COVID-19 Situation Report 210
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An Update Review of Globally Reported SARS-Cov-2 Vaccines in Preclinical and Clinical Stages
International Immunopharmacology 96 (2021) 107763 Contents lists available at ScienceDirect International Immunopharmacology journal homepage: www.elsevier.com/locate/intimp Review An update review of globally reported SARS-CoV-2 vaccines in preclinical and clinical stages Hamid Motamedi a, Marzie Mahdizade Ari b, Shirin Dashtbin b, Matin Fathollahi a, Hadi Hossainpour a, Amirhoushang Alvandi a,c, Jale Moradi a, Ramin Abiri a,d,* a Department of Microbiology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran b Department of Microbiology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran c Medical Technology Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran d Fertility and Infertility Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran ARTICLE INFO ABSTRACT Keywords: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of the rapidly spreading COVID-19 pandemic COVID-19 in the world. As an effective therapeutic strategy is not introduced yet and the rapid genetic SARS-CoV-2 variations in the virus, there is an emerging necessity to design, evaluate and apply effective new vaccines. An Vaccines acceptable vaccine must elicit both humoral and cellular immune responses, must have the least side effects and the storage and transport systems should be available and affordable for all countries. These vaccines can be classified into different types: inactivated vaccines, live-attenuated virus vaccines, subunit vaccines, virus-like particles (VLPs), nucleic acid-based vaccines (DNA and RNA) and recombinant vector-based vaccines (repli cating and non-replicating viral vector). According to the latest update of the WHO report on April 2nd, 2021, at least 85 vaccine candidates were being studied in clinical trial phases and 184 candidate vaccines were being evaluated in pre-clinical stages. -
Updated May 26, 2021 Cross-Border Industry Partnerships on COVID-19 Vaccines and Therapeutics Vaccines • Curevac O Celonic Wi
Updated May 26, 2021 Cross-Border Industry Partnerships on COVID-19 Vaccines and Therapeutics Vaccines • CureVac o Celonic will manufacture 100 million doses of CureVac’s vaccine at its plant in Heidelberg, Germany, providing bulk substance for 50 million doses by the end of 2021. (press release) o Novartis will manufacture CureVac’s vaccine. (press release) o GlaxoSmithKline plc and CureVac N.V. announced a new €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. (press release) o Rentschler Biopharma SE will manufacture CureVac’s vaccine. (press release) o Bayer will support the further development, supply and key territory operations of CureVac’s vaccine candidate. (press release) o Fareva will dedicate a manufacturing plant in France to the fill and finish of CureVac’s vaccine. (press release) o Wacker Chemie AG will manufacture CureVac’s vaccine candidate at its Amsterdam site. (press release) o CureVac will collaborate with Tesla Grohmann Automation to develop an RNA printer that works like a mini-factory and can produce such drugs automatically. (press release) • Moderna o Samsung Biologics will provide large scale, commercial fill-finish manufacturing for Moderna’s vaccine in South Korea. (press release) o Baxter International will provide fill/finish services and supply packaging for Moderna. (press release) o Sanofi will manufacture 200 million doses of Moderna’s COVID-19 vaccine starting in September 2021. (press release) o Rovi will produce bulk substance for Moderna’s COVID-19 vaccine, expanding an agreement between the companies. -
Vaccins Contre La Covid-19 Et Utilisation De Cellules D'origine Fœtale
