Candidate SARS-Cov-2 Vaccines in Advanced Clinical Trials: Key Aspects Compiled by John D
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What Do We Know About India's Covaxin Vaccine?
FEATURE Tamil Nadu, India COVID-19 VACCINES [email protected] BMJ: first published as 10.1136/bmj.n997 on 20 April 2021. Downloaded from Cite this as: BMJ 2021;373:n997 http://dx.doi.org/10.1136/bmj.n997 What do we know about India’s Covaxin vaccine? Published: 20 April 2021 India has rapidly approved and rolled out Covaxin, its own covid-19 vaccine. Kamala Thiagarajan examines what we know so far. Kamala Thiagarajan freelance journalist Who developed Covaxin? cheapest purchased by any country in the world at 206 rupees per shot for the 5.5 million doses the Covaxin was developed by Indian pharmaceutical government currently has on order. The government company Bharat Biotech in collaboration with the has capped the price of the vaccine sold in the private Indian Council of Medical Research, a government market, with private hospitals able to charge up to funded biomedical research institute, and its 250 rupees.13 subsidiary the National Institute of Virology. Covaxin does not require storage at sub-zero Bharat Biotech has brought to market 16 original temperatures, which would be hard to maintain in vaccines, including for rotavirus, hepatitis B, Zika India’s climate and with the frequent power cuts in virus, and chikungunya.1 The company reportedly rural areas. Covaxin is available in multi-dose vials spent $60-$70m (£43-£50m; €50-€58m) developing and is stable at the 2-8°C that ordinary refrigeration Covaxin.2 can achieve. How does Covaxin work? Bharat Biotech says it has a stockpile of 20 million The vaccine is similar to CoronaVac (the Chinese doses of Covaxin for India and is in the process of vaccine developed by Sinovac)3 in that it uses a manufacturing 700 million doses at its four facilities complete infective SARS-CoV-2 viral particle in two cities by the end of the year. -
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. -
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 Vaccination Programme: Information for Healthcare Practitioners
COVID-19 vaccination programme Information for healthcare practitioners Republished 6 August 2021 Version 3.10 1 COVID-19 vaccination programme: Information for healthcare practitioners Document information This document was originally published provisionally, ahead of authorisation of any COVID-19 vaccine in the UK, to provide information to those involved in the COVID-19 national vaccination programme before it began in December 2020. Following authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency being given to the COVID-19 Vaccine Pfizer BioNTech on 2 December 2020, the COVID-19 Vaccine AstraZeneca on 30 December 2020 and the COVID-19 Vaccine Moderna on 8 January 2021, this document has been updated to provide specific information about the storage and preparation of these vaccines. Information about any other COVID-19 vaccines which are given regulatory approval will be added when this occurs. The information in this document was correct at time of publication. As COVID-19 is an evolving disease, much is still being learned about both the disease and the vaccines which have been developed to prevent it. For this reason, some information may change. Updates will be made to this document as new information becomes available. Please use the online version to ensure you are accessing the latest version. 2 COVID-19 vaccination programme: Information for healthcare practitioners Document revision information Version Details Date number 1.0 Document created 27 November 2020 2.0 Vaccine specific information about the COVID-19 mRNA 4 Vaccine BNT162b2 (Pfizer BioNTech) added December 2020 2.1 1. -
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. -
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. -
Evidence Assessment STRATEGIC ADVISORY GROUP of EXPERTS (SAGE) on IMMUNIZATION Meeting 15 March 2021
