Exclusive: DoD Wouldn’t Let Troops Wait for FDA-Approved Vaccine

The Pentagon considered as far back as October 2021 offering service members the option of taking the FDA-approved vaccine versus the vaccine authorized for emergency use before facing any punishment, but ultimately decided against it, paving the way for thousands to be discharged from the military, according to documents obtained by Breitbart News.

A senior defense official proposed in an October 20, 2021 action memo allowing service members who did not want to take the vaccine that was under Emergency Use Authorization (EUA) — known as the PfizerBioNTech COVID-19 vaccine — to wait instead for the FDA-approved vaccine — known as Comirnaty — before facing punishment for being unvaccinated.

The action memo, digitally signed by Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight David J. Smith, proposed in a draft memo the following change:

If a Service member, after medical counseling, declines administration of the EUA-manufactured product, DoD health care providers should engage with their logistics chain to secure and administer the [Biologics License Application]-manufactured Pfizer-BioNTech/Comirnaty product prior to any punitive action being taken against the Service member.

The draft memo was proposed as a replacement for one signed by then-acting Assistant Secretary of Defense for Health Affairs Terry Adirim on September 14, 2021, which said the two vaccines were “interchangeable” and should be treated as such by the Department of Defense (DoD).

Adirim’s memo stated:

Per FDA guidance, 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.’1

Consistent with FDA guidance, DoD health care providers will use both the PfizerBioNTech COVID-19 vaccine and the Comirnaty COVID-19 vaccine interchangeably for the purpose of vaccinating Service members in accordance with Secretary of Defense Memorandum, ‘Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members,’ August 24, 2021.

Smith’s action memo was addressed to Adirim, with a recommendation for her to sign the draft memo with the proposed change.

However, the proposal was never adopted, with legal implications for the DoD.

Under 10 U.S.C. Section 1107(a), a defense secretary can order service members to take an FDA-approved vaccine, but he cannot legally order service members to take an EUA-manufactured vaccine without seeking and obtaining a waiver from the president.

Under 10 U.S.C. Section 1107(a), that waiver must be signed by the president then the defense secretary must formally notify Congress of the waiver. Congress has never received notification of such a waiver.

According to the documents obtained by Breitbart News, a senior Air Force official responding to the proposed change argued that adopting the change could open the military up for more litigation and force it to possibly reverse punishments already given.

The Air Force’s acting assistant secretary of manpower and reserve affairs wrote in a response on October 29, 2021, to the draft memo (which had been sent to the military services for coordination):

On behalf of my Component, my formal response to this issuance is: Nonconcur. Below are comments that detail my Component’s objections to this issuance.

His response said the proposed change would suggest that DOD considers the EUA-manufactured vaccine different from the FDA-approved Comirnaty product and could open the Air Force up to lawsuits, and that since adverse action had already possibly been taken, “significant remedial actions” would probably be required.

The Air Force’s response said (emphasis added):

This subverts our current [Department of Air Force] vaccination mandate and may open up the Air Force for increased litigation from individuals who have been mandated since 24 August to be vaccinated. If there is no difference that can otherwise be communicated, we recommend non-concur with this paragraph as it subverts current policy. We are all operating under the belief that the lot issue is a distinction without a difference from a health/safety/medical/legal perspective. As the services have taken action, possibly include adverse action, based on a belief that the distinction is one without meaningful difference, [Office of the Secretary of Defense] retrenchment signifying that the distinction does matter would probably require signifiant remedial actions.

The Air Force was the first branch to begin kicking out service members, with the first 27 members kicked out by December 2021.

Today, at least 7,502 service members have been involuntarily discharged from the military for not being fully vaccinated. It is possible that many of those service members would still be serving if they had been given the chance to wait for an FDA-approved vaccine.

The DoD is now facing several lawsuits from service members over the legal differences between the EUA-only vaccine and the FDA-approved Comirnaty.

Austin had pledged to service members that he would seek a presidential waiver, but it is not clear he ever did so. He said in an August 9, 2021, memo to the military (emphasis added):

Based on these consultations and on additional discussions with leaders of the White House COVID-19 Task Force, I want you to know that 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 licensure, whichever comes first.

Austin had also pledged that his order would only use the FDA-approved vaccine. He wrote in an August 24, 2021, memo that mandated the vaccine: “Mandatory 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.”

Then-Pentagon Press Secretary John Kirby even said vaccines other than Comirnaty would not be made mandatory.

Breitbart News on Friday questioned the Pentagon if Austin ever sought a presidential waiver to mandate the EUA-manufactured vaccine. Breitbart News asked the DoD: “Did [Secretary of Defense Lloyd Austin] ever request a presidential waiver for any of the vaccines that the DoD health providers administered to service members from President Biden?”

The Pentagon did not respond to the question directly, but instead said:

Per FDA guidance, the Pfizer-BioNTech COVID-19 vaccine and the Comirnaty COVID-19 vaccine had the same formulation and the two vaccines were ‘interchangeable.’ Accordingly, DoD health care providers could ‘use doses distributed under the EUA to administer the vaccination series as if the doses were the licensed vaccine.’

However, even if the vaccines function the same way — similar to how a name-brand medication and a generic version may function the same way — the FDA and various court filings use the term “legally distinct,” meaning that as a matter of law they are two different medications. One has received FDA approval, and the other only has an EUA.

Comirnaty has not been widely available in the U.S. for reasons that are not clear. In July 2022, the FDA reissued its EUA of the Pfizer BioNTech COVID-19 vaccine, noting, “There is no adequate, approved, and available alternative to Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19.”

Breitbart News sent a query to Pfizer on Friday regarding the availability of Comirnaty in the U.S., but did not receive a response.

To date, the Army has discharged at least 1,699 soldiers, the Air Force has discharged at least 834 service members, the Navy has discharged at least 1,533 sailors, and the Marine Corps has discharged at least 3,436 Marines.

Their discharges have not been “honorable,” which indicates the service member was kicked out of the military for bad conduct and could affect the person’s future job prospects. This is particularly true for young service members with little other professional experience in their backgrounds.

Tens of thousands more have either refused the vaccines, or have applied for medical, administrative, or religious exemptions and are still awaiting adjudication of their requests.

Federal court judges have ordered the Navy, Air Force, and Marine Corps to stop taking adverse action against any unvaccinated service members who have applied for religious exemption as they fight the mandate on the basis of violation of their religious freedom, but there is evidence that those service members are still facing consequences, such as having promotions delayed and assignments and travel restricted.

There is not yet a class action lawsuit prohibiting adverse action for members of the Army, though various lawyers are working aggressively to file such lawsuits.

According to Sen. Ron Johnson (R-WI) recently, some military whistleblowers have claimed that vaccine vials at a military base were mislabeled “Comirnaty,” despite their lot number appearing on a CDC database listing EUA vaccine lot numbers.

Johnson last month sent a letter to the DoD, FDA, and CDC demanding answers.

“DoD, FDA, and CDC must provide a thorough explanation for why a vaccine lot with the ‘Comirnaty’ label would be listed on a database that is meant to display vaccine lots associated with the EUA,” he wrote.

A spokeswoman for Johnson said the senator has not heard back from the agencies yet.

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