DOCSLIB.ORG

V3P: Region Fact Sheet SEAR

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

V3P: Region Fact Sheet SEAR Highlights The SEAR1 region market is 35% of the global market in volume and 8% in This regional fact sheet is intended value. The regional vaccine procurement habits are different from the rest for use by MoH and vaccine procurement staff. The regional of the world in several ways, which may serve to inform sustainable supply fact sheet provides information strategies: on all vaccines procured by SEAR • lower number of vaccine types, with 19 vaccine types compared to 58 including analyses of: reported from all other regions; • the presentations used in SEAR compared to the rest of the • higher use of multi- versus single-dose presentations; world; • lesser use of prefilled syringes than in the rest of the world; • the procurement methods used in SEAR compared to the rest of • an absence of mixed-procuring countries; the world; • very high relative value of BCG and DTP-HepB-Hib vaccines in SEAR, • value to the market of the most compared to the non-SEAR market; frequently reported vaccines to the V3P from SEAR and the rest • three vaccines analysed for price suggest that: of the world; » WAPs in non-Gavi MICs may be lower in SEAR than in non-Gavi, non- • prices paid by SEAR, compared PAHO MICs in the rest of the world; to rest of the world. » non-Gavi MICs in SEAR purchase in variable volumes compared to non- Increased knowledge about several aspects of vaccine market and Gavi, non-PAHO MICs in the rest of the world. purchasing may help to inform the development of policies related to market shaping and vaccine access. Vaccine Market The Vaccine Product Price & For the data in the V3P database, the size of the vaccine market in SEAR Procurement (V3P) initiative was launched to provide all countries is 35% of the global market by volume, but only about 8% by value. This is with a platform for greater vaccine predominantly related to the overall size of the SEAR region, which is the most price & procurement transparency. populous of all regions. However, a majority of HICs from Western Europe do The initiative collects data through not report price data to the V3P, so the relative size of the global market is the WHO and UNICEF Joint higher. Reporting Form, and analyses and distributes information to relevant stakeholders to inform policy The global top 10 vaccines by value are PCV, HPV, Rota, Influenza (seasonal – making and procurement processes. adult), Varicella, DTP-HepB-Hib, MenA,C,Y,W-135 conj, MenC, DTaP-HepB-Hib- As of July 2017, the database IPV, and BCG, and these 10 account for about 49% of the value of the market contained data from 142 countries. in SEAR. The relative value of each vaccine type, in each market, is shown in The fact sheet is exclusively Chart 1 (see page 2). based on the data reported through the JRF & V3P initiative, Chart 1 also shows that the primary differences between the SEAR and the as of July 2017. Pool-procurement non-SEAR markets are the greater relative values of BCG and DTP-HepB- refers to vaccines procured through Hib in the SEAR market. These two vaccines account for about 42% of the UNICEF SD and the PAHO Revolving Fund. Readers may access additional value of the top 10 vaccines. In the non-SEAR market, the value of the top 10 vaccine price and procurement vaccines is more equally distributed. information from reporting countries and procurement agencies (UNICEF and PAHO) on the V3P website (http://www.who.int/immunization/ v3p) or by contacting v3p-project@ who.int. 1SEAR countries contributing to the V3P: Bangladesh, Bhutan, Democratic People's Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, Timor-Leste. WORKING DOCUMENT • November 2017 | 1 SEAR Chart 1. The relative value of the global top 10 vaccines in the SEAR and non-SEAR markets. SEAR non-SEAR Products and Presentations SEAR uses a smaller number of vaccine types (19) than any much lower prevalence of prefilled syringes in SEAR than in other WHO region (58 in non-SEAR countries). No vaccines non-SEAR countries (1% versus 18%). are exclusive to SEAR. Chart 2 shows a greater predominance of multi-dose SEAR uses five out of six presentations reported by all other presentations in SEAR compared to non-SEAR countries regions (an intranasal sprayer is reported from non-SEAR (84% versus 48%), where 10-dose and 20-dose but at a frequency of <1% - not shown). However, there is a presentations account for 68% of all presentation sizes. Chart 2. Prevalence of presentation sizes in SEAR and non-SEAR countries. SEAR non-SEAR WORKING DOCUMENT • November 2017 | 2 SEAR Procurement Method Chart 3. Prevalence of procurement method in SEAR and non-SEAR countries. Procurement in SEAR is split between self- procuring (45%) and pool-procurement SEAR non-SEAR (55%). The prevalence of pool-procurement in non-SEAR countries is similar (54%), but 16% of countries are mixed-procuring, which is absent in SEAR (see Chart 3). Vaccine Prices There is very limited data for non-Gavi MICs in SEAR, but for three vaccines analysed, WAPs for these countries in SEAR were 23 to 50% lower than for the same single-dose vaccines in non-Gavi, non-PAHO MICs in the non-SEAR market (see Chart 4). Chart 4. WAPs for three select single-dose vaccines in self-procuring non-Gavi MICs in SEAR and non-Gavi, non-PAHO MICs in non-SEAR, in 20162. Minimum, maximum, and median prices for vaccines procured in SEAR are shown in Table 1 (see page 4). Vaccine Availability Reported manufacturers from SEAR and globally, for each vaccine type, are shown in Table 2 (see page 5). 