Categories
News

More evidence Covid was tinkered with in a lab? Now scientists find virus contains tiny chunk of DNA that matches sequence patented by Moderna THREE YEARS before pandemic began – Daily Mail

Genetic match discovered in Covid’s unique furin cleavage site on spike protein

Matched genetic sequence patented by Moderna for cancer research purposes

Researchers say one in 3trillion chance Covid developed the code naturally 

http://archive.today/2022.02.24-054810/https://www.dailymail.co.uk/news/article-10542309/Fresh-lab-leak-fears-study-finds-genetic-code-Covids-spike-protein-linked-Moderna-patent.html

Categories
News

£200m Covid vaccine factory put up for sale after failing to produce a single dose – The Telegraph

In the two years since, ministers have been racing to rectify this. The spread of Covid spurred the Government to funnel more than £200m of taxpayer cash into a new Vaccine Manufacturing & Innovation Centre (VMIC), with hopes of bringing forward the opening date to summer 2021 and delivering millions of doses to get the population jabbed.

Although the money went in, jabs have yet to come out. More than six months after it was slated to open, VMIC’s doors are still closed. Its role in beating Covid has been non-existent.

Now, the mega-vaccine plant is up for sale – a step insiders say was unavoidable. “Without a buyer, VMIC would fail or it wouldn’t open,” one Westminster source says. 

http://archive.today/2022.02.12-152154/https://www.telegraph.co.uk/business/2022/02/12/200m-covid-vaccine-factory-put-sale-failing-produce-single-dose/

Categories
News

AstraZeneca sees $4B in COVID vaccine sales as revenue soars – AP News

AstraZeneca recorded a big jump in revenue on Thursday as it begins to take a profit from its coronavirus vaccine for the first time.

The company recorded full-year revenues of $37.4 billion, an increase of 38% from the year before at constant exchange rates. Part of the boost came from $4 billion in sales of its COVID-19 vaccine, developed with the University of Oxford.

Despite rising revenue, AstraZeneca reported a pre-tax loss of $265 million due to costs from its purchase of U.S. drug company Alexion Pharmaceuticals and new drug research.

The Anglo-Swedish drugmaker said in November it would begin to take a “modest” profit from the COVID-19 shot, which it had been providing “at cost” — around $2 to $3 —following an agreement with Oxford. Other COVID-19 vaccine producers, such as Pfizer and Moderna, have been booking hefty profits on their shots all along.

In the three months to September, the company said revenue jumped by about 50%, to a record $9.9 billion. The increase was due to sales of more than $1 billion in COVID-19 vaccines and the inclusion for the first time of some $1.3 billion worth of revenue from its rare disease business unit following the recent acquisition of Alexion.

http://archive.today/2022.02.10-112738/https://apnews.com/article/coronavirus-pandemic-business-health-europe-oxford-d5b4503c4a21afe1a68d6a7a1bc8a460

Categories
Publications

Report provides references indicating that HEK293 cells were derived from an aborted fetus – The Niche

The following recent report provides references indicating that HEK293 cells were derived from an aborted fetus:

Sander Lee, T., Feeney, M.B., Schmainda, K. M., Sherley, J. L., and Prentice, D. A. (2020) “Human Fetal Tissue from Elective Abortions in Research and Medicine: Science, Ethics, and Law.” Issues in Law & Med 35, 3-61.

Footnote 81 in the article provides the following link:

https://wayback.archive-it.org/7993/20170404095417/https:/www.fda.gov/ohrms/
dockets/ac/01/transcripts/3750t1_01.pdf

This link provides a 2001 US-FDA Meeting Transcript of the FDA-CBER Vaccines and Related Biological Products Advisory Committee. It contains the testimony of scientist Alex J. van der Eb, Ph.D., who participated in the development of HEK293 cells. On page 81 of the transcript, when describing the derivation of HEK293 cells, which were a focus of the committee meeting, Dr. van der Eb states:

