BNT162b2

Browse the articles related to this topic below.

Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNtech) in Aotearoa New Zealand – The Lancet

Post author By EvidenceNotFear
Post date 20 January 2023

Although rare, a statistically significant association between BNT162b2 vaccination and myo/pericarditis and AKI was observed. While the association between BNT162b2 and myo/pericarditis has been confirmed internationally, further research is required to understand the association of AKI. BNT162b2 was not found to be associated with most of the AESIs investigated, providing reassurances around the safety of the vaccine.

https://archive.today/2023.01.23-080922/https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4329970

Publications

Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older – Science Direct

Post author By EvidenceNotFear
Post date 13 January 2023

Findings
Four outcomes met the threshold for a statistical signal following BNT162b2 vaccination including pulmonary embolism (PE; RR = 1.54), acute myocardial infarction (AMI; RR = 1.42), disseminated intravascular coagulation (DIC; RR = 1.91), and immune thrombocytopenia (ITP; RR = 1.44). After further evaluation, only the RR for PE still met the statistical threshold for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination with either the mRNA-1273 or Ad26 COV2.S vaccines.

Interpretation
This early warning system is the first to identify temporal associations for PE, AMI, DIC, and ITP following BNT162b2 vaccination in the elderly. Because an early warning system does not prove that the vaccines cause these outcomes, more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals. FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.

http://archive.today/2023.01.10-210629/https://www.sciencedirect.com/science/article/pii/S0264410X22014931

Tags Ad26 COV2.S, Age Groups, BNT162b2, Collateral Damage, COVID-19, Elderly, Janssen, Moderna, mRNA-1273, Pfizer, Science Direct, Vaccination

Publications

Changes of ECG parameters after BNT162b2 vaccine in the senior high school students – PubMed

Post author By EvidenceNotFear
Post date 5 January 2023

The purpose of this study is to determine the ECG parameter change and the efficacy of ECG screening for cardiac adverse effect after the second dose of BNT162b2 vaccine in young population. In December 2021, in cooperation with the school vaccination system of Taipei City government, we performed a ECG screening study during the second dose of BNT162b2 vaccines. Serial comparisons of ECGs and questionnaire survey were performed before and after vaccine in four male-predominant senior high schools. Among 7934 eligible students, 4928 (62.1%) were included in the study. The male/female ratio was 4576/352. In total, 763 students (17.1%) had at least one cardiac symptom after the second vaccine dose, mostly chest pain and palpitations. The depolarization and repolarization parameters (QRS duration and QT interval) decreased significantly after the vaccine with increasing heart rate. Abnormal ECGs were obtained in 51 (1.0%) of the students, of which 1 was diagnosed with mild myocarditis and another 4 were judged to have significant arrhythmia. None of the patients needed to be admitted to hospital and all of these symptoms improved spontaneously. Using these five students as a positive outcome, the sensitivity and specificity of this screening method were 100% and 99.1%, respectively. Conclusion: Cardiac symptoms are common after the second dose of BNT162b2 vaccine, but the incidences of significant arrhythmias and myocarditis are only 0.1%. The serial ECG screening method has high sensitivity and specificity for significant cardiac adverse effect but cost effect needs further discussed. What is Known: • The incidence of cardiac adverse effects was reported to be as high as 1.5 per 10 000 persons after the second dose BNT162b2 COVID-19 vaccine in the young male population based on the reporting system. What is New: • Through this mass ECG screening study after the second dose of BNT162b2 vaccine we found: (1) The depolarization and repolarization parameters (QRS duration and QT interval) decreased significantly after the vaccine with increasing heart rate; (2) the incidence of post-vaccine myocarditis and significant arrhythmia are 0.02% and 0.08%; (3) The serial ECG screening method has high sensitivity and specificity for significant cardiac adverse effect.

https://pubmed.ncbi.nlm.nih.gov/36602621/

Archive link: https://web.archive.org/web/20230000000000*/https://pubmed.ncbi.nlm.nih.gov/36602621/

Tags Age Groups, BNT162b2, Cardiac Arrhythmia, Children, Collateral Damage, COVID-19, ECG, Heart Problems, Myocarditis, Pfizer, PubMed, Statistics, Studies, Taiwan, Vaccination

Publications

Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older

Post author By EvidenceNotFear
Post date 1 December 2022

Our early warning safety system is the first to identify-four new statistical signals for modestly elevated risks (RR less than 2) of four serious outcomes of AMI, PE, DIC, and ITP following BNT162b2 vaccination. This FDA and CMS COVID-19 vaccine safety study is one of the largest studies of elderly persons aged 65 years and above including approximately 34 million doses administered to more than 17 million Medicare insured persons. Our surveillance monitoring did not detect statistical signals for the mRNA-1273and Ad26 COV2.S vaccines for any of the 14 monitored outcomes.

