An Overview of Nanocarrier-Based Adjuvants for Vaccine Delivery
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Supplemental Information and Guidance for Vaccination Providers Regarding Use of 9-Valent HPV Vaccine
Supplemental information and guidance for vaccination providers regarding use of 9-valent HPV A 9-valent human papillomavirus (HPV) vaccine (9vHPV, Gardasil 9, Merck & Co.) was licensed for use in females and males in December 2014.1,2,3,4 The 9vHPV was the third HPV vaccine licensed in the United States by the Food and Drug Administration (FDA); the other vaccines are bivalent HPV vaccine (2vHPV, Cervarix, GlaxoSmithKline), licensed for use in females, and quadrivalent HPV vaccine (4vHPV, Gardasil, Merck & Co.), licensed for use in females and males.5 In February 2015, the Advisory Committee on Immunization Practices (ACIP) recommended 9vHPV as one of three HPV vaccines that can be used for routine vaccination of females and one of two HPV vaccines for routine vaccination of males.6 After the end of 2016, only 9vHPV will be distributed in the United States. In October 2016, ACIP updated HPV vaccination recommendations regarding dosing schedules.7 CDC now recommends two doses of HPV vaccine (0, 6–12 month schedule) for persons starting the vaccination series before the 15th birthday. Three doses of HPV vaccine (0, 1–2, 6 month schedule) continue to be recommended for persons starting the vaccination series on or after the 15th birthday and for persons with certain immunocompromising conditions. Guidance is needed for persons who started the series with 2vHPV or 4vHPV and may be completing the series with 9vHPV. The information below summarizes some of the recommendations included in ACIP Policy Notes and provides additional guidance.5-7 Information about the vaccines What are some of the similarities and differences between the three HPV vaccines? y Each of the three HPV vaccines is a noninfectious, virus-like particle (VLP) vaccine. -
Adenoviral Vector COVID-19 Vaccines: Process and Cost Analysis
processes Article Adenoviral Vector COVID-19 Vaccines: Process and Cost Analysis Rafael G. Ferreira 1,* , Neal F. Gordon 2, Rick Stock 2 and Demetri Petrides 3 1 Intelligen Brasil, Sao Paulo 01227-200, Brazil 2 BDO USA, LLP, Boston, MA 02110, USA; [email protected] (N.F.G.); [email protected] (R.S.) 3 Intelligen, Inc., Scotch Plains, NJ 07076, USA; [email protected] * Correspondence: [email protected] Abstract: The COVID-19 pandemic has motivated the rapid development of numerous vaccines that have proven effective against SARS-CoV-2. Several of these successful vaccines are based on the adenoviral vector platform. The mass manufacturing of these vaccines poses great challenges, especially in the context of a pandemic where extremely large quantities must be produced quickly at an affordable cost. In this work, two baseline processes for the production of a COVID-19 adenoviral vector vaccine, B1 and P1, were designed, simulated and economically evaluated with the aid of the software SuperPro Designer. B1 used a batch cell culture viral production step, with a viral titer of 5 × 1010 viral particles (VP)/mL in both stainless-steel and disposable equipment. P1 used a perfusion cell culture viral production step, with a viral titer of 1 × 1012 VP/mL in exclusively disposable equipment. Both processes were sized to produce 400 M/yr vaccine doses. P1 led to a smaller cost per dose than B1 ($0.15 vs. $0.23) and required a much smaller capital investment ($126 M vs. $299 M). The media and facility-dependent expenses were found to be the main contributors to the operating cost. -
Characterization of Avian Influenza H5N1 Virosome
