Coast Guard pushing questionably sourced Comirnaty vax on objectors: whistleblower
"All experienced members have no trust in the chain of command and feel responsible to research on their own to figure out if this is what it is," said military attorney R. Davis Younts.
The Facts Inside Our Reporter’s Notebook
- argument before a Navy administrative separation board
- representative said it was from France
- FDA's Biologics License Application supplemental approval letter dated Dec. 16, 2021
- original Aug. 23, 2021, Biologics License Application approval letter
- more recent supplemental approval letter dated July 8, 2022
The Coast Guard is allegedly pushing unwilling service members to take a questionably sourced version of Pfizer-BioNTech's Comirnaty COVID-19 vaccine that may not comply with FDA standards for the fully-approved version, according to an officer's sworn whistleblower statement.
The military can only legally force service members to receive vaccines that are fully approved by the FDA, not those under FDA emergency use authorization (EUA). While Comirnaty was fully approved by the FDA, the Pfizer-BioNTech COVID-19 Vaccine under EUA is not fully approved. Despite being identical vaccines, they are legally distinct.
When the EUA was reissued for the Pfizer-BioNTech COVID-19 Vaccine in July, the FDA noted, "There is no adequate, approved, and available alternative to Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19."
Although Comirnaty and Moderna's Spikevax have been approved, "there are not sufficient quantities of approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA," the FDA explained.
Military attorney R. Davis Younts successfully argued before a Navy administrative separation board that the service's mandate for the experimental COVID vaccines was not a lawful order since the fully FDA-approved versions of the vaccines (such as Comirnaty) haven't been made available to military members.
A memo sent to Congress on Monday entitled "Whistleblower Report of Illegal Department of Defense Activity" included evidence from nine military officers across all the military branches who allege that "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."
According to a declaration included in the report and written under penalty of perjury to Sen. Ron Johnson (R-Wisc.) by Coast Guard Lieutenant Chad Coppin, a shipment of vaccines labeled as Comirnaty was delivered in early June to his unit's medical clinic. However, when he checked the lot number with Pfizer to find out where it was manufactured, a representative said it was from France.
Coppin told Just the News that another Pfizer representative said the vendor location for that lot was in Kalamazoo, Mich. The representative didn't know if "vendor" meant the location was a manufacturing site or used for shipping, Coppin said.
According to the FDA's Biologics License Application supplemental approval letter dated Dec. 16, 2021, the Comirnaty vaccine is supposed to be manufactured in Belgium. It does not mention Kalamazoo or France.
Both the original Aug. 23, 2021, Biologics License Application approval letter for Comirnaty and a more recent supplemental approval letter dated July 8, 2022 (after the Coast Guard received the Comirnaty shipment) for children ages 12-15, do mention Kalamazoo as a manufacturing location in addition to Belgium. However, Pfizer said in a statement that the vaccine approved last August wouldn't be produced but the vaccine that was later approved in December would be produced.
None of the approval letters mention France.
Coppin told Just the News that a Pfizer representative put him in touch with a director at the Department of Health and Human Services who was part of the vaccine rollout. The director thought that the vaccine at Coppin's clinic came from Kalamazoo, but after Coppin emailed the director a few questions and followed up when he didn't receive a response, the director said the Defense Department ordered him to stop talking with Coppin.
When Coppin asked the director if his questions were concerning, the director said that they weren't concerning to him. Coppin was later informed by his commander that the Pentagon said he was not to talk with the director anymore.
The label on the Comirnaty vials is not the same as the FDA fully-approved label, which Coppin confirmed both with the FDA's Purple Book and a Pfizer representative. The labels should be the same.
With the Comirnaty-labeled vaccines now available at some Coast Guard clinics, the service is "absolutely" pressuring reluctant service members to take the vaccine, Coppin told Just the News. He was given five days to comply with the mandate following the arrival of the Comirnaty shipment. After choosing not to receive the vaccine, he is receiving the Coast Guard equivalent to a letter of reprimand.
