DOCSLIB.ORG

In the News 2016 - 2017 TABLE of CONTENTS

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
In the News 2016 - 2017 TABLE of CONTENTS In the News 2016 - 2017 TABLE OF CONTENTS Protein Sciences press release 8 June 22, 2017 Superior Protection by Flublok® Influenza Vaccine in Seniors Documented in New England Journal of Medicine Protein Sciences press release 10 April 19, 2017 Peer-reviewed Publication Confirms the Absence of Rhabdovirus in Cell Line Used for Manufacturing of Flublok Protein Sciences press release 12 April 4, 2017 Flublok Quadrivalent Influenza Vaccine Adds a 9-Month Shelf Life to Its List of Benefits Protein Sciences press release 14 March 21, 2017 Protein Sciences Gears Up to Combat Pandemic Influenza Due to Recent Outbreaks in China Protein Sciences press release 16 February 22, 2017 Protein Sciences and Partnership for Influenza Vaccine Introduction (PIVI) Team Up to Combat the Flu in Mongolia Protein Sciences press release 18 January 12, 2017 U.S. Protein Sciences’ Zika Vaccine Shows Good Results in Preclinical Testing: Bio-Manguinhos/ Fiocruz Joins International Consortium Fierce Pharma 20 December 1, 2016 Small flu vax players poised to win ‘sizable’ share of market, firm predicts TABLE OF CONTENTS Protein Sciences press release 6 November 11, 2016 Flublok® Influenza Vaccine Now Available in Mexico Fierce Pharma 8 October 17, 2016 Protein Sciences CEO Eyes GSK, Sanofi goliaths in fight to ‘take over’ quadrivalent flu vax market Protein Sciences press release 10 October 11, 2016 FDA Approves Flublok® Quadrivalent Flu Vaccine Protein Sciences press release 12 September 22, 2016 Protein Sciences and Avanzcare Announce Licensing of Influenza Vaccines for the MENA Region The Hartford Courant 14 September 8, 2016 Protein Sciences Secures A Potentially Huge Federal Contract For Flu Vaccines Protein Sciences press release 16 September 7, 2016 BARDA Awards Protein Sciences Multi-Million Dollar Contract for Pandemic Preparedness Protein Sciences press release 18 August 10, 2016 First Doses of Flublok® Influenza Vaccine of 2016/17 Have Shipped Protein Sciences press release 19 July 12, 2016 2016/17 Formulation of Flublok® Influenza Vaccine Receives FDA Approval Protein Sciences press release 22 November 11, 2016 Flublok® Influenza Vaccine Now Available in Mexico Fierce Pharma 24 October 17, 2016 Protein Sciences CEO Eyes GSK, Sanofi goliaths in fight to ‘take over’ quadrivalent flu vax market Protein Sciences press release 26 October 11, 2016 FDA Approves Flublok® Quadrivalent Flu Vaccine Protein Sciences press release 28 September 22, 2016 Protein Sciences and Avanzcare Announce Licensing of Influenza Vaccines for the MENA Region The Hartford Courant 30 September 8, 2016 Protein Sciences Secures A Potentially Huge Federal Contract For Flu Vaccines Protein Sciences press release 32 September 7, 2016 BARDA Awards Protein Sciences Multi-Million Dollar Contract for Pandemic Preparedness Protein Sciences press release 34 August 10, 2016 First Doses of Flublok® Influenza Vaccine of 2016/17 Have Shipped Protein Sciences press release 35 July 12, 2016 2016/17 Formulation of Flublok® Influenza Vaccine Receives FDA Approval Protein Sciences press release 36 June 29, 2016 UMN Pharma Joins Protein Sciences’ International Zika Vaccine Consortium Protein Sciences press release 38 June 28, 2016 Protein Sciences Announces Exclusive License to uniQure of Cell Line and Technology for Production of Human Gene Therapies Protein Sciences press release 39 June 28, 2016 Flublok® Influenza Vaccine a Great Alternative to FluMist for adults 18 and older Protein Sciences press release 40 June 23, 2016 FDA Approved Longer Shelf Life for Game Changer, Flublok® Influenza Vaccine Protein Sciences press release 42 April 19, 2016 Protein Sciences Corporation, Sinergium Biotech and Mundo Sano Announce Zika Vaccine Partnership Protein Sciences press release 44 April 12, 2016 Protein Sciences and Orygen Biotecnologia Announce Agreement to License Flublok® Influenza Vaccine for Brazil Protein Sciences press release 46 February 12, 2016 Protein Sciences, UNIGEN Reach Agreement to Source Flublok® Influenza Vaccine from Japan WTNH news story 47 February 4, 2016 Meriden Company Working on Zika Virus Vaccine Superior Protection by