WHO Target Product Profile for Plague Vaccines (Draft)
|
|
- Loraine Lambert
- 5 years ago
- Views:
Transcription
1 WHO Target Product Profile for Plague Vaccines (Draft) Karene Yeung Initiative for Vaccine Research Department of Immunization, Vaccines and Biologicals
2 Outline Background Purpose Target audience Development and consultative process Expertise of working group Draft of Target Product Profile 2
3 Background Bubonic and pneumonic plague Large plague reservoirs in African, Asian and South American continents Outbreaks Emergence of antibiotic-resistance strains WHO priorities for product development 3
4 Purpose Development of new-generation of plague vaccines o Recrudescence of plague outbreaks o Availability of new vaccine technologies o Biodefense concerns Set out preferred and minimal characteristics for the next-generation plague vaccines from a public health perspective 4
5 Target audience Vaccine scientists Product developers Manufacturers Funding agencies Policy makers 5
6 Development and consultative process Early Feb Mid Feb Development of 1 st draft of TPP internally Identification of working group (WG) members with a variety of expertise Collection of Declaration of Interests from WG Early Mar Mid Mar Late Mar Early Apr Mid Apr Review and feedbacks on 1 st draft of TPP by WG Discussion on 1 st draft of TPP and comments through a teleconference Development of 2 nd draft of TPP Review and feedbacks on 2 nd draft of TPP by WG Discussion on 2 nd draft of TPP and comments through a teleconference Development of 3 rd draft of TPP Public consultation on 3 rd draft of TPP through an online platform 6
7 Expertise of working group 1. Research and development expertise in bacteriology and immunology 2. Research and development expertise in assays and animal models 3. Vaccine efficacy and effectiveness 4. Epidemiology/ public health/ vaccine policy 5. Deployment expertise in relevant countries 6. Modelling expertise 7. High income country regulators 8. Outbreak response 9. Ethics 7
8 DRAFT TARGET PRODUCT PROFILE (TPP) FOR PLAGUE VACCINES 8
9 Strategies Reactive/ emergency use o To prevent plague in vaccinated individuals in the face of an outbreak o To interrupt chains of transmission to terminate outbreaks o Populations experiencing an outbreak o Populations at high risk for importation of plague cases from areas experiencing an outbreak Preventive/ prophylactic use o To protect populations living in areas where plague is endemic o Health care workers (HWCs) at particularly high risk of plague due to their profession 9
10 Vaccine characteristics 1. Indication for use 2. Target population 3. Safety/ reactogenicity 4. Measures of efficacy 5. Dose regimen 6. Durability of protection 7. Route of administration 8. Coverage 9. Product stability and storage 10. Co-administration with other vaccines 11. Presentation 12. Registration and Prequalification Reactive/ emergency use Preventive/ prophylactic use Preferred Critical/ Minimal Preferred Critical/ Minimal 10
11 Indication for use Preferred Critical or Minimal Preferred Critical or Minimal For active immunization of at-risk persons in the area of an on-going outbreak to protect against plague; to be used in conjunction with other control measures to curtail or end an outbreak. For active immunization of persons considered potentially at risk to protect against plague. Risk groups will include communities in endemic areas and certain HCWs 1. 1 HCWs at particularly high risk of plague due to their profession (e.g. HCWs in endemic areas, laboratory personnel, deployed international HCWs) 11
12 Target population Preferred Critical or Minimal Preferred Critical or Minimal All age groups 2,3,4 excluding infants. Suitable for administration to pregnant and lactating women and to immunodeficient persons. All age groups 2,3,4 potentially excluding infants, pregnant and lactating women, and immunodeficient persons at the time of initial authorization based on the safety profile of the vaccine in these special populations 5. All age groups 2,3,4. Suitable for administration to pregnant and lactating women and to immunodeficient persons. All age groups 2,3,4 excluding pregnant and lactating women and immunodeficient persons 6. 2 Plague has occurred in people of all ages (infants up to age 96) 3 Ju C, Liu Z, Zhang G et al. Epidemiological characteristics of human plague in different age groups in China from Zhonghua Liu Xing Bing Xue Za Zhi 2014;35: Migliani R, Chanteau S, Rahalison L et al. Epidemiological trends for human plague in Madagascar during the second half of the 20th century: a survey of notified cases. Tropical Medicine & International Health 2006;11: This determination would rely on whether the vaccine benefit outweighs safety risks - similar to the minimal characteristics for other populations. As vaccine products are used in these populations and more data is generated on the safety profile for use in infants, pregnant and lactating women, and immunodeficient persons, the label should be updated accordingly Post-licensure studies including the assessment of immunogenicity in pregnant and lactating women and immunocompromised individuals are expected.
