DRAFT Landscape of COVID-19 Candidate Vaccines – 10 August 2020
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1 English Package Insert BCG VACCINE (Freeze-Dried)
English Package insert BCG VACCINE (Freeze-Dried) DESCRIPTION BCG Vaccine is a live freeze-dried vaccine derived from attenuated strain of Mycobacterium bovis, (Bacillus Calmette Guerin) used for the prevention of tuberculosis. It contains Sodium Glutamate as stabilizer. The vaccine meets requirements of WHO when tested by the methods outlined in WHO, TRS 979 (2013). COMPOSITION Live, attenuated BCG Vaccine (Bacillus Calmette Guerin strain) Each 0.1 ml contains between: 2x105 and 8 x 105 C.F.U. Reconstitute with Sodium Chloride Injection Dose: 0.05 ml, Intradermal for infants under one year old 0.1 ml, Intradermal for children over one year of age and adult. RECONSTITUTION BCG vaccine vial of 20 doses (0.05 ml) for infants under one year old/ 10 doses (0.1 ml) for children over one year of age and adult to be reconstituted by adding the entire content of the supplied container of diluents (Sodium Chloride Injection). Carefully invert the vial a few times to resuspend freeze-dried BCG. Gently swirl the vial of resuspended vaccine before drawing up each subsequent dose. The resulting suspension should be homogenous, slightly opaque and colourless. Reconsitute only with diluent provided by manufacture. Using an incorrect diluent any result in damage to the vaccine and / or serious reactions to those receiving the vaccine. Use immediately after reconstitution. If the vaccine is not used immediately then it should be stored in the dark at 2º to 8º C for no longer than 6 hours (1 immunisation session). Any opened vial remaining at the end of a vaccination session (within six hours of reconstitution) must be discard. -
Editorial 10.5005/Ijmb-24-3-Iv
Editorial 10.5005/ijmb-24-3-iv COVID-19 Vaccines: Lets Go for It SARS CoV-2, also christened as COVID-19 is an acute respiratory illness caused by a novel coronavirus which originated from Wuhan China in 2019 and within a short span affected virtually each and every country around the globe, throwing healthcare preparedness and economy out of gear. The world was faced with a pandemic leading to overcrowded hospitals and overflowing mortuaries. Lockdowns imposed in countries jeopardized routine life never to normalize again. India has been among the top three countries with the maximum number of afflicted people. Thankfully , our statistics with respect to mortality is better as compared to the western world. The last year 2020 was completely COVIDISED if we may say so. The world economy is in doldrums and the health infrastructure is overstretched and fatigued. Everytime we feel that the disease is under control, the virus cleverly mutates to become more infective and develops increased ability to escape the immune surveillance. Efforts to develop a vaccine against this scourge were initiated at a war footing across the globe. A number of vaccines were approved for emergency use since the scientific committee didn’t have the time to wait further. In India, two vaccines- Covaxin and Covishield have been approved by the Government of India for mass vaccination. The mammoth program was initiated with first preference for the healthcare workers and frontline warriors. In the next phases, elderly population followed by the rest of the population in a phased manner was planned. It is really incredible and praiseworthy about the immaculate planning and implementation of the initiative in our country where the diversity is both a boon as well as bane. -
Association for Consumer Research
ASSOCIATION FOR CONSUMER RESEARCH Labovitz School of Business & Economics, University of Minnesota Duluth, 11 E. Superior Street, Suite 210, Duluth, MN 55802 Cyborg As Commodity: Exploring Conceptions of Self-Identity, Body and Citizenship Within the Context of Emerging Transplant Technologies Ai-Ling Lai, University of Leicester, UK This paper explores how advances in transplant technologies shape conceptions of self-identity, embodiment and citizenship. Drawing on the posthuman writing of Donna Haraway and through phenomenological interviews, I explore ambivalence towards the commoditization of the cyborg-body, suggesting that biotechnology may potentially lead to a