Flublok® Influenza Vaccine in Seniors Documented in New England Journal of Medicine For Immediate Release: Contact: June 22, 2017 Courtney Reis, Communications Associate Protein Sciences Corporation Phone: (203) 686-0800, ext 301 Meriden, CT—Protein Sciences Corporation strated statistically significantly better protection announced the publication of clinical trial results by Flublok based on considerably fewer people comparing Flublok® Quadrivalent – the quadrivalent contracting the flu after vaccination with Flublok version of Flublok® influenza vaccine – to a tradition- Quadrivalent. Today, we announce that these peer- al egg-based quadrivalent inactivated vaccine. The reviewed results have been published in the highly data published in the June 22nd issue of the New respected New England Journal of Medicine. England Journal of Medicine showed that Flublok Furthermore, physicians are eligible for up to 1 Quadrivalent provided significantly improved pro- hour AMA PRA category 1 CME credit for reading tection against laboratory confirmed influenza ill- the article. Clearly, Flublok represents a major step ness in older adults. forward in combating influenza on a global scale.” The publication notes that approximately 9,000 Flublok is the only flu vaccine made without the use people aged 50 and older were enrolled and ran- of eggs and therefore is not subject to the mutations domized in an efficacy study designed to compare that are sometimes introduced into the vaccine dur- Flublok Quadrivalent to a traditional quadrivalent ing the process of egg adaptation that can cause the vaccine. People who were given Flublok Quadriva- traditional vaccines to be ineffective. lent were over 40% less likely to develop culture- Flublok contains three times more active ingredi- confirmed influenza. This data satisfies both pre- ents than traditional vaccines and produced signifi- specified criteria for noninferiority and superiority cantly higher immune responses to the A strains of of Flublok over the traditional egg-based quadriva- influenza (especially H3N2) in the Flublok Quadriva- lent inactivated vaccine. Flublok Quadrivalent was lent study. approved by the FDA in October 2016 and will be Furthermore, Flublok Quadrivalent is the first and available nationwide in prefilled syringes for the up- only high antigen-content quadrivalent flu vac- coming flu season. cine that with its high efficacy makes it ideal for “This study shows that Flublok® Quadrivalent, pro- older adults and those with a compromised im- duced with modern recombinant technology can mune system. Flublok is highly purified and does provide better protection against confirmed influ- not contain influenza virus, antibiotics, formalde- enza-like illness among older adults than standard- hyde, preservatives, egg protein, latex, gluten or dose quadrivalent influenza vaccine produced with gelatin unlike other flu vaccines. Flublok Quad- traditional technology,” said Lisa Dunkle MD, Chief rivalent is FDA approved for adults 18 and older. Medical Officer of Protein Sciences. “We demon- www.flublok.com. 8 PROTEIN SCIENCES About Protein Sciences Healthcare professionals wishing to order Flublok Protein Sciences is a world leader in vaccine should contact one of the following distributors: development and protein production. Our mission Protein Sciences Corporation: is our inspiration: to save lives and improve health 203-686-0800 through the creation of innovative vaccines and www.flublok.com biopharmaceuticals. FFF Enterprises: 800-843-7477 About Flublok www.myfluvaccine.com Flublok, the world’s first recombinant protein- Cardinal Health: based vaccine for the prevention of seasonal influ- 866-677-4844 enza disease, was initially approved by the U.S. FDA www.cardinalhealth.com/flu in January 2013. McKesson: FDA expanded its approval in October 2014 to in- 877-MCK-4FLU clude everyone over 18 years and approved a nine- mms.mckesson.com month shelf life in June 2016. Moore Medical: Flublok is also licensed for sale in Mexico and 800-234-1464 licensure in additional countries, including Japan, is www.mooremedical.com/flu expected in the near future. Henry Schein: Flublok is the only flu vaccine made in a 100% egg- 800-772-4346 free system using modern cell culture technology, www.henryschein.com