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COVID-19 Vaccine Candidates and Abortion-Derived Cell Lines – Charlotte Lozier Institute

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.

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

Last Updated 2 June 2021

 

🟩 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)1 Country Strategy2 Clinical Trial Status3 Public Funding4 Design & Development Production Confirm-atory
Lab Tests
WHOLE VIRUS VACCINE – LIVE ATTENUATED or INACTIVATED
Beijing Institute of Biological Products/ Sinopharm China Inactivated virus

“BBIBP-CorV”

Given: Intramuscular

2 doses (3 weeks apart)

WHO granted Emergency Use Listing (EUL) 7May2021

Early approval in China

Phase 3

Phase 3

🟩

Vero monkey cells

Wang et al., Cell 182, P713, 6Aug2020

 

🟩

Vero monkey cells

Wang et al., Cell 182, P713, 6Aug2020

 

🟩

Cytopathic test

Vero monkey cells

Wang et al., Cell 182, P713, 6Aug2020

Wuhan Institute of Biological Products/ Sinopharm China Inactivated virus

“New Crown COVID-19”

Given: Intramuscular

2 doses (3 weeks apart)

Phase 3

Phase 3

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 Research India Inactivated virus
“BBV152”
Given: Intramuscular
2 doses (2 weeks apart)
India EUA granted

Phase 3

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
Institute of Medical Biology, Chinese Academy of Medical Sciences China Inactivated virus
“SARS-CoV-2 vaccine”
Given: Intramuscular
2 doses (2 weeks apart)
Phase 3

Phase 1/2

Phase 1/2

🟩

Vero monkey cells

Pu et al., medRxiv, 6Oct2020

🟩

Vero monkey cells

Pu et al., medRxiv, 6Oct2020

🟩
Antibody ELISA
Neutralizing antibody cytopathic effect
Vero monkey cells
Pu et al., medRxiv, 6Oct2020
Supplement
John Paul II Medical Research Institute USA Live attenuated virus

 

Pre-clinical 🟩

Ethical cell lines as a matter of policy

🟩

Perinatal human cells (term umbilical cord and placental)

Research Institute for Biological Safety Problems Kazakhstan Inactivated virus

“QazCovid-in”

Given: Intramuscular

2 doses (3 weeks apart)

Phase 3

Phase 1/2

Sinovac Biotech Co., Ltd. China Inactivated virus

“CoronaVac”

Given: Intramuscular

2 doses (2 weeks apart)

 

WHO granted Emergency Use Listing (EUL) 1June2021

Phase 4

China granted conditional marketing authorization 8Feb2021
Chile, Brazil, Turkey, Indonesia EUA granted

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 Dynavax France
USA
UK
Inactivated Virus
“VLA2001”
plus adjuvant CpG1018
Given: Intramuscular
2 doses (3 weeks apart)
Phase 3

Phase 1/2

🟩

Vero monkey cells

 

🟩

Vero monkey cells

Same platform as IXIARO, Valneva press release, 22April2020

Valneva COVID-19 – VLA2001

VIRAL VECTOR-BASED VACCINE
Altimmune USA Replication-deficient

Adenovirus vector

“AdCOVID”

Given: Intranasal
1-2 doses

Phase 1/2 🔺

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)

WHO granted Emergency Use Listing (EUL) on 15Feb2021

UK EUA granted

India EUA granted

Phase 3

Phase 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, 30July2020

🔺
HEK293 cellsvan Doremalen et al., Nature, 30July2020
MRC-5 cells
Almuqrin et al., ResearchSquare 20Oct2020
CanSino Biologics, Inc.

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

China Replication-deficient

Adenovirus vector

“Ad5-nCoV”

Given: Intramuscular

1 dose

EUA in Chile, Hungary, Pakistan, Mexico

Phase 3

Phase 3

Phase 2

Phase 2

Phase 2

Phase 1

Phase 1

🔺

HEK293 cells

🔺

HEK293 cells

Biospace, 12May2020

🔺
Gamaleya Research Institute Russia Replication-deficient

Adenovirus vectors

(rAd26-S+rAd5-S)

“Gam-COVID-Vac”

“Sputnik V”

Given: Intramuscular

2 doses (3 weeks apart)

Phase 3

Phase 3

EUA in 39 countries as of Mar2021

Early approval in Russia August 2020

Phase 1/2

Phase 1/2

🔺

HEK293 cells

🔺

HEK293 cells
Gamaleya has not published details on this vaccine, but has posted information on use of cell lines for their other adenoviral vaccines