Analysis from The Epoch Times can be found here: Pfizer’s COVID-19 Vaccine Linked to Blood Clotting: FDA

http://archive.today/2022.12.19-065727/https://www.sciencedirect.com/science/article/pii/S0264410X22014931

Tags Blood Clots, BNT162b2, COVID-19, Elderly, FDA, Pfizer, Science Direct, Side-effects, Statistics, Vaccination

Publications

Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults – Science Direct

Post author By EvidenceNotFear
Post date 22 September 2022

Results
Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

Discussion
The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.

http://archive.today/2023.01.12-064142/https://www.sciencedirect.com/science/article/pii/S0264410X22010283

Tags Adverse Drug Reaction, BioNTech, BNT162b2, Brighton Collaboration, Coalition for Epidemic Preparedness Innovations, COVID-19, Moderna, mRNA, mRNA-1273 NCT04368728, NCT04470427, Pfizer, Randomized Controlled Trials, Safety Platform for Emergency vACcines, SARS-CoV-2, Science Direct, Side-effects, Trials, Vaccination, WHO

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Summary of the Public Assessment Report for COVID-19 Vaccine Pfizer/BioNTech – GOV.UK

Post author By EvidenceNotFear
Post date 16 August 2022

The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need. In principle, a decision on licensing a vaccine could be taken in these circumstances without data from reproductive toxicity studies animals, but there are studies ongoing and these will be provided when available. In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: however, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated. These judgements reflect the absence of data at the present time and do not reflect a specific finding of concern. Adequate advice with regard to women of childbearing potential, pregnant women and breastfeeding women has been provided in both the Information for UK Healthcare Professionals and the Information for UK recipients.

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

Tags BioNTech, BNT162b2, Breastfeeding, Children, Collateral Damage, COVID-19, Department of Health and Social Care, GOV.UK, Government, MHRA, mRNA, Pfizer, Policy, Pregancy, Public Assessment Report, Toxicity, UK, Vaccination

Publications

SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents – JAMA

Post author By EvidenceNotFear
Post date 20 April 2022

The risk of myocarditis in this large cohort study was highest in young males after the second SARS-CoV-2 vaccine dose, and this risk should be balanced against the benefits of protecting against severe COVID-19 disease.

https://jamanetwork.com/journals/jamacardiology/fullarticle/2791253

Archive link: https://web.archive.org/web/20230000000000*/https://jamanetwork.com/journals/jamacardiology/fullarticle/2791253

Publications

4th Dose COVID mRNA Vaccines’ Immunogenicity & Efficacy Against Omicron VOC – medRxiv

Post author By EvidenceNotFear
Post date 15 February 2022

RESULTS Of 1050 eligible HCW, 154 and 120 were enrolled to receive BNT162b2 and mRNA1273, respectively, and compared to 426 age-matched controls. Recipients of both vaccine types had a ∼9-10-fold increase in IgG and neutralizing titers within 2 weeks of vaccination and an 8-fold increase in live Omicron VOC neutralization, restoring titers to those measured after the third vaccine dose. Breakthrough infections were common, mostly very mild, yet, with high viral loads. Vaccine efficacy against infection was 30% (95%CI:-9% to 55%) and 11% (95%CI:-43% to +43%) for BNT162b2 and mRNA1273, respectively. Local and systemic adverse reactions were reported in 80% and 40%, respectively.

CONCLUSIONS The fourth COVID-19 mRNA dose restores antibody titers to peak post-third dose titers. Low efficacy in preventing mild or asymptomatic Omicron infections and the infectious potential of breakthrough cases raise the urgency of next generation vaccine development.

https://www.medrxiv.org/content/10.1101/2022.02.15.22270948v1.full-text

Tags Alpha Variant, BNT162b2, COVID-19, Efficacy, Health Care Workers, Immunity, Israel, medRxiv, mRNA, mRNA-1273, Omicron Variant, SARS-CoV-2, T-Cell, Vaccination, Variant of Concern, Variants

Publications

Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021 – JAMA

Post author By EvidenceNotFear
Post date 25 January 2022

Question  What is the risk of myocarditis after mRNA-based COVID-19 vaccination in the US?