making it unnecessary to use an infectious influenza virus, antibiotics or harsh chemicals in manufactur- Flublok Safety Information ing. Flublok is approved for people 18 and older to Flublok is highly purified and does not contain any prevent influenza disease. The most common side preservatives (e.g., thimerosal, which contains mer- effect from Flublok is pain at the site of injection. cury), egg proteins, gelatin or latex. Headache, fatigue or muscle ache may occur. In addition, Flublok contains three times more Tell the doctor if you have ever experienced antigen than traditional flu vaccines (3x45mcg Guillain-Barré syndrome (severe muscle weakness) or hemagglutinin protein versus 3x15mcg hemagglu- have had a severe allergic reaction to any component tinin protein) and was shown to have better efficacy of Flublok vaccine. in a 2014/15 post-marketing study.* Vaccination with Flublok may not pro- Flublok is an accurate copy of the virus coat and is tect all individuals. Please see the complete not subject to the egg-adapted mutations that can Package Insert available at www.flublok.com or call be associated
Load more

Recommended publications
  • February 17, 2021
    January 30 – February 17, 2021 This weekly science review is a snapshot of the new and emerging scientific evidence related to COVID-19 during the period specified. It is a review of important topics and articles, not a guide for policy or program implementation. The findings captured are subject to change as new information is made available. We welcome comments and feedback at [email protected]. In depth: Should second doses of COVID-19 vaccines be delayed? Main message: While the rollout of multiple vaccines has offered hope to control or end the COVID-19 pandemic, global vaccine demand will continue to outpace supply for the foreseeable future. To date, people in 130 countries have not yet received a single dose of COVID-19 vaccine. In countries where vaccination has begun, limited supplies of vaccine in combination with surges in cases and deaths have overwhelmed health care systems. Further, the emergence of more transmissible SARS-CoV-2 variants has led many to question existing vaccine rollout plans and propose alternative strategies. Some countries and experts have recommended delaying second doses of vaccine to maximize the number of people who receive at least one dose. This raises a critical question: What do we know about vaccines, especially the vaccines for COVID-19, that may allow flexibility in vaccine schedules? This is a complex question and there may not be a straightforward answer. Our knowledge is evolving rapidly as vaccine trials progress and rollout continues, and we must keep in mind that different approaches to vaccine scheduling may be appropriate in different settings.
    [Show full text]
  • ADVISORY COMMISSION on CHILDHOOD VACCINES TABLE of CONTENTS December 8, 2017
    ADVISORY COMMISSION ON CHILDHOOD VACCINES TABLE OF CONTENTS December 8, 2017 TAB • ACCV Agenda 1 • ACCV Charter • ACCV Roster • 2017 Meeting Dates • Meeting Minutes 2 o Draft Minutes – September 8, 2017 • Vaccine Injury Compensation Trust Fund Statement 3 o Vaccine Injury Compensation Trust Fund Summary Sheet for the Period of 10/1/2016 – 9/30/2017 • VICP Data and Statistics 4 • Meeting Presentations & Updates 5 o Report from the Division of Injury Compensation Programs 5.1 o Report from the Department of Justice 5.2 o Petitions to Add Injuries to the Vaccine Injury Table Introduction 5.3 o Petition to Add Tics as an Injury to the Vaccine Injury Table 5.4 o Petition to Add Asthma as an Injury to the Vaccine Injury Table 5.5 5.6 o Petition to Add Pediatric Autoimmune Neuropsychiatric Syndrome (PANS), Pediatric Infection-Triggered Autoimmune Neuropsychiatric Disorders (PITANDS), and Pediatric Autoimmune Neuropsychiatric Disorders (PANDAS) as Injuries to the Vaccine Injury Table o Petition to Add Experimental Autoimmune Encephalomyelitis (EAE) and/or 5.7 Acute Demyelinating Encephalomyelitis (ADEM) as injuries to the Vaccine Injury Table 5.8 o Update on the Immunization Safety Office Vaccine Activities (CDC) o Update on the National Institute of Allergy and Infectious Diseases Vaccine 5.9 Activities (NIH) o Update on the Center for Biologics, Evaluation and Research Vaccine 5.10 Activities (FDA) 5.11 o Update from the National Vaccine Program Office • Program Related Articles 6 6.1 o Popular Science, “Why Are We So Bad At Producing The Right