Evidence Assessment STRATEGIC ADVISORY GROUP OF EXPERTS (SAGE) ON IMMUNIZATION Meeting 15 March 2021 FOR RECOMMENDATION BY SAGE Prepared by the SAGE Working Group on COVID-19 vaccines EVIDENCE ASSESSMENT: Ad26.COV2.S COVID-19 vaccine Key evidence to inform policy recommendations on the use of Ad26.COV2.S COVID-19 vaccine Evidence retrieval • Based on WHO and Cochrane living mapping and living systematic review of Covid-19 trials (www.covid-nma.com/vaccines) Retrieved evidence Majority of data considered for policy recommendations on Ad26.COV2.S Covid-19 vaccine are published in scientific peer reviewed journals: • Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine. NEJM. February 2021. DOI: 10.1056/NEJMoa2034201. Jerald Sadoff, Mathieu Le Gars, Georgi Shukarev, et al. • FDA briefing document Janssen Ad26.COV2.S (COVID-19) Vaccine • Ad26 platform literature: Custers et al. Vaccines based on the Ad26 platform; Vaccine 2021 Quality assessment Type of bias Randomization Deviations from Missing outcome Measurement of Selection of the Overall risk of intervention data the outcome reported results bias Working Group Low Low Low Low Low LOW judgment 1 EVIDENCE ASSESSMENT The SAGE Working Group specifically considered the following issues: 1. Trial endpoints used in comparison with other vaccines Saad Omer 2. Evidence on vaccine efficacy in the total population and in different subgroups Cristiana Toscano 3. Evidence of vaccine efficacy against asymptomatic infections, reducing severity, hospitalisations, deaths, and efficacy against virus variants of concern Annelies Wilder-Smith 4. Vaccination after SARS-CoV2 infection. 5. Evidence on vaccine safety in the total population and in different subgroups Sonali Kochhar 6. -
Immunogenicity and Safety of a Third Dose, and Immune Persistence Of
medRxiv preprint doi: https://doi.org/10.1101/2021.07.23.21261026; this version posted July 25, 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 Immunogenicity and safety of a third dose, and immune persistence of 2 CoronaVac vaccine in healthy adults aged 18-59 years: interim results 3 from a double-blind, randomized, placebo-controlled phase 2 clinical 4 trial 5 6 Hongxing Pan MSc1*, Qianhui Wu MPH2*, Gang Zeng Ph.D.3*, Juan Yang Ph.D.1, Deyu 7 Jiang MSc4, Xiaowei Deng MSc2, Kai Chu MSc1, Wen Zheng BSc2, Fengcai Zhu M.D.5†, 8 Hongjie Yu M.D. Ph.D.2,6,7†, Weidong Yin MBA8† 9 10 Affiliations 11 1. Vaccine Evaluation Institute, Jiangsu Provincial Center for Disease Control and 12 Prevention, Nanjing, China 13 2. School of Public Health, Fudan University, Key Laboratory of Public Health Safety, 14 Ministry of Education, Shanghai, China 15 3. Clinical Research Department, Sinovac Biotech Co., Ltd., Beijing, China 16 4. Covid-19 Vaccine Department, Sinovac Life Sciences Co., Ltd., Beijing, China 17 5. Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China 18 6. Shanghai Institute of Infectious Disease and Biosecurity, Fudan University, 19 Shanghai, China 20 7. Department of Infectious Diseases, Huashan Hospital, Fudan University, 21 Shanghai, China 22 8. Sinovac Biotech Co., Ltd., Beijing, China NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. -
Periodic Update on AEFI
CONSOLIDATED REGIONAL AND GLOBAL INFORMATION ON ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) AGAINST COVID-19 AND OTHER UPDATES Thirteenth report WASHINGTON, DC Updated: 10 May 2021 1 OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS CANADA • As of 30 April 2021, 13,420,198 doses of the COVID-19 vaccines of Pfizer-BioNTech, Moderna, Oxford- AstraZeneca, and the vaccine Covishield (AstraZeneca manufactured by the Serum Institute of India), had been administered. • A total of 4,548 individual reports of one or more adverse events (0.034% of doses administered) were received. Of these, 748 were considered serious events (0.006% of doses administered), with anaphylaxis being the one most frequently reported. • Of total reports, there were 2,072 non-serious and 520 serious events associated with the Pfizer-BioNTech vaccine. For the Moderna vaccine, 1,457 non-serious and 103 serious events were reported; for Covishield, there were 201 non-serious and 48 serious events, and for Oxford-AstraZeneca, 65 non-serious events and 62 serious events. • A total of 13,596 adverse events following immunization (AEFI) were reported, with 4,548 reports with one or more events. The most frequently reported non-serious adverse events were injection-site reactions, paresthesia, itching, hives, headache, hypoesthesia, and nausea. There were 61 reports of anaphylaxis. • Although 55% of vaccine doses were administered to women as of 30 April, and 45% to men, most of the reported adverse events were in women (84.3% of total doses). At the same time, 43.0% of total events were reported for people between the ages of 18 and 49, who account for 24% of people vaccinated. -