🔺
ImmunityBio and NantKwest USA Replication-deficient Adenovirus vector recombinant
“hAd5 S-Fusion + N-ETSD”
Given: Subcutaneous
Phase 1/2

Phase 1/2

Phase 1
Phase 1
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 Merck USA

France

Replication-competent recombinant measles virus

“TMV-083”

Given: Intramuscular

Development Discontinued
Phase 1/2Phase 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 DCFusogenic testHEK293TFusogenic testS protein expressionVero monkey cellsHörner et al., PNAS 22Dec2020Hörner et al. Supplement
Israel Institute for Biological Research (IIBR) Israel Replication-competent recombinant vesicular stomatitis virus (VSVΔG)
“IIBR-100”
Given: Intramuscular1 dose
Phase 1/2 🟩
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

USA Replication-deficient

Adenovirus vector

“Ad26.COV2-S”
Given: Intramuscular

1 dose
(some trials use 2 doses, 8 weeks apart)

FDA Emergency Use Authorization Approved

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

🔺
Laboratorio Avi-Mex Mexico Live recombinant Newcastle Disease Virus

Expressing spike-fusion chimeric protein

“Patria”

Given: Intramuscular or Intranasal

Phase 1 🟩

Bacterial cells

BSRT7 hamster cells

Per Sun et al., Vaccines 17Dec2020

🟩

Chicken eggs

Per Sun et al., Vaccines 17Dec2020

🟩

Neutralization Assay

Vero monkey cells

Per Sun et al., Vaccines 17Dec2020

Meissa Vaccines, Inc. USA Live attenuated recombinant RSV viral vector

“MV-014-210”

Given: Intranasal

1-3 doses (5 weeks apart)

Phase 1 🟩 🟩

Vero monkey cells

Spike expressing,

Based on recombinant RSV platform

Rega Institute, KU Leuven Belgium Replication-competent attenuated yellow fever vaccine (YF17D) vector

“YF-S0”

Given: Intramuscular
1 dose

Pre-clinical 🟩

BHK-21J hamster cells
Sanchez-Felipe et al., Nature, 1Dec2020

🟩

BHK-21J hamster cells
Sanchez-Felipe et al., Nature, 1Dec2020

🟩🔺
Antibody titer
Pseudovirus
HEK293T cells
Immunoblot
BHK-21J hamster cells
Sanchez-Felipe et al., Nature, 1Dec2020
ReiThera Italy Replication-deficient simian adenovirus encoding S

“GRAd COV2”

Given: Intramuscular

1 dose

Phase 2/3

Phase 1

🔺

HEK293T cells

Development and rescue of recombinant

Capone et al., bioRxiv 22Oct2020

🔺

HEK293T cells

Capone et al., bioRxiv 22Oct2020

🔺

HEK293T cells

Capone et al., bioRxiv 22Oct2020

Merck and IAVI USA Replication-competent recombinant vesicular stomatitis virus (VSVΔG)

“V590”

Given: Intramuscular

Development Discontinued
Phase 1
Operation 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

China Lentivirus minigenes +

Adult human APC (antigen-presenting cells)

“COVID-19/aAPC”

Given: Subcutaneous

3 doses (2 weeks apart)

Phase 1 🟩
Shenzhen Geno-immune

Medical Institute

China Lentivirus minigenes +

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

“LV-SMENP-DC”

Given: Subcutaneous and Intravenous

1 dose

Phase 1/2 🟩
Vaxart USA Replication-deficient

Adenovirus vector

“VXA-CoV2-1”

plus dsRNA adjuvant

Given: Oral

2 doses (4 weeks apart)

Phase 1 🔺

HEK293 cells

🔺

HEK293 cells

Moore et al., bioRxiv 6Sept2020

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

Recombinant RBD dimer

plus adjuvant

”ZF2001”

Given: Intramuscular

2 or 3 doses (28 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. China Protein vaccine

“SCB-2019”

plus adjuvant CpG 1018

Given: Intramuscular
2 doses (3 weeks apart)

Phase 2/3

Phase 1

CEPI 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

🟩🔺
PseudovirusHEK293 cellsRef’d: Nie et al., Emerging Microbes & Infections 24Mar2020Cytopathic effect Vero monkey cellsLiang et al., bioRxiv, 24Sept2020
COVAXX and United Biomedical USA
Taiwan
Protein vaccine