2Vaccines were selected on the basis of sufficient data for analyses – data for the same presentations from at least two countries in both SEAR and non-SEAR. WORKING DOCUMENT • November 2017 | 3 SEAR Table 1. Proportion of countries self-procuring, minimum, median, and maximum prices, number of products, and number of manufacturers for each vaccine type reported from at least three SEAR countries, in 2016. SEAR price (all procurement methods, all income Vaccine type (ranked by groups): lowest (presentation size) / highest frequency of use) SEAR SEAR (presentation size) / median in SEAR N different N different products in products % of countries % of self-procuring in self-procuring N manufacturers N manufacturers N manufacturers reported globally reported bOPV1,3 45 $0.08 (20-dose) / $1.65 (10-dose) / $0.14 8 6 10 BCG 60 $0.05 (10-dose) / $4.96 (20-dose) / $0.14 9 7 16 IPV 38 $0.83 (10-dose) / $23.64 (5-dose) / $1.90 5 4 7 DTP-HepB-Hib 38 $0.77 (10-dose) / $6.31 (5-dose) / $1.50 5 5 11 HepB (ped) 20 $0.17 (1-dose) / $1.73 (1-dose) / $0.60 3 3 13 Measles 40 $0.17 (5-dose) / $2.33 (10-dose) / $0.28 3 2 5 MMR 50 $1.40 (10-dose) / $5.73 (2-dose) / $3.73 4 2 5 Td 50 $0.11 (10-dose) / $1.36 (10-dose) / $0.19 2 2 13 DTP 50 $0.17 (10-dose) / $0.41 (10-dose) / $0.21 3 3 8 JE 100 $0.45 (5-dose) / $7.86 (1-dose) / $0.70 3 2 5 TT 0 $0.79 (10-dose) / $0.79 (10-dose) / $0.79 1 1 14 DT 100 $0.19 (10-dose) / $1.47 (1-dose) / $0.32 2 2 11 MR 33 $0.58 (2-dose) / $0.62 (10-dose) / $0.61 1 1 3 WORKING DOCUMENT • November 2017 | 4 SEAR Table 2. Vaccine manufacturers reported by SEAR countries, and additional manufacturers reported from other regions but not from SEAR. Vaccine type Manufacturers reported by SEAR countries Additional manufacturers not reported by SEAR BCG BB-NCIPD; GreenSignal Bio Pharma Limited; InterVax; AJ Vaccines A/S; Biomed Lublin; China CNBG; FAP (Fundação Japan BCG Laboratory; PT Bio Farma (Persero); Serum Ataulpho de Paiva); Institut Pasteur Iran; Institut Pasteur Tunis; IVAC Institute of India; Thai Red Cross Society (Institute of Vaccines and Medical Biologicals); Mikrogen; Torlak Institute of Virology, Vaccines and Sera bOPV1,3 Bharat Biotech; GSK; Haffkine Bio; PT Bio Farma Birmex; Boryung Biopharma; China CNBG; Razi Institute Iran (Persero); Sanofi Pasteur; Serum Institute of India DT PT Bio Farma (Persero); Serum Institute of India Arabio; BB-NCIPD; Biological E; China CNBG; InterVax; Mikrogen; Razi Institute Iran; Sanofi Pasteur; Torlak Institute of Virology, Vaccines and Sera DTP Biological E; PT Bio Farma (Persero); Serum Institute Boryung Biopharma; Butantan; IVAC (Institute of Vaccines and Medical of India Biologicals); Mikrogen; Torlak Institute of Virology, Vaccines and Sera DTP-HepB-Hib Biological E; Janssen; LG Life Sciences; PT Bio Farma Arabio; Bharat Biotech; Centro de Ingeniería Genética y Biotecnología; (Persero); Serum Institute of India GSK; Panacea Biotec; Shantha Biotechnics Private Limited HepB (ped) LG Life Sciences; PT Bio Farma (Persero); Serum Biokangtai; China CNBG; Dalian Hissen; GSK; Janssen; Merck Institute of India Vaccines; Mikrogen; NCPC GeneTech; Sanofi Pasteur MSD; VABIOTECH IPV Bilthoven Biologicals; PT Bio Farma (Persero); Sanofi GSK; Institute of Medical Biology – Chinese Academy of Medical Pasteur; Shantha Biotechnics Private Limited Sciences; Serum Institute of India JE Chengdu Institute of Biological Products Co., Ltd; GPO- China CNBG; Sanofi Pasteur; VABIOTECH MBP Co., Ltd. Measles PT Bio Farma (Persero); Serum Institute of India Biovac SA; Mikrogen; POLYVAC (Center for Research and Production of Vaccine and Biologicals) MMR GSK; Serum Institute of India China CNBG; Merck Vaccines; Sanofi Pasteur MR Serum Institute of India Beijing Minhai Biotech; China CNBG Td Sanofi Pasteur; PT Bio Farma (Persero) AJ Vaccines A/S; BB-NCIPD; Biological E; Boryung Biopharma; Butantan; GSK; InterVax; Mikrogen; Razi Institute Iran; Serum Institute of India; Torlak Institute of Virology, Vaccines and Sera TT Biological E BB-NCIPD; Bharat Biotech; Boryung Biopharma; Finlay; GSK; InterVax; IVAC (Institute of Vaccines and Medical Biologicals); Mikrogen; PT Bio Farma (Persero); Sanofi Pasteur; Serum Institute of India; Shantha Biotechnics Private Limited; Torlak Institute of Virology, Vaccines and Sera DISCLAIMER Information contained in the V3P database is provided by participating countries and/or organizations procuring on behalf of countries that have agreed to share vaccine price and procurement data with V3P.
Recommended publications
  • Clinical Trial Protocol