13 Safety/ reactogenicity Preferred Critical or Minimal Preferred Critical or Minimal Safety and reactogenicity sufficient to provide a highly favorable risk-benefit profile, ideally with only mild and transient adverse events related to vaccination and no serious adverse events related to vaccination with the vaccine or vaccine-platform, including in individuals with compromised immune function or when administered in pregnancy. Safety and reactogenicity whereby vaccine benefit clearly outweighs safety risks. Safety and reactogenicity at least comparable to WHOrecommended routine vaccines, ideally with only mild and transient adverse events related to vaccination and no serious adverse events related to vaccination with the vaccine or vaccine platform, including in individuals with compromised immune function or when administered in pregnancy. Safety and reactogenicity whereby vaccine benefit clearly outweighs safety risks. 13
14 Measures of efficacy Preferred Critical or Minimal Preferred Critical or Minimal At least 80% efficacy 7 in preventing bubonic and pneumonic forms of plague in the target population. Rapid onset of protective immunity (less than one week). At least 70% efficacy 7 in preventing bubonic and pneumonic form of plague predicted and stop transmission in the affected population. Rapid onset of protective immunity (less than 10 days). At least 80% efficacy 7 in preventing bubonic and pneumonic form of plague in the target population. At least 70% efficacy 7 in preventing bubonic and pneumonic form of plague in the target population. 7 Clinical investigation should include assessment of immunogenicity in pregnancy and among immunocompromised individuals to identify potentially clinically relevant differences. If demonstration of clinical efficacy is not feasible, immunogenicity and efficacy data generated in standardized and relevant animal models bridged with clinical immunogenicity may be considered. Passive therapy using human sera may also provide evidence of biological effect. If efficacy trials are not feasible, the predicted efficacy should be at the level specified for desired efficacy. 14
15 Dose regimen Preferred Critical or Minimal Preferred Critical or Minimal Single-dose regimen highly preferred. Primary series: no more than 2 doses, with preference for less than onemonth interval between doses and good protection after the first dose. Single-dose regimen highly preferred. Primary series: no more than 3 doses, and with preference for less than one-month interval between doses. 15
16 Durability of protection Preferred Critical or Minimal Preferred Critical or Minimal Confers protection of at least 2 years. Confers protection of at least one year. Confers long-lasting protection of 10 years or more following the primary series and can be maintained indefinitely by booster doses. Confers protection of at least 5 years after primary series and can be maintained indefinitely by booster doses. 16
17 Route of administration Preferred Critical or Minimal Preferred Critical or Minimal Oral or nonparenteral route. A route enabling rapid mass administration. A route enabling rapid mass administration. Where injection (IM or SC) is required, using standard volumes for injection as specified in programmatic suitability for prequalification. Oral or nonparenteral route. A route compatible with use in routine immunization programs. A route compatible with use in routine immunization programs. Where injection (IM, ID or SC) is required, using standard volumes for injection as specified in programmatic suitability for prequalification. IM=Intramuscular, ID=Intradermal; SC=Subcutaneous 17
18 Coverage Preferred Critical or Minimal Preferred Critical or Minimal Coverage against all plague strains. Coverage against the most common outbreak plague strains. Coverage against all plague strains. Coverage against plague strains circulating in the endemic areas. 18
