Pfizer

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No point vaccinating those who’ve had COVID-19: Findings of Cleveland Clinic study – News-Medical.Net

Post author By EvidenceNotFear
Post date 8 June 2021

Scientists from the Cleveland Clinic, USA, have recently evaluated the effectiveness of coronavirus disease 2019 COVID-19) vaccination among individuals with or without a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

The study findings reveal that individuals with previous SARS-CoV-2 infection do not get additional benefits from vaccination, indicating that COVID-19 vaccines should be prioritized to individuals without prior infection. The study is currently available on the medRxiv* preprint server.

https://www.news-medical.net/news/20210608/No-point-vaccinating-those-whoe28099ve-had-COVID-19-Findings-of-Cleveland-Clinic-study.aspx

Tags BioNTech, Cleveland Clinic, Covax, COVID-19, FDA, Immunity, medRxiv, News-Medical.Net, Pfizer, SARS-CoV-2, Vaccination

News

Pfizer begins testing its Covid vaccine in children aged 5-11 as Moderna CEO says his company’s shot for kids will be available by the early fall – Daily Mail

Post author By EvidenceNotFear
Post date 8 June 2021

Pfizer-BioNTech announced on Tuesday they have begun late-stage clinical trials of their coronavirus vaccine in children ages five to 11
Lower doses will be used for kids, 10 micrograms, compared to the 30 micrograms that those ages 12 and above receive
The company says it is hoping for data in the latter half of 2021, and is still in the early stages for trials in children between six months to four years old
On Monday, Moderna CEO Stéphane Bancel said he believes his company’s vaccine will be available for kids as young as five years old by early fall
Parents and doctors have been debating about whether or not to inoculate children because they make up just 0.1% of all COVID deaths

https://www.dailymail.co.uk/health/article-9664191/Pfizer-begins-testing-Covid-vaccine-children-ages-5-11.html

Tags BioNTech, Children, ClinicalTrials.gov, COVID-19, Daily Mail, Moderna, Pfizer, Trials, UK, Vaccination

Publications

Necessity of COVID-19 vaccination in previously infected individuals – medRxiv

Post author By EvidenceNotFear
Post date 5 June 2021

Conclusions Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination, and vaccines can be safely prioritized to those who have not been infected before.

https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v2

Tags BioNTech, Covax, COVID-19, FDA, Immunity, medRxiv, News-Medical.Net, Pfizer, SARS-CoV-2, Vaccination

Videos

Dr David Bauer: ‘Pfizer vaccine produces fewer key antibodies’ – MSN News

Post author By EvidenceNotFear
Post date 4 June 2021

Dr Bauer of the Francis Crick Institute explains that the Pfizer vaccine produces 5-6 times fewer neutralising antibodies that play a key role in protecting us from the Indian variant. He suggests that booster Pfizer jabs will be essential.

https://www.msn.com/en-gb/news/other/dr-david-bauer-pfizer-vaccine-produces-fewer-key-antibodies/vi-AAKHPO1

Tags BioNTech, BNT162b2, Booster Immunisations, COVID-19, Dr. David Bauer, Francis Crick Institute, Indian Variant, Neutralising Antibodies, Pfizer, RT-PCR, SARS-CoV-2, Serological Response, Vaccination, Variant of Concern, Variants

Publications

Pfizer-BioNTech vaccine recipients have lower antibody levels targeting the Delta variant first discovered in India – The Francis Crick Institute

Post author By EvidenceNotFear
Post date 3 June 2021

Levels of antibodies in the blood of vaccinated people that are able to recognise and fight the new SARS-CoV-2 Delta variant first discovered in India (B.1.617.2) are on average lower than those against previously circulating variants in the UK, according to new laboratory data from the Francis Crick Institute and the National Institute for Health Research (NIHR) UCLH Biomedical Research Centre, published today (Thursday) as a Research letter in The Lancet.

