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jueves, 7 de enero de 2021

Update: COVID-19 Vaccine Candidates and Abortion-Derived Cell Lines

 CHARLOTTE LOZIER INSTITUTE


El enlace a la página web es éste:


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To view this chart as a PDF, see: COVID-19 Vaccine Candidates and Abortion-Derived Cell Lines


Updated January 4, 2021

Accurate information about the development and production of COVID-19 vaccines is essential, especially because many proposed candidates use newer molecular technologies for production of a viral vaccine. One concern regarding the ethical assessment of viral vaccine candidates is the potential use of abortion-derived cell lines in the development, production or testing of a vaccine. This analysis utilizes data from the primary scientific literature when available, along with data from clinical trial documents, reputable vaccine tracking websites, and published commercial information.1 It is the hope that by providing accurate data, recipients can make well-informed decisions regarding vaccine choices.

 

For additional background and guidance, please see:


A Visual Aid to Viral Infection and Vaccine Production for a visual primer on the various strategies for viral vaccine production.

COVID-19 Vaccines & Fetal Cell Lines for an infographic description of how fetal cell lines are sometimes used to produce vaccines.

 

Flow Chart for Creation and Testing of Vaccines


Design & Development: conceptualization, preparatory experiments,
and specification for how vaccine will be constructed and produced.

Production: process used to manufacture final vaccine to be given to people.

 

Confirmatory Lab Tests on Product: tests to analyze quality, 

nucleic acid or protein sequence, protein conformation, antibody reactivity, etc. 

of final vaccine product.

 

Vaccination: giving final produced vaccine to people.


 
   

NOTA: La tabla que se proporciona, a continuación, se entenderá mejor escuchando de nuevo los minutos 26 a 30 aproximadamente, de la entrevista a la dra. Pilar Calva que llevó a cabo el padre Javier Olivera Ravasi.


Entrevista a la Dra. Pilar Calva por el padre Javier Olivera RAvasi acerca del material fetal utilizado en ciertas vacunas (43 minutos)


Phase 2Phase 1 

🟩

Recombinant DNA sequence in Agrobacterium, transformation of plant cells

🟩

Plant expression of protein and VLP

Ward et al., medRxiv 6Nov2020

🟩🔺

Pseudovirus

HEK293 cells

Ward et al., medRxiv 6Nov2020

Analysis of SARS-CoV-2 (COVID-19) Vaccine Candidates

Last Updated 4 January 2020

 

🟩 DOES NOT USE abortion-derived cell line

 

 

🔺 DOES USE abortion-derived cell line

 

 

🟩🔺 SOME tests DO NOT use abortion-derived cells, SOME DO.

 

�  Currently undetermined

Sponsor(s)1CountryStrategy2Clinical Trial Status3Public Funding4Design & DevelopmentProductionConfirm-atory
Lab Tests
    
WHOLE VIRUS VACCINE – LIVE ATTENUATED or INACTIVATED
Beijing Institute of Biological Products/ SinopharmChinaInactivated virus

“BBIBP-CorV”

Given: Intramuscular

2 doses (2 weeks apart)

Early approval in China

Phase 3

Phase 3

🟩

Vero monkey cells

 

🟩

Vero monkey cells

 

🟩

Cytopathic test

Wuhan Institute of Biological Products/ SinopharmChinaInactivated virus

Unnamed

Given: Intramuscular

2 doses (2 weeks apart)

Phase 3

Early approval in China

Phase 1/2

🟩

Vero monkey cells
Xia et al., JAMA 324, 951, 13Aug2020

🟩

Vero monkey cells

Xia et al., JAMA 324, 951, 13Aug2020

🟩
Plaque reduction neutralization test
Vero monkey cells
Xia et al., JAMA 324, 951, 13Aug2020
Bharat Biotech/Indian Council of Medical ResearchIndiaInactivated virus
“BBV152”
Given: Intramuscular2 doses (2 weeks apart)
India EUA granted

Phase 3

Phase 1/2

Phase 1/2

Phase 1/2

🟩

Vero monkey cells

Yadav et al., ResearchSquare 10Sept2020

🟩

Vero monkey cells

Yadav et al., ResearchSquare 10Sept2020

🟩
Antibody ELISA
Plaque reduction
Vero monkey cellsYadav et al., ResearchSquare 10Sept2020
John Paul II Medical Research InstituteUSALive attenuated virus

 