dystopian posthuman consumer society. [to cite]: Ai-Ling Lai (2012) ,"Cyborg As Commodity: Exploring Conceptions of Self-Identity, Body and Citizenship Within the Context of Emerging Transplant Technologies ", in NA - Advances in Consumer Research Volume 40, eds. Zeynep Gürhan-Canli, Cele Otnes, and Rui (Juliet) Zhu, Duluth, MN : Association for Consumer Research, Pages: 386-394. [url]: http://www.acrwebsite.org/volumes/1011658/volumes/v40/NA-40 [copyright notice]: This work is copyrighted by The Association for Consumer Research. For permission to copy or use this work in whole or in part, please contact the Copyright Clearance Center at http://www.copyright.com/. Cyborg as Commodity: Exploring Conception of Self-Identity, Body and Citizenship within the Context of Emerging Transplant Technologies Ai-Ling Lai, University of Leicester, UK ABSTRACT technology (Thompson 2004). In doing so, I aim to contribute to This paper explores how advances in transplant technologies previous writings by Johnson and Roberts (1997) and Belk (1990). shape conceptions of self-identity, embodiment and citizenship. Most notably, these scholars observe how the marketing of organ Drawing on the posthuman writing of Donna Haraway and from transplantation has previously been predicated on the ‘mechanistic’ phenomenological interviews, I explore ambivalence towards the metaphor of the body (Belk 1990). -
Edical Sciences Esearch (IJAMSCR)
Dr. N. Sriram et al / Int. J. of Allied Med. Sci. and C lin. Research Vol-9(1) 2021 [ 1-10] International Journal of Allied Medical Sciences and Clinical Research (IJAMSCR) ISSN: 2347 -6567 IJAMSCR |Volume 9 | Issue 1 | Jan - Mar - 2021 www.ijamscr.com Review article Medical research Development of new covid -19 vaccines from india : A systematic review 1Dr. N. Sriram, 2S. Kameshwaran , 3Asokkumar DS , 4N. Elavarasan, 5M. Sarbudeen 1Department of Pharmaceutics, Hits College of Pharmacy, Bogaram, Ghatkesar, Hyderabad, Telangana, India 2-5 Excel college of Pharmacy, Komarapalayam, Namakkal, Tamilnadu – 637303. *Corresponding Author :Dr. N. Sriram email: [email protected] ABSTRACT Extreme acute respiratory syndrome Coronavirus 2 (SARS -CoV-2) is an extremely pathogenic new virus that has triggered the current worldwide coronavirus disease pandemic (COVID -19). Currently, substantial effort has been made to produce successful and safe medicines and SARS-CoV-2 vaccines. To avoid more morbidity and death, a successful vaccine is important. Though some regions which deploy COVID -19 vaccines on the basis of protection and immunogenicity data alone, the aim of vaccine research is to obtain d irect proof of vaccine effectiveness in protecting humans against SARS-CoV -2 and COVID-19 infections in order to selectively increase the production of effective vaccines. A SARS-CoV-2 candidate vaccine can function against infection, illness, or transmiss ion and a vaccine that is capable of minimising all of these components may lead to disease control. In this study, we discussed the Bharat Biotech and Covishield Serum Institute of India's Covaxin - India's First Indigenous Covid -19 Vaccine. -
Molecular Pharming to Support Human Life on the Moon, Mars, and Beyond
UC Berkeley UC Berkeley Previously Published Works Title Molecular pharming to support human life on the moon, mars, and beyond. Permalink https://escholarship.org/uc/item/0vc0786j Journal Critical reviews in biotechnology, 41(6) ISSN 0738-8551 Authors McNulty, Matthew J Xiong, Yongao Mary Yates, Kevin et al. Publication Date 2021-09-01 DOI 10.1080/07388551.2021.1888070 Peer reviewed eScholarship.org Powered by the California Digital Library University of California Critical Reviews in Biotechnology ISSN: (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/ibty20 Molecular pharming to support human life on the moon, mars, and beyond Matthew J. McNulty, Yongao (Mary) Xiong, Kevin Yates, Kalimuthu Karuppanan, Jacob M. Hilzinger, Aaron J. Berliner, Jesse Delzio, Adam P. Arkin, Nancy E. Lane, Somen Nandi & Karen A. McDonald To cite this article: Matthew J. McNulty, Yongao (Mary) Xiong, Kevin Yates, Kalimuthu Karuppanan, Jacob M. Hilzinger, Aaron J. Berliner, Jesse Delzio, Adam P. Arkin, Nancy E. Lane, Somen Nandi & Karen A. McDonald (2021): Molecular pharming to support human life on the