The results also show that levels of these antibodies are lower with increasing age and that levels decline over time, providing additional evidence in support of plans to deliver a vaccination boost to vulnerable people in the Autumn.

https://www.crick.ac.uk/news/2021-06-03_pfizer-biontech-vaccine-recipients-have-lower-antibody-levels-targeting-the-delta-variant-first-discovered-in-india

Publications

Neutralising antibody activity against SARS-CoV-2 VOCs B.1.617.2 and B.1.351 by BNT162b2 vaccination – The Lancet

Post author By EvidenceNotFear
Post date 3 June 2021

In the case of single-dose recipients, our data show that NAbTs are significantly lower against B.1.617.2 and B.1.351 VOCs relative to B.1.1.7, implying that although a single dose might still afford considerably more protection than no vaccination, single-dose recipients are likely to be less protected against these SARS-CoV-2 variants. These data therefore suggest that the benefits of delaying the second dose, in terms of wider population coverage and increased individual NAbTs after the second dose,⁷ must now be weighed against decreased efficacy in the short-term, in the context of the spread of B.1.617.2. Worldwide, our data highlight the ongoing need to increase vaccine supply to allow all countries to extend second-dose protection as quickly as possible.

In the longer term, we note that both increased age and time since the second dose of BNT162b2 significantly correlate with decreased NAb activity against B.1.617.2 and B.1.351—both of which are also characteristic of the population in the UK at highest risk of severe COVID-19 (ie, older and vaccinated earlier), independent of other existing factors such as compromised immune status or comorbidity, or geographic-specific responses to vaccination.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01290-3/fulltext

Publications

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

Post author By EvidenceNotFear
Post date 2 June 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.

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 22Dec2020 Hörner 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/

Tags Aborted Fetal Cells, Abortion, BNT162b2, Charlotte Lozier Institute, COVID-19, Fetal Cells, HEK293T, Johnson & Johnson, Moderna, mRNA, PER.C6, Pfizer, Research, Vaccination, WI-38

Opinion

Release Us From This Servitude – James Delingpole & Toby Young, London Calling

Post author By EvidenceNotFear
Post date 31 May 2021

Fresh from their smash reunion tour this weekend, James and Toby recap the weekend’s anti-lockdown march that wound from Parliament Square to Toby’s doorstep.

We then parse the testimony of the PM’s former “top man,” Dominic Cummings, before the House’s Health and Science select committees last week and who came out of it better. Do you want a Prime Minister or a Monarch (and by “monarch” we’re not talking about the one we’ve already got.)

https://ricochet.com/podcast/london-calling/release-us-from-this-servitude/

Tags AstraZeneca, COVID-19, Dr. Soumya Swaminathan, Financial Incentives, Government, James Delingpole, London Calling, Pfizer, Pharmaceutical Industry, Policy, Protests, Sir Patrick Vallance, Toby Young, Vaccination, Vaccine Damage, Vaccine Hesitancy, WHO

News

CDC investigates dozens of reports of heart inflammation in teenagers and young adults that occur four days after their second dose of Moderna or Pfizer vaccines – Daily Mail

Post author By EvidenceNotFear
Post date 23 May 2021

CDC looking into reports that a small number of teens and young adults vaccinated against the coronavirus that may have experienced heart problems
Condition, known as myocarditis, results in an inflammation of the heart muscle which can occur following certain infections
Problems have been occurring four days after the second dose has been given
Dozens of cases have been reported to the agency in recent week
It is not yet clear which vaccine might be responsible, Moderna or Pfizer
The agency’s vaccine safety group was sparse in details, saying only that there were ‘relatively few’ cases and levels were similar to normal
Group also said that the conditions may be entirely unrelated to vaccination

https://www.dailymail.co.uk/news/article-9608675/CDC-investigating-heart-problems-teenagers-young-adults-Moderna-Pfizer-vaccine.html#comments

Tags BioNTech, CDC, Children, Moderna, mRNA, Myocarditis, Pfizer, Teenagers, Vaccination, Vaccine Damage

Publications

The four phases of clinical trials – Pfizer

Post author By EvidenceNotFear
Post date 20 May 2021

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

Tags Clinical, Pfizer, Pharmaceutical Industry, Studies, Trials

Publications

Vaccinating children against SARS-CoV-2 – BMJ

Post author By EvidenceNotFear
Post date 13 May 2021

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

Tags BioNTech, BMJ, Children, COVID-19, FDA, mRNA, Pfizer, Risk, SARS-CoV-2, Side-effects, Transmission, Vaccination, Vaccine Damage

News

Were fears of a third wave overblown? – The Spectator

Post author By EvidenceNotFear
Post date 11 May 2021

So, the third wave is officially no more. New modelling by SPI-M, the government’s committee on modelling for pandemics, has, at a stroke, eradicated the predicted surge in new infections, hospital admissions and deaths which it had pencilled in for the autumn or winter as a result of lockdown being eased.

