***The Iowa Standard is an independent media voice. We rely on the financial support of our readers to exist. Please consider a one-time sign of support or becoming a monthly supporter at $5, $10/month - whatever you think we're worth! If you’ve ever used the phrase “Fake News” — now YOU can actually DO something about it! You can also support us on PayPal at [email protected] or Venmo at Iowa-Standard-2018 or through the mail at: PO Box 112 Sioux Center, IA 51250

Officers representing five branches of the military submitted a memo, “Whistleblower Report of Illegal Department of Defense Activity,” to members of Congress this week informing how the Department of Defense (DOD) has unlawfully administered Emergency Use Authorized (EUA) COVID shots as if they are fully licensed Food and Drug Administration (FDA) approved products, in order to force service members to take the injection through unlawful threats against their careers and livelihoods.

Advertisement

The memo, submitted under the Military Whistleblower Protection Act, is signed by nine officers representing five branches of the U.S. military – U.S. Air Force, U.S. Army, U.S. Navy, U.S. Marine Corps, and U.S. Coast Guard. These whistleblowers are requesting that members of Congress promptly investigate the unlawful actions by the military and hold those responsible individuals accountable.

The memo states, “Please end illegal EUA mandates and all related fraudulent activity to ensure that our military can once again be counted on to uphold the rule of law in support of our Constitution.”

“Since 24 August 2021, the Department of Defense (DoD) has unlawfully administered Emergency Use Authorized (EUA) products (i.e., products authorized but not approved by the Food and Drug Administration (FDA)) as if they were fully licensed FDA approved products. Military members have not been allowed to exercise their legal right to refuse EUA products, despite the Department of Justice’s (DOJ) assertion that ‘Comirnaty-labeled’ vaccines only became available for the DoD to order on 20 May 2022. Evidence also exists that the new ‘Comirnaty-labeled’ products are not FDA approved in accordance with applicable laws.’”

The memo also points out that under the law, 21 U.S. Code section 360bbb-3(e)(1)(A)(II)(iii), recipients of an EUA product are required to be informed of their option to accept or refuse administration.

“This means that by law,” states the memo, “no one can mandate EUA products and the Government must inform recipients of their right to refuse. Service members are not being informed of the option to refuse administration of EUA products, nor are they provided with any other required information such as the risks associated with the product.”

The detailed memo calls into question the status of the new “Comirnaty-labeled” products and the evidence of “fraudulent labeling,” which would be a federal crime. The DoD has induced confusion by publishing memoranda asserting that the FDA-approved Comirnaty could be used interchangeably with EUA products.

“In a memorandum issued on 9 August 2021, Secretary of Defense (SECDEF) Lloyd Austin indicated his comprehension of EUA law, stating, ‘I will seek the President’s approval to make the vaccines mandatory no later than mid-September, or immediately upon the U.S. Food and Drug Administration (FDA) licensure, whichever comes first.’ On 23 August 2021, the FDA approved (fully licensed) the first COVID-19 vaccine under the trade name Comirnaty®. Of interest, the FDA ended its legal marketing status that same day. The next day, SECDEF issued a memorandum that stated ‘[m]andatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.’ Shortly thereafter, in a posting on the National Institute of Health website, enclosure (1), Pfizer announced they would not produce any of the licensed product ‘over the next few months while EUA authorized product is still available and being made available for U.S. distribution.’ For nine months afterwards, this lack of fully licensed product has been confirmed by hundreds of service members, who have provided military leadership hundreds of complaints, many with photo evidence, indicating all vials found in Military Treatment Facilities were EUA products. A Freedom of Information Act (FOIA) response from the Defense Health Agency (DHA) in April 2022, enclosure (2), confirmed DHA had no record of ‘Comirnaty’ COVID-19 vaccines being ordered, received, in stock, available, or administered to any service member by any service branch (Army, Navy, Marine Corps, Air Force, or Coast Guard).”

Assistant Secretary of Defense for Health Affairs (ASD HA), Dr. Terry Adirim, sent a memo on September 14, 2021, stating “these two vaccines are interchangeable and DoD health care providers should use doses distributed under the EUA to administer the vaccination series as if the doses were the licensed vaccine.” Dr. Adirim cited the FDA’s Q&A website to justify use of EUA Pfizer-BioNTech shots instead of Comirnaty. The website provided advice regarding the use of the EUA product to complete a “vaccination series,” stating medical providers could use the two products “interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns.”  However, the FDA website did not address the legal difference between the products.

Fully licensed products are required to follow all Biologic License Application requirements. Affixing a “Comirnaty-label” on a product that has not followed all BLA requirements constitutes fraudulent labeling – a federal crime.

In fact, the “CDC’s COVID-19 Vaccine Lot Number and Expiration Dates” states, “These files contain all lots for COVID-19 vaccines made available under Emergency Use Authorization (EUA) for   distribution in the United States. The vials and cartons for COVID-19 vaccines authorized under EUAs are not 2D barcoded following the standards used for products licensed by the US Food and Drug Administration.”

