Federal judge rejects DOD claim that Pfizer EUA and Comirnaty vaccines are ‘interchangeable’

There are some important distinctions between the Pfizer-BioNTech EUA jab and the Comirnaty jab, as stated by this ruling.

1. 1. The Pfizer-BioNTech EUA jab comes in packaging that states that informed consent is necessary for administration due to its experimental nature.  The packaging of the Comirnaty jab does not have a statement about informed consent or being experimental.  This is a legal distinction between the two products.
   2. The approved Comirnaty jab may only be manufactured in BLA-approved manufacturing facilities.  There is no indication that all EUA-labeled vials are from BLA-approved facilities.  If the vial of jab was manufactured in a non-BLA-approved facility, then it can in no way be considered approved, no matter what the formulation is.
   3. Only certain lots of the Pfizer-BioNTech EUA jabs are of the same formulation as the approved Comirnaty jab.  It is necessary to know the lot number of a Pfizer-BioNTech EUA jab to know its formulation.
   4. For those in the military, please note that this court ruling states that “The  DOD acknowledges that the President has not executed a wavier under this section, ECF No. 45 at 52:8-9, so as things now stand, the DOD cannot mandate vaccines  that only have an EUA.”  In other words, only approved jabs can be mandated.  “[T]he DOD concedes that some  of its current vials are not BLA-compliant, and that there is no policy to ensure that  servicemembers get only BLA-compliant vaccines.”  The EUA jabs can only be used with a presidential waiver.  And since no presidential waiver was executed, anyone who has given you an EUA jab against your will or under duress has committed an unlawful act.  The order is lawfully fulfilled only when approved jabs are administered.

The plaintiffs next argue that the mandate violates their statutory right  to refuse an EUA vaccine. ECF No. 3-2 at 20-21. Under the EUA statute, recipients  of EUA drugs must be “informed . . . of the option to accept or refuse administration  of the product.” 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III); see also 5 U.S.C.  § 706(2)(C) (APA provision prohibiting agency action taken “in excess of statutory  jurisdiction, authority, or limitations, or short of statutory right”). And under 10  U.S.C. § 1107a, “[i]n the case of the administration of [an EUA] product . . . to  members of the armed forces,” that statutory right to refuse “may be waived only by  the President only if the President determines, in writing, that complying with such  requirement is not in the interests of national security.” 10 U.S.C. § 1107a(a)(1). The  DOD acknowledges that the President has not executed a wavier under this section, ECF No. 45 at 52:8-9, so as things now stand, the DOD cannot mandate vaccines  that only have an EUA. 10 U.S.C. § 1107a(a)(1).

One problem with this argument is that the DOD’s guidance documents  explicitly say only FDA-licensed COVID-19 vaccines are mandated. See, e.g., ECF  No. 1-3 at 2 (DOD mandate memorandum) (“Mandatory vaccination against  COVID-19 will only use COVID-19 vaccines that receive full licensure from the [FDA] in accordance with FDA-approved labeling and guidance.”); and ECF No. 1- 7 at 11 (Air Force guidance) (“Only an FDA-licensed vaccine may be  mandated . . . .”). The plaintiffs present a facial challenge, ECF No. 33 at 10  (“Plaintiffs’ claims are facial challenges to a generally applicable military  regulation . . . .”), and on its face, the mandate does not require anyone to take an  EUA vaccine.

Notably, though, the plaintiffs have shown that the DOD is requiring  injections from vials not labeled “Comirnaty.” Indeed, defense counsel could not  even say whether vaccines labeled “Comirnaty” exist at all. ECF No. 45 at 48:5-7.  (Although the DOD’s response said it had an adequate Comirnaty supply, it later  clarified that it was mandating vaccines from EUA-labeled vials. See id. at 46:22- 47:3.) In the DOD’s view, this is fine because the contents of EUA-labeled vials are  chemically identical to the contents of vials labeled “Comirnaty” (if there are any  such vials). According to the DOD’s argument, this means servicemembers are not  required to accept “a product authorized for emergency use.” 10 U.S.C.  § 1107a(a)(1). Rather, the DOD argues that once the FDA licensed Comirnaty, all EUA-labeled vials essentially became Comirnaty, even if not so labeled. ECF No.  45 at 60:1-3. Thus, the DOD argues, the “product” injected is a chemical formulation that has received full FDA licensure—not merely an EUA—so § 1107a does not  apply. Id. at 65:1-6.8

The DOD’s interpretation of § 1107a is unconvincing. For starters, FDA  licensure does not retroactively apply to vials shipped before BLA approval. See 21  U.S.C. § 355(a) (“No person shall introduce . . . into interstate commerce any new  drug, unless an approval of an application [for FDA licensure] is effective with respect to such drug.” (emphasis added)). Thus, as a legal matter, vaccines sent  before August 23—and vaccines produced after August 23 in unapproved  facilities—remain “product[s] authorized for emergency use under section 564 of  the Federal Food, Drug, and Cosmetic Act.” § 1107a(a)(1).9 Section 1107a’s explicit  cross-reference to the EUA provisions suggests a concern that drugs mandated for  military personnel be actually BLA-approved, not merely chemically similar to a  BLA-approved drug. And the distinction is more than mere labeling: to be BLA  compliant, the drug must be produced at approved facilities, see ECF No. 1-4 at 2;  21 C.F.R. §§ 600.11, 600.20-.21, and there is no indication that all EUA-labeled vials are from BLA-approved facilities.10 Moreover, the DOD concedes that some  of its current vials are not BLA-compliant, and that there is no policy to ensure that  servicemembers get only BLA-compliant vaccines. See ECF No. 45 at 61:10-12. It  is difficult to see how vials that the DOD admits are not BLA-compliant—and thus  could only be EUA products—could fall outside § 1107a’s prohibition on mandatory  administration.

— Judge Allen Winsor

The judge denied an injunction because

the plaintiffs have not shown a substantial  likelihood of success on this APA claim.

This is a requirement for an injunction in a legal matter.  Fortunately, Judge Allen Winsor provided the legal work-around for those who wanted an injunction.

Sources:

• 
  November 12, 2021. Allen Winsor. “DOE et al v. AUSTIN et al, Case Number 3:21-Cv-01211, 12 NOV 21, US District Court for the Northern District of Florida, Pages 12-15.” Google Docs.
  https://docs.google.com/document/d/1GJK_7afp6XHoB0Yo4dKopBCL7BYUqI1765uXF6FBJ-0/edit,
  Local copy.
  Cloud Document, Judgment.
• 
  November 30, 2021. Michael Nevradakis. “Federal Judge Rejects DOD Claim That Pfizer EUA and Comirnaty Vaccines Are ‘Interchangeable.’” Children’s Health Defense.
  https://childrenshealthdefense.org/defender/judge-allen-winsor-pfizer-eua-comirnaty-vaccines-interchangeable/.
  Activist.

See also, on this site:

• Military, Federal Employees and Civilian Contractors Sue Biden
• The ten points of the Nuremberg Code
• FDA approves Comirnaty COVID-19 Vaccine
• Pfizer admits: they will NEVER manufacture Comirnaty