…As Philip Thomas explained here on Sunday, Imperial College has also assumed strangely low estimates for the number of people in Britain carrying antibodies. If you are going to use assumptions that are far more pessimistic than real world data suggests, it is small wonder that SPI-M keeps predicting waves and surges that turn out to be wide of the mark. The question is: why are these modelling teams using such negative assumptions?

https://www.spectator.co.uk/article/how-likely-is-a-third-wave-

Tags AstraZeneca, Capacity, COVID-19, Hospitals, Imperial College, London School of Hygiene and Tropical Medicine, Modelling, Peak, Pfizer, SPI-M, The Spectator, Third Wave, Trials, UK, USA, Vaccination

News

Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine – The New York Times

Post author By EvidenceNotFear
Post date 4 May 2021

The vaccine brought in $3.5 billion in revenue in the first three months of this year, nearly a quarter of its total revenue, Pfizer reported. The vaccine was, far and away, Pfizer’s biggest source of revenue.

On Tuesday, the company announced just how much money the shot is generating.

The vaccine brought in $3.5 billion in revenue in the first three months of this year, nearly a quarter of its total revenue, Pfizer reported. The vaccine was, far and away, Pfizer’s biggest source of revenue.

The company did not disclose the profits it derived from the vaccine, but it reiterated its previous prediction that its profit margins on the vaccine would be in the high 20 percent range. That would translate into roughly $900 million in pretax vaccine profits in the first quarter.

https://www.nytimes.com/2021/05/04/business/pfizer-covid-vaccine-profits.html

Tags AstraZeneca, BioNTech, Covax, COVID-19, EU, Financial Incentives, GAVI Alliance, Israel, Johnson & Johnson, Medical Industry, Moderna, NIH, Pfizer, Pharmaceutical Industry, Profit, The New York Times, USA

News

Healthy children simply do not need a Covid jab – The Telegraph

Post author By EvidenceNotFear
Post date 3 May 2021

I won’t have been the only parent concerned by news last week that the Pfizer vaccine may be approved for use on children as early as June and potentially rolled out to school pupils from September. Healthy children are at almost no serious risk from Covid-19 – the recovery rate for this age group has been calculated at over 99.99 per cent. The argument that children should have the vaccine is not based on a belief that they need or benefit from it but on the logic that it would be good for our communities at large if children were jabbed. In short, those advocating it assume that children have an obligation to protect adults.

It’s worth noting that the UK Government has granted immunity from liability for harms to all Covid-19 vaccine manufacturers. Can we really ask children to accept a greater risk than the manufacturers themselves are prepared to live with?

https://www.telegraph.co.uk/news/2021/05/03/healthy-children-simply-do-not-need-covid-jab

Tags Children, Clinical, COVID-19, Herd Immunity, Modelling, Pfizer, Trials, University College London, Vaccination

News

Denmark to cancel Johnson & Johnson coronavirus vaccine rollout, except on voluntary basis – RT

Post author By EvidenceNotFear
Post date 3 May 2021

Danish authorities have opted for a more cautious path, even though Reuters reported that excluding J&J’s shot could significantly delay the country’s vaccination efforts.

Danish drug officials last month abandoned the use of AstraZeneca’s Covid-19 vaccine, also citing the risk of blood clots. In March, Denmark became the first country in the world to temporarily suspend the AstraZeneca shot, but unlike its European neighbors, the country made that suspension permanent.

https://www.rt.com/news/522790-denmark-cancels-johnson-vaccine/

Tags AstraZeneca, BioNTech, Blood Clots, COVID-19, Denmark, Johnson & Johnson, Moderna, Pfizer, RT, Side-effects, Vaccination, Vaccine Damage, WHO

News

Schools back mass vaccinations for children as headteachers say ‘peer pressure’ will boost take up – The Telegraph

Post author By EvidenceNotFear
Post date 2 May 2021

Schools back mass vaccinations for children, with headteachers saying that “peer pressure” will boost take up.