“UB-612”

S1-RBD-protein; Multitope Peptide-Based Vaccine (MVP)

Given: Intramuscular
2 doses (4 weeks apart)

Phase 2/3

Phase 1

🟩cDNA in expression vector; transfect CHO hamster cells

Guirakhoo et al., bioRxiv, 30Nov2020

🟩

CHO hamster cells
Guirakhoo et al., bioRxiv, 30Nov2020

🟩🔺
Antibody blocked binding to hACE2 HEK293
Guirakhoo et al., bioRxiv, 30Nov2020
Federal Budgetary Research Institution State Research Center of Virology and Biotechnology “Vektor” Russia Protein 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)
Phase 3

Early approval in Russia Oct 2020

Phase 1/2

🟩

chemically synthesized peptide antigens

Instituto Finlay de Vacunas Cuba Protein vaccine
“Finlay-FR-1”
(“Soberana 01”)
Receptor-binding domain (RBD) SARS-CoV-2 spike + adjuvant
Given: Intramuscular2 doses (4 weeks apart)
Phase 1/2
Phase 1

RBD produced in mammalian cells
Garcia-Rivera, MEDICC Review, 30Oct2020

RBD produced in mammalian cells
Garcia-Rivera, MEDICC Review, 30Oct2020
Instituto Finlay de Vacunas Cuba Protein vaccine
“Finlay-FR-2”
(“Soberana 02”)
Receptor-binding domain (RBD) SARS-CoV-2 spike chemically bound tetanus toxoid + adjuvant
Given: Intramuscular2 doses (4 weeks apart)
Phase 2
Phase 1

RBD produced in mammalian cells
Garcia-Rivera, MEDICC Review, 30Oct2020

RBD produced in mammalian cells
Garcia-Rivera, MEDICC Review, 30Oct2020
John Paul II Medical Research Institute USA Recombinant 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)
USA Protein 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

Medicago Canada Protein 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

Phase 2

Phase 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

Migal Galilee Research Institute Israel Protein vaccine

E. coli expressed chimeric S and N proteins

Given: Oral

Pre-clinical 🟩

Bacterial production system

MigVax’s corona subunit vaccine

Novavax USA Protein 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., Science, 27Nov2020
Bangaru et al., Supplement
Bangaru et al., bioRxiv preprint, 6Aug2020;

Graphical view

🟩🔺

Pseudovirus

HEK293 cells
Bangaru et al., Science, 27Nov2020
Bangaru et al., Supplement
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 3

Phase 2

Phase 1/2

Operation Warp Speed

HHS-BARDA

$2,072,775,336 total

🟩

Recombinant baculovirus

Francica et al., bioRxiv 2Mar2021

🟩

Sf9 insect cells

Francica et al., bioRxiv 2Mar2021

Baculovirus expressed recombinant protein

🟩🔺

Pseudovirus

HEK293T cells

Francica et al., bioRxiv 2Mar2021

Sorrento USA Protein 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

Sorrento USA Protein 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 Pittsburgh USA Protein 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. Australia Protein 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

 

Walter Reed Army Institute of Research (WRAIR) / U.S. Army Medical Research and Development Command USA Protein vaccine

”SpFN”

Spike-Ferritin nanoparticle with ALFQ adjuvant

Given: Intramuscular

2-3 doses (4 weeks apart; plus 6 months after initial injection)

Phase 1 🔺

Expi293 cells

Carmen et al., bioRxiv 28April2021

🔺

Expi293 cells

Carmen et al., bioRxiv 28April2021

🟩🔺

Pseudovirus

HEK293 cells

Virus neutralization

Vero monkey cells

Joyce et al., bioRxiv 25Mar2021

& Supplement

RNA VACCINE
Arcturus Therapeutics USA mRNA 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 2

 

Phase 1/2

🟩

Sequence designed on computer

🟩

No cells used

de Alwis et al., bioRxiv 3Sept2020

🟩🔺

protein test

HEK293

Protein expression

Hep3b cells

Plaque reduction neutralization

Vero monkey cells

de Alwis et al., bioRxiv 3Sept2020

CureVac Germany mRNA vaccine

non-replicating

“CVnCoV”

in vitro transcription

lipid nanoparticle encapsulated

Given: Intramuscular

2 doses (4 weeks apart)