Whistleblower 1LT Mark Bashaw stated in the memo, “Using the CDC’s database, I was able to verify that the ‘Comirnaty Labeled’ vials with lot number FW1331, that has shown up on various U.S. military and U.S. Coast Guard bases, is listed on CDC’s COVID-19 Vaccines under Emergency Use Authorized list.”

Whistleblower LT Chad Coppin also presented testimony in the memo that, “On June 10, 2022, a shipment of 60 Comirnaty vials packaged in six boxes of ten vials, was received by my Coast Guard medical clinic in Juneau, AK. I found this interesting as they arrived unannounced to any service members and to date, FDA approved Comirnaty labeled vials had never been seen in the USA. Prior to this date, only emergency use authorization shots have been available to fulfill the DoD/DHS mandate. I inquired to my medical staff as to where these Comirnaty labeled vials came from and it was revealed that the vials were shipped to our medical clinic from the US ARMY at Ft. Detrick, MD. I called Ft. Detrick with the information I had received in an email regarding the shipping and arrival instructions of Comirnaty to our Coast Guard unit. A US Army civilian contractor answered my call and confirmed they had sent our unit the package of 60 vials (6 boxes of 10 vials each) of Comirnaty ‘grey cap.’ He explained to me that the Comirnaty labeled vials were sent to Ft. Detrick from the Kalamazoo, MI Pfizer plant and Ft. Detrick then shipped them to our USCG bases. I requested any information about manufacturing locations of this product and he mentioned that I would have to call Pfizer at Kalamazoo, MI for any additional information and that he had nothing further to provide me.”

LT Coppin also discovered that the Comirnaty product was manufactured in an unauthorized location.

He testified, “After many hours working through Pfizer’s customer service phone numbers to no avail, I eventually made contact with a Pfizer customer service representative on July 7, 2022 who could assist me with my question. The Pfizer Customer Service representative was able to look up our Lot number FW 1331 and stated as heard in the recording I have provided, that Lot FW1331 was manufactured in France…  The significance of the France manufacturing location is that it is not an authorized manufacturing location as per the FDA’s Comirnaty BLA Supplement Approval letter dated December 16, 2021. As written in the supplement approval letter to Mr. Patel, it states, ‘We have approved your request submitted and received on November 18, 2021, to supplement your Biologics License Application (BLA) under section 351(a) of the Public Health Service Act for COVID-19 Vaccine, mRNA {COM/RNA TY), to include a new 30 microgram dose formulation (Tris/Sucrose) of COM/RNA TY manufactured at the Pfizer Manufacturing Belgium NV, Puurs, Belgium (Pfizer, Puurs) facility.’”

“This invalidates the claim presented by Commanding Officers at Department of Defense and United States Coast Guard installations that the Comirnaty labeled vaccine being offered is actually FDA approved. Commanding Officer’s [Sic] are using this shipment of Comirnaty from Ft. Detrick to try and convince and coerce the remaining unvaccinated service members into compliance with their order to receive a fully FDA approved COVID-19 vaccine,” wrote Coppin.

The FDA played the same unlawful shell game last year when it announced it approved the BioNTech injection, Comirnaty. On October 20, 2021, the FDA sent a follow-up letter regarding the original approval to Pfizer pharmaceutical company that stated, “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 23, 2021 letter of authorization in its entirety with revisions incorporated to authorize for emergency use the administration of a single booster dose of Comirnaty.”

On page 7 footnote 13 of that letter, the FDA clearly states, “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” (emphasis added).

The FDA did a bait and switch by announcing it approved its “first COVID-19 vaccine” in order to push the “vaccine” mandates and protect the Pfizer pharmaceutical company from legal liability. The Pfizer injection, on the other hand, is still considered experimental under U.S. law.

The CDC stated that “Comirnaty products are not orderable at this time. NDCs are listed per FDA Structured Product Label (SPL) document for the BLA licensed product. These codes are not included in CDC Vaccine Code Set files at this time. Pfizer has provided the following statement regarding the Comirnaty 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. 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.’”

Liberty Counsel Founder and Chairman Mat Staver said, “Members of Congress need to immediately investigate these unlawful actions by the Department of Defense to stop the unlawful shot mandate and hold accountable those who fraudulently represented that the shots being administered were FDA approved. There is currently no fully FDA-approved licensed COVID shot available to the civilian population. Everything that is available remains under the EUA law. That means that people have the option to accept or refuse the shots. It is indisputable that for many months the military forced the shots when they knew they were under the Emergency Use Authorization law and not FDA approved. And now the recent narrative that the military has an FDA approved shot is highly questionable. Our military service members have been threatened and punished in violation of federal law.”

Author: Liberty Counsel

(adsbygoogle = window.adsbygoogle || []).push({});

LEAVE A REPLY

Please enter your comment!
Please enter your name here