Pre-clinical🟩

Ethical cell lines as a matter of policy

🟩

Perinatal human cells (term umbilical cord and placental)

Sinovac Biotech Co., Ltd.ChinaInactivated virus

“PiCoVacc”

Given: Intramuscular

2 doses (2 weeks apart)

Phase 3

Early approval in China

Phase 3

Phase 1/2

Phase 1/2

Phase 1/2

🟩

Vero monkey cells

 

🟩

Vero monkey cells

Gao et al., Science 369, 77, 3July2020

🟩🔺

protein test

HEK293 cells

Supplement Gao et al., Science 369, 77, 3July2020

Valneva and DynavaxFrance
USA
UK
Inactivated Virus
“VLA2001”
plus adjuvant CpG1018
Given: Intramuscular
Pre-clinical🟩

Vero monkey cells

 

🟩

Vero monkey cells

Same platform as IXIARO, Valneva press release, 22April2020

VIRAL VECTOR-BASED VACCINE
AltimmuneUSAReplication-deficient

Adenovirus vector

“AdCOVID”

Given: Intranasal

Pre-clinical🔺

PER.C6 cells

🔺

PER.C6 cells

Same platform as NasoVAX

NasoVAX uses PER.C6

Licensed PER.C6 from Janssen

🔺
AstraZeneca

University of Oxford

 

USA

UK

Replication-deficient

Adenovirus vector

“AZD1222”

“ChAdOX1nCoV-19”

Given: Intramuscular

2 doses (4 weeks apart)

UK EUA granted
India EUA grantedPhase 3

Phase 3

Phase 3

Phase 2/3

Phase 2/3

Phase 1/2

Phase 1/2

Operation Warp Speed

HHS-BARDA

$1.2 Billion

CEPI up to  $384 Million

🔺

HEK293 cells

🔺

HEK293 cells

van Doremalen et al., Nature preprint, 30July2020

🔺
CanSino Biologics, Inc.

Beijing Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

ChinaReplication-deficient

Adenovirus vector

“Ad5-nCoV”

Given: Intramuscular

1 dose

Phase 3

Phase 3

Phase 2

Phase 2

Phase 2

Phase 1

Phase 1

🔺

HEK293 cells

🔺

HEK293 cells

Biospace, 12May2020

🔺
Gamaleya Research InstituteRussiaReplication-deficient

Adenovirus vectors

(rAd26-S+rAd5-S)

“Sputnik V”

Given: Intramuscular

2 doses (3 weeks apart)

Phase 3

Early approval in Russia August 2020

Phase 1/2

Phase 1/2

🔺

HEK293 cells

🔺

HEK293 cells

🔺
ImmunityBio and NantKwestUSAReplication-deficient Adenovirus vector recombinant
“hAd5 S-Fusion + N-ETSD”
Given: Subcutaneous
Phase 1🔺
E.C7 cells
(derivative of HEK293 cells)
Rice et al., bioRxiv 30July2020
🔺

E.C7 cells
(derivative of HEK293 cells)
Rice et al., bioRxiv 30July2020

🔺
Protein and antibody tests
HEK293T cells
Rice et al., bioRxiv 30July2020
Seiling et al., medRxiv 6Nov2020
Institut Pasteur and Themis and MerckUSA

France

Replication-competent recombinant measles virus

“TMV-083”

Given: Intramuscular

Phase 1/2

Phase 1

CEPI up to $4.9 Million🔺HEK293T

Development and rescue of recombinant measles virus

Hörner et al., PNAS 22Dec2020

Hörner et al. Supplement

“SARS-CoV-2 S-encoding vaccine candidates… were generated as described previously

 

🟩

Vero monkey cells

Hörner et al., PNAS 22Dec2020

Hörner et al. Supplement

🟩🔺
Lentiviral vectors for antigenic DC

Fusogenic test

HEK293T

Fusogenic test

S protein expression

Vero monkey cells

Hörner et al., PNAS 22Dec2020

Hörner et al. Supplement

Israel Institute for Biological Research (IIBR)IsraelReplication-competent recombinant vesicular stomatitis virus (VSVΔG)
“IIBR-100”
Given: Intramuscular1 dose
Phase 1🟩
BHK hamster cells
Vero monkey cells
Yahalom-Ronen et al., bioRxiv 19June2020
🟩
Vero monkey cells
Yahalom-Ronen et al., bioRxiv 19June2020
🟩
Plaque reduction; immunofluorescence
Vero monkey cells
Yahalom-Ronen et al., bioRxiv 19June2020
Janssen Research & Development, Inc.

