Indonesia Gets Bio Farma Infant Pentavalent Vaccines

Total Page：16

File Type：pdf, Size：1020Kb

Indonesia gets Bio Farma infant pentavalent vaccines 26 August 2013 | News | By BioSpectrum Bureau Singapore: The Indonesian Ministry of Health introduced a new immunization program and a pentavalent vaccine for babies aged two months-to-one year. The vaccine would provide immunity against diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenzae type B. The pentavalent vaccine, which was being developed by Bio Farma since 2007, was launched by the ministry on August 22, 2013, in Lapangan Karang Pawitan Kabupaten Karawang. Mr Juliman, production director, Bio Farma, said that besides lowering the frequency of babies' shots, the pentavalent vaccine leads to greater efficiencies. "The use of pentavalent vaccine is expected to diminish production costs, cold chain costs, injector costs, and encourage health officers to be efficient. This cost efficiency will translate to affordability for the people," he added. Along with the various advantages, the use of pentavalent vaccine is projected to become a future trend for vaccine producers in developing countries. Besides fulfilling domestic demand, Bio Farma plans to export the vaccine to the other countries after the vaccine passes the WHO prequalification assessment, a requirement for the vaccine to be accepted internationally. It is estimated that the pentavalent vaccine demand in Indonesia will reach 15 million doses-a-year, based on the average number of babies' births in Indonesia of five million per year. Bio Farma has held clinical trials for the pentavalent vaccine since 2010. The vaccine has passed the phase III clinical trial process, ensuring its efficacy for humans. The trial was conducted with Hasan Sadikin Hospital (medical faculty of Padjajaran University) and Cipto Mangunkusumo Hospital (medical faculty of Indonesian University). Pentavalent has also been registered with the National Agency of Drug and Food Control (NADFC). "This year we will produce and supply the vaccine to four provinces, West Java, Bali, NTB and Yogyakarta, while later we will be able to produce and fulfill the demand of all provinces of Indonesia," said Mr Juliman..