19 Product stability and storage Preferred Shelf life of at least 5 years at 2-8 o C. Preferably thermostable at higher temperatures for several days. The need for a preservative is determined and any issues are addressed including absence of toxicity. Vaccine Vial Monitor (VVM): Proof of feasibility and intent to apply a VVM to the primary container. Vaccines that are not damaged by freezing temperatures (<0 o C) are preferred. Vaccines stable out of cold chain are preferred. If not, vaccines that can be delivered via the Controlled Temperature Chain are preferred 8. Critical or Minimal Shelf life of at least 12 months at -20 o C and one month at 2-8 o C. The need for a preservativ e is determined and any issues are addressed including absence of toxicity. Preferred Shelf life of at least 5 years at 2-8 o C. Preferably thermostable at higher temperatures for several days. The need for a preservative is determined and any issues are addressed including absence of toxicity. Vaccine Vial Monitor (VVM): Proof of feasibility and intent to apply a VVM to the primary container. Vaccines that are not damaged by freezing temperatures (<0 o C) are preferred. Vaccines stable out of cold chain are preferred. If not, vaccines that can be delivered via the Controlled Temperature Chain are preferred Critical or Minimal Shelf life of at least 2 years at -20 o C and 6 months at 2-8 o C. The need for a preservative is determined and any issues are addressed including absence of toxicity. Vaccine Vial Monitor (VVM): Proof of feasibility and intent to apply a VVM to the primary distribution container. 19
20 Co-administration with other vaccines Preferred Critical or Minimal Preferred Critical or Minimal The vaccine will be given as a stand-alone product not co-administered with other vaccines. The vaccine can be co-administered with other vaccines. The vaccine will be given as a standalone product not co-administered with other vaccines. 20
21 Presentation Preferred Critical or Minimal Preferred Critical or Minimal If oral administration, mono-dose presentation in plastic tubes with a volume of 1-2 ml; or multi-dose (10-20) with a dropper presentation with a maximal dosage volume of 0.05 ml (1 drop) or 0.1 ml (2 drops); with favorable taste (e.g. sweet). If injectable administration, vaccine is provided as a liquid product in 10-dose presentation with a volume of 0.5 ml. Multi-dose presentations should be formulated, managed and discarded in compliance with WHO s multi-dose vial policy. If oral administration, monodose presentation in glass vial with a volume of 1-2 ml or multi-dose container with a dropper device with doses. If injectable administration, vaccine is provided as a liquid or lyophilized product in mono-dose or multi-dose (10-20) presentations with a volume of 0.5 ml. Multi-dose presentations should be formulated, managed and discarded in compliance with WHO s multi-dose vial policy. If not supplied in a dualbarrel syringe, lyophilized vaccine will need to be accompanied by paired separate vials of the appropriate diluent. If oral administration, 2-5 doses with a volume of 1-2 ml in plastic tubes; with favorable taste (e.g. sweet). If injectable administration, vaccine is provided as a liquid product in mono-dose or multidose (2) presentations with a maximal dosage volume of 0.5 ml. Multi-dose presentations should be formulated, managed and discarded in compliance with WHO s multi-dose vial policy. If oral administration, 2-5 doses with a volume of 1-2 ml in plastic tubes. If injectable administration, vaccine is provided as a liquid or lyophilized product in mono-dose or multi-dose (5-10) presentations with a maximal dosage volume of 0.5 ml. Multi-dose presentations should be formulated, managed and discarded in compliance with WHO s multi-dose vial policy. If not supplied in a dualbarrel syringe, lyophilized vaccine will need to be accompanied by paired separate vials of the 21 appropriate diluent.
22 Registration and prequalification Preferred Critical or Minimal Preferred Critical or Minimal Should be WHO pre-qualified according to the process outlined in Procedures for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. Should be WHO pre-qualified according to the process outlined in Procedures for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. 22
23 THE END Thank you 23
WHO Target Product Profiles for MERS-CoV Vaccines. May 2017
1 Purpose of the document WHO Target Product Profiles for MERS-CoV Vaccines May 2017 Selected disease areas are identified as WHO priorities for research and product development. In the case of MERS-CoV,
More informationTarget Product Profile and Technical Requirements for Conjugated Pneumococcal Vaccines. AMC Pre-tender meeting. Copenhagen 10 March 2011