    Clinical Trial Protocol

    PROTOCOL Dok.#: 129K-PMS-MR Page 1 of 55 Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children Phase IV PMS-MR-0417 CLINICAL TRIAL PROTOCOL Sponsor PT BIO FARMA (PERSERO) Jl. Pasteur No. 28 Bandung – 40161 Indonesia August 2017 The information contained in this document is the property of Bio Farma and is confidential. It may be submitted to a Regulatory Authority, an Institutional Review Board/Ethics Committee, or an Investigator or a Pharmacist for the purpose of assessment in relation to registration of the product or initiation of a clinical trial. Reproduction or disclosure of the information in whole or in part is forbidden without the written consent of Bio Farma. This document must be returned to Bio Farma Versionupon request. 1.0 August 2017 PT Bio Farma PROTOCOL Dok.#: 129K-PMS-MR Page 2 of 55 Reactogenicity and Protectivity Following Measles-Rubella (MR) Routine Immunization in Indonesian Infants and Children PMS-MR-0417 CLINICAL TRIAL PHASE IV (POST MARKETING SURVEILLANCE) Sponsor PT. BIO FARMA (PERSERO) Jl. Pasteur No. 28 Bandung – 40161 INDONESIA Investigational Product Measles-Rubella (MR) Vaccine Manufacturing Sites Serum Institute of India PVT.LTD. 212/2, Hadapsar, Pune 411028, India Principal Investigator Dr. dr. Dominicus Husada, SpA(K) Sub-Investigators dr. Dwiyanti Puspitasari, SpA(K) dr. Leny Kartina, SpA(K) Medical Advisor Prof. Dr.dr. Ismoedijanto, SpA(K) Prof. dr. Parwati S. Basuki, SpA(K) Biometry Dr. dr. Windhu Purnomo, MS Monitors Dr. Novilia Sjafri Bachtiar, dr., M.Kes. Rini Mulia Sari, dr. Julianita Fahmi, dr. Asep Irham Fattahul Qur'an, dr Biological Laboratory Rini Mulia Sari, dr.
  • 1 English Package Insert BCG VACCINE (Freeze-Dried)

    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.
  • DRAFT Landscape of COVID-19 Candidate Vaccines – 10 August 2020

