Global Vaccine Market Features and Trends
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PEDIARIX Is a Vaccine
HIGHLIGHTS OF PRESCRIBING INFORMATION • If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior These highlights do not include all the information needed to use vaccine containing tetanus toxoid, the decision to give PEDIARIX should PEDIARIX safely and effectively. See full prescribing information for be based on potential benefits and risks. (5.2) PEDIARIX. • The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.3) PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis • Syncope (fainting) can occur in association with administration of Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus injectable vaccines, including PEDIARIX. Procedures should be in place Vaccine], Suspension for Intramuscular Injection to avoid falling injury and to restore cerebral perfusion following Initial U.S. Approval: 2002 syncope. (5.4) • If temperature ≥105°F, collapse or shock-like state, or persistent, ----------------------------- INDICATIONS AND USAGE ---------------------------- PEDIARIX is a vaccine indicated for active immunization against diphtheria, inconsolable crying lasting ≥3 hours have occurred within 48 hours after tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, receipt of a pertussis-containing vaccine, or if seizures have occurred and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants within 3 days after receipt of a pertussis-containing vaccine, the decision born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX to give PEDIARIX should be based on potential benefits and risks. (5.5) may be given as early as 6 weeks of age through 6 years of age (prior to the • For children at higher risk for seizures, an antipyretic may be 7th birthday). -
Financial Statements of Intercell AG As of December 31, 2010 According to UGB (Austrian GAAP)
Financial Statements of Intercell AG as of December 31, 2010 according to UGB (Austrian GAAP) Intercell . STATUTORY FINANCIAL STATEMENTS . MMX Intercell . STATUTORY FINANCIAL STATEMENTS . MMX 01 // *. // Table of Contents I Balance Sheet 2 II Income Statement 4 III Notes 5 1. General principles 5 2. Summary of accounting and valuation method principles 5 3. Details of the balance sheet and income statement 6 4. Other information 11 Movement in fixed assets 16 IV Management Report 18 1. Report on the operation activities 18 2. Financial Review 24 3. Risks 25 4. Reporting on the internal control and risk management system regarding financial reporting 27 5. Disclosure according to Section 243a of the Austrian Commercial Code 28 6. Operational and Strategic Outlook 29 7. Events after the Balance Sheet Date 30 V Auditor’s Report 31 VI Declaration by the Management Board 33 *. Imprint 34 Intercell . STATUTORY FINANCIAL STATEMENTS . MMX 02 // I. // Balance Sheet December 31, 2010 December 31, 2009 A s s e t s EUR TEUR A. Fixed assets I. Intangible assets 1. Concessions, industrial property and similar rights and assets, and licenses in such rights and assets 19.029.092,52 3.793 2. Book value added by a merger 12.364.220,08 12.364 3. Prepayments 8.400,69 76 31.401.713,29 16.233 II. Tangible assets 1. Leasehold improvements 94.365,64 0 2. Machinery and equipment 1.880.222,07 1.915 3. Other equipments, factory and office equipment 357.854,84 380 2.332.442,55 2.295 III. Financial assets Shares in affiliated companies 4.954.970,54 130.117 38.689.126,38 148.645 B. -
Press Release Sanofi Pasteur Sanofi Pasteur Mounts Emergency
Press release Sanofi Pasteur Lyon, France, February 26, 2008 Sanofi Pasteur: www.sanofipasteur.com Media Relations: Tel.: + 33 4 37 37 50 38 Media Relations US: Tel.: + 1 570 839 44 46 Sanofi Pasteur Mounts Emergency Response to Yellow Fever Epidemic in Latin America - Six Million Doses of StamarilTM vaccine shipped in record time to Brazil and Paraguay - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that six million doses of StamarilTM1 yellow fever vaccine have been shipped upon UNICEF’s request to respond to the yellow fever epidemic in Latin America. Brazil received four million doses of StamarilTM vaccine early February and an additional two million doses were shipped to Paraguay over the weekend in response to urgent requests from Health Authorities. “Sanofi Pasteur mobilized its teams to make this public health emergency a priority,” said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. “This ability to respond to an emergency in record time illustrates the company’s commitment to global health.” The yellow fever vaccine that was provided to Brazil and Paraguay is part of the UNICEF vaccine stockpile which is reserved for outbreak responses. Sanofi Pasteur is currently the only vaccine supplier to the UNICEF yellow fever vaccine stockpile. Sanofi Pasteur is the largest provider of yellow fever vaccine worldwide with 200 million doses of vaccine provided to 150 countries over the past 20 years. About yellow fever Yellow fever is a viral disease that occurs in both rural and urban areas in Africa and South America. There is no treatment for yellow fever, only prevention by immunization. -