Vaccins contre la Covid-19 et utilisation de cellules d’origine fœtale : un questionnement éthique pour les chrétiens. Dr Michel Cambrelin La pandémie Covid-19 due au nouveau Coronavirus SARS-CoV-2 n’épargne pas nos sociétés occidentales, qui sont fortement ébranlées malgré leur richesse et leur technologie, et notre pays ne fait pas exception1. Après les échecs successifs des tentatives de contenir cette épidémie, la vaccination nous est présentée comme la planche de salut. Cette vaccination a pour principe de présenter à l’organisme receveur des éléments inoffensifs appartenant au virus, ce qui va lui permettre de fabriquer des anticorps prêts à le défendre lorsque le virus essaiera de le pénétrer. Pour ces vaccins différentes techniques ont été utilisées, qui pour certaines sont assez nouvelles, que nous expliquerons plus loin. De multiples questions et rumeurs circulent sur les vaccins Covid en particulier à ARN messager (ARNm), auxquelles l’OMS2 et la Société de Pathologie Infectieuse de Langue Française3 ont apporté leurs réponses. Bien que les Français y semblaient réticents au départ, une politique de vaccination croissante se met en place, dont on critique maintenant la lenteur du démarrage. Cependant une autre question interpelle les chrétiens, respectueux de la vie humaine constituant un don de Dieu dès la conception4, question qui n’est pas abordée dans les médias ni dans les recommandations scientifiques : certains vaccins contre la Covid auraient été élaborés à l’aide de cellules de fœtus avortés ! Nous allons tenter d’apporter les éléments de réponse nécessaires à cette question, qui semble ignorée du débat public, sans aborder les autres questions d’innocuité et d’efficacité de ces vaccins qui ont aussi leur importance éthique. -
1 Title: Interim Report of a Phase 2 Randomized Trial of a Plant
medRxiv preprint doi: https://doi.org/10.1101/2021.05.14.21257248; this version posted May 17, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. 1 Title: Interim Report of a Phase 2 Randomized Trial of a Plant-Produced Virus-Like Particle 2 Vaccine for Covid-19 in Healthy Adults Aged 18-64 and Older Adults Aged 65 and Older 3 Authors: Philipe Gobeil1, Stéphane Pillet1, Annie Séguin1, Iohann Boulay1, Asif Mahmood1, 4 Donald C Vinh 2, Nathalie Charland1, Philippe Boutet3, François Roman3, Robbert Van Der 5 Most4, Maria de los Angeles Ceregido Perez3, Brian J Ward1,2†, Nathalie Landry1† 6 Affiliations: 1 Medicago Inc., 1020 route de l’Église office 600, Québec, QC, Canada, G1V 7 3V9; 2 Research Institute of the McGill University Health Centre, 1001 Decarie St, Montreal, 8 QC H4A 3J1; 3 GlaxoSmithKline Biologicals SA (Vaccines), Avenue Fleming 20, 1300 Wavre, 9 Belgium; 4 GlaxoSmithKline Biologicals SA (Vaccines), rue de l’Institut 89, 1330 Rixensart, 10 Belgium; † These individuals are equally credited as senior authors. 11 * Corresponding author: Nathalie Landry, 1020 Route de l’Église, Bureau 600, Québec, Qc, 12 Canada, G1V 3V9; Tel. 418 658 9393; Fax. 418 658 6699; [email protected] 13 Abstract 14 The rapid spread of SARS-CoV-2 globally continues to impact humanity on a global scale with 15 rising morbidity and mortality. Despite the development of multiple effective vaccines, new 16 vaccines continue to be required to supply ongoing demand. -
Information & Consent Form
INFORMATION & CONSENT FORM RESEARCH TITLE: A Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older SHORT TITLE: A randomized controlled study, assessing the safety and immunogenicity of a COVID-19 vaccine in adults PROTOCOL NUMBER: CP-PRO-CoVLP-021 RESEARCHERS: Principal Investigator: Dr. Scott Halperin, Pediatric Infectious Disease Specialist, IWK Health Centre Co-Investigators: Dr. Joanne Langley, Pediatric Infectious Disease Specialist, IWK Health Centre Dr. Jeannette Comeau, Pediatric Infectious Disease Specialist, IWK Health Centre FUNDER: Medicago R&D Inc. SPONSOR: Medicago R&D Inc. 1020 route de l’Église, bureau 600 Québec (QC), Canada G1V 3V9 Introduction You are being asked to take part in this research study to assess the safety and ability of an investigational study vaccine to generate an immune response against the virus causing COVID-19 disease. You can decide if you want to take part in this study or not. Your choice will not change the quality of care that you will receive outside of this study. Please take time to read the following information about the study. Feel free to ask the study staff any questions that you may have. Informed consent means agreeing to take part in a research study, but only when you fully understand what this means for you. You sign this informed consent form only if you agree to take part in this study. Signing the form shows that you have understood what this means for you and that you want to take part. -