Phase 3

Phase 2/3

Phase 2

Phase 1

CEPI up to $15.3 Million 🟩

Sequence designed on computer

🟩

No cells used

Rauch et al., bioRxiv 9Feb2021

🟩

Protein test

Reticulocyte lysate,
HeLa cells

Rauch et al., bioRxiv 9Feb2021

Imperial College London UK mRNA vaccine

Self-amplifying

”LNP-nCoVsaRNA”

in vitro transcription

lipid nanoparticle encapsulated

Given: Intramuscular

2 doses

Phase 1 🔺

Expression plasmid

HEK293 cells

McKay et al., bioRxiv 25April2021

🟩

No cells used

McKay et al., bioRxiv 25April2021

🟩🔺

Pseudovirus

HEK293T cells

McKay et al., bioRxiv 25April2021

Moderna, Inc.

with National Institutes of Health

USA mRNA 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

Plaque reduction neutralization

Vero monkey cells

Corbett et al., Nature , 5Aug2020

Pfizer and BioNTech USA

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

Neutralization assay

Vero monkey cells

Vogel et al., bioRxiv 8Sept2020

Providence Therapeutics Canada mRNA vaccine

“PTX-COVID19-B”

mRNA in vitro transcription from plasmid template using T7 RNA polymerase
LNP (lipid nanoparticle) encapsulated

Given: Intramuscular

2 doses (4 weeks apart)

Phase 1 🔺

HEK293T cells used to select mRNA candidate

Liu et al., bioRxiv 12May2021

🟩

No cells used

Cision, 5Aug2020
Providence Therapeutics

Liu et al., bioRxiv 12May2021

🟩🔺

Pseudovirus, serum neutralization

HEK293T cells

Vero monkey cells

Liu et al., bioRxiv 12May2021

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

2 doses (3 weeks apart)

Phase 1/2 🔺

HEK293T cells used to select mRNA candidate

Kalnin et al., npj Vaccines 19Apr2021

🟩

No cells used

Kalnin et al., npj Vaccines 19Apr2021

Kalnin et al., bioRxiv 14Oct2020

mRNA production in the lab ;

Translate Bio scientific platform

🟩🔺

protein test

& pseudovirus

HEK293 cells

Kalnin et al., npj Vaccines 19Apr2021

Kalnin et al., bioRxiv 14Oct2020

DNA VACCINE
Genexine Korea DNA vaccine

“GX-19”

DNA synthesized in vitro, placed in plasmid vector

Given: Intramuscular and Electroporation

2 doses (4 weeks apart)

Phase 1/2

Phase 1/2

🟩

Sequence designed on computer

🟩

No cells used

Seo et al., Vaccines 24March2021

🟩No cells used

Seo et al., Vaccines 24March2021

Inovio Pharmaceuticals USA DNA vaccine

“INO-4800”

DNA synthesized in vitro, placed in plasmid vector

Given: Intradermal Electroporation

2 doses (4 weeks apart)

Phase 2/3

Phase 2

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

Osaka University, AnGes, Takara Bio Japan DNA vaccine

“AG0301-COVID19”
“AG0302-COVID19”
Chemically synthesized plasmid vector grown in E. coli
Pressure injector
Given: Intramuscular

2 doses (2 weeks apart)

Phase 2/3

Phase 1/2

Phase 1/2

🟩

Sequence designed on computer

🟩

No cells used
E. coli</em
Nishikawa et al., bioRxiv, 14Jan2021

🟩

Virus neutralization

Vero E6 cells monkey cells
Nishikawa et al., bioRxiv, 14Jan2021

Symvivo Corporation Canada DNA vaccine

“bacTRL-spike”
Genetically engineered Bifidobacterium longum

Given: Oral, bacteria bind to gut lining

1 dose

Phase 1 🟩

No cells used

Zydus Cadila India DNA vaccine

“ZyCov-D”
Chemically synthesized plasmid vector grown in E. coli
Given: Intramuscular

3 doses (4 weeks apart)

Phase 3

Phase 1/2

🟩

Sequence designed on computer

🟩

No eukaryotic cells used
E. coli</em
Dey et al., bioRxiv, 26Jan2021

🟩

Expression analysis
Plaque reduction
Vero cells monkey cells
Dey et al., bioRxiv, 26Jan2021
Yadav et al., bioRxiv, 3Feb2021

http://archive.today/2022.06.16-202534/https://lozierinstitute.org/update-covid-19-vaccine-candidates-and-abortion-derived-cell-lines/

Categories
Publications

Had COVID? You’ll probably make antibodies for a lifetime – Nature

People who recover from mild COVID-19 have bone-marrow cells that can churn out antibodies for decades, although viral variants could dampen some of the protection they offer.

