Joyce 🐝 Bowen Brand Ambassador @ beBee

2 years ago · 2 min. reading time · 0 ·

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Illegal Use Authorization Update

Illegal Use Authorization Update

3) EUASs last only as long as the HHS declaration justifying EUAs and may be revised or revoked at any time. An EUA may only be issued after the Secretary of Health and Human Services makes a declaration that certain emergency circumstances exist justifying an EUA, EUAS issued under such declaration last only so long as the declaration is in effect; the EUA ceases to be effective upon termination of such declaration The FDA also has the authority revoke of revise an EUA at any time. The agency is directed to “periodically review the circumstances and the appropriateness” of an EUA, and the “progress made with respect to approval” of licensure of a product authorized under an EUA The FDA may revise of revoke an EUA If the criteria for issuance are no longer met or other circumstances make such revision of revocation “appropriate to protect the public health or safety.” America’s biopharmaceutical companies are supportive of the FDA's robust new EUA qQuidance that brings greater scientific transparency to the COVID 19 vaccine review process and have pledged "to make the safety and well being of vaccinated individuals the top priority in development’ of these first vaccines

Since treatment is available and this has a survival rate of 99+ percent, this action is completely illegal. No EUA can be approved under these circumstances. [Here come our militarily imposed injections…]

1) An Emergency Use Authorization Is different than FDA licensure of a vaccine. EUASs are used in certain types of emergencies, like COVID 19, when there is no adequate, approved and available alternative to the EUA product. During these situations, the Federal Food, Drug and Cosmetic Act permits the FDA to issue EUAs to facilitate access to medical interventions, such as vaccines. Importantly, however, an EUA is not the same as an FDA approval or licensure. For example, there are different evidentiary requirements for licensure of a Biologics License Application (BLA) and issuance of an EUA for a vaccine. Furthermore, an EUA expires upon termination of the rekevant emergency declaration, whereas there is no “termination” of a BLA The FDA may issue an EUA, when, among other things, the agency determines that based on all of the available scientific evidence, the known and potential benefits of the vaccine outweigh the known and potential risks. To underscore this, FDA Commissioner Stephen Hahn has said repeatedly in recent weeks and months that the agency would only consider an EUA if it felt the risks associated with the vaccine were “much lower than the risks of not having a vaccine and the potential benefit of having a vaccine” The agency has further taken steps to ensure the robust vaccine candidate review process by engaging the Vaccines & Related Biological Products Advisory Committee (VRBPAC) to discuss the development and potential authorization of vacanes to prevent COVID 19 after Issuing guidance on FDA's recommendations for an EUA submission for a COVID 19 vaccine. 2) COVID-19 Emergency Use Authorization standards are robust. Recently, the FDA issued guidance specifically on EUAs for COVID 19 vaccines. The recommendations include key information and data that FDA recommends to support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data and regulatory and administrative information This FDA guidance clarifies that an assessment regarding any potential EUA for COVID 19 vaccines would be made on a case by case basis considenng the target population, the charactenstics of the vaccines, and the totality of the relevant available scientific evidence, including preclinical and human clinical study data on the vaccine’s safety and effectiveness. The FDA plans to convene an open session of its VRBPAC (in addition to the general session

https://catalyst.phrma.org/understanding-the-emergency-use-authorization-process-for-covid-19-vaccines

3) EUASs last only as long as the HHS declaration justifying EUAs and may be revised or revoked at any time. An EUA may only be issued after the Secretary of Health and Human Services makes a declaration that certain emergency circumstances exist justifying an EUA, EUAS issued under such declaration last only so long as the declaration is in effect; the EUA ceases to be effective upon termination of such declaration The FDA also has the authority revoke of revise an EUA at any time. The agency is directed to “periodically review the circumstances and the appropriateness” of an EUA, and the “progress made with respect to approval” of licensure of a product authorized under an EUA The FDA may revise of revoke an EUA If the criteria for issuance are no longer met or other circumstances make such revision of revocation “appropriate to protect the public health or safety.” America’s biopharmaceutical companies are supportive of the FDA's robust new EUA qQuidance that brings greater scientific transparency to the COVID 19 vaccine review process and have pledged "to make the safety and well being of vaccinated individuals the top priority in development’ of these first vaccines


But here we have the treatment and no need for any dangerous obligatory shot.