Comparative Characteristics of the Main Coronavirus Vaccines
Acta Scientific MICROBIOLOGY (ISSN: 2581-3226) Volume 4 Issue 9 September 2021 Editorial Comparative Characteristics of the Main Coronavirus Vaccines Pavel F Zabrodskii* Received: June 23, 2021 Saratov Medical University "REAVIZ", Saratov, Russian Federation Published: August 01, 2021 *Corresponding Author: Pavel F Zabrodskii, Saratov Medical University "REAVIZ", © All rights are reserved by Pavel F Saratov, Russian Federation. Zabrodskii. Since the beginning of the epidemic, vaccine development has been a priority for all developed countries. According to WHO (26 adenovirus rather than human adenovirus should reduce the risk virus. The fact that the vaccine was developed using chimpanzee January 2021), more than 60 vaccines worldwide are already in of allergic reactions and severe side-effects. However, the disadvan- clinical trials. More than 170 are being tested on animals. There tage of this product, as with all vector vaccines, is that the technol- ogy itself is new and has not previously been used in health care. One of the pluses for vector drug manufacturers is their speed of are 22 vaccines that have made it through the final phase of testing. creation. The vaccine is registered for use in the European Union. It The vaccine, developed by US company “Pfizer” and its German is licensed for emergency use in another 20 countries. clinical trials ended on 9 November 2020. In addition to EU coun- partner “BioNTech”, has been registered first in the EU. Phase III - ceutical company Sinovac Biotech, which has shown controversial tries, the vaccine is used in Australia, Saudi Arabia, Switzerland, “CoronaVac” is an inactivated vaccine from Chinese biopharma - Norway, Iceland, Serbia and some other countries. -
Improving the Regulatory Response to Vaccine Development During a Public Health Emergency
Every Minute Matters: Improving the Regulatory Response to Vaccine Development During a Public Health Emergency RASHMI BORAH* ABSTRACT In recent months, our lives have been turned upside down by the novel coronavirus (COVID-19) emergency. With no cure or vaccine in sight, millions of people have contracted the virus, and the death toll has surpassed that of World War I in a fraction of the time. In fact, the past decade has been marked by a series of highly publicized public health emergencies, including the devastating Ebola and Zika virus global outbreaks. Some of this panic arose from a failure to manufacture and distribute vaccines in a timely fashion. This failure occurred despite having several viable vaccine candidates, adequate funding, and strong public support for the vaccines. This Article explains how these failures are the consequence of a complex network of existing regulatory pathways and insufficient incentives to produce affordable vaccinations during a public health emergency. Fortunately, there are several ways that both the U.S. Patent and Trademark Office and the U.S. Food and Drug Administration can improve and streamline the process of patenting, approving, manufacturing, and distributing a vaccination. The last decade has demonstrated that public health emergencies occur quickly, and affected communities cannot afford the delays and mishaps that characterized the vaccine response to COVID-19, Ebola, and Zika. This Article explores three ways to facilitate the development and distribution of vaccinations during a public health emergency. First, the U.S. Patent and Trademark Office can establish a dedicated public health emergency patent pathway for vaccine technology developed specifically in response to a public health emergency.