moon, mars, and beyond, Critical Reviews in Biotechnology, DOI: 10.1080/07388551.2021.1888070 To link to this article: https://doi.org/10.1080/07388551.2021.1888070 © 2021 The Author(s). Published by Informa View supplementary material UK Limited, trading as Taylor & Francis Group Published online: 09 Mar 2021. Submit your article to this journal Article views: 455 View related articles View Crossmark data Full Terms & Conditions of access and use can be found at https://www.tandfonline.com/action/journalInformation?journalCode=ibty20 CRITICAL REVIEWS IN BIOTECHNOLOGY https://doi.org/10.1080/07388551.2021.1888070 REVIEW ARTICLE Molecular pharming to support human life on the moon, mars, and beyond a,b a,bà a,bà a,c Matthew J. -
'Astrazeneca' Covid-19 Vaccine
Medicines Law & Policy How the ‘Oxford’ Covid-19 vaccine became the ‘AstraZeneca’ Covid-19 vaccine By Christopher Garrison 1. Introduction. The ‘Oxford / AstraZeneca’ vaccine is one of the world’s leading hopes in the race to end the Covid-19 pandemic. Its history is not as clear, though, as it may first seem. The media reporting about the vaccine tends to focus either on the very small (non-profit, academic) Jenner Institute at Oxford University, where the vaccine was first invented, or the very large (‘Big Pharma’ firm) AstraZeneca, which is now responsible for organising its (non-profit) world-wide development, manufacture and distribution. However, examining the intellectual property (IP) path of the vaccine from invention to manufacture and distribution reveals a more complex picture that involves other important actors (with for-profit perspectives). Mindful of the very large sums of public money being used to support Covid-19 vaccine development, section 2 of this note will therefore contextualise the respective roles of the Jenner Institute, AstraZeneca and these other actors, so that their share of risk and (potential) reward in the project can be better understood. Section 3 provides comments as well as raising some important questions about what might yet be done better and what lessons can be learned for the future. 2. History of the ‘Oxford / AstraZeneca’ vaccine. 2.1 Oxford University and Oxford University Innovation Ltd. The Bayh-Dole Act (1980) was hugely influential in the United States and elsewhere in encouraging universities to commercially exploit the IP they were generating by setting up ‘technology transfer’ offices. -
Orchard and Pharming HAE Collaboration
Joint analyst call: Orchard Therapeutics & Pharming Group Dr Sijmen de Vries, CEO, Pharming Group Dr Anurag Relan, CMO, Pharming Group Dr Bobby Gaspar, CEO, Orchard Therapeutics 1 July 2021 Forward-looking Statements This presentation may contain forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development plans, our clinical results and other future conditions. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial or business performance, conditions, plans, prospects, trends or strategies, objectives of management and other financial and business matters; our current and prospective product candidates, planned clinical trials and preclinical studies, projected research and development costs, current and prospective collaborations; and the estimated size of the market for our product candidates, the timing and success of our development and commercialization of our product candidates and the market acceptance thereof, are forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While we may elect to update these forward-looking statements at some point in the future, we assume no obligation to update or revise any forward-looking statements except to the extent required by applicable law. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. -
BCG Vaccination and Immunity Against COVID-19: a Fact Or Fiction