Periodic Update on AEFI
CONSOLIDATED REGIONAL AND GLOBAL INFORMATION ON ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) AGAINST COVID-19 AND OTHER UPDATES WASHINGTON, DC Updated: 31 March 2021 1 OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS CANADA § As of 19 March 2021, 3,729,312 doses of the Pfizer-BioNTech, Moderna, and Covishield vaccines had been administered. § A total of 2,530 individual reports of one or more adverse events (0.068% of doses administered) were reported. Of these, 320 were considered serious events (0.009% of doses administered), with anaphylaxis being the most frequently reported. § There were a total of 7,397 adverse events following immunization (AEFI) (consisting of 2,530 reports of one or more events), mostly non-serious adverse events, such as injection-site reactions, partesia, itching, hives, headache, hyposthesia, and nausea. Only 0.8% of cases corresponded to anaphylaxis (59 cases, or 15.8 cases per million doses administered). § Most adverse events reported were among women, and in people between the ages of 18 and 49, these being the groups prioritized for vaccination § A total of 24 reported adverse events were identified as post-vaccination deaths. After medical review, it was determined that 13 of these deaths were not linked to administration of the COVID-19 vaccine, while the other 11 are still under investigation. Link: https://health-infobase.canada.ca/covid-19/vaccine-safety/ UNITED STATES § Nearly 126 million doses of the Pfizer-BioNTech and Moderna vaccines were administered between 14 December 2020 and 29 March 2021. § The Vaccine Adverse Event Reporting System (VAERS) received 2,509 reports of deaths (0.0019% of doses administered) that have not been linked to the vaccine. -
Building Visualizations to Uncover Insights in Clinical Trial and Pipeline Data
Building visualizations to uncover insights in clinical trial and pipeline data: a COVID-19 vaccine case study Matt Eberle, Lead Developer, Analytics and Custom Solutions, BizInt Solutions, Inc. Diane Webb, President and Co-Founder, BizInt Solutions, Inc. Wednesday, March 24, 2021, 2:00 pm ET This session will start momentarily…. Webinar Host Susie Corbett PHT Chair Pharmaceutical & Health Technology Community https://connect.sla.org/pht/home Matt Eberle Lead Developer, Analytics and Custom Solutions, BizInt Solutions, Inc. [email protected] Following over ten years of experience at Wyeth, Pfizer and Sunovion as a Senior Information Scientist and Pharmaceutical Information Analyst, since 2013 Matt has helped BizInt customers use the BizInt Smart Charts and VantagePoint tools to create new solutions to address their challenges and problems. Matt lives outside Boston, MA. Diane Webb President and Co-Founder, BizInt Solutions, Inc. [email protected] Diane has over 30 years of experience managing the development of software tools to analyze and present competitive intelligence information, with a focus on drug pipeline, clinical trial and patent data. In 1996 Diane and John Willmore started BizInt Solutions to develop and market the BizInt Smart Charts product family. Diane & John live near Seattle, WA, with their current pack of four longhaired dachshunds. Building visualizations to uncover insights in clinical trial and pipeline data: a COVID-19 vaccine case study Part I: Dashboard visualizations and initial challenges PHT Pharma -
The Covid–19 Pandemic and Haemglobin Isorders