Target Product Profile and Technical Requirements for Conjugated Pneumococcal Vaccines 1 Target Product Profile for AMC support The specifications relate to the public health impact and suitability of
More informationUpdating the Malaria Vaccine Technology Roadmap
Updating the Malaria Vaccine Technology Roadmap Vasee Moorthy MRCP PhD MPAC 14 March 2013 Purpose of this MPAC session MPAC to be updated on the strategic R&D framework for malaria vaccines, including
More informationDeveloping a novel Group B Streptococcus (GBS) Vaccine. Patrick Tippoo
Developing a novel Group B Streptococcus (GBS) Vaccine Patrick Tippoo Presentation 1. Overview of Biovac 2. GBS Project Overview 3. African Significance Biovac Overview A Centre of Excellence rooted in
More informationWHO Target Product Profile for Nipah virus Vaccine. June 2017
1 Purpose of the document WHO Target Product Profile for Nipah virus Vaccine June 2017 Selected disease areas are identified as WHO priorities for product development. In the case of Nipah virus (NiV),
More informationHeat Stable Oral Rotavirus Vaccine
Heat Stable Oral Rotavirus Vaccine Davinder Gill, PhD 11 th International Rotavirus Symposium 4 th September 2014, New Delhi 1 We are working with a pre-approved oral rotavirus vaccine Licensed in the
More informationEbola Vaccines and Vaccination
Ebola Vaccines and Vaccination Report of the SAGE Working Group on Ebola Vaccines and Vaccination with provisional recommendations for vaccination September 30, 2015 SECTION C: CONCLUSIONS AND RECOMMENDATIONS
More informationWHO Preferred Product Characteristics for RSV Vaccines
WHO Preferred Product Characteristics for RSV Vaccines 1 TABLE OF CONTENTS I. Introduction 3 II. Context of available interventions 3 III. WHO strategic vision for RSV vaccines 4 IV. RSV vaccines for maternal
More informationExpedited procedure for evaluating pandemic influenza A (H1N1) 2009 vaccines
Expedited procedure for evaluating pandemic influenza A (H1N1) 2009 vaccines Preamble On 11 June 2009, WHO declared an influenza pandemic caused by influenza A (H1N1) 2009 virus 1. On 13 July 2009, WHO
More informationWHO Recommendations and Guidelines for the Prevention of Perinatal Hepatitis B and Use of Hepatitis B Vaccines
WHO Recommendations and Guidelines for the Prevention of Perinatal Hepatitis B and Use of Hepatitis B Vaccines Steven Wiersma,, Medical Officer WHO/EPI EPI,, Geneva March, 2006 Epidemiology Strategy WHO
More informationRSV vaccine research and development: WHO technical roadmap
RSV vaccine research and development: WHO technical roadmap Johan Vekemans (MD, PhD) WHO Initiative for Vaccine Research Washington, 18 th December 2017 What is WHO s Initiative for Vaccine Research (IVR)
More informationSummary of Product Characteristics
Summary of Product Characteristics 1) NAME OF THE MEDICINAL PRODUCT Meningococcal A conjugate vaccine 5 micrograms, Lyophilized Brand name- MenAfriVac 2) QUALITATIVE AND QUANTITATIVE COMPOSITION After
More informationNew Vaccine Delivery Technologies
Photo: PATH New Vaccine Delivery Technologies 6 th Annual CUGH Conference Mobilizing Research for Global Health Boston, USA Darin Zehrung dzehrung@path.org Senior Technical Officer and Portfolio Leader,
More informationDeveloping a Target Product Profile for a Preventive HIV Vaccine
Developing a Target Product Profile for a Preventive HIV Vaccine Topics to be Covered Overview of TPPs What are they? What is the purpose and benefit of using a TPP? What is usually in a TPP? What are
More informationEvidence to Recommendation Table 1
Evidence to Recommendation Table 1 Questions: Can the duration of the entire course and/or the number of doses administered of current PEP regimens be reduced while maintaining immunogenicity and effectiveness?
More informationHepatitis B vaccination of newborns in rural China: evaluation of an out-of-coldchain delivery strategy. Istanbul, Turkey March 15-17, 2006
Hepatitis B vaccination of newborns in rural China: evaluation of an out-of-coldchain delivery strategy Istanbul, Turkey March 15-17, 2006 Contents Introduction Objective Methods and Implementation Results
More informationGlobal and National Trends in Vaccine Preventable Diseases. Dr Brenda Corcoran National Immunisation Office.
