DoD Vaccine Lot Irregularities

September 01, 2022

Summary:

Pharmaceutical manufacturer (Pfizer) and government agency (FDA, CDC, CBER, and DoD) personnel know not which vials of COMIRNATY are licensed, available for ordering, inventoried, or meet the demands of SECDEF Austin’s mandatory vaccination requirements.  Trust is eroded and morale is destroyed.

Indisputable Facts:

Pfizer and the Center for Biologics Evaluation and Research (CBER) agree to label EUA products as BLA-compliant.

https://www.fda.gov/media/151733/download Page 27 (a) – “CBER requested and the Applicant (Pfizer) agreed that only EUA-labeled lots that had also undergone CBER lot release according to the BLA would be considered BLA-compliant and listed those lots at the website included in the ‘Dear Health Care Provider’ letter.”  No statute allows an experimental substance to be legally considered a full licensure drug.  Experimental drugs under an EUA require the voluntary consent of the individual to participate because of shielded liabilities and 21 USC §360bbb-3(L).  CBER personnel and Pfizer colluded for an experimental substance to be “considered” a licensed drug.  The mixing of statutes associated with full licensure drugs and experimental substances has significant legal ramifications for the pharmaceutical company and unwitting recipients.  Products offered as a full licensure drug must operate according to those statutes.

Pfizer received approval on December 16, 2021 to use NDC 0069-2025-X for the new Tris-Sucrose formulation packages but plainly stated they had no intention of manufacturing the product for months.  The CDC published the following in December of 2021: “Pfizer has provided the following statement regarding the COMINARTY branded NDCs and labels:”

“Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY).  At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.”

“Pfizer subsequently received approval to amend its FDA BLA License on December 16, 2021 to include its tris-sucrose formulation COVID-19 vaccine (COMIRNATY) for use in individuals 16 and older.  At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 3 new NDCs (0069-2025-10, 0069-2025-25, 0069-2025-01) and images of labels with the new tradename.”

“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.”

The CDC informed US Navy LT Bill Moseley on April 01, 2022 (almost 60 days later) in an email that Pfizer had manufactured neither the original formulation nor their Tris-sucrose formulation:

“0069-2025-01 – Tris-sucrose formulation.  Pfizer is not yet manufacturing product with the COMIRNATY label”

“0069-2025-10 – Tris-sucrose formulation.  Pfizer is not yet manufacturing product with the COMIRNATY label”

“0069-2025-25 – Tris-sucrose formulation.  Pfizer is not yet manufacturing product with the COMIRNATY label”

The CDC spokesperson informed USN LT Bill Moseley, “We meet regularly with Pfizer and Moderna and are closely tracking the plans for their vaccines and eventual transition from EUA labeled product to BLA tradename labeled product.  None of the NDCs you have cited are currently being manufactured/available for ordering.” 

On April 04, 2022 USN NAVMEDCEN SAN CA (USA) Civilian Robert C. Klant informed USN LT Moseley of the following: 

“Sir, we can’t sign your “unavailability” statement because it conflicts with what USAMMA is telling us, i.e. that the vaccine is actually available and can be shipped to NMCSD, with some advance notice (to mean not available at the time of request), if you decide to accept it.

We regularly rely on USAMMA for vaccine supply/distribution information of all kinds, not just COVID, and we have no cause to doubt their representations on this occasion.You’ll have to ask Pfizer/CDC why they are giving you conflicting information.”

On May 12, 2022 the CDC informed USN LT Moseley that “The information provided on 4/1/2022 is still correct.  The BLA licensed Comirnaty (Pfizer) and Spikevax (Moderna) vaccines are still not available for ordering.  Every effort is being made to first utilize the EUA labeled product that has already been manufactured and is still available.  The EUA products represent the exact same formulations manufactured under the same processes as the BLA licensed products.”

The FDA produced release letters for lots of “COVID-19 Vaccine, mRNA” (COMIRNATY license name) vials under the new NDCs contradicting CDC’s public statements about Pfizer not manufacturing COMIRNATY:

Lot 1330 released on March 01, 2022

Lot 1331 released on April 12, 2022

Lot 1333 released on April 20, 2022

Suzann Burk, Director of the Division of Disclosure and Oversight Management (DDOM) at the Center for Biologics Evaluations and Research (CBER), presented an affidavit in support of Coker v. Austin defense attorney’s motion to dismiss. 

Director Burk’s affidavit details information for COMIRNATY lot FW1331. The record shows that the product was manufactured on 01/28/2022. Additionally, the lot number utilizes NDC 0069-2025-X. She presented this document to lend credence to DoD’s claim of having licensed products to comply with SECDEF Austin’s mandatory full licensure vaccination requirements. The DoD is in possession of lot FW1331 and has informed service members these are “COMIRNATY labeled (FDA-approved)” vials. However, neither the DoD nor the DOJ claim these are full licensure drugs.