THE COVID–19 PANDEMIC AND HAEMGLOBIN ISORDERS UPDATE: 29 June 2021 Vaccinations “Immunization is a key component of primary health care and an indisputable human right. It is also one of the best health investments money can buy. Vaccines are thus critical to the prevention and control of infectious-disease outbreaks. They underpin global health security and will be a vital tool in the battle against antimicrobial resistance”. – WHO https://www.who.int/health- topics/vaccines-and- immunization “Since the beginning of the pandemic, WHO has taken steps to prevent an “infodemic”— defined by the organization as “an overabundance of information and the rapid spread of misleading or fabricated news, images, and videos.” WHO and the Wikimedia Foundation, the nonprofit organization that administers Wikipedia, have established a collaboration to expand the public’s access to the latest and most reliable information about COVID-19”. Information about the initiative is available at: https://www.who.int/news/item/22-10- 2020- the-world-health-organization-and-wikimedia-foundation-expand-access-to- trusted- information-aboutcovid-19-on-wikipedia TIF shares the concerns of false information and misleading overabundance of information. This often happens in the effort to enhance hope to a population that is suffering not only from the disease itself, but also from its economic future, since lockdown/isolation practices are stifling the market economies of every country around the world. Hope however, must be based on realistic expectations and information. For these reasons, TIF updates on new developments concerning vaccinations and new therapies are scanned for accuracy and are reviewed now more regularly. -
Supplemental 1 (PDF)
Supplemental Table 1. Summary of Formulations and Subtype Target in Influenza Vaccine Pandemic Clinical Trials. Adapted from the WHO, “Pandemic and Potentially Pandemic Viruses.” (165) Inactivated Whole Inactivated Inactivated Live Viral Virus Split Virus Subunit Attenuated Recombinant Vector DNA Peptide Undefined Total H1N1 20 251 84 26 14 36 431 H2N2 1 2 3 H3N2 1 2 1 6 1 11 H5N1 43 64 29 6 9 5 5 161 H5N2 2 9 11 H5N3 7 7 H6N1 1 1 H7N1 4 4 H7N3 3 3 H7N7 1 1 2 4 H7N9 8 1 7 4 1 21 H9N2 7 1 8 Non- 6 1 4 11 specific Total 73 330 124 57 33 11 8 4 36 676 Supplemental Table 2. Current Phase III SARS-CoV-2 Vaccine Candidates Phase Previous # of Doses Storage Developer Vaccine III Platform Vaccine Antigen Clinical Trial #s References (Days) Temp. Efficacy Use Anhui Zhifei Longcom Adjuvanted NCT04445194, Biopharmaceutical/ Protein RBD- 2 or 3 NCT04466085, Institute of ZF2001 MERS 2-8o C (1) subunit Dimer NCT04550351, Microbiology, Chinese NCT04646590 Academy of Sciences Bharat Biotech/ Indian CTRI/2020/07/026300, Council of Medical NCT04471519, Research/ National COVAXIN Inactivated Whole- 2 2-8o C CTRI/2020/09/027674, (2) Institute of Virology/ (BBV152) virus virion CTRI/2020/11/028976, Ocugen/ Precisa NCT04641481 Medicamentos ChiCTR2000030906, ChiCTR2000031781, NCT04313127, CanSino Biologics/ NCT04341389, Non- Beijing Institute of S NCT04398147, Ad5-nCoV replicating Ebola 1 2-8o C (3, 4) Biotechnology/ protein NCT04526990, viral vector Petrovax NCT04540419, NCT04552366, NCT04566770, NCT04568811 RABV, EudraCT 2020-004066-19, LASV, YFV, NCT04449276, -
Coronavirus Vaccine Tracker
https://nyti.ms/2MHNdRL U.S.A. World Health Coronavirus Vaccine Tracker By Carl Zimmer, Jonathan Corum and Sui-Lee Wee Updated April 5, 2021 PHASE 1 PHASE 2 PHASE 3 AUTHORIZED APPROVED ABANDONED 50 35 23 5 8 4 Vaccines Vaccines Vaccines Vaccines Vaccines Vaccines testing safety in expanded in large-scale in early or approved abandoned and dosage safety trials efficacy tests limited use for full use after trials Vaccines typically require years of research and testing before reaching the clinic, but in 2020, scientists embarked on a race to produce safe and effective coronavirus vaccines in record time. Researchers are currently testing 86 vaccines in clinical trials on humans, and 23 have reached the final stages of testing. At least 77 preclinical vaccines are under active investigation in animals. New additions and recent updates April 5 The Walter Reed Army Institute of Research enters Phase 1. April 5 Japanʼs KM Biologics begins Phase 1/2. April 2 Franceʼs OSE Immunotherapeutics enters Phase 1. March 31 The Pfizer-BioNTech vaccine is highly effective in adolescents. March 31 Some Johnson & Johnson doses are delayed by a U.S. factory mix-up. March 30 Chinaʼs Jiangsu Rec-Biotechnology enters Phase 1. March 27 Turkeyʼs Middle East Technical and Bilkent University begin Phase 1. March 25 A vaccine from Chinaʼs Zhongyianke Biotech enters Phase 2. March 23 U.S. officials question the completeness of AstraZenecaʼs trial results. March 23 Daiichi Sankyo and the University of Tokyo enter Phase 1/2. March 22 AstraZenecaʼs vaccine is found to be 79% effective in a large U.S. -