    DRAFT Landscape of COVID-19 Candidate Vaccines – 10 August 2020

    DRAFT landscape of COVID-19 candidate vaccines – 10 August 2020 28 candidate vaccines in clinical evaluation COVID-19 Vaccine Number of Route of Clinical Stage Vaccine platform Type of candidate vaccine Timing of doses developer/manufacturer doses Administration Phase 1 Phase 1/2 Phase 2 Phase 3 PACTR202006922165132 Non-Replicating University of Oxford/AstraZeneca ChAdOx1-S 1 IM 2020-001072-15 2020-001228-32 ISRCTN89951424 Viral Vector Interim Report NCT04383574 Sinovac Inactivated Inactivated 2 0, 14 days IM NCT04456595 NCT04352608 Wuhan Institute of Biological Inactivated Inactivated 2 0,14 or 0,21 days IM ChiCTR2000031809 ChiCTR2000034780 Products/Sinopharm Beijing Institute of Biological Inactivated Inactivated 2 0,14 or 0,21 days IM ChiCTR2000032459 ChiCTR2000034780 Products/Sinopharm NCT04283461 NCT04405076 NCT04470427 Moderna/NIAID RNA LNP-encapsulated mRNA 2 0, 28 days IM Interim Report 2020-001038-36 BioNTech/Fosun Pharma/Pfizer RNA 3 LNP-mRNAs 2 0, 28 days IM NCT04368728 ChiCTR2000034825 CanSino Biological Inc./Beijing Institute Non-Replicating ChiCTR2000030906 ChiCTR2000031781 Adenovirus Type 5 Vector 1 IM of Biotechnology Viral Vector Study Report Study Report Anhui Zhifei Longcom Adjuvanted recombinant protein 0,28 or 0,28,56 Protein Subunit 2 or 3 IM NCT04445194 NCT04466085 Biopharmaceutical/Institute of (RBD-Dimer) days DISCLAIMER: These landscape documents have been prepared by the World Health Organization (WHO) for information purposes only concerning the 2019-2020 pandemic of the novel coronavirus. Inclusion of any particular product or entity in any of these landscape documents does not constitute, and shall not be deemed or construed as, any approval or endorsement by WHO of such product or entity (or any of its businesses or activities).
  • Editorial 10.5005/Ijmb-24-3-Iv

    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.
  • Edical Sciences Esearch (IJAMSCR)

    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.
  • 'Astrazeneca' Covid-19 Vaccine

    '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.
  • 1C 173/49 Importer / Manufacturer: Biogenetech Co., Ltd. / PT. Bio

    1C 173/49 Importer / Manufacturer: Biogenetech Co., Ltd. / PT. Bio

    Registration No.: 1C 173/49 Importer / Manufacturer: Biogenetech Co., Ltd. / PT. Bio Farma SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICAL PRODUCT Measles Vaccine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition Dose Volume 0.5 ml Measles Virus strain CAM 70 not less than 1000 CCID50 Kanamycin sulphate not more than 100 μgm Erythromycin not more than 30 μgm Diluent Water for injection (WFI) 3. PHARMACEUTICAL FORM It is a live, attenuated virus vaccine. Each dose contains not less than 1,000 CCID50 (cell culture infective doses 50%) of Measles virus strain CAM 70, prepared in SPF chicken embryo and not more than 100 mcg of kanamycin sulphate and 30 mcg of erythromycin. This vaccine is a freeze- dried product that must be reconstituted only with the sterile diluent provided separately for that purpose. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Prophylactic immunization against Measle. 4.2 Posology and method of administration Immunization schedule In countries where the incidence and mortality from measles is high in the first year of life, the recommended age for vaccination against measles is at 9 months of age (270 days) or shortly after. Incountries where infection occurs later in life (due to sustained high vaccination coverage), the age of vaccination can be moved to 12-15 months. It is recommended that all children have two (2) opportunities for measles immunization to reduce the number both of unvaccinated children and of those who are vaccinated but fail to respond to the vaccine (primary vaccination failure). Although generally administered at school entry (4-6 years of age), the second opportunity for measles immunization may be provided as early as one (1) month following the first dost through routine or supplemental immunization activities.
  • Welcome NOTE President