Findings  In this descriptive study of 1626 cases of myocarditis in a national passive reporting system, the crude reporting rates within 7 days after vaccination exceeded the expected rates across multiple age and sex strata. The rates of myocarditis cases were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively).

Meaning  Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men.

http://archive.today/2022.08.24-225032/https://jamanetwork.com/journals/jama/fullarticle/2788346

Tags Age Groups, BioNTech, BNT162b2, Collateral Damage, COVID-19, JAMA, Moderna, mRNA, mRNA-1273, Myocarditis, Pfizer, Side-effects, USA, Vaccination, Vaccine Damage, VAERS

Publications

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

Post author By EvidenceNotFear
Post date 16 December 2021

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

Tags Aborted Fetal Cells, Abortion, BNT162b2, Dr James L Sherley, Fetal Cells, HEK293T, Moderna, Professor Paul Knoepfler PhD, Research, The Niche, Vaccination

Publications

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

Post author By EvidenceNotFear
Post date 16 December 2021

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/

Tags Aborted Fetal Cells, Abortion, BNT162b2, Fetal Cells, HEK293T, Moderna, Professor Paul Knoepfler PhD, Research, The Niche, Vaccination

Publications

Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel – The New England Journal of Medicine

Post author By EvidenceNotFear
Post date 2 December 2021

Background
Approximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer–BioNTech) by May 31, 2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance.

Conclusions
The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.

http://archive.today/2021.10.10-032642/https://www.nejm.org/doi/full/10.1056/NEJMoa2109730

Tags BioNTech, BNT162b2, Cardiology, COVID-19, FDA, Heart Problems, Israel, Israeli Ministry of Health, Myocarditis, Pfizer, Side-effects, The New England Journal of Medicine, Vaccination, Vaccine Damage

News

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

Post author By EvidenceNotFear
Post date 19 November 2021

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

Tags Aborted Fetal Cells, Abortion, BNT162b2, COVID-19, Fetal Cells, HEK293T, Johnson & Johnson, Moderna, mRNA, National Geographic, PER.C6, Pfizer, Research, Spike Protein, The Niche, Vaccination, WI-38

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November 8, 2021 Summary Basis for Regulatory Action – Comirnaty – FDA

Post author By EvidenceNotFear
Post date 8 November 2021

Introduction

BioNTech Manufacturing GmbH (in partnership with Pfizer Inc.) submitted a Biologics License Application (BLA) STN BL 125742 for licensure of COVID-19 Vaccine, mRNA. The proprietary name of the vaccine is COMIRNATY. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine is administered intramuscularly (IM) as a series of two 30 μg doses (0.3 mL each) 3 weeks apart.

For commentary, see FDA report finds all-cause mortality higher among vaccinated – Israel Nation News.

http://archive.today/2021.10.11-032110/https://www.fda.gov/media/151733/download

Tags All Cause Mortality, Approval, BioNTech, BNT162b2, Clinical, Comirnaty, Control Group, COVID-19, FDA, Israel Nation News, mRNA, Pfizer, Regulations, Trials, Vaccination

Publications

Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections – medRxiv

Post author By EvidenceNotFear
Post date 25 August 2021

This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity. Individuals who were both previously infected with SARS-CoV-2 and given a single dose of the vaccine gained additional protection against the Delta variant.

https://www.medrxiv.org/content/10.1101/2021.08.24.21262415v1

Tags BioNTech, BNT162b2, COVID-19, Delta Variant, Immunity, medRxiv, mRNA, Natural Immunity, Pfizer, Reinfection, Risk, SARS-CoV-2, Vaccination, Variants

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

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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

Publications

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

Post author By EvidenceNotFear
Post date 16 April 2021

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/

Tags Autopsy, BNT162b2, Cause of Death, COVID-19, Germany, Immunity, mRNA, NCBI, SARS-CoV-2, Side-effects, Spike Protein, Sterile Immunity, Vaccination, Vaccine Damage