The U.S. Department of Defense by law cannot mandate a medical product unless it’s fully licensed, and there are no fully licensed COVID-19 vaccines available in the U.S. That’s just one of the reasons there are 23 lawsuits challenging the military’s mandate.
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The COVID-19 vaccines granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) are voluntary products that cannot be administered to military personnel and civilians without informed consent.
In the military, this voluntary consent requirement for investigational drugs was upheld in the anthrax vaccine case, Doe v Rumsfeld (2003), which determined that in the absence of a presidential waiver, the U.S. Department of Defense (DOD) can legally mandate vaccines only if they are FDA-approved.
The voluntary consent requirement for COVID-19 EUA vaccines remains in place, despite false reports that the currently available EUA Pfizer-BioNTech and Moderna products have a Biologics License Application (BLA) and are FDA-approved.
Comirnaty had an expired marketing date on the FDA-approved BLA when the DOD mandated it, and Pfizer is not distributing Comirnaty in the U.S.
As a result, military personnel and civilians are within their legal rights to refuse the vaccine, per Title 21 U.S. Code §360bbb-3(e)(1)(a)(ii) and related regulations.
This article will detail how the courts clarified DOD was implementing an illegal vaccine mandate in November 2021, and how despite that, the DOD continues to coerce vaccine uptake and punish for noncompliance — similar to what occurred during the years following the illegal experimental anthrax vaccine mandate.
Congress should investigate DOD’s illegal enforcement EUA drug mandate
On Aug. 23, 2021, behind closed doors and without public discussion, the FDA approved a BLA (BLA125742) for the Comirnaty SARS-CoV-2 vaccine. The BLA expired the same day it was issued.
On Aug. 24, 2021, the DOD issued a vaccine mandate for a drug that did not exist and did not have an active BLA.
For the majority of vaccinations that occurred under the DOD mandate from August to December 2021, there was no license for the drug.
Congress has probable cause to investigate the DOD for two reasons.
First, the DOD knew the drug’s license was expired prior to the military mandate. Second, the DOD knew and understood that an EUA-labeled drug cannot be substituted for an FDA-approved drug, as clearly indicated in Doe v Rumsfeld.
In a future Congressional oversight investigation, the DOD must prove that it did not willfully enact an illegal mandate of the SARS-CoV2 vaccine.
The secretary of defense must also admit he knows the FDA-approved Comirnaty vaccine is not available to service members, and also that he knows the Comirnaty vaccine would have a BLA label with distinct National Drug Codes.
On Sept. 13, 2021, the National Institutes of Health published an announcement stating:
“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.”
On Sept. 14, 2021, the acting assistant secretary of defense published a memorandum stating the Pfizer-BioNTech and Comirnaty vaccines can be used “interchangeably.”
This resulted in an increase in vaccination uptake across the branches of the military.
However, there are very strict FDA requirements for “Biosimilar and Interchangeable Products” and these requirements would make it an unprecedented for an EUA drug to be approved as biosimilar to an FDA-approved drug, with additional testing required for biosimilar approval and comparison to the, in this case, not-yet-produced Comirnaty.
“There are no data available on the interchangeability of COMIRNATY with COVID-19 vaccines from other manufacturers to complete the vaccination series. Individuals who have received 1 dose of COMIRNATY should receive a second dose of COMIRNATY to complete the vaccination series.”
FDA-approved drugs have marketing requirements, packaging and labeling requirements, package insert and informed consent fact sheet requirements, designated facility and product manufacturing requirements, and distribution and administration requirements that are different from those for EUA drugs.
The DOD communicated the concept of “interchangeably” in violation of the FDA requirements for biosimilar substitutions and in violation of the law, under the Doe v Rumsfeld ruling.
FDA, Pfizer and Congress colluded to deceive public
The FDA colluded in misleading and confusing the public by violating its own requirement that an EUA drug, for which pharma companies can’t be held liable if the product causes injury, cannot coexist in the market with its FDA-approved counterpart — which does not come with the same liablity protection.
As previously reported by The Defender, the FDA informed product recipients in a fact sheet that both BioNTech and Comirnaty are actually under EUA liability shield protections:
“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.”
