew Peters interviews Trump’s COVID HHS Advisor drop’s his Bombshell that the Task Force misled POTUS:
https://www.bitchute.com/video/tcWRMbwulvb3/
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Mohammed Javed
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I saw a comment talking about agendas – Yes, some give more weights to their agendas. I would say ‘hidden agendas’. Is it not true – Common man who goes to poll to choose his/her representative is manipulated to believe that lies are truths?
Covid-drama seems to be going on – now EUA and approval! If the great dramatist Shakespear was alive, would he not have a super great plot for his drama?
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