Published online: 2020-11-13 THIEME Commentary 239 BCG Vaccination and Immunity against COVID-19: A Fact or Fiction Rajendra Prasad1 Rishabh Kacker1 Huda Shamim1 Nikhil Gupta2 1Department of Pulmonary Medicine, Era’s Lucknow Medical College & Hospital, Lucknow, Uttar Pradesh, India 2Department of General Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India Ann Natl Acad Med Sci (India):2020;56:239–241 The first case of the novel Coronavirus disease, named doses of BCG vaccine are not recommended. BCG is prefer- COVID-19, was reported in Wuhan, China, on December 31, ably given at birth to provide protection in the early years 2019. The illness has variable manifestations, ranging from when infection can often lead to diseases such as miliary common cold to the more severe Middle East respiratory TB or tubercular meningitis. By the late 1940s, several stud- syndrome (MERS) and severe acute respiratory syndrome ies had appeared, providing evidence in favor of the utility (SARS). While the mortality rates of SARS and MERS was of BCG in protection against TB. In 1950s, major trials were estimated to be approximately 12% and 30%, respectively, set up by the Medical Research Council in the United King- the mortality rates in cases of COVID-19 is estimated to be dom and by the Public Health Service in the United States. much lower at around 4.03%.1 Nevertheless, the pandemic Soon it became evident that the procedure employed in the of COVID-19 is an issue that needs to be taken seriously. United Kingdom was highly efficacious against TB,4 whereas However, there are striking differences on how COVID-19 is that in the United States provided little or no protection.5 On behaving in different countries. -
Developing Countries Vaccine Manufacturers Network: Doing Good by Making
Vaccine 31S (2013) B176–B183 Contents lists available at SciVerse ScienceDirect Vaccine j ournal homepage: www.elsevier.com/locate/vaccine Review Developing Countries Vaccine Manufacturers Network: Doing good by making ଝ high-quality vaccines affordable for all a,∗ b,1 c,2 d,3 e,4 Sonia Pagliusi , Luciana C.C. Leite , Mahima Datla , Morena Makhoana , Yongzhong Gao , f,5 g,6 h,7 i,8 Mahendra Suhardono , Suresh Jadhav , Gutla V.J.A. Harshavardhan , Akira Homma a DCVMN International, Chemin du Canal 5, 1260 Nyon, Switzerland b Instituto Butantan, Av. Vital Brazil 1500, Sao Paulo 05503-900, Brazil c Biological E Ltd, 18/1&3, Azamabad, Hyderabad 500 020, A.P., India d The Biovac Institute, 15, Alexandra Road, Pinelands, Cape Town, South Africa e Xiamen Innovax Biotech Co., Ltd. No. 130 XinYuan Road, Haicang District, Xiamen, Fujian 361022, China f PT. Biofarma, Jl. Pasteur no. 28, Bandung 40181, Indonesia g Serum Institute of India, 212/2, Off. Poonawalla Road, Hadapsar, Pune 411 028, India h Bharat Biotech International Ltd, Genome Valley, Turkapally, Shameerpet (M), Hyderabad 500 078, India i Bio-Manguinhos | Fiocruz, Av. Brasil, 4365 – Manguinhos, Rio de Janeiro 21040-360, Brazil a r t i c l e i n f o a b s t r a c t Article history: The Developing Countries Vaccine Manufacturers Network (DCVMN) is a unique model of a public and Received 30 July 2012 private international alliance. It assembles governmental and private organizations to work toward a Received in revised form 19 October 2012 common goal of manufacturing and supplying high-quality vaccines at affordable prices to protect people Accepted 19 November 2012 around the world from known and emerging infectious diseases. -
(A, C, Y, W, X) Meningococcal Conjugate Vaccine for Global Use
pathogens Article Evaluation of Critical Quality Attributes of a Pentavalent (A, C, Y, W, X) Meningococcal Conjugate Vaccine for Global Use Barbara Bolgiano 1,* , Eilís Moran 1, Nicola J. Beresford 1, Fang Gao 1, Rory Care 1, Trusha Desai 1, Ida Karin Nordgren 1, Timothy R. Rudd 1 , Ian M. Feavers 1, Prashant Bore 2, Sushil Patni 2, Vinay Gavade 2, Asha Mallya 2, Sameer Kale 2, Pankaj Sharma 2, Sunil K. Goel 2, Sunil Gairola 2, Suhas Hattarki 2, Nikhil Avalaskar 2, Annamraju D. Sarma 2, Marc LaForce 2, Neil Ravenscroft 3, Lakshmi Khandke 4, Mark R. Alderson 4 , Rajeev M. Dhere 2 and Sambhaji S. Pisal 2 1 National Institute for Biological Standards and Control, South Mimms, Potters Bar EN6 3QG, UK; [email protected] (E.M.); [email protected] (N.J.B.); [email protected] (F.G.); [email protected] (R.C.); [email protected] (T.D.); [email protected] (I.K.N.); [email protected] (T.R.R.); [email protected] (I.M.F.) 2 Serum Institute of India Pvt. Ltd., Hadapsar, Pune 411028, India; [email protected] (P.B.); [email protected] (S.P.); [email protected] (V.G.); [email protected] (A.M.); [email protected] (S.K.); [email protected] (P.S.); [email protected] (S.K.G.); [email protected] (S.G.); [email protected] (S.H.); [email protected] (N.A.); [email protected] (A.D.S.); [email protected] (M.L.); [email protected] (R.M.D.); [email protected] (S.S.P.) 3 Department of Chemistry, University of Cape Town, Rondebosch, Cape Town 7701, South Africa; [email protected] Citation: Bolgiano, B.; Moran, E.; 4 Center for Vaccine Innovation and Access, PATH, Seattle, WA 98121, USA; [email protected] (L.K.); Beresford, N.J.; Gao, F.; Care, R.; [email protected] (M.R.A.) Desai, T.; Nordgren, I.K.; Rudd, T.R.; * Correspondence: [email protected]; Tel.: +44-1707641209 Feavers, I.M.; Bore, P.; et al. -