    Welcome NOTE President

    2015 welcome NOTE from the president EXECUTIVE COMMITEE MEMBERS Mr. Mahendra Suhardono President Bio Farma, Indonesia Mr. Rajender Kumar Suri Dr. Akira Homma Vice President Treasurer Panacea Biotech Limited, India Bio-Manguinhos (Fiocruz),Brazil Mr. Rayasam Prasad Ms. Meng Li Mr. Patrick Tippoo Biological E. Limited, India China National Biotec Group Co.Ltd., China The Biovac Institute, South Africa Mr. Juliman Dr. Steven Gao Mr. Adar Poonawalla GAVI Board Alternate Xiamen Innovax Biotech Co. Ltd., China GAVI Board Representative Bio Farma, Indonesia Serum Institute of India Ltd., India Member Organizations’ Geographical Presence Argentina Bangladesh Brazil Cuba Egypt India Indonesia IR of Iran Mexico P.R. China Republic of Korea Saudi Arabia South Africa Taiwan Thailand Vietnam Name of the company : Arab Company for Pharmaceutical Products (Arabio) Head of Institution : Dr. Majed Saeed Bahatheq (Arabio CEO) Established : Arabio is a limited liability company established in 2005 Location : Saudi Arabia Overview of the company Arabio is a biopharmaceutical company specialized in human vaccines, and other biopharmaceuticals. It is the first biopharmaceutical company in the Gulf Cooperation Council (GCC). The size and scope of activities intended to be made in Arabio would make Arabio the first biological company of its kind in the Middle East. Arabio aims to bring to the markets of the Middle East, North Africa, and high quality products that comply with the international quality standards. Arabio has production lines of pre-filled syringes, liquid vials and lyophilized vials from the best global machines suppliers to make high quality products and meet cGMP & international standards. Description of ARABIO capabilities – Biological sterile manufacturing – PFS and vial filling – PFS and vial blister packaging Arabio Partners: 1.
  • Dentons Flashpoint Daily Global Situation Report

    Dentons Flashpoint Daily Global Situation Report

    Dentons Flashpoint Daily Global Situation Report December 14, 2020 Global Situation Update: December 14, 2020 KEY TAKEAWAYS The US orders First COVID-19 emergency action The UN calls on vaccines to be after huge cyber every country administered in the security breach to declare a US and Canada involving the “climate emergency.” today. SolarWinds’ Orion platform. Note: This report is based on sources and information deemed to be true and reliable, but Dentons makes no representations to same. Global Globally, confirmed coronavirus cases surpassed 72 million infections and 1.6 million deaths. • Secretary-General Guterres called on every • German biotech firm CureVac has enrolled the country to declare a “climate emergency” as first participant for a Phase 2b/3 clinical trial world leaders marking the fifth anniversary of of its COVID-19 vaccine candidate, expected the Paris climate accord made mostly to include more than 35,000 participants in incremental pledges relative to the scale of the Europe and Latin America. crisis. • Peru suspended clinical trials of a Chinese Sinopharm Covid-19 vaccine after one of the volunteers involved in the program suffered a “serious adverse event”. Note: This report is based on sources and information deemed to be true and reliable, but Dentons makes no representations to same. Global Over the past week, the global curve for new cases continued to flatten, while topping 72 million. One week ago, the count was 67 million. The US continues to be the global leader for new infections, reporting more than 200,000 new cases for most of last week. Turkey has become the new global hotspot, with new cases doubling in eight days to over 1.8 million.
  • Responsive COVID-19 Vaccines for Recovery Project Under the Asia Pacific Vaccine Access Facility (Guaranteed by the Republic of Indonesia)

    Responsive COVID-19 Vaccines for Recovery Project Under the Asia Pacific Vaccine Access Facility (Guaranteed by the Republic of Indonesia)

    Report and Recommendation of the President to the Board of Directors Project Number: 54425-001 March 2021 Proposed Loan PT Bio Farma (Persero) Responsive COVID-19 Vaccines for Recovery Project under the Asia Pacific Vaccine Access Facility (Guaranteed by the Republic of Indonesia) Distribution of this document is restricted until it has been approved by the Board of Directors. Following such approval, ADB will disclose the document to the public in accordance with ADB’s Access to Information Policy. CURRENCY EQUIVALENTS (as of 5 March 2021) Currency unit – rupiah (Rp) Rp1.00 = $0.0000697 $1.00 = Rp14,349 ABBREVIATIONS ADB – Asian Development Bank AEFI – adverse event following immunization APVAX – Asia Pacific Vaccine Access Facility Bio Farma – PT Bio Farma (Persero) COVID-19 – coronavirus disease Indofarma – PT Indofarma Tbk LIBOR – London interbank offered rate M&E – monitoring and evaluation MOH – Ministry of Health PAM – project administration manual RRC – rapid response component TA – technical assistance UNICEF – United Nations Children’s Fund VAP – Vaccination Allocation Plan VIRAT – Vaccination Introduction Readiness Assessment Tool WHO – World Health Organization NOTE In this report, “$” refers to United States dollars. Vice-President Ahmed M. Saeed, Operations 2 Director General Ramesh Subramaniam, Southeast Asia Department (SERD) Directors Ayako Inagaki, Human and Social Development Division (SEHS), SERD Winfried Wicklein, Country Director, Indonesia Resident Mission (IRM), SERD Said Zaidansyah, Deputy Country Director, IRM,
  • BCG Vaccination and Immunity Against COVID-19: a Fact Or Fiction

    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

    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.