August 2021 Factsheet Access to Vaccines
ACCESS TO HEALTHCARE AND PRICING ACCESS TO VACCINES GRI Standards : 416-1, 416-2 : Customer Health and Safety EXECUTIVE SUMMARY Vaccines have a great impact on public health. The World Health Organization considers immunization to be one of the most effective and cost-effective health interventions. It has eradicated smallpox, reduced the global incidence of polio by 99% to date,1 and dramatically reduced morbidity, disability and mortality due to diphtheria, tetanus, pertussis, tuberculosis and measles. Despite these important achievements, there is still a long way to go: 19.7 million children worldwide still have no access to a full cycle of basic vaccines.2 Due to lower immunization coverage in some countries, we are witnessing a resurgence of diseases that had almost disappeared, such as measles or pertussis. This affects people around the world, including in high-income countries. True to its vision of a world where no one suffers or dies from a vaccine-preventable disease, Sanofi Pasteur is committed to improve sustainable access to vaccines, with the help of key partnerships to provide effective and affordable vaccines and protection for all populations. This document presents some of our key commitments and initiatives illustrating our longstanding dedication to global access to health through prevention and vaccination. 1 WHO Factsheet on Poliomyelitis, last updated July 2019. https://www.who.int/news-room/fact-sheets/detail/poliomyelitis 2 WHO Factsheet on Immunization, last updated July 2020. https://www.who.int/en/news-room/fact-sheets/detail/immunization-coverage Access to Vaccines Factsheet 1 Published August 2021 TABLE OF CONTENTS 1. -
Expanded-Access Drugs Consentsta00011 Revised Version IRB Approved
University of North Carolina at Chapel Hill Consent to Participate in an Experimental Treatment ______________________________________________________________________________ Consent Form Version Date: April 28, 2017 IRB Protocol #: 17-1178 Title of Protocol : Expanded Access Stamaril Vaccine Principal Investigator : Margaret Vimmerstedt Principal Investigator Department : Campus Health Services Principal Investigator Phone number : 919-966-2281 Principal Investigator Email Address : [email protected] Co-Investigators: Thevy Chai, Ann Chelminski, Amy Sauls Funding Source and/or Sponsor: Sanofi Pasteur ______________________________________________________________________________ What are some general things you should know about compassionate use protocols? You are being asked to take part in an expanded access (“compassionate use”) protocol. You are invited to take part in an Expanded Access Program of Stamaril vaccine. Stamaril vaccine helps protect against yellow fever virus. This document explains why this program is being carried out. It will help you decide whether you wish to take part. Taking part in this program is completely voluntary. If anything in this document is unclear, or if you have any questions about this program, please ask one of the program team members . You may refuse or you may withdraw your consent to participate, for any reason, without penalty. You may not receive any direct benefit from receiving this treatment. There also may be risks of this therapy. Deciding not to be in the study or leaving the study before it is done will not affect your relationship with the Principal Investigator, your regular health care provider, or the University of North Carolina-Chapel Hill. You do not have to be in the protocol study in order to receive health care. -
Summary of Phase 3 Protocol – VAT00008
Summary of Phase 3 protocol – VAT00008 The phase 3 trial follows positive initial results from a phase 2 clinical trial (VAT00002)1. In that trial, the COVID-19 vaccine candidate was administered to 722 adults to assess the safety, reactogenicity and immunogenicity of 3 doses and to identify an optimal vaccine dose. Results showed strong rates of neutralizing antibody response with 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old), across all doses2. A 10µg antigen formulation of the SARS-CoV-2 adjuvanted recombinant protein-based vaccine developed by Sanofi Pasteur in combination with GSK’s AS03 adjuvant will be evaluated in a Phase 3 trial (VAT00008)2 for efficacy, immunogenicity and safety compared to a placebo. The trial is conducted in 2 stages, the first with a monovalent (single antigen) vaccine comprising the spike protein of the original SARS-CoV-2 virus (D614) and the second stage with bivalent (2-antigen) vaccine comprising spike protein of D614 and spike protein of the SARS-CoV-2 Beta variant (B.1.351). Participants will be categorized as naïve (not previously infected) and non-naïve (evidence of previous infection) based on serological and virological ascertainment of prior SARS-CoV-2 infection at the time of vaccination. Non-naïve participants will be capped at 20% of the total study population. The primary objective is the prevention of symptomatic COVID-19 with onset at least 14 days after the second injection of the vaccine in SARS-CoV-2 naïve individuals. Safety of the vaccines will be evaluated throughout the study compared to placebo. -