“So the kidney material, the fetal kidney material was as follows. The kidney of the fetus was, with an unknown family history, was obtained in 1972 probably. The precise date is not known anymore. The fetus, as far as I can remember was completely normal. Nothing was wrong. The reasons for the abortion were unknown to me. I probably knew it at that time, but it got lost, all this information.”

https://archive.ph/Ho1vV#comment-44067

https://wayback.archive-it.org/7993/20170404095417/https:/www.fda.gov/ohrms/dockets/ac/01/transcripts/3750t1_01.pdf

Categories
Publications

Explainer on 293 or HEK cells and their use in COVID vaccines – The Niche

What’s the deal with 293 cells and COVID-19 vaccine production?

There has been a lot of confusion and even misinformation about 293 cells out there related to the pandemic.

Different types of 293 cells have been used in research on COVID-19 vaccines by different manufacturers, but there are no cells in the actual vaccines. Some have gotten that wrong.

Also, 293s are not stem cells and, more specifically, are quite different from human embryonic stem cells. This has also often been an area of confusion.

What about at the ethical or moral level? I personally see no problem in vaccine research and production using 293 or other human cells.

The uncertainty over the origin of the fetus used to make 293 cells leaves things a little fuzzy in that regard, but I’d said it also makes it harder to somehow condemn 293 cells as immoral to use in research, if that’s one’s agenda.

http://archive.today/2022.07.01-165654/https://ipscell.com/2021/12/293-cells/

Categories
News

Here are the facts about fetal cell lines and COVID-19 vaccines – National Geographic

In the wake of federal vaccine mandates in the U.S., debate has erupted over the waves of fire fighters,police staff, and other workers who have applied for religious exemptions to getting their COVID-19 shots. The number of applications is likely to spike as the January 4 vaccination deadline nears for large private businesses and some healthcare facilities. And one common reason people give for religious exemptions is the link between vaccines and human fetal cells.

It’s true that such cells have been used either in the testing or development and production of COVID-19 vaccines. The cells are grown in a laboratory and were derived from a few elective abortions performed more than three decades ago. These same cell lines are also used to test and advance our understanding of several routine drugs, including acetaminophen, ibuprofen, and aspirin, and they continue to be used for treatment research in diseases such as Alzheimer’s and hypertension.

http://archive.today/2022.01.28-071320/https://www.nationalgeographic.com/science/article/here-are-the-facts-about-fetal-cell-lines-and-covid-19-vaccines

Categories
Opinion Videos

Conscience & Vaccines – Fr. Ambrose Astor, Lumen Fidei Institute

Those who have received the vaccine should, however, examine their conscience and ask themselves what exactly they knew at the time. If they knew nothing about the ethical issues, was this for lack of having taking the trouble to find out? Ignorance is sometimes culpable. However in those who have a duty to know (priests, doctors, government officials, judges), it is always culpable.

https://www.lumenfidei.ie/conscience-vaccines/

Categories
Opinion

Vaccine Control Group – The Mind Renewed with Julian Charles

Julian Charles of The Mind Renewed podcast interviews Diny Fielder-van Kleeff from The Vaccine Control Group.

We are joined by the author Diny Fielder-van Kleeff, co-founder of the Vaccine Control Group—or, more fully, the SARS-CoV-2 Vaccine Control Group—for an in-depth interview on the aims and objectives of this intriguiging and potentially highly significant “community cooperative” study.

“The Vaccine Control Group is a worldwide independent long-term study that is seeking to provide a baseline of data from unvaccinated individuals for comparative analysis with the vaccinated population, to evaluate the success of the Covid-19 mass vaccination programme and assist future research projects. This study is not, and will never be, associated with any pharmaceutical enterprise as its impartiality is of paramount importance. The VaxControlGroup is a community cooperative, for the people. All monies raised will be re-invested into the project and its community.”—VaxControlGroup

https://www.themindrenewed.com/interviews/2021/1446-int-197

Categories
Publications

“He who pays the piper calls the tune”: Researcher experiences of funder suppression of health behaviour intervention trial findings – PLOS ONE

Background
Governments commonly fund research with specific applications in mind. Such mechanisms may facilitate ‘research translation’ but funders may employ strategies that can also undermine the integrity of both science and government. We estimated the prevalence and investigated correlates of funder efforts to suppress health behaviour intervention trial findings.