On August 31, 2022, the Defense Logistics Agency released an official statement regarding the shipment of COMIRNATY to DoD components. “We began shipping Comirnaty labeled vaccine in June 2022. From the week of June 13, 2022, through the week of August 29, 2022, we will have shipped 9600 doses (160 boxes) of vaccine.”

On August 31, 2022, the FDA updated the status for COMIRNATY utilizing NDC 0069-2025-X stating “there is no adequate, approved, and available alternative to Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19.”  The FDA has provided the same status for COMIRNATY since August 23, 2021.

Discrepancies:

CBER requested Pfizer to label EUA products as BLA-compliant, and Pfizer agreed, contradicting congressionally passed statutes.  Therefore, a court must be assured that products offered to service personnel are licensed and not just referred to as BLA-compliant since CBER and Pfizer have conspired to change the legal meaning of this phrase.

Pfizer was issued NDCs 0069-2025-01, 0069-2025-10, and 0069-2025-25 on December 16, 2021, but informed the CDC that they would not manufacture products under those codes for months.

Suzann Burk produced a document demonstrating that Pfizer manufactured COMIRNATY vials in January of 2022 only a month after Pfizer told the CDC they would not do so for some time.

CDC informed USN LT Moseley on April 01 and May 12 that Pfizer has yet to start manufacturing under those NDCs contradicting Pfizer’s documentation and CBER DDOM Director, Suzann Burk’s sworn affidavit.

USAMMA told the United States Navy in April of 2022 that they could order COMIRNATY contradicting CDC’s official statement.

Pifzer, who holds “regular” talks with the CDC, had not changed their official position about not manufacturing lots under those NDCs as of May 12, 2022.  This contradicts Suzann Burk’s testimony.

How did the FDA produce lot release documents for COMIRNATY vials using NDC 0069-2025-X when Pfizer told the CDC that they were not manufacturing under those NDCs?

Are these lot numbers also EUA products labeled as BLA-compliant, i.e., with a bogus label?  Did CBER grant permission to Pfizer to ship mislabeled vials with a ‘Dear Health Care Provider” letter? Is this the only reason the DOJ and DoD personnel refer to these lots as BLA-compliant and and not FDA-licensed?

The lot numbers associated with the DoD shipments have manufacturing dates prior to Pfizer receiving their marketing approval (May 18, 2022) for Tris-Sucrose and CDC’s statement and before the CDC received notification of Pfizer’s intent.

Courts must take the position that as long as an EUA is active, no licensed vaccines are available to the DoD for legal purposes of punishment.  An EUA by statute can only exist when no FDA-licensed products are available for general commercial marketing.

The United States Government has exclusive rights to all COVID-19 vaccines, and the DoD treats the approved product as an experimental substance. As a result, service members are not free to access approved products on demand. Furthermore, because of the FERES doctrine, US Government officials shield Pfizer from potential lawsuits by only providing “licensed” products (if factual) to DoD personnel and not under general commercial marketing activities.

Suzann Burk stated “I declare under penalty of perjury that the foregoing Exhibit 1 and the facts contained in this declaration are true and correct pursuant to 28 U.S.C. § 1746.”  Is she simply stating that the document is an official Pfizer document or is she attesting to the accuracy of the data contained within the document?  Therefore, Who is lying to the American people regarding COMIRNATY labeled vials within DoD?  Did the FDA lie about the lot release letters?  Did the CDC lie about Pfizer manufacturing COMIRNATY?  Did Pfizer lie about manufacturing COMIRNATY?  Has the FDA been lying to the American people since January 28, 2022 that there are no alternatives to Pfizer BioNTech COVID-19 Vaccine?  Why did CBER request Pfizer to state that EUA vials of BioNTech are BLA-compliant denoting a FDA-licensed product?

The DOJ produced an affidavit from CBER demonstrating that neither Pfizer, CDC, FDA, CBER, DOJ, nor the DoD can be trusted by any court to accurately determine the viability of licensed COVID-19 products within the DoD.  Therefore, Congress only authorized the HHS to issue EUAs if there are no licensed products available for general commercial marketing.  The FDA has issued several EUAs from August 23, 2021, through August 31, 2022, stating that no licensed products are available in the market, and courts must agree to that statement.  DoDI 6200.02 requires commanders to ensure service members’ right to refuse an EUA medical product is protected until the President issues a waiver.  Commanders have violated their oath of office by waiving the informed consent rights of DoD personnel without the authority of the President.  

The DOJ can not prove that the facts contained in Suzann Burk’s supporting affidavit are factual, given the significant conflicting statements by other official government agencies. Therefore, the court must dismiss Suzann Burk’s testimony with prejudice.