Association of American Physicians and Surgeons (AAPS) Releases Statement on FDA ‘Approval Letter’ for COVID-19 Vaccine

2021-08-25

疫苗紧急使用授权引进/卖出

TUCSON, Ariz., Aug. 25, 2021 (GLOBE NEWSWIRE) -- The expected FDA “approval letter” for the Pfizer COVID-19 vaccine was issued on Aug 23, and the Biden Administration immediately called on companies to require vaccination. “Full approval” would remove the legal impediment that vaccines only available under an Emergency Use Authorization (EUA) must be voluntary and cannot be mandated. A statement released by the Association of American Physicians and Surgeons (AAPS) noted that the FDA’s “approval letter” actually approves a biologics license application (BLA) from BioNTech Manufacturing GmbH in Mainz, Germany, for its product COMIRNATY. FDA extended the EUA for the Pfizer-BioNTech COVID-19 vaccine, which is legally distinct from though in most other respects the same as Comirnaty. “Full approval does not actually apply to vials not labeled ‘Comirnaty,’” AAPS states. In any event, AAPS notes that “bureaucratic approval does not abrogate the right of individuals to give or withhold informed consent to medical interventions.” AAPS points out that the approval bypassed the normal advisory committee and public comment requirements. The FDA-approved package insert for Comirnaty contains a warning about the risk of myocarditis, and post-marketing studies are required. There is no mention, however, of blood clotting or neurologic complications, or the unprecedented number of lethal and disabling complications reported to the Vaccine Adverse Events Reporting System (VAERS), states AAPS. “AAPS opposes vaccine mandates, supports the need for fully informed consent, and affirms the right of patients to refuse medical treatment even if it is recommended by their physician(s).” The Association of American Physicians and Surgeons has represented physicians in all specialties since 1943. Its motto is omnia pro aegroto, everything for the patient.

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