The FDA approved Comirnaty yet continued to allow Pfizer to sell stockpiles of the EUA Pfizer-BioNTech vaccine, stating:
“In the August 23, 2021 revision, FDA clarified that, subsequent to the FDA approval of COMIRNATY (COVID-19 Vaccine, mRNA) for the prevention of COVID-19 for individuals 16 years of age and older, this EUA would remain in place for the Pfizer-BioNTech COVID-19 Vaccine for the previously-authorized indication and uses.”
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On Aug. 23, 2021, Pfizer published a letter for healthcare professionals in which the company falsely claimed some lots of EUA Pfizer-BioNTech vaccine are considered “BLA-approved,” despite having a legally distinct EUA label:
“Many lots of Pfizer-BioNTech COVID-19 Vaccine are in circulation that were authorized for emergency use, and are labelled in accordance with the EUA. Some of these lots comply with the recently approved BLA for COMIRNATY and are therefore considered “BLA-approved” lots for administration to individuals 16 years of age and older.”
Attorneys and health policy analysts in September 2021 outlined for Congress via a Congressional Research Service report how the Comirnaty and Pfizer-BioNTech are legally distinct.
Here’s an excerpt from the report:
“Why did FDA refer to Comirnaty and the Pfizer-BioNTech vaccine as ‘legally distinct’?
“In the EUA, FDA states that the Comirnaty and Pfizer-BioNTech vaccines ‘are legally distinct with certain differences that do not impact safety or effectiveness.’ While the Comirnaty and Pfizer-BioNTech vaccines have the same formulation, they are legally allowed to be marketed and used pursuant to different legal authorities.
“Specifically, Comirnaty is licensed pursuant to a BLA issued under the Public Health Service (PHS) Act (42 U.S.C. §262). The Pfizer-BioNTech vaccine is authorized for emergency use pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. §360bbb-3).
“Each product must be manufactured, labeled, marketed, distributed, and administered in accordance with the requirements of the legal regime under which it was approved or authorized. These requirements may differ in a number of ways.
“For example, under the EUA, the Pfizer-BioNTech vaccine must be accompanied by fact sheets for the vaccine administrator and recipient informing them, among other things, of the product’s emergency authorization, known and anticipated risks and benefits, and the right to decline the vaccine [emphasis added]. Comirnaty need not be accompanied by this information if it is being administered pursuant to the BLA rather than the EUA; instead, the PHS Act and other FDA regulatory labeling requirements apply.
“As another example, the Pfizer-BioNTech vaccine may be manufactured only at facilities identified and agreed upon in Pfizer’s EUA request, must be distributed directly by Pfizer or through authorized distributors to emergency response stakeholders (as defined in the EUA) as directed by the U.S. government, and must be administered by vaccination providers (as defined in the EUA) only to individuals 12 years of age and older.
“These limitations do not apply to Comirnaty vaccines manufactured and distributed pursuant to the BLA; instead, the PHS Act and FD&C Act requirements apply. Comirnaty may be manufactured only at facilities identified and approved in the BLA.”
Court verdict questioned legality of DOD’s mandate enforcement
On Nov. 12, 2021, District Judge Allen Winsor stated in his ruling on Doe v Austin, (Case No. 3:21-cv-1211-AW-HTC), “The DOD’s interpretation of § 1107a is unconvincing.”
Judge Winsor wrote:
“On August 23, 2021 — roughly eight months after the EUA first became effective — the FDA approved a Biologics License Application (“BLA”) and issued a full FDA license to produce and distribute the vaccine and label it with its proprietary name, ‘Comirnaty.’ ECF No. 1-4 at 2-3.
“The BLA approval requires that Pfizer produce Comirnaty only at approved locations, subject to specific manufacturing, packaging, and labeling requirements. Id. at 2 (Doe v Austin, page 5).
“Notably, though, the plaintiffs have shown that the DOD is requiring injections from vials not labeled ‘Comirnaty.’ Indeed, defense counsel could not even say whether vaccines labeled ‘Comirnaty’ exist at all. ECF No. 45 at 48:5-7. (Although the DOD’s response said it had an adequate Comirnaty supply, it later clarified that it was mandating vaccines from EUA-labeled vials. See id. at 46:22-47:3.)