Education leaders would be willing to help facilitate a vaccine roll-out at schools around the country, according to Geoff Barton, general secretary of the Association of School and College Leaders (ASCL), the largest union for secondary school heads.

…“I think there will be a sense of schools wanting to step up and play their part and explain to children why having the vaccine is important during assemblies and in tutor time.”

…He explained that vaccinating children at school could result in higher take-up because pupils would not want to feel socially isolated by refusing to have the jab.

…“The peer pressure of seeing that your friends are lining up to do it is likely to make the overall numbers taking up the vaccine higher,” he said. Some scientists have argued that if Covid rates rose significantly it would be a priority to vaccinate children to prevent any more disruption or closures of schools during the next academic year.

https://www.telegraph.co.uk/news/2021/05/02/schools-back-mass-vaccinations-children-headteachers-say-peer/

Tags Behaviour Change, BioNTech, Children, COVID-19, MHRA, National Education Union, Peer Pressure, Pfizer, Schools, The Association of School and College Leaders, The Telegraph, UK, UsForThem, Vaccination

News

Court approves settlement in Shiley heart-valve case – United Press International

Post author By EvidenceNotFear
Post date 1 May 2021

Published 19 August 1992

New York-based Pfizer said the agreement will cost it between $165 million and $215 million, on a pretax basis, and will be offset by proceeds from the sale of most of its Shiley Inc. assets earlier this year as well as expected insurance reimbursements.

https://www.upi.com/Archives/1992/08/19/Court-approves-settlement-in-Shiley-heart-valve-case/4515714196800/

Tags Bjork-Shiley Convexo-Concave Heart Valve, Compensation, Court Cases, Liability, Medical Industry, Pfizer, Pharmaceutical Industry, United Press International, USA

News

Oxford jab ‘could be banned for under-40s’ after blood clot reports double – The METRO

Post author By EvidenceNotFear
Post date 24 April 2021

Under-40s may be offered an alternative to the Oxford-AstraZeneca vaccine after blood clot reports doubled, reports claim.

The chance of dying from a blood clot after having the jab is about one in one million – with 19 fatalities from around 20 million vaccinations. However, the total number of people in the UK who developed blood clots after getting one dose has gone from 79 to 168 in a fortnight, Medical Healthcare Products and Regulatory Agency (MHRA) data suggests.

Tags Adverse Drug Reaction, AstraZeneca, Blood Clots, COVID-19, METRO, MHRA, Moderna, Pfizer, Side-effects, UK, Vaccination, Vaccine Damage

News

AstraZeneca vaccine: Does the AstraZeneca vaccine use mRNA? – The Express

Post author By EvidenceNotFear
Post date 21 April 2021

Many of the vaccines developed to protect against COVID-19 are forms of messenger RNA (mRNA) vaccines.

The Moderna and Pfizer/BioNTech vaccines are forms of mRNA vaccine.

Unlike the Pfizer/BioNTech and Moderna coronavirus vaccines, the Oxford/AstraZeneca vaccine is not an mRNA vaccine.

Instead, the AstraZeneca vaccine is a viral vector vaccine made from a weakened form of a common cold virus from chimpanzees.

https://www.express.co.uk/life-style/health/1424769/astrazeneca-vaccine-does-astrazeneca-vaccine-use-mrna-evg

Tags BioNTech, Moderna, mRNA, Pfizer, The Express, Vaccination

News

The shock and reality of catching COVID after being vaccinated – NPR

Post author By EvidenceNotFear
Post date 21 April 2021

Robin Hauser, a pediatrician in Tampa, Florida, got COVID in February. What separates her from the vast majority of the tens of millions of other Americans who have come down with the virus is this: She got sick seven weeks after her second dose of the Pfizer-BioNTech vaccine.

https://www.pbs.org/newshour/health/the-shock-and-reality-of-catching-covid-after-being-vaccinated

Tags BioNTech, CDC, Clinical, COVID-19, Florida, Moderna, NPR, Pfizer, Statistics, Trials, Vaccination