    [Show full text]
  • COVID-19 Vaccine: Critical Questions with Complicated Answers
    Review Biomol Ther 29(1), 1-10 (2021) COVID-19 Vaccine: Critical Questions with Complicated Answers Mohammad Faisal Haidere1,†, Zubair Ahmed Ratan2,3,†, Senjuti Nowroz4, Sojib Bin Zaman5, You-Jung Jung6, Hassan Hosseinzadeh2,* and Jae Youl Cho7,* 1Department of Soil, Water and Environment, University of Dhaka, Dhaka 1000, Bangladesh 2School of Health & Society, University of Wollongong, NSW 2500, Australia 3Department of Biomedical Engineering, Khulna University of Engineering and Technology, Khulna 9203, Bangladesh 4Department of Chemistry, University of Dhaka, Dhaka 1000, Bangladesh 5Department of Medicine, School of Clinical Sciences, Monash University, Victoria 3800, Australia 6Biological Resources Utilization Department, National Institute of Biological Resources, Incheon 22689, Republic of Korea 7Department of Integrative Biotechnology, and Biomedical Institute for Convergence at SKKU (BICS), Sungkyunkwan University, Suwon 16419, Republic of Korea Abstract COVID-19 has caused extensive human casualties with significant economic impacts around the globe, and has imposed new challenges on health systems worldwide. Over the past decade, SARS, Ebola, and Zika also led to significant concerns among the scientific community. Interestingly, the SARS and Zika epidemics ended before vaccine development; however, the scholarly com- munity and the pharmaceutical companies responded very quickly at that time. Similarly, when the genetic sequence of SARS- CoV-2 was revealed, global vaccine companies and scientists have stepped forward to develop a vaccine, triggering a race toward vaccine development that the whole world is relying on. Similarly, an effective and safe vaccine could play a pivotal role in eradi- cating COVID-19. However, few important questions regarding SARS-CoV-2 vaccine development are explored in this review. Key Words: COVID-19, Vaccine, Vaccine backfires, Vaccine safety INTRODUCTION vember 2002 in the Guangdong province of China.
    [Show full text]
  • Scientific Consultation on Zika Virus Vaccine Development
    World Health Organization and National Institute of Allergy and Infectious Diseases, National Institutes of Health Scientific Consultation on Zika Virus Vaccine Development January 10–11, 2017 5601 Fishers Lane Rockville, Maryland Meeting Summary Tuesday, January 10, 2017 INTRODUCTION Anthony S. Fauci, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), United States The National Institute of Allergy and Infectious Diseases (NIAID) and the World Health Organization (WHO) convened the Scientific Consultation on Zika Virus Vaccine Development to discuss challenges and recent advances in the development of Zika virus (ZIKV) vaccines. The NIAID Director opened the meeting by stating that the recent spread of ZIKV mirrors that of other emerging arboviruses in the Americas in the past several years, including chikungunya, West Nile, and dengue. The NIAID research response to Zika builds on those experiences. A primary goal of this research is to develop medical countermeasures including diagnostics, therapeutics, and vaccines. Challenges specific to the development of a Zika vaccine include: the lack of adequate animal models; uncertainties in the epidemiology, which affect clinical trial site selection; the likelihood that the vaccine will need to induce sterilizing immunity to prevent congenital Zika syndrome (CZS); preexisting immunity to other flaviviruses in some regions; and potential specific risks such as Guillain-Barré syndrome (GBS) and the administration of live vaccines to pregnant women. Several Zika vaccine candidates are being developed with different development timelines and likely target populations. The planned timelines include large, well-controlled clinical trials to evaluate safety and efficacy, and if successful, subsequent licensure; should public health need and available safety and efficacy data justify deployment of vaccine before licensure, access through appropriate regulatory mechanisms could be considered.