Many people who have been infected with SARS-CoV-2 will probably make antibodies against the virus for most of their lives. So suggest researchers who have identified long-lived antibody-producing cells in the bone marrow of people who have recovered from COVID-19.

https://www.nature.com/articles/d41586-021-01442-9

Categories
Publications

Risk in Vaccine Research and Development Quantified – PLOS ONE

Published in 20th March 2013

A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative.

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0057755

Categories
Publications

The four phases of clinical trials – Pfizer

The process of learning about and developing an investigational medicine is divided into four phases. At first, very few people receive the medicine being studied. The number of people participating in clinical studies grows along with our understanding of the investigational medicine, and the research continues as long as the potential benefits outweigh the risks.

https://www.pfizer.com/science/clinical-trials/guide-to-clinical-trials/phases

Categories
Publications

Graphene – All You Need to Know – nanowerk

The use of graphene-based materials in pharmaceutical nanotechnology has recently received more attention due to their unique chemical structure and physicochemical properties—including an ultra-high surface area, optical, thermal and electrical conductivities, and a good biocompatibility.

GO nanosheets tend to be hydrophilic and the surface contains reactive groups for an increased functionality or for loading drugs through covalent and non-covalent interactions. In addition, graphene-based nanomaterials can also be functionalized with diagnostic probes that have fluorescent and/or luminescent properties and can target ligands such as proteins, peptides, nucleic acids, antibodies, lipids, carbohydrates and folic acid.

In pharmaceutical applications, graphene-based nanomaterials possess a lot of potential for improving drug circulation times, in target drug and gene delivery systems, for acting as therapeutic agents and diagnostic tools, as well as graphene nanotheranostic agents that combine both diagnostic and therapy approaches in a single system.

The use of graphene-based materials in pharmaceutical nanotechnology has recently received more attention due to their unique chemical structure and physicochemical properties—including an ultra-high surface area, optical, thermal and electrical conductivities, and a good biocompatibility.

GO nanosheets tend to be hydrophilic and the surface contains reactive groups for an increased functionality or for loading drugs through covalent and non-covalent interactions. In addition, graphene-based nanomaterials can also be functionalized with diagnostic probes that have fluorescent and/or luminescent properties and can target ligands such as proteins, peptides, nucleic acids, antibodies, lipids, carbohydrates and folic acid.

In pharmaceutical applications, graphene-based nanomaterials possess a lot of potential for improving drug circulation times, in target drug and gene delivery systems, for acting as therapeutic agents and diagnostic tools, as well as graphene nanotheranostic agents that combine both diagnostic and therapy approaches in a single system.

The use of graphene-based materials in pharmaceutical nanotechnology has recently received more attention due to their unique chemical structure and physicochemical properties—including an ultra-high surface area, optical, thermal and electrical conductivities, and a good biocompatibility.

GO nanosheets tend to be hydrophilic and the surface contains reactive groups for an increased functionality or for loading drugs through covalent and non-covalent interactions. In addition, graphene-based nanomaterials can also be functionalized with diagnostic probes that have fluorescent and/or luminescent properties and can target ligands such as proteins, peptides, nucleic acids, antibodies, lipids, carbohydrates and folic acid.

In pharmaceutical applications, graphene-based nanomaterials possess a lot of potential for improving drug circulation times, in target drug and gene delivery systems, for acting as therapeutic agents and diagnostic tools, as well as graphene nanotheranostic agents that combine both diagnostic and therapy approaches in a single system.

The use of graphene-based materials in pharmaceutical nanotechnology has recently received more attention due to their unique chemical structure and physicochemical properties—including an ultra-high surface area, optical, thermal and electrical conductivities, and a good biocompatibility.

GO nanosheets tend to be hydrophilic and the surface contains reactive groups for an increased functionality or for loading drugs through covalent and non-covalent interactions. In addition, graphene-based nanomaterials can also be functionalized with diagnostic probes that have fluorescent and/or luminescent properties and can target ligands such as proteins, peptides, nucleic acids, antibodies, lipids, carbohydrates and folic acid.