Not for Distribution in Australia, Canada, Japan Or the United States
Not for distribution in Australia, Canada, Japan or the United States Proposed Merger of Equals between Vivalis and Intercell Creation of a European Biotech Leader in Vaccines and Antibodies Vivalis (“Vivalis”) and Intercell AG (“Intercell”) to merge and form Valneva SE (“Valneva”), headquartered in Lyon (France) and listed on the regulated markets of NYSE Euronext in Paris and the Vienna Stock Exchange Intercell shareholders to receive 13 Vivalis new ordinary shares for 40 Intercell shares, implying a 31.7% premium for Intercell shareholders based on the average share prices over the last three months Additionally, Intercell shareholders to receive 13 new preferred shares for 40 Intercell shares. Each preferred share to be converted into 0.4810 new Valneva ordinary shares in the event of successful approval of Intercell’s Pseudomonas vaccine Implied ownership of Valneva immediately post-merger completion: 55% former Vivalis shareholders / 45% former Intercell shareholders Merger unanimously approved by the Supervisory Boards of Vivalis and Intercell Irrevocable undertakings to vote in favor of the merger received from holders of 68.5% of the voting rights in Vivalis, including Groupe Grimaud Fully committed EUR 40 million rights issue to be launched shortly after merger completion, to further strengthen Valneva’s financial profile. The Fonds Stratégique d'Investissement (“FSI”) supports the merger and will participate in the rights issue Merger of Equals structure with each company contributing equally to Valneva’s Supervisory Board, and Valneva’s Management Board being comprised of two Vivalis and two Intercell Management Board members Not for distribution in Australia, Canada, Japan or the United States Nantes (France) and Vienna (Austria), Dec. -
Sanofi and Translate Bio Initiate Phase 1 Clinical Trial of Mrna Influenza Vaccine
Sanofi and Translate Bio Initiate Phase 1 Clinical Trial of mRNA Influenza Vaccine June 22, 2021 -- Trial will evaluate potential of next generation of influenza vaccines with combined mRNA technology and flu vaccine development expertise -- -- Positive preclinical safety and immunogenicity data for mRNA influenza vaccine candidates support initiation of Phase 1 clinical trial -- -- Interim data anticipated by the end of 2021; outcomes from this clinical trial will inform next steps of our mRNA-based influenza vaccine program and strategy -- LEXINGTON, Mass., June 22, 2021 (GLOBE NEWSWIRE) -- Sanofi Pasteur, the vaccines global business unit of Sanofi and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, have initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. Flu seasons that are dominated by A/H3N2 strain circulation activity tend to be more severe, especially among those considered at-risk such as older adults and younger children. “The first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of influenza vaccines. We've all witnessed the promise of mRNA technology during this pandemic and are now looking to extend that promise to select annual vaccines,” said Jean-François Toussaint, Global Head of Research and Development, Sanofi Pasteur. “In line with our global leadership and our 70-year history of protecting people with influenza vaccines, we will always focus on developing products that demonstrate protection beyond flu, as we believe it is critical to demonstrate protecting patients from hospitalizations due to cardiovascular events and pneumonia. -
Press Release INDIA
Press Release INDIA Sanofi and GSK receive approval for Phase 3 efficacy trial of their COVID-19 vaccine candidate in India Clinical trial to assess the safety, efficacy and immunogenicity of an adjuvanted recombinant-protein COVID-19 vaccine candidate Phase 3 clinical trial will include more than 35,000 volunteers from several countries, including sites in the US, Asia, Africa and Latin America Mumbai, INDIA – July 08, 2021 - Sanofi and GSK received approval for their Phase 3 clinical study in India, to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the US, Asia, Africa, and Latin America. As COVID-19 vaccination becomes available, study participants are encouraged to receive an approved COVID-19 vaccine during the study, if they wish to do so. As part of the study design, all participants including the control group will be offered the study vaccine as soon as it is determined to be safe and effective. “India is participating in Sanofi Pasteur’s pivotal Phase 3 study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country.” said Annapurna Das, Country Head, Sanofi Pasteur India. “As the virus continues to evolve, we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development program. We believe our COVID-19 adjuvanted, recombinant vaccine can make a significant contribution to the ongoing fight against COVID-19 and are committed to initiating our clinical program in India, at the earliest” she added About the Phase 3 study The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS- CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection. -
