Was granting Emergency Use Authorization (EUA) for the COVID vaccines legal?

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SumballoFarm

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in December 2020, the U.S Food and Drug Administration (FDA) approved Moderna and Pfizer COVID vaccines for emergency use in the U.S. The Johnson & Johnson COVID vaccine was also recently approved for EUA.

According to Section 564 §360bbb-3 of the Federal Food, Drug, and Cosmetic Act, https://www.govinfo.gov/content/pkg...-title21-chap9-subchapV-partE-sec360bbb-3.pdf. "Regarding emergency use approval (EUA), the FDCA states that the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases only when “there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition.”

An "adequate, approved, and available" alternative to the vaccines for treating Covid19 was in existence before the Moderna, Pfizer and J&J COVID vaccines were approved for emergency use in the U.S. Veklury (remdesivir), was approved by the FDA as a viable treatment of COVID19 on October 22, 2020. See https://www.fda.gov/drugs/drug-safe...ent-covid-19-science-safety-and-effectiveness.

Given the approval of Veklury (remdesivir) on October 22, 2020, before the Pfizer and Moderna EUA, according to to Section 564 of the Federal Food, Drug, and Cosmetic Act, none of the vaccines should have been eligible for EUA by the FDA.
 
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Timothy Bair

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Feb 17, 2021
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in December 2020, the U.S Food and Drug Administration (FDA) approved Moderna and Pfizer COVID vaccines for emergency use in the U.S. The Johnson & Johnson COVID vaccine was also recently approved for EUA.

According to Section 564 §360bbb-3 of the Federal Food, Drug, and Cosmetic Act, https://www.govinfo.gov/content/pkg...-title21-chap9-subchapV-partE-sec360bbb-3.pdf. "Regarding emergency use approval (EUA), the FDCA states that the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases only when “there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition.”

An "adequate, approved, and available alternative to the vaccines for treating Covid19 was in existence before the Moderna, Pfizer and J&J COVID vaccines were approved for emergency use in the U.S. Veklury (remdesivir), was approved by the FDA as a viable treatment of COVID19 on October 22, 2020. See https://www.fda.gov/drugs/drug-safe...ent-covid-19-science-safety-and-effectiveness.

Given the approval of Veklury (remdesivir) on October 22, 2020, before the Pfizer and Moderna EUA, according to to Section 564 of the Federal Food, Drug, and Cosmetic Act, none of the vaccines should have been eligible for EUA by the FDA.
This is where President Trump and myself disagreed regarding vaccines...The efficacy of Hydroxychloroquine was proven early on ironically by his own urging...Rather than the bureaucratic fool Fauci- Birx as advisors he should have enlisted Dr's Grace and Zelenko, imho Dr


 
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