Transparency in the Development and Procurement of Covid-19 Vaccines
FOR WHOSE BENEFIT? TRANSPARENCY IN THE DEVELOPMENT AND PROCUREMENT OF COVID-19 VACCINES This document summarises the findings from 20 COVID-19 vaccine candidates our For Whose Benefit? report, it provides included in analysis1 an overview of the key risks of a lack of Name of vaccine Name of vaccine transparency in COVID-19 vaccine clinical trials developer and procurement contracts, and suggests Moderna mRNA-1273 recommendations for reform. Pfizer/BioNTech Comirnaty (BNT162b2) Our findings carry important implications, not only for the Medicago CoVLP development of COVID-19 medical technology, but also (w/GSK adjuvant) for future health emergencies and the wider governance of Anhui Zhifei Longcom ZF2001 pharmaceutical development and public procurement. The elements highlighted in our analysis are important in bringing Bharat Biotech Covaxin (BBV152) COVID-19 vaccines to market whilst offering important CureVac CVnCoV opportunities to move the dial in wider conversations on transparency beyond the pandemic. Clover Biopharmaceuticals SCB-2019 (w/GSK adjuvant) Sinopharm (Beijing) BBIBP-CorV AZD1222 / Covishield Key Findings AstraZeneca (ChAdOx1 nCoV-19) The report reveals a disturbing trend of poor transparency CanSino Biologics Convidicea (Ad5-nCoV) in clinical trials as well as in contracting for the supply of vaccines. This is highlighted by: Johnson & Johnson Ad26.COV2.S • The incoherent global clinical trial transparency policy Novavax NVX-CoV2373 landscape. • Poor sharing of vaccine clinical trial protocols. Sinovac Biotech CoronaVac Gamaleya Research • The frequent use of media to announce clinical trial Sputnik V Institute results without the accompanying publication of the associated data analysis, facilitating misinformation and AnGes AG0302-COVID19 misunderstanding. Zydus Cadila ZyCoV-D • Extremely low publication of contracts worldwide. -
COVID-19 Vaccine Candidates Information Updated: 03/17/2021
COVID-19 Vaccine Candidates Information Updated: 03/17/2021 Manufacturer Vaccine Storage Doses Handling + Efficacy Timeline of Fed Govt Technology/Type Requirements Administration Development Contract Pfizer/BioNTech mRNA vaccine Distributed at -80 Original Mix with Reported 95% EUA granted 100 mil to -60 ᵒC and can protocol for 5 diluent on site. efficacy (Press Dec. 11, 2020. doses in 2 dose series 21 be stored at this doses/vial in Release) original days apart temperature until protocol. Once one vial Vaccination purchase. expiry date. Changed to 6 removed from Efficacy reduced began Dec. 14, doses per vial. pizza box, the towards UK and 2020 Additional May be stored entire box is South African 100 mil -25ᵒC to -15ᵒC FDA advises to considered as Variants (Press January 2021 purchased for two weeks use all available having started Release). Pfizer completed Dec.23, cumulatively with doses, now to thaw. enrolling children 2020 to one return to -80 considered 6 ages 12+ in Phase have by to -60 ᵒC. (may be able to May be III trial. They July 2021. get 7). transported at hope for data by Stable for 5 hours: -25ᵒC to - summer 2021 120 2-8 ᵒC Minimum order: 15ᵒC. (here). million 1024 doses total by Stable for up to (based on 5 Phase I clinical the end of 30 days in doses per vial) trial to March shipping box if dry investigate the 2021 and ice is maintained safety and another and 5 days after efficacy of a 3rd 180 at 2-8 ᵒC for a booster shot of million by total of 35 days.