DOD Thwarts the Law, Lies to Troops, Declares EUA Vaccines to Be “FDA Approved”

In August, we reported that the military could not legally force troops to get the experimental “vaccine” because the approved product (COMIRNATY) was not yet available in the United States. While formulaically identical, the Pfizer-BioNTech Emergency Use Authorization product is legally distinct from the FDA-approved COMIRNATY product, with very different standards for efficacy, safety, and manufacturer responsibility. Yet media outlets and politicians ran with the headline that the Pfizer shots were “FDA approved,” leading the military to dispense with the requirement for informed consent that allowed troops to not be forced into medical experimentation (see Army Regulation 40–562 chapter 7-2).

This presented a challenge to the Biden administration, who was chomping at the bit to force universal vaccination on the troops, despite the fact that to date less than 100 troops have suffered COVID-related death in a population of 2.4 million. In fact, 19X more troops have committed suicide than have died with COVID-19. Under current regulation, troops could legally decline to be vaccinated because the military has no FDA-approved vaccines to administer.

Not to be denied, the Department of Defense issued a memo in September that simply declared the Pfizer-BioNTech vaccine and COMIRNATY to be the same thing. This is despite the fact that they are not the same thing, and are not approved under the same FDA orders. Basically, the Acting Assistant Secretary of Defense (ASD) for Health Affairs Terry Adirim wrote a memo completely denying the nature of the FDA approval for the Pfizer shots.

Military members are being forced to take experimental vaccines as if they are approved because the Department of Defense simply declared COMIRNATY to be legally the same as the experimental product, and Adirim referenced FDA guidance that noted the two products are the same in terms of safety and efficacy even though they are legally distinct.

According to FDA guidance (emphasis ours):

Comirnaty has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

The legal distinction is that one product indemnifies the manufacturer and the government from injury responsibility, while the other does not. The FDA claims that the two products are the same in terms of safety and effectiveness (they are), but fails to reveal that if a patient is injured thinking they are taking an FDA-approved shot, they will quickly find out that they actually took an emergency use shot and are personally responsible for the consequences.

Also revealed in the FDA guidance is the lack of long-term safety data, which is obvious considering the products have been around less than two years. From the guidance (emphasis ours):

The EUA for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial in approximately 18,000 individuals who received the vaccine and approximately 18,000 who received a placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group. The duration of safety follow-up for the vaccinated and placebo participants was a median of two months after receiving the second dose.

Follow-up data from this ongoing clinical trial was analyzed by FDA to determine the safety and effectiveness of Comirnaty. The updated analysis to determine effectiveness for individuals 16 years of age and older included approximately 20,000 Comirnaty and 20,000 placebo recipients who did not have evidence of SARS-CoV-2 infection through seven days after the second dose.  Overall, the vaccine was 91% effective, with 77 cases of COVID-19 occurring in the vaccine group and 833 COVID-19 cases in the placebo group.

The safety was evaluated in approximately 22,000 Comirnaty and 22,000 placebo recipients 16 years of age and older. More than half of the vaccine and placebo recipients were followed for safety for at least four months after the second dose. After issuance of the EUA, participants were unblinded in a phased manner over a period of months to offer placebo participants Comirnaty.  Overall, in blinded and unblinded follow-up, approximately 12,000 Comirnaty recipients have been followed for at least 6 months.

The 95% effectiveness quoted is a simple calculation (8 patients in the vaccine group versus 162 in the control group) of relative risk reduction, not absolute risk reduction which is much lower (we expose this difference here). Also notable is the fact that the EUA was approved with a trial that followed participants for a mere two months after vaccination and COMIRNATY was approved via a clinical trial that observed effectiveness over just one week after the second dose was administered – this is before the patient would even be considered fully vaccinated (two weeks after the second dose).

Also concerning is that the EUA trial eventually allowed the placebo group to go ahead and take vaccines anyway, making it impossible to determine any correlation between those who took the vaccine and effectiveness or side effects. The trial to approve these drugs became essentially worthless.

Yet these trials and this guidance were enough to convince the DoD to simply declare emergency use vaccines to be FDA approved. The memo even uses quotes to imply the FDA guidance states an equivalency that it does not (emphasis ours):

…DoD health care providers should “use doses distributed under the EUA to administer the vaccination series as if the doses were the licensed vaccine.”

The FDA guidance says no such thing. Service members are being lied to and denied their right to informed consent. The DoD admits their bait-and-switch later in the memo:

…DoD health care providers will use both the Pfizer-BioNTech COVID-19 vaccine and the Comirnaty COVID-19 vaccine interchangeably for the purpose of vaccinating Service members…

The Department of Defense is lying to the troops, denying them their rights, and defying regulation to push a political agenda. It is unconscionable.

See the memo here: