Review of COVID‑19 Vaccine
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SARS-Cov-2 RBD219-N1C1 Was Diluted in 20 Mm Tris, 150 Mm Nacl, Ph 7.5 (TBS Buffer) Before
bioRxiv preprint doi: https://doi.org/10.1101/2020.11.04.367359; this version posted November 5, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Title Page SARS‑CoV-2 RBD219-N1C1: A Yeast-Expressed SARS-CoV-2 Recombinant Receptor-Binding Domain Candidate Vaccine Stimulates Virus Neutralizing Antibodies and T-cell Immunity in Mice 1 2 3 Jeroen Pollet1,2, Wen-Hsiang Chen1,2, Leroy Versteeg1, Brian Keegan1, Bin Zhan1,2, Junfei 4 Wei1, Zhuyun Liu1, Jungsoon Lee1, Rahki Kundu1, Rakesh Adhikari1, Cristina Poveda1, 5 Maria-Jose Villar Mondragon1, Ana Carolina de Araujo Leao1, Joanne Altieri Rivera1, Portia 6 M. Gillespie1, Ulrich Strych1,2, Peter J. Hotez1,2,3,4,*, Maria Elena Bottazzi1,2,3* 7 1 Texas Children’s Hospital Center for Vaccine Development, Houston, TX, USA 8 2 Departments of Pediatrics and Molecular Virology & Microbiology, National School of Tropical 9 Medicine, Baylor College of Medicine, Houston, TX, USA 10 3 Department of Biology, Baylor University, Waco, TX, USA 11 4 James A. Baker III Institute for Public Policy, Rice University, Houston, TX, USA 12 * Correspondence: 13 Corresponding Authors 14 [email protected]; [email protected] 15 16 bioRxiv preprint doi: https://doi.org/10.1101/2020.11.04.367359; this version posted November 5, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Yeast-expressed SARS-CoV-2 RBD 17 Abstract 18 There is an urgent need for an accessible and low-cost COVID-19 vaccine suitable for low- and 19 middle-income countries. -
Main Outcomes of Discussion of WHO Consultation on Nucleic Acid
MAIN OUTCOMES OF DISCUSSION FROM WHO CONSULTATION ON NUCLEIC ACID VACCINES I. Knezevic, R. Sheets 21-23 Feb, 2018 Geneva, Switzerland CONTEXT OF DISCUSSION • WHO Consultation held to determine whether the existing DNA guidelines were due for revision or if they remained relevant with today’s status of nucleic acid vaccine development and maturity towards licensure (marketing authorization) • Presentation will cover alignment to existing guidelines • Current status of development of DNA and RNA vaccines, both prophylactic & therapeutic • Main outcomes of discussion • Next steps already underway & planned STATUS OF DEVELOPMENT OF NUCLEIC ACID VACCINES • First likely candidate to licensure could be a therapeutic DNA vaccine against Human Papilloma Viruses • Anticipated to be submitted for licensure in 3-5 years • Other DNA vaccines are likely to follow shortly thereafter, e.g., Zika prophylaxis • RNA vaccines – less clinical experience, but therapeutic RNAs anticipated in 2021/22 timeframe to be submitted for licensure • For priority pathogens in context of public health emergencies, several candidates under development (e.g., MERS-CoV, Marburg, Ebola) MAIN OUTCOMES - GENERAL • Regulators expressed need for updated DNA guideline for prophylaxis and therapy • Less need at present for RNA vaccines in guideline but need some basic PTC • Flexibility needed now until more experience gained for RNA vaccines that will come in next few years • Revisit need for a more specific guideline at appropriate time for RNA vaccines • Institutional Biosafety Committees are regulated by national jurisdictions & vary considerably • How can WHO assist to streamline or converge these review processes? Particularly, during Public Health Emergency – can anything be done beforehand? MAIN OUTCOMES - DEFINITIONS • Clear Definitions are needed • Proposed definition of DNA vaccine: • A DNA plasmid(s) into which the desired immunogen(s) is (are) encoded and prepared as purified plasmid preparations to be administered in vivo. -
Ifs Recommendations for Covid 19 Vaccination Before Art
16 – 17 JULY 2020 PRAGATI MAIDAN - DELHI INDIAN FERTILITY SOCIETY IFS RECOMMENDATIONS FOR COVID 19 VACCINATION BEFORE ART IFS SECRETARIAT +91 11 40018184 +91 9899308083 indianferlitysociety [email protected] www.indianferlitysociety.org indianferlitysociety 302, 3rd Floor, Kailash Building, ifsdelhi 26, Kasturba Gandhi Marg, C.P. New Delhi - 110001 Cosmo Tech is the Most Important Trade show for the Suppliers to EXPAND Strengthen Increase Multiply Profits New Markets Pan New Market Customer Base India & World Customer Soaring Boost Network Brand Sales Brand Recall Value with the Industry Visibility ORGANIZED BY CALL EMAIL +91 9971811937 [email protected] +91 9999302797 [email protected] +91 9811141938 [email protected] W W W .C O SMO TEC HEXPO IND IA .C O M Dr. Sudha Prasad Dr. Neena Malhotra President Secretary General Indian Fertility Society Indian Fertility Society Director, Matritava Advanced IVF & Professor, ART Centre, Department of Training Cenre, Vasant Vihar, New Delhi Obstetrics and Gynaecology, AIIMS, New Delhi Dr. Sonia Malik Dr. Kuldeep Jain Past President Indian Fertility Society, Past President Indian Fertility Society, Director & Nova Southend Fertility & Director, KJIVF New Delhi IVF Delhi NCR Dr. KU Kunjumoideen Dr. A K Pandey Joint Secretary Indian Fertility Society, Dean Academics &. Co Ordinator Director ARMC IVF Calicut. Molecular Lab. ESI Medical college Faridabad Dr. Charu Jandial Dr. Sumita Aggarwal Member IFS, Consultant, Member IFS, Fellow, Nova Southend Fertility & IVF Delhi NCR Nova Southend Fertility & IVF Delhi NCR Introduction The coronavirus pandemic has wreaked havoc on life In these trying mes, as sociees are gradually trying to and healthcare globally. According to WHO database as return to a state of normalcy, it is also important to on 7th June 2021, there have been 173 million consider sexual and reproducve health of people. -
Review of COVID-19 Vaccine Subtypes, Efficacy and Geographical Distributions Andre Ian Francis ,1 Saudah Ghany,1 Tia Gilkes,1 Srikanth Umakanthan2
Review Postgrad Med J: first published as 10.1136/postgradmedj-2021-140654 on 6 August 2021. Downloaded from Review of COVID-19 vaccine subtypes, efficacy and geographical distributions Andre Ian Francis ,1 Saudah Ghany,1 Tia Gilkes,1 Srikanth Umakanthan2 1Department of Clinical Medical ABSTRACT 2021, the Ad26.COV2.S, developed by Janssen Sciences, The Faculty of Medical As of 1 May 2021, there have been 152 661 445 (Johnson & Johnson) and Moderna on 30 April.4 Sciences, The University of the COVAX, coordinated by WHO, Gavi: The West Indies, St. Augustine, Covid-19 cases with 3 202 256 deaths globally. Trinidad and Tobago This pandemic led to the race to discover a vaccine Vaccine Alliance, the Coalition for Epidemic 2Pathology unit, Department to achieve herd immunity and curtail the damaging Preparedness Innovations (CEPI), acts as a of Paraclinical Sciences, The effects of Covid-19. This study aims to discuss the most programme that supports the development of University Of The West Indies, St. COVID-19 vaccine candidates and negotiates their Augustine, Trinidad and Tobago recent WHO-approved Covid-19 vaccine subtypes, their status and geographical scheduled updates as of 4 pricing to ensure low- and- middle- income countries have a fair shot at receiving vaccines.5 Correspondence to May 2021. The keywords “Covid-19, Vaccines, Pfizer, Mr. Andre Ian Francis, The BNT162b2, AstraZeneca, AZD1222, Moderna, mRNA- This article aims at discussing the most recent University of the West Indies, St. 1273, Janssen, Ad26.COV2.S” were typed into PubMed. WHO- approved COVID-19 vaccine subtypes, their Augustine, Trinidad and Tobago; Thirty Two relevant PubMed articles were included in status and geographical scheduled updates as of 4 andre. -
V.5 3/18/2021 1 COVID-19 Vaccine FAQ Sheet
COVID-19 Vaccine FAQ Sheet (updated 3/18/2021) The AST has received queries from transplant professionals and the community regarding the COVID-19 vaccine. The following FAQ was developed to relay information on the current state of knowledge. This document is subject to change and will be updated frequently as new information or data becomes available. What kinds of vaccines are available or under development to prevent COVID-19? There are currently several vaccine candidates in use or under development. In the United States, the Government is supporting six separate vaccine candidates. Several other vaccines are also undergoing development outside of the United States government sponsorship and further information can be found here: NYTimes Coronavirus Vaccine Tracker: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine- tracker.html Washington Post Vaccine Tracker: https://www.washingtonpost.com/graphics/2020/health/covid-vaccine-update- coronavirus/ v.5 3/18/2021 1 The types of vaccines are as follows (March 1, 2021) 1: Table 1: Vaccines Under Development or Available Through EUA Vaccine Type Compound Name [Sponsor] Clinical Notes Trial Phase mRNA mRNA-1273 [Moderna] Phase 3 Emergency use in U.S., E.U., other countries Approved in Canada BNT162b2 (Comirnaty) [Pfizer] Phase 2/3 Emergency use in U.S., E.U., other countries Also approved in Canada and other countries Replication- AZD1222 (Covishield) Phase 2/3 Emergency use defective [AstraZeneca] in U.K., India, adenoviral other countries vector (not U.S.) JNJ-78326735/Ad26.COV2.S -
COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions
Centers for Disease Control and Prevention Center for Preparedness and Response COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions Clinician Outreach and Communication Activity (COCA) Webinar Wednesday, December 30, 2020 Continuing Education Continuing education will not be offered for this COCA Call. To Ask a Question ▪ All participants joining us today are in listen-only mode. ▪ Using the Webinar System – Click the “Q&A” button. – Type your question in the “Q&A” box. – Submit your question. ▪ The video recording of this COCA Call will be posted at https://emergency.cdc.gov/coca/calls/2020/callinfo_123020.asp and available to view on-demand a few hours after the call ends. ▪ If you are a patient, please refer your questions to your healthcare provider. ▪ For media questions, please contact CDC Media Relations at 404-639-3286, or send an email to [email protected]. Centers for Disease Control and Prevention Center for Preparedness and Response Today’s First Presenter Tom Shimabukuro, MD, MPH, MBA CAPT, U.S. Public Health Service Vaccine Safety Team Lead COVID-19 Response Centers for Disease Control and Prevention Centers for Disease Control and Prevention Center for Preparedness and Response Today’s Second Presenter Sarah Mbaeyi, MD, MPH CDR, U.S. Public Health Service Clinical Guidelines Team COVID-19 Response Centers for Disease Control and Prevention National Center for Immunization & Respiratory Diseases Anaphylaxis following mRNA COVID-19 vaccination Tom Shimabukuro, MD, MPH, MBA CDC COVID-19 Vaccine -
Considerations for Causality Assessment of Neurological And
Occasional essay J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp-2021-326924 on 6 August 2021. Downloaded from Considerations for causality assessment of neurological and neuropsychiatric complications of SARS- CoV-2 vaccines: from cerebral venous sinus thrombosis to functional neurological disorder Matt Butler ,1 Arina Tamborska,2,3 Greta K Wood,2,3 Mark Ellul,4 Rhys H Thomas,5,6 Ian Galea ,7 Sarah Pett,8 Bhagteshwar Singh,3 Tom Solomon,4 Thomas Arthur Pollak,9 Benedict D Michael,2,3 Timothy R Nicholson10 For numbered affiliations see INTRODUCTION More severe potential adverse effects in the open- end of article. The scientific community rapidly responded to label phase of vaccine roll- outs are being collected the COVID-19 pandemic by developing novel through national surveillance systems. In the USA, Correspondence to SARS- CoV-2 vaccines (table 1). As of early June Dr Timothy R Nicholson, King’s roughly 372 adverse events have been reported per College London, London WC2R 2021, an estimated 2 billion doses have been million doses, which is a lower rate than expected 1 2LS, UK; timothy. nicholson@ administered worldwide. Neurological adverse based on the clinical trials.6 kcl. ac. uk events following immunisation (AEFI), such as In the UK, adverse events are reported via the cerebral venous sinus thrombosis and demyelin- MB and AT are joint first Coronavirus Yellow Card reporting website. As of ating episodes, have been reported. In some coun- authors. early June 2021, approximately 250 000 Yellow tries, these have led to the temporary halting of BDM and TRN are joint senior Cards have been submitted, equating to around authors. -
Different Types of COVID-19 Vaccines