Johnson & Johnson

USAReplication-deficient

Adenovirus vector

“Ad26”
Given: Intramuscular

1 or 2 doses (8 weeks apart)

Phase 3

Phase 3

Phase 1/2

Operation Warp Speed

HHS-BARDA

$1,457,887,081 total

🔺

PER.C6 cells

🔺

PER.C6 cells

Tostanoski et al.Nature Medicine, 3Sept2020;

J&J, 30March2020;

Janssen Vaccine Technologies

🔺
Merck and IAVIUSAReplication-competent recombinant vesicular stomatitis virus (VSVΔG)

“V590”

Given: Intramuscular

Pre-clinicalOperation Warp Speed

HHS-BARDA

$38,033,570

🟩

Vero monkey cells

🟩

Vero monkey cells

Use rVSV Ervebo platform

Ervebo uses Vero cell culture-11 Description

Shenzhen Geno-immune

Medical Institute

ChinaLentivirus minigenes +

Adult human APC (antigen-presenting cells)

 

Phase 1🟩
Shenzhen Geno-immune

Medical Institute

ChinaLentivirus minigenes +

Adult human CD/T cells (dendritic cells and T cells)

“LV-SMENP-DC”

Phase 1/2🟩
VaxartUSAReplication-deficient

Adenovirus vector

“VXA-CoV2-1”

plus dsRNA adjuvant

Given: Oral

Phase 1🔺

HEK293 cells

🔺

HEK293 cells

Moore et al., bioRxiv 6Sept2020

🔺
PROTEIN-BASED VACCINE
Anhui Zhifei Longcom Biopharmaceutical/Institute of Microbiology, Chinese Academy of SciencesChinaProtein vaccine

Recombinant RBD dimer

plus adjuvant

Given: Intramuscular

2 or 3 doses (30 days apart)

Phase 3

Phase 2

Phase 1/2

Phase 1

🔺

HEK293T cells

Dai et al., Cell 6Aug2020

🟩

CHO hamster cells

Dai et al., Cell 6Aug2020

🔺

Pseudovirus

HEK293T cells

Dai et al., Cell 6Aug2020

Clover Biopharmaceuticals, Inc.ChinaProtein vaccine

“SCB-2019”

plus adjuvant CpG 1018

Given: Intramuscular

Phase 1CEPI up to $69.5 Million🟩cDNA in expression vector; transfect CHO hamster cells

Liang et al., bioRxiv, 24Sept2020

Trimer-Tag system;

Liu et al., Scientific Reports 2017

🟩

CHO hamster cells

Trimer-Tag system;

Liu et al., Scientific Reports 2017

🟩🔺Pseudovirus

HEK293 cells

Ref’dNie et al., Emerging Microbes & Infections 24Mar2020

Cytopathic effect

Vero monkey cells

Liang et al., bioRxiv, 24Sept2020

Federal Budgetary Research Institution State Research Center of Virology and Biotechnology “Vektor”RussiaProtein vaccine
“EpiVacCorona”
chemically synthesized peptide antigens of SARS-CoV-2, conjugated to a carrier protein
adsorbed on an aluminum-containing adjuvant
Given: Intramuscular2 doses (3 weeks apart)
Early approval in Russia Oct 2020

Phase 1

Phase 1

🟩

chemically synthesized peptide antigens

John Paul II Medical Research InstituteUSARecombinant Protein

Perinatal human cells (term umbilical cord and placental)

Pre-clinical🟩

Ethical cell lines as a matter of policy

🟩

Perinatal human cells (term umbilical cord and placental)

Kentucky BioProcessing, Inc.
(British American Tobacco)
USAProtein vaccine
“KBP-201”
Plant-expressed RBD
Given: Intramuscular2 doses (3 weeks apart)
Phase 1/2🟩

Recombinant DNA sequence for RBD of SARS-CoV-2

🟩

Plant expression of RBD peptide

MedicagoCanadaProtein on Virus-Like Particle

“CoVLP”

Plant-expressed spike protein particle with adjuvant, CpG1018 or AS03

Given: Intramuscular

2 doses (3 weeks apart)

Phase 2/3
NovavaxUSAProtein vaccine

“NVX-CoV2373”