“In the DOD’s view, this is fine because the contents of EUA-labeled vials are chemically identical to the contents of vials labeled ‘Comirnaty’ (if there are any such vials). According to the DOD’s argument, this means servicemembers are not required to accept ‘a product authorized for emergency use.’ 10 U.S.C. § 1107a(a)(1).
“Rather, the DOD argues that once the FDA licensed Comirnaty, all EUA-labeled vials essentially became Comirnaty, even if not so labeled. ECF No. 45 at 60:1-3. Thus, the DOD argues, the ‘product’ injected is a chemical formulation that has received full FDA licensure — not merely an EUA — so § 1107a does not apply. Id. at 65:1-6.8.
“The DOD’s interpretation of § 1107a is unconvincing. For starters, FDA licensure does not retroactively apply to vials shipped before BLA approval. See 21 U.S.C. § 355(a) (‘No person shall introduce . . . into interstate commerce any new drug, unless an approval of an application [for FDA licensure] is effective with respect to such drug’ [emphasis added]).
“Thus, as a legal matter, vaccines sent before August 23 — and vaccines produced after August 23 in unapproved facilities — remain ‘product[s] authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act.’ § 1107a(a)(1).
“Section 1107a’s explicit cross-reference to the EUA provisions suggests a concern that drugs mandated for military personnel be actually BLA-approved, not merely chemically similar to a BLA-approved drug. And the distinction is more than mere labeling: to be BLA compliant, the drug must be produced at approved facilities, see ECF No. 1-4 at 2; 21 C.F.R. §§ 600.11, 600.20-.21, and there is no indication that all EUA-labeled vials are from BLA-approved facilities.
“Moreover, the DOD concedes that some of its current vials are not BLA-compliant, and that there is no policy to ensure that servicemembers get only BLA-compliant vaccines. See ECF No. 45 at 61:10-12. It is difficult to see how vials that the DOD admits are not BLA-compliant — and thus could only be EUA products — could fall outside § 1107a’s prohibition on mandatory administration.”
One detail Judge Winsor did not take notice of was the same-day expiration of the Comirnaty BLA on Aug. 23, 2021. (See page 23 of the original version of Comirnaty’s “Highlights of Prescribing Information.”)
If Judge Winsor were to revise his verdict summation, documenting the subsequent re-issuance of the BLA in December 2021 with different National Drug Codes and without a marketing expiration date, this would result in a more comprehensive record of the facts to benefit other pending lawsuits.
Despite this court verdict, the DOD refused to change course on the SARS-CoV-2 vaccine military mandate.
Similarly, with the anthrax vaccine, the DOD spent a decade in the judicial process defending what was ultimately decided as an illegal mandate of an experimental drug that eventually did acquire FDA approval years later.
During this time, service members faced court-martial, confinement, and loss of rank, pay and retirement benefits. Years of experience were lost in separated service members, specifically pilots. The personnel losses were not counterbalanced in the pursuit to protect the health of the force.
Again today, the DOD is struggling to meet recruiting goals, yet still remains steadfastly on course while negatively affecting the lives of thousands of service members and their families.
It is apparent that only Congress can provide the necessary oversight to prevent this mandate from exacerbating critical personnel shortages in the U.S. Armed Forces and to safeguard our national security.
Pharmaceutical contracts in the DOD are lucrative with 1.4 million active-duty personnel (with additional DOD civilians, National Guard, and Reserve units). These contracts with mandated populations remain profitable even with years of attorney fees.
There are currently 23 lawsuits by service members against the DOD SARS-CoV-2 vaccine mandate, and thousands of service members awaiting religious accommodation request approvals.
Other service members face involuntary separation for refusing a voluntary EUA drug. As of late April 2022, there is at least one marine at Quantico who was retained in an administration separation board after agreement with the defense lawyer that there was no possible way for the service member to comply with the vaccine order because FDA-approved Comirnaty and Spikevax are not available.
The FDA approved Spikevax using a similar bait-and-switch strategy as Comirnaty, adding to the evidence that the FDA acted unethically and the DOD should have reasonably known to verify the licensure and availability of these two products.
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