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This court application was made under Rule 65, Fed.R.Civ.P., moving for a preliminary injunction against Defendants enjoining them from continuing to authorize the emergency use of the so-called “Pfizer-BioNTech COVID-19 Vaccine,”(1) “Moderna COVID-19 Vaccine”(2) and the “Johnson & Johnson (Janssen) COVID-19 Vaccine”(3) (collectively, the “Vaccines”)(4) pursuant to their respective EUAs, and from granting full Food and Drug Administration (“FDA”) approval of the Vaccines:
- for the under-18 age category;
- for those, regardless of age, who have been infected with SARS-CoV-2 prior to vaccination; and
- until such time as the Defendants have complied with their obligation to create and maintain the requisite “conditions of authorization” under Section 546 of the Food, Drugs and Cosmetics Act, 21 U.S.C. § 360bbb– 3(e), thereby enabling Vaccine candidates to give truly voluntary, informed consent.
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Civil Action No. 2:21-cv-00702-CLM
Filed on 07/19/21
IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ALABAMA
AMERICA’S FRONTLINE DOCTORS, et al
XAVIER BECERRA, Secretary of the U.S. ) Department of Health and Human Services, et al