Pfizer-BioNTech Help stop the pandemic Type of vaccine: Messenger RNA, or mRNA, a genetic Different Types material that tells your body how to make proteins that by getting vaccinated triggers an immune response inside our bodies of COVID-19 Effectiveness: 95% based on clinical trials Even if you are undocumented Common side effects: Pain and/or swelling in the arm and/or don’t have insurance, you and tiredness, headache, muscle pain, chills, fever, or can get the vaccine—for free. Vaccines: nausea in the body that may last two days Recommended Ages: 16 and older (currently testing the vaccine in kids ages 12-15) Understanding How Dosage: Two shots, 21 days apart They Work Visit VaccinateALL58.com Moderna for the newest information about when and where the vaccine Type of vaccine: Messenger RNA, or mRNA, a genetic will be available to you. material that tells your body how to make proteins that triggers an immune response inside our bodies Sign up at myturn.ca.gov or Effectiveness: 94.1% based on clinical trials call 1-833-422-4255 to find out Common side effects: Pain and/or swelling in the arm if it’s your turn to get vaccinated and and tiredness, headache, muscle pain, chills, fever, or schedule vaccination appointments. nausea in the body that may last two days Recommended Ages: 18 years and older (currently testing the vaccine in kids ages 12-17) Dosage: Two shots, 28 days apart Johnson & Johnson Follow us on social media for more COVID-19 tips and information. Type of vaccine: A viral vector, it uses a harmless version of a different -
Understanding How Vaccines Work
➤ For more information on vaccines, Understanding vaccine-preventable diseases, and vaccine safety: How Vaccines Work http://www.cdc.gov/vaccines/conversations Last reviewed Februar y 2013 Diseases that vaccines prevent can be The body keeps a few T-lymphocytes, called memory cells that go dangerous, or even deadly. Vaccines greatly into action quickly if the body encounters the same germ again. When the familiar antigens are detected, B-lymphocytes produce reduce the risk of infection by working with antibodies to attack them. the body’s natural defenses to safely develop immunity to disease. This fact sheet explains How Vaccines Work how the body fights infection and how Vaccines help develop immunity by imitating an infection. This type of infection, however, does not cause illness, but it does cause vaccines work to protect people by the immune system to produce T-lymphocytes and antibodies. producing immunity. Sometimes, after getting a vaccine, the imitation infection can cause minor symptoms, such as fever. Such minor symptoms are normal and should be expected as the body builds immunity. Once the imitation infection goes away, the body is left with a The Immune System— supply of “memory” T-lymphocytes, as well as B-lymphocytes that The Body’s Defense Against Infection will remember how to fight that disease in the future. However, it To understand how vaccines work, it is helpful to first look at how typically takes a few weeks for the body to produce T-lymphocytes the body fights illness. When germs, such as bacteria or viruses, and B-lymphocytes after vaccination. Therefore, it is possible that invade the body, they attack and multiply. -
Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)
Grant Final Report Grant ID: R18 HS 017045 Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Inclusive dates: 12/01/07 - 09/30/10 Principal Investigator: Lazarus, Ross, MBBS, MPH, MMed, GDCompSci Team members: Michael Klompas, MD, MPH Performing Organization: Harvard Pilgrim Health Care, Inc. Project Officer: Steve Bernstein Submitted to: The Agency for Healthcare Research and Quality (AHRQ) U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Abstract Purpose: To develop and disseminate HIT evidence and evidence-based tools to improve healthcare decision making through the use of integrated data and knowledge management. Scope: To create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events, in order to improve the safety of national vaccination programs. Methods: Electronic medical records available from all ambulatory care encounters in a large multi-specialty practice were used. Every patient receiving a vaccine was automatically identified, and for the next 30 days, their health care diagnostic