Global and National Trends in Vaccine Preventable Diseases Dr Brenda Corcoran National Immunisation Office Global mortality 2008 Children under 5 years of age 1.5 million deaths due to vaccine preventable
More informationHeat and Freeze Sensitivity of Vaccines
Heat and Freeze Sensitivity of Vaccines DCVMN Workshop "Vaccine quality management systems for manufacturing excellence" Michael Rush, MBA Executive Director - Global Health Policy October 24-25, 2013
More informationGAVI s Financing for Pneumococcal Vaccines, including the Advance Market Commitment
GAVI s Financing for Pneumococcal Vaccines, including the Advance Market Commitment Tania Cernuschi Third Regional Pneumococcal Symposium, Istanbul, 13th - 14th February 2008 1 The GAVI Alliance Public-private
More informationEstablishing a cholera stockpile: What do we need? Alejandro Costa Epidemic Readiness and Intervention
Establishing a cholera stockpile: What do we need? Alejandro Costa Epidemic Readiness and Intervention Outline 1. Experience Meningococcal vaccine stockpile Yellow Fever vaccine stockpile 2. Criteria for
More informationStability Studies and Choice of VVM Category. Temperature Intelligence Solutions
Stability Studies and Choice of VVM Category Overview These slides are focused mainly on vaccines The principles involved in choice of a vaccine vial monitor (VVM) or more generically a timetemperature
More informationBCG. Program Management. Vaccine Quality
Program Management 50_16 To change from general to selective BCG vaccination, an efficient notification system must be in place in addition to the following criteria: an average annual notification rate
More informationCONTROLLED TEMPERATURE CHAIN:
Photo: WHO/WPRO CONTROLLED TEMPERATURE CHAIN: Myths & Truths Innovative Solutions & Approaches TechNet 2017 Wednesday, 18 October 2017 Anna-Lea Kahn WHO/IVB, Switzerland Joe Woodring WHO/WPRO, Philippines
More informationVaccine assessment for prequalification
Vaccine assessment for prequalification Briefing on Vaccine Prequalification for manufacturers DCVMN meeting, Kunming, China, 13 March 2016 Olivier Lapujade World Health Organization, EMP/RHT/PQT lapujadeo@who.int
More informationHepatitis B vaccination: a completed schedule enough to control HBV lifelong? MILAN, ITALY November 2011
Viral Hepatitis Prevention Board Hepatitis B vaccination: a completed schedule enough to control HBV lifelong? MILAN, ITALY 17-18 November 2011 Objectives To review long-term efficacy of hepatitis B vaccine
More informationGian Gandhi. Vaccine Pre tender Meeting UNICEF Supply Division
An Advance Market Commitment for new vaccines The Pneumococcal Pilot Gian Gandhi GAVI Alliance Vaccine Pre tender Meeting UNICEF Supply Division Copenhagen, 10 December 2008 2 Objectives ofthepresentation
More informationSUMMARY OF PRODUCT CHARACTERISTICS
Registration No. 1B 12/46 Importer / Manufacturer: GPO-MBP SUMMARY OF PRODUCT CHARACTERISTICS 1. ME OF THE MEDICAL PRODUCT ORAL POLIOMYELITIS VACCINE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vaccine
More informationSummary of Key Points
Summary of Key Points WHO Position Paper on Vaccines against Pertussis September 2015 1 Background l Pertussis (whooping cough), caused by the bacterium Bordetella pertussis, was one of the most common
More informationUpdated WHO position paper on pertussis vaccines. Geneva, Switzerland October 2010
Updated WHO position paper on pertussis vaccines Geneva, Switzerland October 2010 Introduction Replaces the position paper on pertussis vaccines published in the Weekly Epidemiological Record in January
More informationWHO Preferred Product Characteristics for Next-Generation Influenza Vaccines
WHO Preferred Product Characteristics for Next-Generation Influenza Vaccines DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS WHO preferred product characteristics for next generation influenza vaccines
More informationSUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) I.P. Injectable, Suspension for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.5 ml contains:
More informationNavigating vaccine introduction: a guide for decision-makers JAPANESE ENCEPHALITIS (JE) Module 4. How should my country introduce JE vaccines?
