FDA Pulls Pfizer and Moderna EUAs, Doesn't Mention "Comirnaty" or "SpikeVax"
FDA Pulls Pfizer and Moderna EUAs, Doesn't Mention "Comirnaty" or "SpikeVax"
The mRNA Inoculation Is Dead. Long Live The mRNA Inoculation.
Yesterday the FDA abruptly ended the Emergency Use Authorizations for Pfizer’s and Moderna’s monovalent COVID-19 mRNA inoculations.
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
However, there are two relevant terms missing from their news release: “Comirnaty” and “SpikeVax”.
Comirnaty, readers will recall, is the brand name under which the Pfizer/BioNTech mRNA inoculation was granted full FDA approval.
SpikeVax is the brand name under which the Moderna mRNA inoculation was granted full FDA approval.
The Pfizer/BioNTech inoculation was approved on August 23, 2021.
We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.
The Moderna inoculation was approved on January 31, 2022.
We are issuing Department of Health and Human Services U.S. License No. 2256 to ModernaTX, Inc., Cambridge, Massachusetts, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.
These products are not covered under an Emergency Use Authorization, but have gone all the way through the full FDA approval process.
However, these products are monovalent preparations.
We know Comirnaty is a monovalent preparation because Pfizer describes it as a monovalent preparation.
Original [Monovalent] Vaccines
Comirnaty (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine that is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine are also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. The formulation for use as a primary series in individuals 12 years of age and older has a gray cap and label with a gray border.
Further, Pfizer’s Comirnaty.com website (which was taken down sometime after April 15, 2023), explicitly stated that no bivalent preparations had received FDA approval (emphasis mine).
Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b) (1) of the FD&C; Act unless the declaration is terminated or authorization revoked sooner.
When I visited the Comirnaty.com website while preparing this article I found it had been redirected to a different website, covidvaxoption.com. The Wayback Machine Internet Archive at https://web.archive.org has the original website archived as of April 15, 2023.
I attempted to archive the redirected website on the Wayback Machine Internet Archive but it doesn’t archive cleanly.
The SpikeVax website is still up, but it uses contradictory language regarding its status as an approved vaccine.
Based on the extant remarks made at the time, SpikeVax appears to also be a monovalent preparation, with Moderna’s bivalent preparation being covered under Emergency Use Authorization.
Certainly the FDA’s web page on bivalent COVID-19 inoculations did not use either “Comirnaty” or “SpikeVax” in describing the Pfizer/BioNTech preparations. That page used “Moderna COVID-19 Vaccine, Bivalent” and “Pfizer-BioNTech COVID-19 Vaccine, Bivalent” instead. That page was also taken down some time after April 8, 2023—that being the latest date the page was archived at the Wayback Machine Internet Archive.
It would appear, then, that neither company’s bivalent COVID inoculations were ever granted full FDA approval. Comirnaty and SpikeVax are not bivalent preparations, and neither company’s bivalent preparation is Comirnaty/SpikeVax.
This leads to a question: The FDA modified the Emergency Use Authorizations. Where does that leave the FDA Approved mRNA inoculations?
Bear in mind what the FDA news release actually says (emphasis mine):
The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
“Authorized” presumably refers to products covered under Emergency Use Authorization.
Comirnaty and SpikeVax enjoy a status of “approved”.
Why cancel the Emergency Use Authorization and not address the FDA approved monovalent preparations?
For that matter, why did Pfizer take down their Comirnaty.com website?
This is relevant because Cominarty has not, for the most part, been available in the United States. BNT162b2—the label applied to the Pfizer/BioNTech EUA formulation—is the formulation generally made available in the United States (although it has been reported that nine lots of Comirnaty were shipped and distributed in the United States).
This already caused Pfizer some heartburn, as Federal District Court Judge Allen Winsor
ruled in December of 2021 that Pfizer’s EUA product was legally distinct from Comirnaty.So long as the EUAs were in effect, in practical terms this was a distinction without a difference. However, the ending of the HHS Public Health Emergency makes that a distinction with a huge difference.