In pharmaceutical applications, graphene-based nanomaterials possess a lot of potential for improving drug circulation times, in target drug and gene delivery systems, for acting as therapeutic agents and diagnostic tools, as well as graphene nanotheranostic agents that combine both diagnostic and therapy approaches in a single system.

An international team of researchers has developed a drug delivery technique that utilizes graphene strips as “flying carpets” to deliver two anticancer drugs sequentially to cancer cells, with each drug targeting the distinct part of the cell where it will be most effective. The technique was found to perform better than either drug in isolation when tested in a mouse model targeting a human lung cancer tumor.

https://web.archive.org/web/20220403192812/https://www.nanowerk.com/what_is_graphene.php

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Human Augmentation – The Dawn of a New Paradigm – GOV.UK

The Development, Concepts and Doctrine Centre (DCDC) has worked in partnership with the German Bundeswehr Office for Defence Planning to understand the future implications of human augmentation (HA), setting the foundation for more detailed Defence research and development.

The project incorporates research from German, Swedish, Finnish and UK Defence specialists to understand how emerging technologies such as genetic engineering, bioinformatics and the possibility of brain-computer interfaces could affect the future of society, security and Defence. The ethical, moral and legal challenges are complex and must be thoroughly considered, but HA could signal the coming of a new era of strategic advantage with possible implications across the force development spectrum.

HA technologies provides a broad sense of opportunities for today and in the future. There are mature technologies that could be integrated today with manageable policy considerations, such as personalised nutrition, wearables and exoskeletons. There are other technologies in the future with promises of bigger potential such as genetic engineering and brain-computer interfaces. The ethical, moral and legal implications of HA are hard to foresee but early and regular engagement with these issues lie at the heart of success.

Original: https://www.gov.uk/government/publications/human-augmentation-the-dawn-of-a-new-paradigm

Archive: http://archive.today/2021.09.12-013335/https://www.gov.uk/government/publications/human-augmentation-the-dawn-of-a-new-paradigm

Notes:

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Publications

Vaccinating children against SARS-CoV-2 – BMJ

Hard to justify right now for most children in most countries

Following widespread vaccination against SARS-CoV-2 of older adults and other highly vulnerable groups, some high income countries are now considering vaccinating children; just days ago, the US Food and Drug Administration authorized the use of the Pfizer/BioNTech vaccine in children 12-15 years of age. Young people have been largely spared from severe covid-19 so far, and the value of childhood vaccination against respiratory viruses in general remains an open question for three reasons: the limited benefits of protection in age groups that experience only mild disease; the limited effects on transmission because of the range of antigenic types and waning vaccine induced immunity; and the possibility of unintended consequences related to differences in vaccine induced and infection induced immunity. We discuss each in turn.

https://www.bmj.com/content/373/bmj.n1197

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Skeptical of medical science reports? – NCBI

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as editor of The New England Journal of Medicine”.

More recently, Richard Horton, editor of The Lancet, wrote that “The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness”.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4572812/

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Publications

COVID-19 vaccine refusal is higher among health and social care workers who feel pressured by their employers – London School of Hygiene and Tropical Medicine

Health and social care workers who felt under greater pressure from their employers to receive COVID-19 vaccination were more likely to decline it, according to preliminary new research highlighting factors influencing uptake.

https://www.lshtm.ac.uk/newsevents/news/2021/covid-19-vaccine-refusal-higher-among-health-and-social-care-workers-who-feel

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Publications

Social bonds in response to the Covid-19 crisis: when financial markets save lives

Social bonds are an attractive investment for worldwide institutional and individual investors looking for a socially responsible investment with a clear, unambiguous purpose and a portfolio diversification opportunity with attractive risk-adjusted returns. Although the social bond market has been growing fast, it has so far remained a niche sector.

