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20 Oct 2023 04:05:30 UTC
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UK HEALTHCARE PROFESSIONAL- SARS-COV-2 COVID-19 RNA vaccine BNT162b1
https://pubmed.ncbi.nlm.nih.gov/33053279/ https://pubmed.ncbi.nlm.nih.gov/32785213/
Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines
"It will also be apparent in what we say about workforce expansion that someone other than a registered healthcare professional may actually be administering unlicensed vaccines – and as a basic issue of fairness, we think they should benefit from the same immunity from civil liability as a registered healthcare professional who is performing the same role, if the person who is not a healthcare professional is following one of the proposed new protocols."
https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines#civil-liability-and-immunity
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001on the Community code relating to medicinal products for human use
https://uk.reuters.com/article/us-astrazeneca-results-vaccine-liability/astrazeneca-to-be-exempt-from-coronavirus-vaccine-liability-claims-in-most-countries-idUKKCN24V2EN
AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries
https://media.tghn.org/medialibrary/2020/11/C4591001_Clinical_Protocol_Nov2020_Pfizer_BioNTech.pdf
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)Protocol C4591001Page 1A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
https://www.nature.com/articles/s41586-020-2639-4
Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults
https://www.clinicaltrials.gov/ct2/results?term=BNT162b&draw=2&rank=6#rowId5
6 Studies found for: BNT162b
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-08/Pfizer-COVID-19-vaccine-ACIP-presentation-508.pdf
Pfizer/BioNTechCOVID-19 mRNA vaccineOverview for ACIP Meeting
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/943417/Information_for_healthcare_professionals.pdf
REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS2 Version 3.2 10/12/2020
This medicinal product does not have a UK marketing authorisation but has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over.
https://cormandrostenreview.com/report/
Review report Corman-Drosten et al. Eurosurveillance 2020
External peer review of the RTPCR test to detect SARS-CoV-2 reveals 10 major scientific flaws at the molecular and methodological level:
https://archive.is/6m4N2#selection-819.0-827.235
ClinicalTrials.gov
https://archive.vn/BNoWtPhase I/II study of COVID-19 RNA vaccine BNT162b1 in adults
https://archive.vn/s9nMz
https://archive.vn/uVYJB
Trial record 6 of 6 for: BNT162b
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).
Condition or disease  Intervention/treatment  Phase 
SARS-CoV-2 Infection COVID-19 Biological: BNT162b1 Biological: BNT162b2 Other: Placebo Phase 2 Phase 3 Interventional (Clinical Trial)
Estimated Enrollment  : 43998 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
Actual Study Start Date  : April 29, 2020
Estimated Primary Completion Date  : August 1, 2021
Estimated Study Completion Date  : January 29, 2023
...............................................................................................................
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
https://www.nejm.org/doi/suppl/10.1056/NEJMoa2027906/suppl_file/nejmoa2027906_protocol.pdf
https://www.ebi.ac.uk/biostudies/studies/S-EPMC7583697?xr=true
https://europepmc.org/article/MED/33053279
https://www.nejm.org/doi/10.1056/NEJMoa2027906
https://clinicaltrials.gov/show/NCT04368728
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https://www.youtube.com/watch?v=WbnUrUDAhqA
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