As I commented when Dementia Joe announced that the COVID PHE would end on May 11, ending the PHE notionally should end the EUAs.
Ending the emergency declarations means ending the Emergency Use Authorizations for the dangerous and toxic mRNA inoculations as well as the ineffectual PAXLOVID therapeutic from Pfizer. Ending the emergency declarations means ending Pfizer’s feeding at the public trough to push these poisons on people.
As a reader pointed out—and as was reported by CNN—the FDA’s position is that ending the PHE did not impair the EUAs.
The US Food and Drug Administration said Tuesday that when the Biden administration ends the emergency, existing emergency use authorizations for Covid-19 vaccines, tests or treatments will not be affected, and the agency may continue to issue emergency use authorizations.
“Importantly, the ending of the public health emergency declared by HHS under the Public Health Service Act will not impact FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met,” the agency said in a statement to CNN.
Since the start of the Covid-19 public health emergency, it “has allowed the FDA to provide important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders,” according to the statement.
In addition to the public health emergency, HHS has issued two other emergency declarations that provide broader access to medical measures for Covid-19. For instance, the emergency use authorizations for tests, treatments and vaccines are not tied to the public health emergency, but HHS will have to determine when to end the declaration that allows their use.
An HHS Fact Sheet regarding the termination of the PHE makes a similar assertion.
FDA’s EUAs for COVID-19 products (including tests, vaccines, and treatments) will not be affected. The ending of the COVID-19 PHE will not affect the FDA’s ability to authorize various products, including tests, treatments, or vaccines for emergency use. Existing EUAs for COVID-19 products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met.
How does Section 564
still apply if the PHE is ending on May 11?Section 564 establishes the EUA authority as follows (in subsection (a)(1)).
Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [42 U.S.C. 262], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).
Subsection (b) further clarifies the requisite declaration under which EUAs may be authorized.
(b) Declaration of emergency or threat justifying emergency authorized use
(1) In generalThe Secretary may make a declaration that the circumstances exist justifying the authorization under this subsection for a product on the basis of—
(A) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents;
(B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, of attack with—
(i) a biological, chemical, radiological, or nuclear agent or agents; or
(ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces;
(C) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or
(D) the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act [42 U.S.C. 247d–6b] sufficient to affect national security or the health and security of United States citizens living abroad.
As Katherine Watt of Bailiwick News outlined, HHS Secretary Xavier Becerra used a legal shell game to cancel the Public Health Emergency while retaining the PHE powers.
The emergency authorities held by the Health and Human Services Secretary under the Public Health Emergency (PHE) program of the 1944 Public Health Service Act, as established by Congress and President Reagan in 1983 and expanded by Congress and Presidents Bush I, Clinton, Bush II, Obama, Trump and Biden since then will not expire in May.
Current HHS Secretary Xavier Becerra recently — very quietly — extended his Public Health Emergency authority and derivative Emergency Use Authorization power, using slightly different wording, through a Federal Register notice effective March 15, 2023.
Specifically, what Secretary Becerra did without any fanfare was to quietly use the latter portion of Subsection (b)(1)(C) above to extend the EUAs in the absence of a PHE.
From the Federal Register Notice.
In light of this, I have now amended the February 4, 2020 determination to recognize the fact that there is ‘‘a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad’’ and that involves a biological agent, namely the novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019–nCoV, or SARS–CoV–2). (Emphasis added). If the current conditions change such that there is no longer a ‘‘public health emergency’’ within the meaning of section 564, the section 564(b)(1)(C) determination would remain in place because I have determined that there is also a ‘‘significant potential for a public health emergency’’ under that section. This avoids the need to issue a new determination under section 564 when there is no longer a ‘‘public health emergency,’’ but there is still a ‘‘significant potential for a public health emergency’’ involving SARS–CoV–2.
Interestingly enough, this change was made after both my article and the CNN article on the ending of the PHE.
Secretary's Becerra makes no mention of this finding in his open letter to US Governors dated February 9, nor is there any mention of this in any of the news releases by HHS either in March or February.