Conclusions
One in five researchers in this global sample reported being pressured to delay, alter, or not publish the findings of health behaviour intervention trials. Regulation of funder and university practices, establishing study registries, and compulsory disclosure of funding conditions in scientific journals, are needed to protect the integrity of public-good research.

http://archive.today/2021.08.26-220224/https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255704

Categories
News

Health researchers report funder pressure to suppress results – Nature

Government agencies such as health departments might be more inclined to intervene if findings from a study they commissioned are not as expected or if they are heavily invested in the health intervention — such as an education or health programme — being trialled, she adds.

A 2016 inquiry into the delayed publication of research commissioned by UK government agencies identified cases in which publication was “manipulated to fit with political concerns”. More recently, the British Medical Journal reported four instances of politicization and suppression of science in the United Kingdom during the COVID-19 pandemic.

http://archive.today/2021.08.20-134039/https://www.nature.com/articles/d41586-021-02242-x

Categories
News

Genetically engineered ‘Magneto’ protein remotely controls brain and behaviour – The Guardian (2016)

Article from 24 Mar 2016

Researchers in the United States have developed a new method for controlling the brain circuits associated with complex animal behaviours, using genetic engineering to create a magnetised protein that activates specific groups of nerve cells from a distance.

https://www.theguardian.com/science/neurophilosophy/2016/mar/24/magneto-remotely-controls-brain-and-behaviour

http://archive.today/2022.01.22-042350/https://www.theguardian.com/science/neurophilosophy/2016/mar/24/magneto-remotely-controls-brain-and-behaviour

Categories
Publications

Time to assume that health research is fraudulent until proven otherwise? – BMJ

Stephen Lock, my predecessor as editor of The BMJ, became worried about research fraud in the 1980s, but people thought his concerns eccentric. Research authorities insisted that fraud was rare, didn’t matter because science was self-correcting, and that no patients had suffered because of scientific fraud. All those reasons for not taking research fraud seriously have proved to be false, and, 40 years on from Lock’s concerns, we are realising that the problem is huge, the system encourages fraud, and we have no adequate way to respond.

http://archive.today/2021.08.21-072242/https://blogs.bmj.com/bmj/2021/07/05/time-to-assume-that-health-research-is-fraudulent-until-proved-otherwise/

Categories
Publications

Biosafety Level Guidance for COVID-19 Research – Consolidated Sterilizer Systems

A Biological Safety Level (BSL 1, 2, 3, or 4) is assigned to a biological lab as a safeguard to protect laboratory personnel, as well as the surrounding environment and community.

With research into potential treatments, therapies and vaccines for the SARS-CoV-2 virus (known widely as the COVID-19 Coronavirus) exploding across the globe, many institutions and laboratories are wondering whether their equipment and lab are considered safe to contain samples of the virus. As discussed in our previous blog on biosafety levels, airborne transmissible diseases like COVID-19 are typically categorized as Biosafety Level 3 (BSL-3).  BSL-3 laboratories are almost always purpose-constructed containment laboratories, outfitted with specialized equipment and HVAC systems designed to ensure no airborne particles can exit the contained space.

https://consteril.com/biosafety-level-guidance-covid-19-research/

Categories
Publications

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

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

Categories
News

Cells from human foetuses are important for developing vaccines – but they’re not an ingredient – The Conversation

Two embryonic cell lines have been used to develop COVID-19 vaccines: human embryonic kidney cells called HEK 293 and human embryonic retinal cells called PER.C6. The PER.C6 cell line is from an elective abortion in the Netherlands in 1985, and the HEK 293 cell line comes from an undisclosed source (either spontaneous miscarriage or elective abortion) in the Netherlands in about 1972.