Copy Link

Recommended publications

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.
[Show full text]
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.
[Show full text]
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.
[Show full text]
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.
[Show full text]
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,
[Show full text]
Could Vaccine Dose Stretching Reduce Covid-19 Deaths?
NBER WORKING PAPER SERIES COULD VACCINE DOSE STRETCHING REDUCE COVID-19 DEATHS? Witold Więcek Amrita Ahuja Michael Kremer Alexandre Simoes Gomes Christopher Snyder Alex Tabarrok Brandon Joel Tan Working Paper 29018 http://www.nber.org/papers/w29018 NATIONAL BUREAU OF ECONOMIC RESEARCH 1050 Massachusetts Avenue Cambridge, MA 02138 July 2021 The authors are grateful to Nora Szech, Ezekiel Emanuel, Marc Lipsitch, Prashant Yadav, Patrick Smith, Frédéric Y. Bois, Virginia Schmit, Victor Dzau, Valmik Ahuja, Marcella Alsan, Garth Strohbehn and seminar participants at Harvard, M.I.T., the University of Chicago, and the NBER Entrepreneurship and Innovation Policy and the Economy conference for helpful comments and to Esha Chaudhuri for excellent research assistance. This work was supported in part by the Wellspring Philanthropic Fund (Grant No: 15104) and Open Philanthropy. The views expressed herein are those of the authors and do not necessarily reflect the views of the National Bureau of Economic Research. NBER working papers are circulated for discussion and comment purposes. They have not been peer-reviewed or been subject to the review by the NBER Board of Directors that accompanies official NBER publications. © 2021 by Witold Więcek, Amrita Ahuja, Michael Kremer, Alexandre Simoes Gomes, Christopher Snyder, Alex Tabarrok, and Brandon Joel Tan. All rights reserved. Short sections of text, not to exceed two paragraphs, may be quoted without explicit permission provided that full credit, including © notice, is given to the source. Could Vaccine Dose Stretching Reduce COVID-19 Deaths? Witold Więcek, Amrita Ahuja, Michael Kremer, Alexandre Simoes Gomes, Christopher Snyder, Alex Tabarrok, and Brandon Joel Tan NBER Working Paper No.
[Show full text]
Vaccination and Multiple Sclerosis in the Era of the COVID-19 Pandemic
J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp-2021-326839 on 5 August 2021. Downloaded from Occasional essay Vaccination and multiple sclerosis in the era of the COVID-19 pandemic Tobias Monschein ,1 Hans- Peter Hartung,1,2 Tobias Zrzavy ,1 Michael Barnett ,3 Nina Boxberger,4 Thomas Berger,1 Jeremy Chataway,5 Amit Bar- Or,6 Paulus Stefan Rommer ,1,4 Uwe K. Zettl4 24 ► Additional supplemental INTRODUCTION higher binding affinity. On entering the respira- material is published online In the last century, several pandemics were caused tory epithelial cells, SARS-CoV -2 starts replicating only. To view, please visit by various influenza virus subtypes, with the Spanish and spreading rapidly until it reaches the alveolar the journal online (http:// dx. 1 doi. org/ 10. 1136/ jnnp- 2021- influenza of 1918–1920 being the most severe. epithelial cells of the lung. Hence, a robust innate 326839). Coronaviruses were first described in humans in immune response is triggered.25 The spike protein the 1960s, and since then seven human pathogenic is recognised by pattern recognition receptors For numbered affiliations see coronaviruses have been described.2 The first severe and leads, via downstream signalling, to increased end of article. outbreak was in 2002 with the severe acute respira- interferon production by innate immune cells. Antigen- specific adaptive immunity is critical for Correspondence to tory syndrome coronavirus (SARS- CoV), followed Dr Tobias Monschein, by the Middle East respiratory syndrome corona- the immune response to SARS- CoV-2 infection. Department of Neurology, virus (MERS- CoV) outbreak in 2012.3 The current Both CD8 and CD4 T cells are activated via their Medical University of Vienna, COVID-19 pandemic, which broke out in Wuhan, respective major histocompatibility complexes I or Vienna, Austria; tobias.
[Show full text]
GPEI Consultation with OPV/IPV Manufacturers, National Authorities for Containment and National
Note for the Record GPEI Consultation with OPV/IPV Manufacturers, National Authorities for Containment and National Regulatory Authorities Virtual meeting, 12-13 October 2020 1 Contents Abbreviations ........................................................................................................................................ 2 1. Interrupting poliovirus transmission.......................................................................................... 3 Update on new strategy: Polio Eradication, Integration and Certification Endgame Strategy 2019- 23 – Michel Zaffran (WHO) ................................................................................................................. 3 Update on epidemiology, progress towards eradication & stopping outbreaks – Arshad Quddus (WHO) ................................................................................................................................................. 4 Global stockpile: Update, new plan & forecast of needs (Sabin & Novel type 2 polio vaccines) – David Woods (WHO) .......................................................................................................................... 6 SIA calendar: Options and bOPV projections – William Mbabazi (WHO) .......................................... 7 Supply of IPV & OPV: Current status & demand forecasts – Ann Ottosen (UNICEF) ....................... 8 Essential Immunization: Update on integration, second dose, progress on IPV catch-up campaigns – Alejandro Ramirez Gonzalez (WHO) and Steven Sosler (Gavi)
[Show full text]
Biotech Innovation for Sustainability
SUSTAINABILITY REPORT BIOTECH INNOVATION FOR SUSTAINABILITY 1 SUSTAINABILITY Throughout 2016, Bio Farma continued to innovate in order to improve the quality of life. For this reason, maintaining Gold rating in the annual PROPER assessment that is organized by the Indonesian Ministry of Environment and Forestry displayed a strong commitment made by Bio Farma to continue innovating for future sustainability. Organizing “Forum Riset Life Science Nasional (FRLN)” or National Life Science Research Forum, with “Challenges Toward National Research Independence in Life Science” as the theme in 2016 became another form of contribution given by Bio Farma within the biotechnology innovation industry to accelerate the down-streaming and commercialization of Life Science products, which have been acknowledged as national products and proud works of Indonesia’s best young talents. Domestically- produced Life Science products will push the availability of affordable biopharmaceutical products for all Indonesian people. Through biotechnological innovation, the Company contributes to Sustainable Development Goals (SGDs), which is by ensuring a healthy lifestyle and promoting the welfare of people at any age. We have a strong commitment to transparency and sustainable decision-making SUSTAINABILITY REPORT 2016 BIO FARMA ACCOMPLISHMENTS NOTES ON SUSTAINABLE ABOUT THIS REPORT JOURNEY OF SUSTAINABILITY TOWARDS BUSINESS BIO FARMA’S DEDICATION GOVERNANCE 2 SUSTAINABILITY TABLE OF CONTENTS 5 ACCOMPLISHMENTS TOWARDS SUSTAINABILITY 6 Economic Impact 58 Commitment