Pakistan Veterinary Journal ISSN: 0253-8318 (PRINT), 2074-7764 (ONLINE) Accessible at: www.pvj.com.pk RESEARCH ARTICLE Characterization of Avian Influenza H5N1 Virosome Chatchai Sarachai1, Jiroj Sasipreeyajan2 and Niwat Chansiripornchai2,3* 1Department of Food Animal Clinic, Faculty of Veterinary Medicine, Chiang Mai University, Chiang Mai 50100, Thailand; 2Avian Health Research Unit, Department of Veterinary Medicine, Faculty of Veterinary Science, Chulalongkorn University, Bangkok 10330, Thailand; 3World Organisation for Animal Health (OIE), 12 Rue de Prony, 75017 Paris, France *Corresponding author: [email protected] ARTICLE HISTORY (13-287) ABSTRACT Received: June 30, 2013 The purpose of this study was to prepare and characterize virosome containing Revised: October 20, 2013 envelope proteins of the avian influenza (H5N1) virus. The virosome was prepared Accepted: November 16, 2013 by the solubilization of virus with octaethyleneglycol mono (n-dodecyl) ether Key words: (C12E8) followed by detergent removal with SM2 Bio-Beads. Biochemical analysis Avian influenza by SDS-PAGE and western blotting, indicated that avian influenza H5N1 virosome H5N1 had similar characteristics to the parent virus and contained both the hemagglutinin Virosome (HA, 60-75 kDa) and neuraminidase (NA, 220 kDa) protein, with preserved biological activity, such as hemagglutination activity. The virosome structure was analyzed by negative stained transmission electron microscope (TEM) demonstrated that the spherical shapes of vesicles with surface glycoprotein spikes were harbored. In conclusion, the biophysical properties of the virosome were similar to the parent virus, and the use of octaethyleneglycol mono (n-dodecyl) ether to solubilize viral membrane, followed by removal of detergent using polymer beads adsorption (Bio- Beads SM2) was the preferable method for obtaining avian influenza virosome. -
Vaccine Compositions Comprising Virosomes and A
(19) TZZ__T (11) EP 1 755 666 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 39/145 (2006.01) A61K 9/127 (2006.01) 15.12.2010 Bulletin 2010/50 A61K 47/46 (2006.01) A61K 47/48 (2006.01) A61K 39/39 (2006.01) (21) Application number: 05747432.2 (86) International application number: (22) Date of filing: 26.05.2005 PCT/EP2005/005786 (87) International publication number: WO 2005/117958 (15.12.2005 Gazette 2005/50) (54) VACCINE COMPOSITIONS COMPRISING VIROSOMES AND A SAPONIN ADJUVANT IMPFSTOFFZUSAMMENSETZUNGEN MIT VIROSOMEN UND EINEM SAPONIN-ADJUVANS COMPOSITIONS DE VACCIN COMPRENANT DES VIROSOMES ET UN ADJUVANT A BASE DE SAPONINE (84) Designated Contracting States: (56) References cited: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR WO-A-2004/016281 HU IE IS IT LI LT LU MC NL PL PT RO SE SI SK TR Designated Extension States: • SJOLANDER A ET AL: "Kinetics, localization and HR LV cytokine profile of T cell responses to immune stimulating complexes (iscoms) containing (30) Priority: 28.05.2004 GB 0412039 human influenza virus envelope glycoproteins" 02.06.2004 GB 0412304 VACCINE, BUTTERWORTH SCIENTIFIC. GUILDFORD, GB, vol. 15, no. 9, June 1997 (43) Date of publication of application: (1997-06), pages 1030-1038, XP004115372 ISSN: 28.02.2007 Bulletin 2007/09 0264-410X • MISCHLER R ET AL: "Inflexal<(>R)V a trivalent (60) Divisional application: virosome subunit influenza vaccine: production" 10178216.7 VACCINE, BUTTERWORTH SCIENTIFIC. GUILDFORD, GB, vol. 20, 20 December 2002 (73) Proprietor: GlaxoSmithKline Biologicals SA (2002-12-20),pagesB17-B23,XP004397481ISSN: 1330 Rixensart (BE) 0264-410X • CHEN D ET AL: "Epidermal powder immunization (72) Inventors: of mice and monkeys with an influenza vaccine" • COLLER, Beth-Ann VACCINE, BUTTERWORTH SCIENTIFIC. -
Gsk Vaccines in 2010
GSK VACCINES IN 2010 Thomas Breuer, MD, MSc Senior Vice President Head of Global Vaccines Development GSK Biologicals Vaccines business characteristics Few global players and high barriers to entry – Complex manufacturing – Large scale investment Long product life cycles – Complex intellectual property High probability of R&D success – 70% post-POC New technology/novel products Better pricing for newer vaccines – HPV vaccines (Cervarix, Gardasil) – Pneumococcal vaccines (Synflorix, Prevnar-13) Operating margin comparable to pharmaceutical products Heightened awareness New markets 2 Research & development timelines Identify Produce Pre-Clinical Proof of Registration/ Phase I Phase II Phase III File Antigens Antigens Testing Concept Post Marketing Research (inc. Immunology) Pre-Clinical Development (inc. Formulation Science) Clinical Development (inc. Post Marketing Surveillance) Transfer Process to Manufacturing Build Facility x x Up to $10-20M Up to $50-100M $500M - $1B x x x 1-10 yrs 2-3 yrs 2-4 yrs > 1 yr GSK vaccines business 2009 sales £3.7 billion (+30%) +19% CAGR excl. H1N1 Vaccines represent 13% since 2005 of total GSK sales Sale s (£m) 4000 3500 Recent approvals: 3000 US: Cervarix 2500 EU: Synflorix 2000 Pandemic: Pandemrix; Arepanrix 1500 1000 500 0 2005 2006 2007 2008 2009 Increased Emerging Market presence Growth rate is CER 5 GSK vaccines: fastest growing part of GSK in 2009 2009 Sales Share Growth (CER) Respiratory £ 6,977m 25% +5% Consumer £ 4,654m 16% +7% Anti-virals £ 4,150m 15% +12% Vaccines £ 3,706m 13% +30% CV & Urogenital -
