CITIZEN PETITION FOR REGULATORY ACTION TO REEVALUATE ALL MRNA VACCINES AND REVOKE THEIR USE AUTHORIZATIONS (1st Rev.)

Abstract

Jianqing Wu, Ph.D., J.D, hereby submits this citizen petition to the Commissioner of the U.S. Food and Drug Administration (FDA) under the federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, 21 U.S. § 564(g)(2), 21 U.S. Code § 379dd, 21 C.F.R. §§ 1.21, 7.40(b), 42 U.S. § 262(a)(2), and the Administrative Procedure Act (APA), 5 U.S.C. §553(e). Petitioner requests FDA to suspend all outstanding mRNA vaccine use authorizations, re-evaluate their effectiveness and safety, and revoke their use authorizations as soon as possible, and make a plan to systematically overhaul its approval framework.