Case 2:21-cv-00702-CLM Document 15 Filed 07/19/21 Page 23 of 67
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§ 360bbb–3(e)(1)(A)(i) and (ii): Healthcare Professionals and Vaccine Candidates are Not Adequately Informed
Once an EUA has been issued, § 360bbb–3(e) mandates that the DHHS Secretary “shall [ ] establish” conditions “designed to ensure” that both healthcare professionals and Vaccine candidates receive certain minimum required information that is necessary in order to make voluntary, informed consent possible. The required disclosures that the DHHS Secretary are designed to ensure include inter alia (i) that the Vaccines are only authorized for emergency use and not FDA approved, (ii) the significant known and potential risks of the Vaccines, (iii) available alternatives to the Vaccines, (iv) the option to accept or refuse the Vaccines. The Vaccines are Not Approved by the FDA, but Merely Authorized for Emergency Use Defendants have failed to educate the American public that the FDA has not actually “approved” the Vaccines, and that the DHHS Secretary has not in fact determined that the Vaccines are “safe and effective,” and on the contrary has merely determined, in accordance with the proverbial “weasel language” of the EUA statute, that “it is reasonable to believe” that the Vaccines “may be” effective and that the benefits outweigh the risks. Instead of being so educated, the public is barraged with unqualified “safe and effective” messaging from all levels of federal and state government, the private sector and the media. They hear from no higher authority than the President himself that: “The bottom line is this: I promise you they are safe. They are safe. And even more importantly, they’re extremely effective. If you’re vaccinated, you are protected.” The public are also unaware of the serious financial conflicts-of-interest that burden Dr. Fauci, the National Institute of Allergies and Infectious Diseases, and the Vaccines and Related Biological Products Advisory Committee which advises and consults Defendants with respect to the Vaccine EUAs, as outlined in the Complaint (ECF 10, ¶¶ 250-256). Without the information
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