…Over the last few weeks, several social Covid-19 bonds have already been issued by a number of multilateral institutions and public agencies and are already generating significant investor interest, paving the way for more issuances. The stage is now set for social bonds to move from a niche solution to a mainstream one.

http://archive.today/2021.09.06-173555/https://www.ecmi.eu/sites/default/files/when_financial_markets_save_lives_ecmi_commentary.pdf

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Publications

Coronavirus and depression in adults, Great Britain: January to March 2021 – ONS

1.Main points
Around 1 in 5 (21%) adults experienced some form of depression in early 2021 (27 January to 7 March); this is an increase since November 2020 (19%) and more than double that observed before the coronavirus (COVID-19) pandemic (10%).
Around 1 in 3 (35%) adults who reported being unable to afford an unexpected expense of £850 experienced depressive symptoms in early 2021, compared with 1 in 5 (21%) adults before the pandemic; for adults who were able to afford this expense, rates increased from 5% to 13%. Over the period 27 January to 7 March 2021:

Younger adults and women were more likely to experience some form of depression, with over 4 in 10 (43%) women aged 16 to 29 years experiencing depressive symptoms, compared with 26% of men of the same age.
Disabled (39%) and clinically extremely vulnerable (CEV) adults (31%) were more likely to experience some form of depression than non-disabled (13%) and non-CEV adults (20%).
A higher proportion of adults renting their home experienced some form of depression (31%) when compared with adults who own their home outright (13%).
Almost 3 in 10 (28%) adults living in the most deprived areas of England experienced depressive symptoms; this compares with just under 2 in 10 (17%) adults in the least deprived areas of England.

https://www.ons.gov.uk/peoplepopulationandcommunity/wellbeing/articles/coronavirusanddepressioninadultsgreatbritain/januarytomarch2021

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Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) – CDC

This guidance is intended for clinical laboratory and support staff who handle or process specimens associated with COVID-19. Guidance for Point-Of-Care Testing can be found here.

All laboratories should perform a site-specific and activity-specific risk assessment and follow Standard Precautions when handling clinical specimens. See Biological Risk Assessment: General Considerations for Laboratories

Refer to List Nexternal icon on the Environmental Protection Agency (EPA) website for EPA-registered disinfectants that have qualified under EPA’s emerging viral pathogens program for use against SARS-CoV-2.

Cultures of SARS-CoV-2 should be handled in a Biosafety Level 3 (BSL-3) laboratory using BSL-3 practices, and inoculation of animals with infectious wild-type SARS-CoV-2 should be conducted in an Animal Biosafety Level 3 (ABSL-3) facility using ABSL-3 practices and respiratory protection.

Suspected and confirmed SARS-CoV-2 positive clinical specimens, cultures, or isolates should be packed and shipped as UN 3373 Biological Substance, Category B.

https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html

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COVID 19 – Media Buying Services – Contracts Finder

The UK Cabinet Office awarded £320,000,000 to OMD GROUP LIMITED for COVID 19 – Media Buying Services in advertising, radio and television. The contract runs between 1st April 2021 to 31 March 2022.

Source: GOV.UK Contracts Finder

https://www.contractsfinder.service.gov.uk/notice/6043d1fd-1f8c-4232-a32a-a658e19abcb1?origin=SearchResults&p=1

Mirror: http://archive.today/LNnYR

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Increased risk for COVID-19 in patients with vitamin D deficiency – Science Direct

Vitamin D deficiency is strongly associated with increased risk for coronavirus disease 2019 (COVID-19).

The odds ratio for COVID-19 increases with vitamin deficiency in black individuals.

Diabetes, obesity, and periodontal disease are associated with an increased risk for both COVID-19 and vitamin D deficiency.

Patients with vitamin D deficiency were 4.6 times more likely to be positive for COVID-19 (indicated by the ICD-10 diagnostic code COVID19) than patients with no deficiency (P < 0.001). The association decreased slightly after adjusting for sex (odds ratio [OR] = 4.58; P < 0.001) and malabsorption (OR = 4.46; P < 0.001), respectively. The association decreased significantly but remained robust (P < 0.001) after adjusting for race (OR = 3.76; P < 0.001), periodontal disease status (OR = 3.64; P < 0.001), diabetes (OR = 3.28; P < 0.001), and obesity (OR = 2.27; P < 0.001), respectively. In addition, patients with vitamin D deficiency were 5 times more likely to be infected with COVID-19 than patients with no deficiency after adjusting for age groups (OR = 5.155; P < 0.001).

https://www.sciencedirect.com/science/article/pii/S0899900720303890

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Is a Mask That Covers the Mouth and Nose Free from Undesirable Side Effects in Everyday Use and Free of Potential Hazards? – MPDI