Navigating vaccine introduction: a guide for decision-makers JAPANESE ENCEPHALITIS (JE) Module 4 How should my country introduce JE vaccines? 4 about this guide Japanese encephalitis (JE), a viral infection
More informationUpdates on Typhoid Conjugate vaccine Development: IVI
Updates on Typhoid Conjugate vaccine Development: IVI Sushant Sahastrabuddhe 8 th International Conference on Typhoid Fever and Other Invasive Salmonelloses 2 nd March 2013 Outline of the presentation
More informationBRIEFING ON RTS,S/AS01 MALARIA VACCINE FOR THE SEPTEMBER 2012 MEETING OF MPAC
BRIEFING ON RTS,S/AS01 MALARIA VACCINE FOR THE SEPTEMBER 2012 MEETING OF MPAC Introduction Date: 12 August 2012. Author: WHO Secretariat with input from JTEG Chair The most advanced vaccine candidate against
More informationDetermining the Feasibility of an Oral Cholera Vaccination (OCV) Campaign
Determining the Feasibility of an Oral Cholera Vaccination (OCV) Campaign Updated November, 2016 Examining the feasibility of a vaccination campaign is critical for making decisions about whether or not
More informationExecutive Summary. Final version_29 Sept 2014 Page 1
Executive Summary Final version_29 Sept 2014 Page 1 WHO consultation on influenza vaccines for pregnant and lactating women: Clinical data requirements for product labelling 15 16 July 2014 Geneva, Switzerland
More informationPLAGUE OUTBREAK. Madagascar. External Situation Report 02. Grade
PLAGUE OUTBREAK Madagascar External Situation Report 02 Date of issue: 9 October 2017 1. Situation update Grade 2... Cases... Deaths 387 45... CFR 11.6% The outbreak of plague in Madagascar continues to
More informationEVIDENCE-TO-DECISION TABLE FOR FRACTIONAL DOSE YELLOW FEVER VACCINATION. Yellow fever vaccine: WHO position on the use of fractional doses, June 2017
EVIDENCE-TO-DECISION TABLE FOR FRACTIONAL DOSE YELLOW FEVER VACCINATION Yellow fever vaccine: WHO position on the use of fractional doses, June 2017 1 BENEFITS & HARMS OF THE OPTIONS PROBLEM Question:
More informationEPIDEMIOLOGY OF COMMUNICABLE DISEASES. Dr Saleh Jassim Alwan MBChB. PhD.
EPIDEMIOLOGY OF COMMUNICABLE DISEASES Dr Saleh Jassim Alwan MBChB. PhD. LECTURE 1 OBJECTIVES -To define ( reservoir, source, carrier, zoonosis,. communicable disease, and herd immunity) -To describe 1.
More informationPLAGUE OUTBREAK. Madagascar. External Situation Report 01. Grade
PLAGUE OUTBREAK Madagascar External Situation Report 01 Date of issue: 4 October 2017 1. Situation update Grade 2... Cases... Deaths 194 30... CFR 15.5% On 13 September 2017, the Madagascar Ministry of
More informationPhase 3 efficacy study of a new pentavalent bovine-human reassortant rotavirus vaccine in India
Phase 3 efficacy study of a new pentavalent bovine-human reassortant rotavirus vaccine in India 12 th International Rotavirus Symposium 7-9 September 2016, Melbourne Dr Prasad Kulkarni, MD Serum Institute
More informationEbola Prevention Vaccine Evaluation in Sierra Leone
Ebola Prevention Vaccine Evaluation in Sierra Leone Dr. SAS Kargbo Sierra Leone Ministry of Health and Sanitation Sierra Leone CDC Collaboration World Health Organization, Geneva 9 January 2015 Principal
More informationExpanded Programme on Immunization (EPI):
Expanded Programme on Immunization (EPI): Introduction Four to five million annual deaths could be prevented by 2015 through sustained and appropriate immunization efforts, backed by financial support.
More informationThis vaccine is indicated for the prevention of poliomyelitis in infants, children and adults, for primary and booster vaccinations.
NAME OF THE MEDICINAL PRODUCT IMOVAX POLIO, suspension for injection in a prefilled syringe or multidose Poliomyelitis vaccine (inactivated) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml)
More informationQ&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution)
Q&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution) This document should not be treated as a comprehensive guideline; it serves as a
More informationCEVAC CEVAC BROILER ND K / 5000 doses
CEVAC BROILER ND K / 5 doses CEVAC BROILER ND K Newcastle disease a permanent threat Newcastle Disease is highly contagious and exists in a wide range of forms. It is one of the four major poultry diseases
More informationAdverse Event GACVS. Global Advisory Committee on Vaccine Safety, 910 June 2005
Adverse Event The Committee considered the decision taken by the Government of Japan on 30 May 2005 to suspend routine vaccination with the mouse brainderived Japanese encephalitis (JE) vaccine currently
More informationVaccines: (inter)national regulation and quality in resource limited settings
Vaccines: (inter)national regulation and quality in resource limited settings Raffaella Ravinetto QUAMED Research & Networking Institute of Tropical Medicine Antwerp 12th July 2017 Based on a presentation
More informationWHO/PQT Updates on WHO Prequalification Priorities and Regulatory Systems Strengthening work
WHO/PQT Updates on WHO Prequalification Priorities and Regulatory Systems Strengthening work Dr Drew Meek Prequalification Team Regulation of Medicines and other Health Technologies Essential Medicines
More informationMencevax ACWY. 1 Name of the medicinal product Mencevax ACWY.