.

COVID-19 outpatients: early risk-stratified treatment with zinc plus low-dose hydroxychloroquine and azithromycin: a retrospective case series study

COVID-19 outpatients: early risk-stratified treatment with zinc plus low-dose hydroxychloroquine and azithromycin: a retrospective case series study Roland Derwand*', Martin Scholz", Vladimir Zelenko + Alericn Perms Germasy (o#4( SI6S/. Mesh, Uermany. © Heer Hime Universiy, Dsestorf, Musser 5, 0275, Divsesdor, Cena Menta Grosp Proce, Mono, NY, 1850, (54 ARTICLE INFO ABSTRACT Kepmores The aim of this study was to describe the outcomes of patients with coronavirus disease 2019 (COVID- 19) a in the outpatient setting aMer carly treatment with Zc. low-dose Rydraxychloroquine and azithromycin (triple therapy) dependent on risk stratification. This was & IEUTIPECUVE Case series study in the gen- etal practice setting. A total of 141 COVID-19 patients with Labor atory-<onfirmed severe acute (Esparatory Hysraychicomodne syndrome coronavirus 2 (SARS-(oV-2) inkction i the year 2020 were inchkaded. The main outcome mwa: Jimmisiony swe were isk-stratified treatment decision and fates of hospitalisation nd all-cause death. A median of 4 ays [imtcrquartic range (KR) 3-6 days: available For a - 66/141 patients] after the caset of symptoms, 141 patients (median age 38 years, IQR 40-67 years. 730K make) received 4 prescription kor tipi thesapy for 5 days. Independent public reference data from 377 coafismed COVID- 19 patients in the sane commu ity were used 45 vatreated controb. Of 141 treated patients, 4 (23K) were hospitabsed, which was sig aifcantly fewer (P - 0001) compured with 58 (154K) of 377 untreated patients fodds ratio (OR) 016, 95% compdence interval (CT) 006 0.5) One patient (07K) in the treatment grou ded vervus 13 patients (34K) in the untreated group (OR 02.95TC1003 15. 012} No cardiac side effects were obuerved. Risk stratification based treatment of COVID 19 outpatients as carty 3 possible ater symptom onset ws ing triple therapy. inchadiag the combanation of zinc with low dose hydraxychloroquine. was associated with sgnifcantly fewer hasprtalmations. © 2020 The Author(s). Published by Bisevaer Ud Th i an open acces article wer the CU BY-ACND ticeme

https://reader.elsevier.com/reader/sd/pii/S0924857920304258?token=37AEEFE7C4EDFEB0E26EA8AFCFFD7ED006D8E447B44773AD9B11F3F700B72E7CE68DE9C903F246E6A2224239FFE5F86F

.

I was lied to when I was told the shots were safe for my babies and me. At the time, I believed what I was told with disastrous results.

I’ve studied and researched and studied and research and learned of the data fabrications, data manipulations, and outright ghostwriting of those pieces of paper they try to tell us is science.

I’ve seen too many children who cannot speak. This is quite typical of vaccine-induced brain damage.

These are not vaccinations—they are far worse than that…

As I said in an earlier article:

Please understand that the genetic alterations we are to undergo with these shots are meant to pass down to our progeny. They are most likely based on mathematical/computational models and are completely experimental.

Author in Source Title

It will be the biggest experiment ever done on the human species and is in direct violation of this:

The Nuremberg Code

Please Leave Us Alone.

Copyright December 2020 Joyce Bowen


#EUA #Illegal Use Authorization Update #FDA #COVID #azithromycin
Comments

Zacharias 🐝 Voulgaris

2 years ago #1

I know the 21st century is still in its early stages but it's safe to say that this Covid-19 vaccine is probably the scam of the century! (happy to change my mind if anyone comes with evidence to the contrary since it seems that Joyce has made a very strong case for this statement!)

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