Tuesday evening, Nov. 2, shortly before the 11:59 pm deadline, the U.S. Government—Defendants in Church v. Biden—filed a court-ordered response to Plaintiff's request for emergency relief. The order came after the Biden Administration gave no guarantee that Plaintiffs will not be disciplined or terminated if the government denies their religious exemption requests before the Court rules on Plaintiff's request for emergency relief. Time is critical, as the Safer Federal Workforce Task Force (Task Force) states federal employees must be "fully vaccinated" with a COVID-19 jab by Nov. 22, 2021. To meet this deadline, employees must receive their last shot by Mon., Nov. 8, 2021.
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The 55-page response immediately argues no Plaintiff has "a ripe claim" to seek an order that "would automatically exempt on religious grounds all Christians." Defendants declare Plaintiffs' claims "depend on future events that may never come to pass" and face "no imminent threat of irreparable harm." The Defendants assert:
"Plaintiffs can only speculate that their religious exceptions will be denied, and they will be subject to discipline. And even if Plaintiffs could show that termination were imminent, cases are legion holding that loss of employment does not constitute irreparable injury."
Defendants further state that Plaintiffs have not demonstrated, at this stage, that requiring them to be vaccinated against COVID-19 is not the least prohibitive means to reduce the spread of the virus in the federal workforce and to the members of the public with whom they interact. They assert an injunction against the Department of Defense (DoD) vaccine mandate would "degrade military readiness and result in immediate and substantial harm to the national security." Likewise, the Plaintiff's lawsuit states that "absent a ready military (which will result from mass separations and/or discharges, both honorable and dishonorable) the United States is nothing more than a sitting duck waiting for our foreign adversaries to strike."
Smoke, Mirrors, and the Pfizer Jab
As argued by Plaintiffs, the ostensibly deliberate deception around the Food and Drug Administration's (FDA) Aug. 23, 2021, approval of Pfizer's COMIRNATY vaccine opens the door for many questions. Specifically, why is the military recording on servicemember vaccine forms that they've been given the approved COMIRNATY vaccine when, according to the lawsuit, they were instead given the emergency use authorization (EUA) Pfizer-BioNTech vaccine?
Screenshot / Exhibit 8 / Affidavit of Authentication / Jacob Workman
In addressing the three EUA COVID-19 vaccines and the subsequent approval of the Pfizer shot, Defendants submitted in their Nov. 2 response a 161-page Declaration of Dr. Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research (CBER) at the FDA. At CBER, Marks directs the development and implementation of programs and policies that ensure the safety, purity, and potency of biological products, including blood and blood products, gene therapies, and vaccines.
In his declaration (which Defendants note was submitted in connection with separate litigation in the Northern District of Florida where FDA action was challenged), Dr. Marks explains his personal knowledge of the EUA of the COVID-19 vaccines and the approval of Pfizer's vaccine COMIRNATY. Specifically related to the approval of COMIRNATY, Marks pointed out that vaccines, approved for marketing through applications known as Biologics License Applications (BLA), are approved by the FDA upon a determination that the vaccine and the facility where it is produced is "safe, pure, and potent." The applicant must also consent to an inspection of the manufacturing facility.
Prior to the FDA's Aug. 23, 2021 approval of a BLA for "a COVID-19 vaccine known as Comirnaty," Marks states that in Dec. 2020, "the same formulation of the vaccine known as Pfizer-BioNTech COVID-19 vaccine, was available under an emergency use authorization (EUA)." He indicated that "even after FDA approved Comirnaty [for individuals 16 years of age and up], [the] FDA authorized use of the Pfizer-BioNTech COVID-19 vaccine under an EUA for indications that included the approved use."
Marks further states in his declaration that when reissuing the EUA for Pfizer-BioNTech's vaccine on Oct. 20, 2021, the FDA letter from Acting Chief Scientist Jacqueline A. O'Shaughnessy, Ph.D., advised:
"FDA determined that there is not sufficient approved vaccine available for distribution to the 16 years and older population in its entirety at the times of the FDA's reissuance of the EUA. FDA also determined that there are no products that are approved to prevent COVID-19 in additional populations covered by the EUA, as the vaccine remains under the EUA for uses that have not been approved, specifically for individuals ages 12 through 15 years old."
Screenshot / FDA Oct. 20, 2021 letter to Pfizer reissuing EUA of Pfizer-BioNTech COVID-19 vaccine for ages 16 and up.
Moreover, Marks declaration maintains the interchangeability of the two Pfizer vaccines, adding that "for operational efficiency, to account for the fact that recipients may receive either the BLA or EUA vaccine, after licensure of Comirnaty, [the] vaccine has been distributed with unified Fact Sheets, one for providers and one for recipients," that provide information on both products. He refers and offers a link to "See Fact Sheet for Recipients (Sept. 22, 2021)." The link, however, goes to Fact Sheet information last updated on Oct. 29, 2021, with no access to Sept. 22, 2021 data.
Noting the FDA's "Fast Track" program was used to "expedite the development of drugs that are being studied to treat life-threatening or severely debilitating diseases," Marks declares that the accelerated designation was "granted for Comirnaty on July 7, 2020."
It is worth noting that the July 13, 2020, announcement about the FDA Fast Track designation for the COVID-19 vaccine makes no mention of COMIRNATY. Instead, it references Pfizer and BioNTech.
As explained by Plaintiff attorney Mike Yoder on last Friday's Dark to Light Podcast, with an EUA product, individuals must be informed of the risks, benefits, and consequences of said treatment and be given the option to accept or refuse the treatment. Furthermore, if there is an FDA-approved product, then, by definition, there can't be another product licensed under EUA. But yet, despite the approval of COMIRNATY, the Moderna and Johnson & Johnson shots remain available under EUA.
What's Next?
The Defendants exhaustive response (containing 11 Exhibits totaling 265 pages) in support of the Vaccine Mandate and mass COVID-19 vaccination concludes by summarizing any relief offered by the Court should be "narrowly tailored." They assert the relief sought by Plaintiffs is extraordinary—an order "which would automatically exempt on religious grounds all Christians from the vaccine mandate." They maintain that such an order would "flout bedrock principles of equity and Article III jurisdiction and raise serious question under the Establishment Clause." Defendants point out, "the vaccination orders at issue here have been challenged in numerous other cases, underscoring why this Court should not attempt to decide their legality for all parties and for all time."
Judge Colleen Kollar-Kotelly gave the Plaintiffs until 11:59 pm Wednesday, Nov. 3, 2021, to file a reply brief.