Cjm-2020-0239.Pdf
Canadian Journal of Microbiology Exposure of Agrobacterium tumefaciens to agroinfiltration medium demonstrates cellular remodeling and may promote enhanced adaptability for molecular pharming Journal: Canadian Journal of Microbiology Manuscript ID cjm-2020-0239.R2 Manuscript Type: Article Date Submitted by the 15-Jul-2020 Author: Complete List of Authors: Prudhomme, Nicholas; University of Guelph Pastora, Rebecca; PlantForm Inc. Muselius, Benjamin; University of Guelph McLean, Mike;Draft PlantForm Corporation Canada Cossar, Doug; PlantForm Corporation Canada Geddes-McAlister, Jennifer; University of Guelph, Molecular and Cellular Biology Agrobacterium tumefaciens, agroinfiltration medium, quantitative Keyword: proteomics, molecular pharming Is the invited manuscript for consideration in a Special Not applicable (regular submission) Issue? : https://mc06.manuscriptcentral.com/cjm-pubs Page 1 of 39 Canadian Journal of Microbiology Title: Exposure of Agrobacterium tumefaciens to agroinfiltration medium demonstrates cellular remodeling and may promote enhanced adaptability for molecular pharming. Authors: Prudhomme, N.1, Pastora, R.2, Muselius, B.,1 McLean, M.D.2, Cossar, D.2, Geddes- McAlister, J.1* Affiliations: 1Department of Molecular and Cellular Biology, University of Guelph, Guelph, Ontario, N1G 2W1 2PlantForm Corporation Canada, Toronto, Ontario, M4S 3E2 Draft Corresponding author: Jennifer Geddes-McAlister, Department of Molecular and Cellular Biology, University of Guelph, Guelph, Ontario, N1G 2W1. Phone: 519-824-4120 ext. 52129. Email: [email protected] https://mc06.manuscriptcentral.com/cjm-pubs Canadian Journal of Microbiology Page 2 of 39 Abstract Agroinfiltration is used to treat plants with modified strains of Agrobacterium tumefaciens for the purpose of transient in planta expression of genes transferred from the bacterium. These genes encode valuable recombinant proteins for therapeutic or industrial applications. -
Strategy for COVID-19 Vaccination in India: the Country with the Second Highest Population and Number of Cases ✉ Velayudhan Mohan Kumar 1, Seithikurippu R
www.nature.com/npjvaccines PERSPECTIVE OPEN Strategy for COVID-19 vaccination in India: the country with the second highest population and number of cases ✉ Velayudhan Mohan Kumar 1, Seithikurippu R. Pandi-Perumal 2 , Ilya Trakht3 and Sadras Panchatcharam Thyagarajan 4 Free vaccination against COVID-19 commenced in India on January 16, 2021, and the government is urging all of its citizens to be immunized, in what is expected to be the largest vaccination program in the world. Out of the eight COVID-19 vaccines that are currently under various stages of clinical trials in India, four were developed in the country. India’s drug regulator has approved restricted emergency use of Covishield (the name employed in India for the Oxford-AstraZeneca vaccine) and Covaxin, the home- grown vaccine produced by Bharat Biotech. Indian manufacturers have stated that they have the capacity to meet the country’s future needs for COVID-19 vaccines. The manpower and cold-chain infrastructure established before the pandemic are sufficient for the initial vaccination of 30 million healthcare workers. The Indian government has taken urgent measures to expand the country’s vaccine manufacturing capacity and has also developed an efficient digital system to address and monitor all the aspects of vaccine administration. npj Vaccines (2021) 6:60 ; https://doi.org/10.1038/s41541-021-00327-2 1234567890():,; INTRODUCTION eight vaccine candidates, currently undergoing clinical trials in A year has passed since the first case of novel coronavirus India, is shown in Table 1 and their technical details are given in 13 infections was detected in China’s Wuhan province.