Global Advisory Committee on Vaccine Safety (GACVS)
Global Advisory Committee on Vaccine Safety (GACVS) Report on GACVS meeting June 2013 1 | GACVS June 2013 report Topics Discussed ! Pentavalent vaccine in 4 Asian Countries ! Zoster vaccine safety and varicella vaccine safety in immunocompromised populations ! Immunization during pregnancy ! Yellow fever vaccine safety during mass immunization campaigns in sub-Saharan Africa ! Safety profile: Japanese encephalitis vaccines ! Update: human papillomavirus vaccines ! Update: pandemic influenza vaccine (Pandemrix®) and narcolepsy 2 | GACVS June 2013 report Progressive pentavalent vaccine introduction in 4 Asian Countries ! Sri Lanka (Crucell, Jan 2008): – Within 3 months, 4 deaths and 24 suspected HHE: precautionary suspension of initial lot. – 1 death following immunization April 2009: vaccine suspended, DTwP and Hep B resumed. ! Bhutan (Panacea, Sep 2009) – 5 cases of encephalopathy and/or meningoencephalitis lead to suspended vaccination 23 Oct 2009. (Subsequently, 4 serious AEFI were identified and investigated). ! India (Serum Institute of India, Tamil Nadu and Kerala, Dec 2011; Goa, Pondicherry, Karnataka, Haryana, Jammu and Kashmir, Gujarat and Delhi from Q3 2012 – Q1 2013) – To date, 83 AEFI cases reported, some associated with mortality. ! Vietnam (Crucell, Jun 2010 - May 2013) – 43 serious AEFI investigated, including 27 with fatal outcome. – Following 9 deaths following vaccination reported Dec 2012 - March 2013: vaccine suspended. 3 | GACVS June 2013 report GACVS analysis of common features among countries experiencing significant vaccine safety concerns ! Vaccination programmes are well established and achieves high coverage ! Vaccine introduction was accompanied by thorough training of health-care staff on benefits and risks of vaccine ! Sri Lanka and Bhutan: discontinuation and resumption of pentavalent vaccine did not significantly modify pattern of serious AEFI with previously utilized vaccines ! Limitations in all 4 countries: – Incomplete clinical information complicated causality assessment. -
For the Use Only of a Registered Medical Practitioner Or a Hospital Or a Laboratory ENGERIX B Hepatitis B Vaccine
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory ENGERIX® B Hepatitis B Vaccine (rDNA) IP (Genetically Engineered) 1. NAME OF THE MEDICINAL PRODUCT Hepatitis B Vaccine (rDNA) IP (Genetically Engineered) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ENGERIX B 20 mcg/1 ml (Adult) 1 dose (1 ml) contains : Equivalent to 20 mcg purified HBV surface antigen produced in Saccharomyces cerevisiae; Hydrated Aluminium Oxide IP equiv to 0.5 mg Aluminium ENGERIX B 10 mcg/0.5 ml (Paediatric) 1 dose (0.5 ml) contains: Equivalent to 10 mcg purified HBV surface antigen produced in Saccharomyces cerevisiae; Hydrated Aluminium Oxide IP equiv to 0.25 mg Aluminium For the full list of excipients, see section 6.1 List of excipients 3. PHARMACEUTICAL FORM Suspension for injection The suspension is turbid white. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications ENGERIX B is indicated for active immunization against Hepatitis B Virus infection (HBV) caused by all known subtypes in subjects of all ages considered at risk of exposure to HBV. It can be expected that hepatitis D will also be prevented by immunization with ENGERIX B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. Immunization against hepatitis B is expected in the long term to reduce not only the incidence of this disease but also its chronic complication such as chronic active hepatitis B and hepatitis B associated cirrhosis. In areas of low prevalence of hepatitis B, immunization is particularly recommended for those belonging to groups identified at increased risk of infection (see below), however, universal immunization of all infants and adolescents will contribute to the control of hepatitis B on a population basis. -
