FDA is not following its own Guidance

“In the guidance document Emergency Use Authorization for Vaccines to Prevent COVID-19 (October 2020 Guidance), (1) FDA has provided recommendations that describe key information that would support issuance of an EUA for a vaccine to prevent COVID-19.”(2)

Bud’s comment: THE VACCINES DO NOT PREVENT COVID-19 BASED ON MEDICAL AND RESEARCH REPORTS OF THE EUA VACCINES IN USE. THE VACCINES WERE NOT DESIGNED OR TESTED TO PREVENT COVID-19. FDA IS NOT FOLLOWING ITS OWN CRITERIA AND GUIDANCE FOR ISSUING EMERGENCY USE AUTHORIZATION (EUA) OF THE VACCINES.

(1) Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry, October 2020 (October 2020 Guidance), https://www.fda.gov/media/142749/download
(2) 23 August 2021 Letter from FDA to Robert F. Kennedy, and Meryl Nass, M.D., Children’s Health Defense. pages 6 and 7 https://www.regulations.gov/document/FDA-2021-P-0460-30085

#healthcare #medicalsciences #LAW #REGULATION #FDA #CHILDRENSHEALTHDEFENSE #covid #comment #medical #medicine

About budbromley

Bud is a retired life sciences executive. Bud's entrepreneurial leadership exceeded three decades. He was the senior business development, marketing and sales executive at four public corporations, each company a supplier of analytical and life sciences instrumentation, software, consumables and service. Prior to those positions, his 19 year career in Hewlett-Packard Company's Analytical Products Group included worldwide sales and marketing responsibility for Bioscience Products, Global Accounts and the International Olympic Committee, as well as international management assignments based in Japan and Latin America. Bud has visited and worked in more than 65 countries and lived and worked in 3 countries.
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