Baculovirus expression

plus Matrix M adjuvant

Given: Intramuscular

2 doses (3 weeks apart)

Phase 3

Phase 3

Phase 2

Phase 1

Operation Warp Speed

HHS-BARDA

$1,600,434,523

CEPI up to  $388 Million

🟩🟩

Sf9 insect cells

Bangaru et al.bioRxiv preprint, 6Aug2020;

Graphical view

🟩🔺

Pseudovirus

HEK293 cells

Bangaru et al.bioRxiv preprint, 6Aug2020

Sanofi and GSK

Protein Sciences

 

USA

France

Protein vaccine

Baculovirus expression

plus AS03 adjuvant

Given: Intramuscular

2 doses (3 weeks apart)

Phase 1/2Operation Warp Speed

HHS-BARDA

$2,072,775,336 total

🟩🟩

Sf9 insect cells

Baculovirus expressed recombinant protein ;

 

SorrentoUSAProtein vaccine

“T-VIVA-19”

SARS-Cov-2 spike protein S1 domain fused with human IgG-Fc

Given: Intramuscular

Pre-clinical🟩🟩

CHO cells

Herrmann et al., bioRxiv preprint, 30June2020

🟩

Antibody ELISA;

Neutralization assays

Vero monkey cells

Herrmann et al., bioRxiv preprint, 30June2020

SorrentoUSAProtein vaccine

“STI-6991”

SARS-Cov-2 spike protein expressed on K562 cells

Pre-clinical🟩

K562 cells

Concept: Ji et al., Medicine in Drug Discovery March2020

University of PittsburghUSAProtein vaccine

Adenovirus-expressed

recombinant proteins

“PittCoVacc”

Given: Microneedle arrays

Pre-clinical🔺

HEK293 cells

🔺

HEK293 cells

Kim et al., EBioMedicine , 2April2020

🔺
University of Queensland and CSL Ltd.AustraliaProtein vaccine

“V451”

Recombinant protein with proprietary molecular clamp

Given: Intramuscular

HALTED

Phase 1

Phase 1

Phase 1

CEPI up to $4.5 Million🟩🟩

expiCHO hamster cells

 

    
RNA VACCINE
Arcturus TherapeuticsUSAmRNA vaccine

self-transcribing, replicating

“LUNAR-CoV19” (“ARCT-021”)

in vitro transcription reaction with T7 RNA polymerase from STARR plasmid template

LUNAR proprietary lipid nanoparticle encapsulated

Given: Intramuscular

1 dose

Phase 2

Phase 1/2

🟩

Sequence designed on computer

🟩

No cells used

de Alwis et al., bioRxiv 3Sept2020

🟩🔺

protein test

HEK293

de Alwis et al., bioRxiv 3Sept2020

CureVacGermanymRNA vaccine

non-replicating

“CVnCoV”

in vitro transcription

lipid nanoparticle encapsulated

Given: Intramuscular

2 doses (4 weeks apart)

Phase 2/3

Phase 2

Phase 1

CEPI up to $15.3 Million🟩

Sequence designed on computer

🟩

No cells used

Rauch et al.bioRxiv 23Oct2020

🟩

Protein test

Reticulocyte lysate,
HeLa cells

Rauch et al.bioRxiv 23Oct2020

Moderna, Inc.

with National Institutes of Health

USAmRNA vaccine

non-replicating

“mRNA-1273”

T7 RNA polymerase-mediated transcription from DNA plasmid template

LNP (lipid nanoparticle) encapsulated

Given: Intramuscular

2 doses (4 weeks apart)

FDA Emergency Use Authorization Approved

Phase 3

Phase 2

Phase 1

Operation Warp Speed

HHS-BARDA

$2,479,894,979 total

CEPI up to $1 Million

 

🟩

Sequence designed on computer

🟩

No cells used

Corbett et al., Nature , 5Aug2020

🟩🔺

protein test

& pseudovirus

HEK293 cells

Corbett et al., Nature , 5Aug2020

Pfizer and BioNTechUSA

Germany

mRNA vaccine

non-replicating

“BNT-162a1,b1,b2,b3,c2”

nucleoside-modified mRNA in vitro transcribed by T7 polymerase from a plasmid DNA template

LNP (lipid nanoparticle) encapsulated

Given: Intramuscular

2 doses (3 weeks apart)

