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FDA Emergency Use Authorization for Vaccines to Prevent COVID-19


Downloadables 0 Comments 05/17/2021 

Guidance for Industry (issued on February 22, 2021)

Posted By: Fielden Nolan (nolanf)

Public Comment This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. Comments may be submitted at any time for Agency consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. All comments should be identified with the docket number FDA-2020-D-1137 and complete title of the guidance in the request.


Description Comment  
FDA Emergency Use Authorization for Vaccines Document issued on February 22, 2021. This document supersedes the guidance of the same title issued on October 2020.

   See also: https://www.documentcloud.org/documents/20793561-leopold-nih-foia-anthony-fauci-emailsThousands of pages of Dr. Fauci's emails, obtained from a FOIA (Freedom of Information Act) by the Washington Post have been released to reporters. The emails show that Fauci was warned early in the outbreak that the coronavirus had possibly been "enginee...  READ MORE
- Fielden Nolan (nolanf),  06/03/2021 
   https://pubmed.ncbi.nlm.nih.gov/33113270/AbstractAims of the study: Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating viru...  READ MORE
- Fielden Nolan (nolanf),  05/15/2021 
   - April 28, 2021Download the .PDF belowABSTRACTThe knowledge of biotechnology increases the risk of using biochemical weapons for mass destruction. Prions are unprecedented infectious pathogens that cause a group of fatal neurodegenerative diseases by a novel mechanism. They are transmissible particles that are devoid of nucleic acid. Due to their singular characteristics, Prions emerge as potenti...  READ MORE
- Fielden Nolan (nolanf),  04/28/2021 
  

Stanford Mask Study

Facemasks in the COVID-19 era: A health hypothesis
Category: Published Studies: Masks are INEFFECTIVE
- April 27, 2021(Download .PDF below)"Long-term Consequences of Wearing Facemask Can Cause Health Deterioration, Developing and Progression of Chronic Diseases, and Premature Death."Note: FactCheck.org has this to say about the study:Stanford Medicine says it “strongly supports the use of face masks to control the spread of COVID-19.” Yet viral stories falsely claim a “...  READ MORE
- Fielden Nolan (nolanf),  04/27/2021 
   - April 23, 2021Source: https://scivisionpub.com/pdfs/covid19-rna-based-vaccines-and-the-risk-of-prion-disease-1503.pdfABSTRACT Development of new vaccine technology has been plagued with problems in the past. The current RNA based SARSCoV-2 vaccines were approved in the US using an emergency order without extensive long term safety testing. In this paper the Pfizer COVID-19 vaccine was evalu...  READ MORE
- Fielden Nolan (nolanf),  04/23/2021 
   - April 23, 2021From: https://pubmed.ncbi.nlm.nih.gov/32871846/AbstractBackground/aim: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). One drug that has attracted interest is the antiparasitic compound ivermectin, a macrocyclic lactone derived from the bacterium Streptomyces avermitilis. We carried out a...  READ MORE
- Fielden Nolan (nolanf),  04/23/2021 
   Date: April 19, 2021From: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7680614/See also: https://www.thegatewaypundit.com/2021/04/stanford-study-results-facemasks-ineffective-block-transmission-covid-19-actually-can-cause-health-deterioration-premature-death/PMCID: PMC7680614PMID: 33303303Facemasks in the COVID-19 era: A health hypothesisBaruch Vainshelboim?Author information&n...  READ MORE
- Fielden Nolan (nolanf),  04/19/2021 
   Dear Allan:I am a 71-year-old Michigan pastor. I read all your articles on lewrockwell.com and am in full agreement. My wife and I have been married over 50 years; we trust in God and are not afraid of the coronavirus. I haven’t believed any of the government/media propaganda from day one. The best way to fight off a virus is to stay healthy. Governments love crises and w...  READ MORE
- Fielden Nolan (nolanf),  03/27/2021 
   I am herewith postng a list of a series of publicatons that have been instrumental in providing enlightening insights on the interplay between Covid-19 and the host immune system. They provide so to speak critcal pieces of the puzzle that I have been putng together. Entre puzzles are rarely published. That’s why publicatons rarely bring solutons to complex problems. For your convenience, I h...  READ MORE
- Fielden Nolan (nolanf),  03/16/2021 

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