    [Show full text]
  • Zika Vaccine Development Technology Roadmap April 2019
    Zika Vaccine Development Technology Roadmap April 2019 Acknowledgements This work was built on critical input from the WHO Zika vaccine technical roadmap advisory group members in 2017 who worked primarily on Zika vaccines for outbreak use: Alan Barrett, University of Texas Medical Branch, USA; Amy Lambert, Centers for Diseases Control and Prevention, Fort Collins, USA; Anna Durbin, Johns Hopkins University, Baltimore, USA; David C. Kaslow, PATH, Seattle, USA; Heidi Meyer, PEI, Germany; Carlos Pardo-Villamizar, Neuroviruses Emerging in the Americas Study (NEAS), Colombia and Johns Hopkins University, Baltimore, USA; Laura C. Rodrigues, London School of Hygiene and Tropical Medicine, UK, and Microcephaly Epidemic Research Group (MERG), Brazil; Stephen J. Thomas, State University of New York Upstate Medical University, Syracuse, USA; Wellington Sun, US Food and Drug Administration, USA. The work on Zika vaccines for endemic use was further developed in 2018 and 2019 by: Alan Barrett, University of Texas Medical Branch, USA; Cristina Cassetti, NIH/NIAID, USA; Anna Durbin, Johns Hopkins University, Baltimore, USA; David C. Kaslow, PATH, Seattle, USA; Heidi Meyer, PEI, Germany; Eng-Eong Ooi, Duke-NUS, Singapore; Alexander Precioso, Clinical Trials and Pharmacovigilance Division, Butantan, Brazil; Stephen J. Thomas, State University of New York Upstate Medical University, Syracuse, USA; In-Kyu Yoon, International Vaccine Institute Seoul, South Korea. We are grateful to all individuals and represented institutions that contributed to the discussions at the WHO consultation meetings on Zika Virus vaccine development, and to the members of the WHO Product Development for Vaccines Advisory Committee (http://www.whoint/immunization/research/committees/pdvac). WHO gratefully acknowledges the many individuals and institutions that provided comments to this document during the public consultation.
    [Show full text]
  • Efficacy of a T Cell-Biased Adenovirus Vector As a Zika Virus Vaccine
    University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln Virology Papers Virology, Nebraska Center for 12-20-2018 Efficacy of a T Cell-Biased Adenovirus Vector as a Zika Virus Vaccine Brianna L. Bullard University of Nebraska - Lincoln, [email protected] Brigette N. Corder University of Nebraska - Lincoln Matthew J. Gorman Washington University School of Medicine Michael S. Diamond Washington University School of Medicine Eric A. Weaver University of Nebraska-Lincoln, [email protected] Follow this and additional works at: https://digitalcommons.unl.edu/virologypub Part of the Biological Phenomena, Cell Phenomena, and Immunity Commons, Cell and Developmental Biology Commons, Genetics and Genomics Commons, Infectious Disease Commons, Medical Immunology Commons, Medical Pathology Commons, and the Virology Commons Bullard, Brianna L.; Corder, Brigette N.; Gorman, Matthew J.; Diamond, Michael S.; and Weaver, Eric A., "Efficacy of a T Cell-Biased Adenovirus Vector as a Zika Virus Vaccine" (2018). Virology Papers. 383. https://digitalcommons.unl.edu/virologypub/383 This Article is brought to you for free and open access by the Virology, Nebraska Center for at DigitalCommons@University of Nebraska - Lincoln. It has been accepted for inclusion in Virology Papers by an authorized administrator of DigitalCommons@University of Nebraska - Lincoln. www.nature.com/scientificreports OPEN Efcacy of a T Cell-Biased Adenovirus Vector as a Zika Virus Vaccine Received: 7 August 2018 Brianna L. Bullard 1, Brigette N. Corder1, Matthew J. Gorman2, Michael S. Diamond 2 & Accepted: 10 November 2018 Eric A. Weaver1 Published: xx xx xxxx Zika virus (ZIKV) is a major public health concern due to the risk of congenital Zika syndrome in developing fetuses and Guillain-Barre syndrome in adults.
    [Show full text]
  • Directory 2017.Pdf
    Dear Colleagues and Friends, It gives me immense pleasure to connect with you on the occasion of the 18th Annual General Meeting (AGM) of DCVMN. I would like to take this opportunity to reiterate my gratefulness to you - our Members - to have elected me as President to represent not only a group of extraordinary professionals, but also a Network of companies with global impact. I am honoured and humbled that you have placed your trust in me. I am confident that with your cooperation and support we would certainly take this organisation to the next level. DCVMN and its members are continuously recognized as key players in global health, particularly in tackling emerging outbreaks, elimination of tetanus and measles/rubella and in the eradication of Polio virus. We are proud of what we have been able to accomplish over the years, enabling our Network to demonstrate dynamic growth and to engage in supporting several global health efforts, particularly in protecting people from infectious diseases in developing countries by supplying high-quality, affordable vaccines around the world. Since its inception in 2000, DCVMN has grown at a fast pace and today represents more than 50 vaccine manufacturers. Still we have a long way to go. The current AGM is a great platform for us to ponder upon our priorities and challenges as developing countries manufacturers and also scope out our activities as a network and work towards more effective organizational strategies for the coming years. We must leverage our collective knowledge and organizational experience to bring actionable ideas to the table at this AGM.