Many countries introduced the requirement to wear masks in public spaces for containing SARS-CoV-2 making it commonplace in 2020. Up until now, there has been no comprehensive investigation as to the adverse health effects masks can cause. The aim was to find, test, evaluate and compile scientifically proven related side effects of wearing masks. For a quantitative evaluation, 44 mostly experimental studies were referenced, and for a substantive evaluation, 65 publications were found. The literature revealed relevant adverse effects of masks in numerous disciplines. In this paper, we refer to the psychological and physical deterioration as well as multiple symptoms described because of their consistent, recurrent and uniform presentation from different disciplines as a Mask-Induced Exhaustion Syndrome (MIES). We objectified evaluation evidenced changes in respiratory physiology of mask wearers with significant correlation of O2 drop and fatigue (p < 0.05), a clustered co-occurrence of respiratory impairment and O2 drop (67%), N95 mask and CO2 rise (82%), N95 mask and O2 drop (72%), N95 mask and headache (60%), respiratory impairment and temperature rise (88%), but also temperature rise and moisture (100%) under the masks. Extended mask-wearing by the general population could lead to relevant effects and consequences in many medical fields.

https://www.mdpi.com/1660-4601/18/8/4344/htm

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Vaccine Development, Testing, and Regulation – The History of Vaccines

Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

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Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons – The New England Journal of Medicine

Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1%), in a spontaneous abortion in 104 (12.6%), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2%). A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible vaccine dose in the third trimester. Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4%]), small size for gestational age (23 of 724 [3.2%]), and major congenital anomalies (16 of 724 [2.2%]); no neonatal deaths were reported at the time of interview. Among the participants with completed pregnancies who reported congenital anomalies, none had received Covid-19 vaccine in the first trimester or periconception period, and no specific pattern of congenital anomalies was observed. Calculated proportions of pregnancy and neonatal outcomes appeared similar to incidences published in the peer-reviewed literature 

https://www.nejm.org/doi/full/10.1056/NEJMoa2104983

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Is a Mask That Covers the Mouth and Nose Free from Undesirable Side Effects in Everyday Use and Free of Potential Hazards? – Europe PMC

On the one hand, the advocacy of an extended mask requirement remains predominantly theoretical and can only be sustained with individual case reports, plausibility arguments based on model calculations and promising in vitro laboratory tests. Moreover, recent studies on SARS-CoV-2 show both a significantly lower infectivity and a significantly lower case mortality than previously assumed, as it could be calculated that the median corrected infection fatality rate (IFR) was 0.10% in locations with a lower than average global COVID-19 population mortality rate. In early October 2020, the WHO also publicly announced that projections show COVID-19 to be fatal for approximately 0.14% of those who become ill—compared to 0.10% for endemic influenza—again a figure far lower than expected.

On the other hand, the side effects of masks are clinically relevant.

…We not only found evidence in the reviewed mask literature of potential long-term effects, but also evidence of an increase in direct short-term effects with increased mask-wearing time in terms of cumulative effects for: carbon dioxide retention, drowsiness, headache, feeling of exhaustion, skin irritation (redness, itching) and microbiological contamination (germ colonization).

https://europepmc.org/article/MED/33923935

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First case of postmortem study in a patient vaccinated against SARS-CoV-2 – NCBI

A previously symptomless 86-year-old man received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later from acute renal and respiratory failure. Although he did not present with any COVID-19-specific symptoms, he tested positive for SARS-CoV-2 before he died. Spike protein (S1) antigen-binding showed significant levels for immunoglobulin (Ig) G, while nucleocapsid IgG/IgM was not elicited. Acute bronchopneumonia and tubular failure were assigned as the cause of death at autopsy; however, we did not observe any characteristic morphological features of COVID-19. Postmortem molecular mapping by real-time polymerase chain reaction revealed relevant SARS-CoV-2 cycle threshold values in all organs examined (oropharynx, olfactory mucosa, trachea, lungs, heart, kidney and cerebrum) except for the liver and olfactory bulb. These results might suggest that the first vaccination induces immunogenicity but not sterile immunity.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8051011/

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News Publications

Seven Peer-Reviewed Studies That Agree: Lockdowns Do Not Suppress the Coronavirus – Lockdown Sceptics

There have been at least seven peer-reviewed studies which look at the question of lockdowns from a data point of view, and all of them come to the same basic conclusion: lockdowns do not have a statistically significant relationship with Covid cases or deaths. Here is a list of them with a key quote for ease of reference.

https://lockdownsceptics.org/2021/04/15/seven-peer-reviewed-studies-that-agree-lockdowns-do-not-suppress-the-coronavirus/