Thus, even though in his letter to US Governors Becerra states explicitly that the PHE is ending on May 11, he is continuing the PHE sub rosa.
Thank you for your ongoing partnership throughout the COVID-19 response. I write today to inform you that effective February 11, 2023, I am renewing for 90 days the COVID-19 Public Health Emergency (PHE) as declared under Section 319 of the Public Health Service Act. Based on current trends regarding COVID-19, the U.S. Department of Health and Human Services is planning for this to be the final renewal and for the COVID-19 PHE to end on May 11, 2023. Rather than 60 days’ notice, I am providing 90 days’ notice before the COVID-19 PHE ends to give you and your communities ample time to transition.
In effect, Becerra has extended the FDA authority to issue EUAs for as long as the SARS-CoV-2 virus exists (i.e., indefinitely).
Also, because there is no formal PHE declaration, Becerra appears to have no need to renew the PHE every ninety days.
Which brings us back to the awkward question of where the FDA approved monovalent mRNA inoculations Comirnaty and SpikeVax stand.
By stating that there are no monovalent inoculations “authorized”, has the FDA also summarily rescinded the approval for Comirnaty and SpikeVax? Because there is a technical legal distinction between “authorized” and “approved”—i.e., “authorized” means under the auspices of an EUA, while “approved” means full FDA approval—arguably Comirnaty and SpikeVax are unaffected by this announcement.
However, the FDA has consistently muddied the waters by maintaining an EUA for both the Pfizer and Moderna formulations despite there being a full FDA approved version of each.
Pfizer and BioNTech are certainly producing their mRNA inoculation under the Comirnaty label. In March the Health Minister of Malaysia stated that over 44 million doses of Comirnaty were administered in that country alone.
A total of 44.8 million doses of Comirnaty (Pfizer) Covid-19 vaccines were administered in the country, says Dr Zaliha Mustafa.
The Health Minister said the doses were administered between Feb 24, 2021, and Dec 31 last year.
"The adverse events following immunisation (AEFI) reporting system under the National Pharmaceutical Regulatory Agency (NPRA) recorded a total of 20,153 reports which equates to 450 reports out of every one million doses.
However, for whatever reason, Comirnaty appears to never have been distributed within the United States. Moreover, Comirnaty appears not to have a bivalent formulation. Pfizer has chosen to rely on the EUA mechanism for gaining regulatory approval of both the monovalent and bivalent formulations for the US market. FDA approval was gained, only to be effectively abandoned in favor of the EUA.
With the HHS shell game so that the ending of the COVID Public Health Emergency does not impair the FDA’s authority to grant EUAs, and this termination of the EUAs granted for the monovalent mRNA inoculations from both Pfizer and Moderna, coupled with their complete silence on the FDA-approved versions of these same inoculations, the HHS and the FDA are in effect confirming that the more rigorous approval process for new therapeutics is what is really being terminated here. COVID-19 therapeutics in particular, but ultimately therapeutics for any medical condition, can now be authorized instead of approved—all it takes is a magical “finding” by the HHS Secretary that a “potential” threat exists. There will be no regulatory hearing. There will be no legislative oversight.
By positioning the bivalent mRNA inoculations as the formulations which will survive the expiration of the PHE declaration, and by asserting the FDA’s legal authority to extend the EUAs for those formulations beyond that expiration, the FDA is establishing that, at its whimsy, it will allow Big Pharma to push new drugs out onto the public without even lip service to the clinical trial rigor the approval process nominally imposed on new therapeutics.
The mRNA inoculation is dead. Long live the mRNA inoculation.
District Court for the Northern District of Florida, Winsor, A. DOE et Al v. AUSTIN et Al. Case 3:2021cv01211. 12 Nov. 2021, https://lynnwoodtimes.com/wp-content/uploads/2021/12/WINSORORDER.pdf.
Wow. Something is going on.
Line all the bastards up and let us give them the vaccines to be sure they are getting them and let us see how the issues with adverse reactions affect them not just the children.
I am tired of the rules for thee and not for me by those with no experience.