[Show full text]
The Immunogenicity and Safety of the New Indonesian Dtwp-HB-Hib Vaccine Compared to the Dtwp/HB Vaccine Given with the Hib Vaccine
Paediatrica Indonesiana p-ISSN 0030-9311; e-ISSN 2338-476X; Vol.57, No.3(2017). p. 129-37; doi: http://dx.doi.org/10.14238/pi57.3.2017.129-37 Original Article The immunogenicity and safety of the new Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine Novilia Sjafri Bachtiar1, Kusnandi Rusmil2, Sunarjati Sudigoadi3, Hadyana Sukandar4, Cissy B. Kartasasmita2 Abstract given simultaneously with to the DTwP-HB vaccine.[Paediatr Background Haemophilus influenzae type b (Hib) causes infec- Indones. 2017;57:129-37; doi: http://dx.doi.org/10.14238/ tion with predominant manifestations of pneumonia, meningitis, pi57.3.2017.129-37 ]. and other invasive diseases, occurring primarily in children aged under 2 years, particularly in infants. The World Health Orga- Keywords: DTwP-HB-Hib; Hib; immunogenicity; nization (WHO) and Indonesian Technical Advisory Group for infants; safety; vaccine Immunization recommend to include the Hib vaccine into the national immunization program. The newly developed DTwP- HB-Hib combination vaccine is anticipated to be the preferred choice for Hib vaccine introduction; it is efficient, simple, and has efore the vaccination era, Haemophilus higher coverage. influenza type b (Hib) caused infection with Objective To evaluate the immunogenicity and safety of a new, predominant manifestations of pneumonia, combined Bio Farma DTwP-HB-Hib vaccine, compared to the meningitis, and other invasive diseases registered Hib monovalent vaccine given simultaneously with the Boccurring primarily in children aged under 2 years, local DTwP-HB vaccine, when used as the primary vaccination of Indonesian infants. particularly in infants.1,2 Pneumonia was responsible Methods A prospective, randomized, open-label, phase II study for 19% of deaths in children below 5 years of age, of was conducted on the DTwP-HB-Hib vaccine compared to the which more than 70% were in Sub-Saharan Africa Hib (registered) vaccine given simultaneously with the DTwP-HB 2 vaccine, in Bandung from July 2011 to January 2012.
[Show full text]
Situation Update Response to COVID-19 in Indonesia As of 7 December 2020
Situation Update Response to COVID-19 in Indonesia As of 7 December 2020 As of 7 December, the Indonesian Government has announced 581,550 confirmed cases of COVID-19 in all 34 provinces in Indonesia, with 17,867 confirmed deaths from the virus, and 479,202 people that have recovered from the illness. The government has also reported 72,986 suspected cases. The Indonesian Doctors Association (IDI) announced that as of 5 December, 342 medical personnel had died due to COVID-19, consisting of 192 doctors, 14 dentists and 136 nurses. KawalCOVID19, a group of independent data analysts, revealed the differences in COVID-19 data between the National and regional governments. As of 1 December, confirmed cases recorded by the National Government were 543,975 people, while regional governments’ data as of 30 November recorded 562,215 confirmed cases. Likewise, National Government figures for recovered people and number of deaths were inferior to those reported by the regional governments. Another citizen reporting organization, Lapor COVID-19, found that 135 districts and cities did not consistently update their COVID-19 data in their respective regions. These discrepancies in the data are acknowledged by the Task Force COVID-19 Response and the local governments, who are working to resolve them. On 3 December, The Minister of Health communicated the six types of vaccines that have been determined for use in Indonesia, namely vaccines produced by Bio Farma, AstraZeneca, Sinopharm, Moderna, Pfizer - BioNTech, and Sinovac Biotech. The use of the COVID-19 vaccine can only start following a distribution permit or an emergency use authorization from the Food and Drug Monitoring Agency (BPOM).
[Show full text]
Bio Farma Invites the OIC Country Vaccine Manufacturers to Conduct Research Collaborations
Bio Farma Invites The OIC Country Vaccine Manufacturers To Conduct Research Collaborations Bandung (28/8) The Tunisian and Moroccan delegates representing the Ministry of Health, the vaccine industry of institute Pasteur de Tunis and Pasteur du Maroc Institute, visited Bio Farma on August 28th, 2018 to study vaccine production from upstream to downstream. Received by M. Rahman Roestan, President Director, Adriansjah Azhari, Director of Research and Development, and Juliman, Production Director of Bio Farma, and Wisnu Utomo, Director of Foreign Affairs and International Cooperation, Bappenas. Indonesia, which has been designated as the Vaccine Research Center in the Organization of Islamic Cooperation (OIC) for the field of Vaccines and Bio Technology in December 2017, attracted the attention of OIC member countries, including Tunisia and Morocco, to seek experience and knowledge regarding vaccine manufacturing from upstream to downstream for vaccine production. Bio Farma President Director M. Rahman Roestan said that of the 57 OIC member countries, only about seven countries have had vaccine factories in their countries, including Indonesia, Saudi Arabia, Morocco, Tunisia, Egypt, Senegal and Iran, and from the seven countries, which has been recognized by the World Health Organization (WHO) for basic vaccines is only Indonesia. "Indonesia is one of seven countries whose basic vaccine products have been recognized by WHO, so this makes the Tunisian and Moroccan delegates interested in learning how to manage and produce vaccines, Bio Farma with expertise that has been recognized by WHO, shares with other OIC countries with pleasure, Rahman said. Rahman added "currently the vaccine supply has been running to Saudi Arabia, this cooperation is to meet the needs of vaccines in Arab countries and Gulf countries".
[Show full text]