    [Show full text]
  • Zika Virus Research and Development (R&D) Roadmap
    ZIKV R&D Roadmap v7.1 DRAFT FOR PUBLIC COMMENT February 2021 1 Zika Virus Research and Development (R&D) Roadmap 2 3 Roadmap purpose: To provide a 10-year framework for prioritizing research activities aimed at 4 advancing the development, licensure, manufacture, deployment, and assessment of medical 5 countermeasures (MCMs)—diagnostics, therapeutics, and vaccines—against Zika virus (ZIKV) disease. By 6 highlighting key knowledge gaps, identifying strategic goals and milestones, and encouraging synergistic 7 research and development (R&D) activities, the roadmap will serve as a valuable tool to advance the 8 existing complex field of ZIKV MCM research and stimulate overall investment in R&D and in 9 implementation activities. 10 11 Vision statement: To ensure that robust MCMs to detect, prevent, and control human ZIKV clinical 12 disease, including congenital anomalies and neurodevelopmental disabilities associated with congenital 13 ZIKV infection, are readily available and accessible for use in areas of known or potential ZIKV 14 transmission. These MCMs include: (1) accurate, standardized, and validated diagnostics; (2) safe and 15 effective treatments aimed primarily at preventing congenital ZIKV infection; and (3) safe and effective 16 vaccines to prevent disease, disability, and death. 17 18 INTRODUCTION 19 ZIKV is a mosquito-borne flavivirus that was first isolated in 1947 from a sentinel rhesus monkey in the 20 Zika Forest of Uganda (Dick 1952). Only a handful of ZIKV disease cases in humans had been identified 21 prior to a 2007 outbreak in the State of Yap, Federated States of Micronesia, during which an estimated 22 73% of the population was infected (Duffy 2009, Petersen 2016).
    [Show full text]
  • Development of Vaccines Against Zika Virus
    Review Development of vaccines against Zika virus Gregory A Poland, Richard B Kennedy, Inna G Ovsyannikova, Ricardo Palacios, Paulo Lee Ho, Jorge Kalil Zika virus is an emerging pathogen of substantial public health concern to human beings. Although most infections are Lancet Infect Dis 2018; asymptomatic or present with benign, self-limited symptoms, a small percentage of patients have complications, such 18: e211–19 as congenital anomalies in the developing fetus of pregnant women infected with the virus and neurological Published Online complications (eg, Guillain-Barré syndrome). To date, there is no vaccine, antiviral drug, or other modality available to January 25, 2018 http://dx.doi.org/10.1016/ prevent or treat Zika virus infection. In this Review, we examine vaccine development efforts for Zika virus to date and S1473-3099(18)30063-X research gaps in the development of candidate vaccines against Zika virus. Top research priorities should include Mayo Clinic Vaccine Research development of a better understanding of immunity to Zika virus to establish clear correlates of protection; determination Group, Mayo Clinic, Rochester, of what effect, if any, Zika vaccine-induced immune responses will have on subsequent dengue virus infection; MN , USA (Prof G A Poland MD, evaluation of vaccine immunogenicity and efficacy in healthy adults and in the various subpopulations affected by Zika Prof R B Kennedy PhD, Prof I G Ovsyannikova PhD); virus infection (children, pregnant women, women of childbearing age, and eldery people); and identification
    [Show full text]
  • Considerations for Bioanalytical Characterization and Batch Release of COVID-19 Vaccines ✉ Gautam Sanyal 1 , Anna Särnefält 1 and Arun Kumar 1
    www.nature.com/npjvaccines PERSPECTIVE OPEN Considerations for bioanalytical characterization and batch release of COVID-19 vaccines ✉ Gautam Sanyal 1 , Anna Särnefält 1 and Arun Kumar 1 The COVID-19 pandemic has prompted hundreds of laboratories around the world to employ traditional as well as novel technologies to develop vaccines against SARS-CoV-2. The hallmarks of a successful vaccine are safety and efficacy. Analytical evaluation methods, that can ensure the high quality of the products and that can be executed speedily, must be in place as an integral component of Chemistry, Manufacturing, and Control (CMC). These methods or assays are developed to quantitatively test for critical quality attributes (CQAs) of a vaccine product. While clinical (human) efficacy of a vaccine can never be predicted from pre-clinical evaluation of CQA, precise and accurate measurements of antigen content and a relevant biological activity (termed “potency”) elicited by the antigen allow selection of potentially safe and immunogenic doses for entry into clinical trials. All available vaccine technology platforms, novel and traditional, are being utilized by different developers to produce vaccines against SARS-CoV-2. It took less than a year from the publication of SARS-CoV-2 gene sequence to Emergency Use Authorization (EUA) of the first vaccine, setting a record for speed in the history of vaccine development. The largest ever global demand for vaccines has prompted some vaccine developers to enter multiple manufacturing partnerships in different countries in addition to implementing unprecedented scale-up plans. Quantitative, robust, and rapid analytical testing for CQA of a product is essential in ensuring smooth technology transfer between partners and allowing analytical bridging between vaccine batches used in different 1234567890():,; clinical phases leading up to regulatory approvals and commercialization.