After slow-rolling vaccine mandate enforcement for nearly a year, the Coast Guard is now fast-tracking it, arguing that service members refusing vaccination after being denied religious exemption can't refuse the fully approved Comirnaty, according to Coppin.
It's a "huge deal" that the military is urging service members to take Comirnaty by citing its full FDA approval, Coppin said, because it implicitly undermines the legal authority previously claimed by the Pentagon to force the EUA vaccine on unwilling service members.
Although the Pentagon previously claimed the EUA vaccines were approved, in reality, Coppin alleges, service members were "coerced, lied to, and made to take a vaccine that was never fully approved," despite the legal requirement of informed consent before taking experimental drugs.
The guardsmen have been in a yearlong holding pattern during which they didn't know whether they'd be allowed to stay in the service or forced out, said Younts, who represents military clients being disciplined by their respective branches for seeking religious exemptions to the vaccine mandate. Now, with the five-day compliance deadline to receive the Comirnaty vaccine, they don't have time to plan or get a job, he added, explaining that many guardsmen have contracts with the service that are not yet finished so they were unable to give civilian employers a time for when they would be out of the service.
"The entire process for rolling out this is garbage" and "unprofessional," said Coppin, alleging the enforcement of the vaccine mandate is being made up by the military as they go along.
Younts told Just the News that the "real issue" for his clients is that the military is "still not being straightforward with us about the difference between EUA and full FDA approval." As a result, "there's a complete breakdown in morale, discipline, and trust," he claimed. "All experienced members have no trust in the chain of command and feel responsible to research on their own to figure out if this is what it is."
He said it's "frustrating" to his clients, as they're "losing faith in the military and chain of command" because the only thing that seems to matter to the military is having a fully-vaccinated force, not the actual health and safety of the force or its morale.
The military won't budge on its vaccine mandates despite new, more relaxed, CDC guidance on COVID released Thursday, Younts predicted, "but it absolutely should."
The CDC abandoned its prior COVID recommendations of testing and quarantine for asymptomatic COVID-19 infectees and close contacts; the six-foot rule; and preferential treatment for vaccinated people, especially those who are "up to date" on shots.
The Coast Guard told Just the News on Tuesday to contact Pfizer for information regarding the manufacturing and distribution of the vaccine.
When asked by Just the News about whether the Comirnaty vaccine at its clinics had FDA's full approval, unlike the EUA vaccines, the Coast Guard replied, "The Pfizer vaccine we are currently receiving and will continue to receive is fully licensed and labeled as such."
With regard to the new CDC guidance on COVID, the Coast Guard said, "There have been no changes to The Coast Guard's policy requiring our members to receive the COVID Vaccine."
Pfizer didn't respond to requests for comment.
Other highlights in the whistleblower report include:
- A sworn declaration by Army First Lieutenant Mark Bashaw, who said that when he checked the Comirnaty lot number, he found that it belonged to EUA vaccines, not the fully-approved vaccines.
- In a response in April to a Freedom of Information Act (FOIA) request, the Defense Health Agency claimed it had no responsive records regarding Comirnaty vaccines that the DOD "ordered, received, has on stock, has available, administered to service members, by service branches" or that branches were scheduled to receive.
- An unsigned memo by Under Secretary of Defense for Personnel and Readiness Gil Cisneros that replaces a memo by Assistant Secretary of Defense for Health Affairs Dr. Terry Adirim. Cisneros' memo says that if a service member rejects the EUA vaccine, DOD healthcare providers should "secure and administer" the fully-approved vaccine "prior to any punitive action being taken against the Service member." An internal review of Cisneros' memo conducted in October by then-Acting Assistant Secretary of the Air Force (Manpower and Reserve Affairs) John Fedrigo found that it "subverts our current vaccination mandate and may open up the Air Force for increased litigation from individuals who have been mandated since 24 August to be vaccinated."