FDA Emergency Use Authorization Approved

UK EUA granted

Phase 2/3

Phase 1/2

Phase 1/2

Phase 1

Phase 1

 

Operation Warp Speed

HHS-BARDA

$1.95 Billion

🟩

Sequence designed on computer

🟩

No cells used

Vogel et al., bioRxiv 8Sept2020

🟩🔺

protein test

& pseudovirus

HEK293 cells

Vogel et al., bioRxiv 8Sept2020

Sanofi Pasteur and

Translate Bio

USA

France

mRNA vaccine

non-replicating

“MRT5500”

synthesized by in vitro transcription employing RNA polymerase with a plasmid DNA template

LNP (lipid nanoparticle) encapsulated

Given: Intramuscular

Pre-clinical🟩

Sequence designed on computer

🟩

No cells used

Kalnin et al., bioRxiv 14Oct2020

mRNA production in the lab ;

Translate Bio scientific platform

🟩🔺

protein test

& pseudovirus

HEK293 cells

Kalnin et al., bioRxiv 14Oct2020

    
DNA VACCINE
GenexineKoreaDNA vaccine

“GX-19”style=”border: 1px solid black;”

DNA synthesized in vitro, placed in plasmid vector

Given: Intramuscular and Electroporation

2 doses (4 weeks apart)

Phase 1/2 🟩

Sequence designed on computer

🟩

No cells used

Seo et al., bioRxiv 10Oct2020

Inovio PharmaceuticalsUSADNA vaccine

“INO-4800”

DNA synthesized in vitro, placed in plasmid vector

Given: Intradermal Electroporation

2 doses (4 weeks apart)

Phase 2/3

Phase 1/2

Phase 1

Operation Warp Speed

CEPI up to $22.5 Million

🟩

Sequence designed on computer

🟩

No cells used

Smith et al., Nature 20May2020

🟩🔺

protein test

& pseudovirus

HEK293 cells

Smith et al., Nature 20May2020

Symvivo CorporationCanadaDNA vaccine

Genetically engineered Bifidobacterium longum

“bacTRL-spike”

Given: Oral, bacteria bind to gut lining

1 dose

Phase 1🟩

No cells used

 

  1. Data accumulated from primary literature as referenced in the Chart; AND “COVID-19 Treatment and Vaccine Tracker,” Milken Institute, https://covid-19tracker.milkeninstitute.org/ ; AND “Draft landscape of COVID-19 candidate vaccines,” World Health Organization (WHO), https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
    NOTE that patents are not considered because they are unreliable sources; even the most relevant patents are prospective documents that provide examples of potential use, but do not provide information about actual, current application of an invention or technology.
  2. Prentice, DA and Sander Lee, T. June 15, 2020. A Visual Aid to Viral Infection and Vaccine Production. On Science Series 1. Accessed 19 June 2020 at: https://lozierinstitute.org/a-visual-aid-to-viral-infection-and-vaccine-production/
  3. Phases of Clinical Trials: Pre-clinical- laboratory and animal studies; Phase I- 10-100 people, study safety and dosage; Phase II- tens to hundreds of people, study efficacy, dosage, side effects; Phase III- hundreds to thousands of people, study efficacy and adverse reactions.
  4. HHS-BARDA = U.S. Health and Human Services-Biomedical Advanced Research and Development Authority; CEPI = Coalition of Epidemic Preparedness Innovations; BARDA’s rapidly-expanding COVID-19 medical countermeasure portfolio. Accessed 29 Sept 2020 at https://www.medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx; CEPI’s COVID-19 Vaccine Portfolio, Accessed 29 Sept 2020 at https://cepi.net/COVAX/

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Hay bastantes páginas de interés sobre vacunación, algunas de las cuales (ya publicadas en el blog) se añaden aquí, de nuevo, para que sea así más fácil su localización (los tiempos de los videos son aproximados)


Vacunación DESMONTADA por la doctora María José Martínez Albarracín (video 6 minutos)
El Vaticano y las vacunas a partir de fetos abortados. La Nota aclaratoria de Doctrina de la Fe (video 8 minutos)

La llamada vacuna contra el Covid-19 no es, en realidad, una vacuna (propiamente dicha) [Doctora Maria José Martínez Albarracín)  (video 20 minutos)

No existe una fundamentación científica sobre las medidas tomadas por los gobiernos para erradicar el Cov-19 (Reflexión personal y varios artículos al respecto)

Selección por José Martí