    [Show full text]
  • Mrna Vaccines Against Flaviviruses
    Review mRNA Vaccines against Flaviviruses Clayton J. Wollner and Justin M. Richner * Department of Microbiology and Immunology, University of Illinois College of Medicine, Chicago, IL 60612, USA; [email protected] * Correspondence: [email protected] Abstract: Numerous vaccines have now been developed using the mRNA platform. In this approach, mRNA coding for a viral antigen is in vitro synthesized and injected into the host leading to exoge- nous protein expression and robust immune responses. Vaccines can be rapidly developed utilizing the mRNA platform in the face of emerging pandemics. Additionally, the mRNA coding region can be easily manipulated to test novel hypotheses in order to combat viral infections which have remained refractory to traditional vaccine approaches. Flaviviruses are a diverse family of viruses that cause widespread disease and have pandemic potential. In this review, we discuss the mRNA vaccines which have been developed against diverse flaviviruses. Keywords: flavivirus; mRNA vaccines; Dengue; Zika; tick-borne encephalitis 1. Introduction Flaviviridae is a diverse family of positive sense, RNA viruses that are spread predom- inantly by arthropod vectors [1]. Outbreaks of flaviviruses across the globe have plagued humankind for centuries [2]. Even in modern times, flaviviral outbreaks can lead to global pandemics as demonstrated after the introduction and subsequent spread of West Nile virus Citation: Wollner, C.J.; Richner, J.M. into North America in 1999 and more recently, the emergence of Zika virus into the Western mRNA Vaccines against Flaviviruses. Hemisphere in 2013 [3]. One of the most successful early vaccination campaigns ever Vaccines 2021, 9, 148. https:// was against the flavivirus yellow fever virus in the 1930’s [4].
    [Show full text]
  • Frequently Asked Questions About COVID-19 Candidate Vaccines and Access Mechanisms
    Frequently Asked Questions about COVID-19 Candidate Vaccines and Access Mechanisms Version 3, 6 January 20211,2 Progress in the Development of COVID-19 Vaccines 1. Is there a vaccine against COVID-19? As of January 6th, 2021, there are some COVID-19 vaccines for which certain national regulatory authorities have authorized the use. The World Health Organization (WHO) has also granted Emergency Use Listing (EUL) authorization to the Pfizer/BioNTech vaccine3. The following vaccines have received national regulatory authorization3,4: ● Moderna/ NIAID/ Lonza/ Catalent/ Rovi/ Medidata/ BIOQUAL: Authorized for "emergency use" in the United States (U.S.). ● BioNTech/ Pfizer/ Fosun Pharma/ Rentschler Biopharma: Authorized for use by the European Commission and in the U.S., Mexico, Saudi Arabia, Canada, Bahrain, and the United Kingdom (U.K.). ● Gamaleya Research Institute: as a "registered" vaccine by the Russian Ministry of Health ● CanSino Biologics/ Beijing Institute of Biotechnology/ Petrovax: for "the military" by China’s Central Military Commission. ● Wuhan Institute of Biological Products/ Sinopharm: for "emergency use" in China and the United Arab Emirates. ● Sinovac/ Instituto Butantan/ Bio Farma: for "emergency use" in China. ● Beijing Institute of Biological Products/ Sinopharm: for "emergency use" in China and the United Arab Emirates. As of January 6th, 2021, there are 63 candidate vaccines in clinical evaluation in humans, and 172 candidate vaccines in the preclinical phase5. 1 Document subject to revision as new evidence and information become available. 2 A previous version of the document was published on 27 August 2020: Pan American Health Organization. Frequently Asked Questions (FAQs) about COVID-19 Candidate Vaccines and Access Mechanisms [Internet].
    [Show full text]