Johnson & Johnson used PER.C6 cells in their COVID-19 vaccine development, and the Oxford/AstraZeneca vaccine used HEK 293 cells. CanSino Biologics and Gamaleya Research Institute’s Sputnik V vaccines have also used HEK 293 cells.

Moderna and Pfizer/BioNTech used HEK 293 cells in their proof-of-concept tests to see effectively take up the genetic instructions contained in these vaccines and produce the required spike protein. But human embryonic cell lines were not used to make either company’s final vaccine.

HEK 293 and PER.C6 cell lines have been genetically altered to include the part of the adenovirus instructions that trigger replication of adenoviruses. This allows the production of a large amount of the final vaccination product and allows the removal of the adenoviral replication instructions in the vaccine.

http://archive.today/2022.10.02-145609/https://theconversation.com/cells-from-human-foetuses-are-important-for-developing-vaccines-but-theyre-not-an-ingredient-157484

Categories
Opinion

The ex-Pfizer scientist who became an anti-vax hero – Reuters

Michael Yeadon was a scientific researcher and vice president at drugs giant Pfizer Inc. He co-founded a successful biotech. Then his career took an unexpected turn.

https://www.reuters.com/investigates/special-report/health-coronavirus-vaccines-s

Categories
News

How the British Government subjected thousands of people to chemical and biological warfare trials during Cold War – The Independent (2015)

During the Cold War, the British Government used the general public as unwitting biological and chemical warfare guinea pigs on a much greater scale than previously thought, according to new historical research.

In more than 750 secret operations, hundreds of thousands of ordinary Britons were subjected to ‘mock’ biological and chemical warfare attacks launched from aircraft, ships and road vehicles.

Up until now historians had thought that such operations had been much less extensive. The new research, carried out by Ulf Schmidt, Professor of Modern History at the University of Kent, has revealed that British military aircraft dropped thousands of kilos of a chemical of ‘largely unknown toxic potential’ on British civilian populations in and around Salisbury in Wiltshire, Cardington in Bedfordshire and Norwich in Norfolk.

https://www.independent.co.uk/news/uk/politics/how-british-government-subjected-thousands-people-chemical-and-biological-warfare-trials-during-cold-war-10376411.html

Categories
Publications

Why Most Clinical Research Is Not Useful – Prof. John Ioannidis

Many clinical research studies, even in the major general medical journals, do not satisfy the identifiable features that make them useful. These features include:

  • problem base;
  • context placement;
  • information gain;
  • pragmatism;
  • patient centeredness;
  • value for money;
  • feasibility;
  • transparency.

Most clinical research findings false. Further, most of the true findings do not result in huge human benefit. Reform and improvement in the clinical research are overdue.

See also: Peer review: a flawed process at the heart of science and journals by Richard Smith at the Journal of the Royal Society of Medicine

Quoted summary points

Blue-sky research cannot be easily judged on the basis of practical impact, but clinical research is different and should be useful. It should make a difference for health and disease outcomes or should be undertaken with that as a realistic prospect.

Many of the features that make clinical research useful can be identified, including those relating to problem base, context placement, information gain, pragmatism, patient centeredness, value for money, feasibility, and transparency.

Many studies, even in the major general medical journals, do not satisfy these features, and very few studies satisfy most or all of them. Most clinical research therefore fails to be useful not because of its findings but because of its design.

The forces driving the production and dissemination of nonuseful clinical research are largely identifiable and modifiable.

Reform is needed. Altering our approach could easily produce more clinical research that is useful, at the same or even at a massively reduced cost.

https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002049

Categories
News

Neil Ferguson, the scientist who convinced Boris Johnson of UK coronavirus lockdown, criticised in past for flawed research – The Telegraph

https://www.telegraph.co.uk/news/2020/03/28/neil-ferguson-scientist-convinced-boris-johnson-uk-coronavirus-lockdown-criticised/