codes, laboratory tests, and medication prescriptions were evaluated for values suggestive of an adverse event. Results: Restructuring at CDC and consequent delays in terms of decision making have made it challenging despite best efforts to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial and comparison of ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. However, Preliminary data were collected and analyzed and this initiative has been presented at a number of national symposia. Key Words: electronic health records, vaccinations, adverse event reporting The authors of this report are responsible for its content. -
An Update on Self-Amplifying Mrna Vaccine Development
Review An Update on Self-Amplifying mRNA Vaccine Development Anna K. Blakney 1,* , Shell Ip 2 and Andrew J. Geall 2 1 Michael Smith Laboratories, School of Biomedical Engineering, University of British Columbia, Vancouver, BC V6T 1Z4, Canada 2 Precision NanoSystems Inc., Vancouver, BC V6P 6T7, Canada; [email protected] (S.I.); [email protected] (A.J.G.) * Correspondence: [email protected] Abstract: This review will explore the four major pillars required for design and development of an saRNA vaccine: Antigen design, vector design, non-viral delivery systems, and manufacturing (both saRNA and lipid nanoparticles (LNP)). We report on the major innovations, preclinical and clinical data reported in the last five years and will discuss future prospects. Keywords: RNA; self-amplifying RNA; replicon; vaccine; drug delivery 1. Introduction: The Four Pillars of saRNA Vaccines In December 2019, the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) virus emerged, causing a respiratory illness, coronavirus disease 2019 (COVID-19), in Hubei province, China [1,2]. The virus has spread globally, with the World Health Organization (WHO) declaring it a Public Health Emergency of International concern on 30 January 2020 and a pandemic officially on 7 March 2020 [3]. There is a strong consensus globally that a COVID-19 vaccine is likely the most effective approach to sustainably controlling the COVID-19 pandemic [4]. There has been an unprecedented research effort and global Citation: Blakney, A.K.; Ip, S.; Geall, coordination which has resulted in the rapid development of vaccine candidates and A.J. An Update on Self-Amplifying initiation of human clinical trials. -
COVID-19 Vaccineadmin VAERS
Reporting a Suspected Vaccine Adverse Event Indian Health Service, National Pharmacy & Therapeutics Committee CAPT Matthew Clark, MD, FAAP, FACP, Chair CAPT Ryan Schupbach, PharmD, BCPS, CACP, Vice Chair CAPT Christopher Lamer, PharmD, MHS, BCPS, CDE, Director of Pharmacovigilance October 2020 Potential New Vaccine for COVID-19 • Operation Warp Speed (OWS) • Collaboration between the Federal Government and biopharmaceutical companies to develop medications, diagnostic tests, and vaccines. • Shortened timelines but safety and efficacy are the primary focus. • Vaccines must be at least 50% effective for FDA EUA or approval. • Vaccines must be safe, and benefits of immunization must outweigh any risks of adverse events. • Continued need for influenza immunization • Continued need for scheduled immunizations https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html 2 Vaccine Safety: Common Adverse Events Vaccines are considered to be safe and effective with most common adverse events being mild and are signs that the body is developing immunity: • Pain, swelling, or redness where the shot was given • Mild fever • Chills • Feeling tired • Headache • Muscle and joint aches https://www.vaccines.gov/basics/safety/side_effects 3 Vaccine Safety: Serious Adverse Events More serious side effects are rare but can occur. Some examples are: • Anaphylaxis (0.65 cases/1 million vaccinations) • Thrombocytopenia from Rubella vaccine (1 case/40,000 vaccinations) • Orchitis from Mumps vaccine (0.3 cases/1 million vaccinations) • Intussusception from Rotavirus vaccine (1 case/100,000 vaccinations) • Guillain-Barre from flu vaccine (1 case/1.25 million vaccinations; association is stronger with flu infection than the vaccine) Spencer JP, Trondsen Pawlowski RH, Thomas S. Vaccine Adverse Events: Separating Myth from Reality.