Cervarix, Suspension for Intramuscular Injection
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ----------------------- WARNINGS AND PRECAUTIONS ----------------------- CERVARIX safely and effectively. See full prescribing information for • Because vaccinees may develop syncope, sometimes resulting in falling CERVARIX. with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic CERVARIX [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, movements and other seizure-like activity, has been reported following Recombinant] vaccination with CERVARIX. When syncope is associated with tonic- Suspension for Intramuscular Injection clonic movements, the activity is usually transient and typically Initial U.S. Approval: 2009 responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. (5.1) ----------------------------INDICATIONS AND USAGE ---------------------------- • The tip caps of the prefilled syringes contain natural rubber latex which CERVARIX is a vaccine indicated for the prevention of the following may cause allergic reactions. (5.2) diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18: • cervical cancer, ------------------------------ ADVERSE REACTIONS ------------------------------ • cervical intraepithelial neoplasia (CIN) Grade 2 or worse and • Most common local adverse reactions in ≥20% of subjects were pain, adenocarcinoma in situ, and redness, and swelling at the injection site. (6.1) • cervical intraepithelial -
Product TBL.Productname
product_TBL.productName CVX Short Description CVX Code manufacturer_TBL.manufacturer_name manufacturer_TBL.MVX_CODE MVX status product name status product_TBL.Update_date ACAM2000 vaccinia (smallpox) 75 Acambis, Inc ACA Inactive Inactive 28-May-10 ACAM2000 vaccinia (smallpox) 75 Sanofi Pasteur PMC Active Active 28-May-10 ACEL-IMUNE DTaP 20 Inactive Inactive 1-Sep-10 ACTHIB Hib (PRP-T) 48 Sanofi Pasteur PMC Active Active 28-May-10 ADACEL Tdap 115 Sanofi Pasteur PMC Active Active 28-May-10 Adenovirus types 4 and 7 Adenovirus types 4 and 7 143 Barr Laboratories BRR Inactive Inactive 30-Jul-19 Adenovirus types 4 and 7 Adenovirus types 4 and 7 143 TEVA Pharmaceuticals USA TVA Active Active 23-Jul-19 AFLURIA Influenza, seasonal, injectable 141 bioCSL CSL Inactive Inactive 26-Sep-16 Afluria Influenza, seasonal, injectable 141 Seqirus SEQ Active Active 26-Sep-16 Afluria quadrivalent preservative free influenza, injectable, quadrivalent, preservative free 150 Seqirus SEQ Active Active 4-Oct-16 Afluria quadrivalent, preservative free, pediatric Influenza, injectable,quadrivalent, preservative free, pediatric 161 Seqirus SEQ Active Active 26-Aug-19 Afluria, preservative free Influenza, seasonal, injectable, preservative free 140 bioCSL CSL Inactive Inactive 26-Sep-16 Afluria, preservative free Influenza, seasonal, injectable, preservative free 140 Seqirus SEQ Active Active 26-Sep-16 Afluria, quadrivalent influenza, injectable, quadrivalent 158 Seqirus SEQ Active Active 4-Oct-16 AGRIFLU Influenza, seasonal, injectable, preservative free 140 Novartis Pharmaceutical Corporation NOV Inactive Inactive 15-Nov-17 AS03 adjuvant AS03 Adjuvant 801 GlaxoSmithKline SKB Active Inactive 11-Sep-15 AstraZeneca COVID-19 Vaccine (Non-US tradenames include VAXZEVRIA, COVISHIELD) COVID-19 vaccine, vector-nr, rS-ChAdOx1, PF, 0.5 mL 210 AstraZeneca ASZ Active Active 13-Jul-21 ATTENUVAX measles 05 Merck and Co., Inc. -
Vaccines Licensed for Use in the United States by the Food and Drug
Vaccines Licensed for Use in the United States by the Food and Drug Administration (FDA) Cell Lines Used for Viral Vaccine Production Current FDA list accessed 4 January 2021 Use of Cell Lines for Vaccine Production Vaccine Product Name No fetal cells (linked to FDA vaccine page Vaccine Trade Name fetal cells including package insert) -- no cell lines - bacteria grow independently WI-38 Adenovirus Type 4 and Type 7 Vaccine, No Trade Name Live, Oral -- Anthrax Vaccine Adsorbed Biothrax -- BCG Live BCG Vaccine -- BCG Live TICE BCG -- Cholera Vaccine Live Oral Vaxchora Vero Dengue Tetravalent Vaccine, Live DENGVAXIA -- Diphtheria & Tetanus Toxoids Adsorbed No Trade Name -- Diphtheria & Tetanus Toxoids & Acellular Infanrix Pertussis Vaccine Adsorbed -- Diphtheria & Tetanus Toxoids & Acellular DAPTACEL Pertussis Vaccine Adsorbed Yeast (HepB) Diphtheria & Tetanus Toxoids & Acellular Vero (polio) Pertussis Vaccine Adsorbed, Hepatitis B Pediarix -- diphtheria, tetanus, (recombinant) and Inactivated Poliovirus pertussis Vaccine Combined Vero (polio) Diphtheria and Tetanus Toxoids and -- diphtheria, tetanus, Acellular Pertussis Adsorbed and Inactivated KINRIX pertussis Poliovirus Vaccine Vero (polio) Diphtheria and Tetanus Toxoids and -- diphtheria, tetanus, Acellular Pertussis Adsorbed and Inactivated Quadracel pertussis Poliovirus Vaccine Yeast (HepB) Diphtheria and Tetanus Toxoids and Vero (polio) Acellular Pertussis Adsorbed, Inactivated -- diphtheria, tetanus, Poliovirus, Haemophilus b Conjugate VAXELIS pertussis, haemophilus [Meningococcal -
Human Papillomavirus Vaccines: an Updated Review
Review Human Papillomavirus Vaccines: An Updated Review Liqin Cheng, Yan Wang and Juan Du * Department of Microbiology, Tumor and Cell Biology (MTC), Karolinska Institutet, 17177 Stockholm, Sweden; [email protected] (L.C.); [email protected] (Y.W.) * Correspondence: [email protected] Received: 29 June 2020; Accepted: 14 July 2020; Published: 16 July 2020 Abstract: Human papillomavirus (HPV) vaccines, which were introduced in many countries in the past decade, have shown promising results in decreasing HPV infection and related diseases, such as warts and precancerous lesions. In this review, we present the updated information about current HPV vaccines, focusing on vaccine coverage and efficacy. In addition, pan-gender vaccination and current clinical trials are also discussed. Currently, more efforts should be put into increasing the vaccine’s coverage, especially in low- and middle-income countries. Provision of education on HPV and vaccination is one of the most important methods to achieve this. Vaccines that target HPV types not included in current vaccines are the next stage in vaccine development. In the future, all HPV-related cancers, such as head and neck cancer, and anal cancer, should be tracked and evaluated, especially in countries that have introduced pan-gender vaccination programs. Therapeutic vaccines, in combination with other cancer treatments, should continue to be investigated. Keywords: human papillomavirus; vaccine; Cervarix; Gardasil; Gardasil 9 1. Introduction Human papillomavirus (HPV) infection, one of the most common sexually transmitted diseases, is associated with cancers such as cervical cancer, head and neck squamous cell carcinoma (HNSCC), and anal cancer [1–3]. To date, more than 200 HPV types have been identified [4,5]. -
Current Status of COVID-19 Vaccine Development: Focusing on Antigen Design and Clinical Trials on Later Stages
Immune Netw. 2021 Feb;21(1):e4 https://doi.org/10.4110/in.2021.21.e4 pISSN 1598-2629·eISSN 2092-6685 Review Article Current Status of COVID-19 Vaccine Development: Focusing on Antigen Design and Clinical Trials on Later Stages Pureum Lee 1,2,†, Chang-Ung Kim 1,3,†, Sang Hawn Seo 4, Doo-Jin Kim 1,2,3,* 1Infectious Disease Research Center, Korea Research Institute of Bioscience and Biotechnology, Daejeon 34141, Korea 2Department of Bioscience, University of Science and Technology (UST), Daejeon 34113, Korea 3Department of Biochemistry, Chungnam National University, Daejeon 34134, Korea 4International Vaccine Institute, Seoul 08826, Korea Received: Jan 11, 2021 ABSTRACT Revised: Feb 17, 2021 Accepted: Feb 17, 2021 The global outbreak of coronavirus disease 2019 (COVID-19) is still threatening human *Correspondence to health, economy, and social life worldwide. As a counteraction for this devastating disease, Doo-Jin Kim a number of vaccines are being developed with unprecedented speed combined with new Infectious Disease Research Center, Korea Research Institute of Bioscience and technologies. As COVID-19 vaccines are being developed in the absence of a licensed human Biotechnology, 125 Gwahak-ro, Yuseong-gu, coronavirus vaccine, there remain further questions regarding the long-term efficacy and Daejeon 34141, Korea. safety of the vaccines, as well as immunological mechanisms in depth. This review article E-mail: [email protected] discusses the current status of COVID-19 vaccine development, mainly focusing on antigen design, clinical trials in later stages, and immunological considerations for further study. †Pureum Lee and Chang-Ung Kim contributed equally to this work.