Access to Finance and Barriers to Growth in the Innovative Biopharmaceuticals Sector
Prepared For: EFPIA Leopold Plaza Building Rue du Trône 108 B-1050 Brussels (Belgium) Access to finance and barriers to growth in the innovative biopharmaceuticals sector Prepared By: Charles River Associates 99 Bishopsgate London EC2M 3XD Date: May 2015 CRA Project No. D20318-00 Access to finance and barriers to growth in the innovative biopharmaceuticals sector May 2015 Charles River Associates Table of contents Executive Summary ....................................................................................................................... 1 1. Introduction ........................................................................................................................... 11 1.1. ‘European’ biopharmaceutical companies and existing definitions of company size ..... 11 1.2. The existing literature on growth of biopharmaceutical companies .............................. 15 1.3. The study approach .................................................................................................... 19 1.4. Structure of report ...................................................................................................... 19 2. Is there a problem with the growth of European biopharmaceutical companies? ............ 20 2.1. How do we measure growth? ..................................................................................... 20 2.2. Current landscape of biopharmaceutical companies (EU vs US) ................................. 22 2.3. Views from the interviews .......................................................................................... -
Polio Vaccine (IPV) Revision Date: October 19, 2018
Polio Vaccine (IPV) Revision Date: October 19, 2018 Rationale for Update: Updated recommendations from WHO for OPV doses given on or after April 1, 2016. Please consult the Product Monograph1 for further information about the vaccine. IMOVAX® Polio (Vero Cell Origin) Manufacturer Sanofi Pasteur SA – Distributed by Sanofi Pasteur Limited Licensed use Individuals 6 weeks and older Off-license use None Indications for Children (2 months – 17 years of age): use of • Children previously unimmunized with polio vaccine but have already received provincially diphtheria, pertussis and tetanus-containing vaccines. funded vaccine Note: Combination vaccines containing diphtheria, pertussis, polio, tetanus and/or Hib should be used when indicated. • Children travelling to countries where polio is known to be circulating (exporting and/or infected) and who are unimmunized or whose series is incomplete for age – an accelerated schedule can be considered.2,3 Refer to World Health Organization (WHO) Global Polio Eradication Initiative see www://polioeradication.org/polio-today/polio-now/public-health-emergency-status for current recommendations.4 Adults (18 years of age and older): Primary Immunization – Low Risk: • Students requiring polio vaccine are eligible until the end of grade 12 regardless of age. Due to the limited supply of polio vaccine and the low risk of exposure to polio in Alberta and Canada – the recommendation for the routine immunization of unimmunized adults is suspended until further notice. Adults at increased risk of exposure as -
The Compelling Need for Game-Changing Influenza Vaccines
THE COMPELLING NEED FOR GAME-CHANGING INFLUENZA VACCINES AN ANALYSIS OF THE INFLUENZA VACCINE ENTERPRISE AND RECOMMENDATIONS FOR THE FUTURE OCTOBER 2012 The Compelling Need for Game-Changing Influenza Vaccines An Analysis of the Influenza Vaccine Enterprise and Recommendations for the Future Michael T. Osterholm, PhD, MPH Nicholas S. Kelley, PhD Jill M. Manske, PhD, MPH Katie S. Ballering, PhD Tabitha R. Leighton, MPH Kristine A. Moore, MD, MPH The Center for Infectious Disease Research and Policy (CIDRAP), founded in 2001, is a global leader in addressing public health preparedness and emerging infectious disease response. Part of the Academic Health Center at the University of Minnesota, CIDRAP works to prevent illness and death from targeted infectious disease threats through research and the translation of scientific information into real-world, practical applications, policies, and solutions. For more information, visit: www.cidrap.umn.edu. This report was made possible in part by a grant from the Alfred P. Sloan Foundation. This report is available at: www.cidrap.umn.edu This report was produced and designed by Betsy Seeler Design. © 2012 Regents of the University of Minnesota. All rights reserved. Contents Preface...............................................................................................................................................................2 Executive Summary..........................................................................................................................................5 Chapter.1.