Mencevax ACWY 1 Name of the medicinal product Mencevax ACWY. 2 Qualitative and Quantitative Composition Mencevax ACWY is a lyophilized, preparation of purified polysaccharides from Neisseria meningitidis
More informationSUMMARY OF PRODUCT CHARACTRISTICS
1. NAME OF THE MEDICINAL PRODUCT Purified, Inactivated, Lyophilized Rabies Vaccine, Prepared on Vero Cells INDIRAB 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative Formula per dose of 0.5 ml (Single
More informationImmunization Competencies. For BC Health Professionals
Immunization Competencies For BC Health Professionals September 2010 Preamble The competencies contained in the Immunization Competencies for BC Health Professionals were developed from the Immunization
More informationStockpiling of H5N1 vaccines
Stockpiling of H5N1 vaccines Norbert W. Hehme EVM Influenza Pandemic Working Group EU-Commission Workshop on Stockpiling of Medicinal Products February 21/22, 2008 European Vaccine Manufacturers 1 (EVM)
More informationWASHINGTON, DC
OFFICE OF THE ASSISTANT SECRETARY OF DEFENSE WASHINGTON, DC 20301-1200 HEALTH AFFAIRS SEP 3 0 2009 MEMORANDUM FOR ASSISTANT SECRETARY OF DEFENSE (RESER VE AFFAIRS) SURGEON GENERAL OF THE ARMY SURGEON GENERAL
More informationWhat are the new active vaccine recommendations in the Canadian Immunization Guide?
154 CCDR 17 April 2014 Volume 40-8 https://doi.org/10.14745/ccdr.v40i08a03 1 What are the new active vaccine recommendations in the Canadian Immunization Guide? Warshawsky B 1 and Gemmill I 2 on behalf
More informationMeasles. Phases of accelerated measles control activities (measles mortality reduction and measles elimination) are indicated in Appendix 80_5.
Program Management 80_1 With renewed global commitment to achieving measles mortality reduction, the 2003 World Health Assembly stressed the importance of achieving the goals adopted by the United Nations
More informationBoostrix version 1. Elements for a Public Summary. Overview of disease epidemiology. Pertussis Epidemiology
Boostrix 2.1.2015 version 1 VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Pertussis Epidemiology Pertussis (whooping cough), which is caused by Bordetella pertussis bacteria,
More informationUpdated: 26 August 2010
Australian Technical Advisory Group on Immunisation (ATAGI) Updated advice on the use of pandemic and seasonal influenza vaccines in children
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Ducat (DE: Nobivac RC, SE : Nobivac Ducat vet.) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Per
More informationGuidelines for management of suspected sepsis in young infants where referral is not possible
Guidelines for management of suspected sepsis in young infants where referral is not possible Kenya Paediatrics Association Conference, 26-29 April 2016, Eldoret Kenya 1 Kenya Paediatrics Association Conference,
More informationSUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT Poliomyelitis Vaccine, Live (Oral) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.1 ml = 2 drops contains: Polio Virus Type 1 (Sabin strain) Not less than 10
More informationPriorix TM Measles, mumps and rubella vaccine (live, attenuated)
Priorix TM Measles, mumps and rubella vaccine (live, attenuated) QUALITATIVE AND QUANTITATIVE COMPOSITION Priorix is a lyophilised mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived
More informationH1N Influenza Q & A With a Focus on Panvax
November 6, 2009 1 of 5 H1N1-2009 Influenza Q & A With a Focus on Panvax 1. What H1N1 vaccines are available in Canada? The vaccines available in Canada to protect against H1N1-2009 influenza are: Arepanrix
More informationSUMMARY OF PRODUCT CHARACTRISTICS
1. NAME OF THE MEDICINAL PRODUCT Typhoid (Vi Capsular Polysaccharide)-Tetanus Toxoid Conjugate Vaccine. Typbar-TCV 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative Formula per dose of 0.5 ml (Single
More informationElements for a Public Summary
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Pertussis Epidemiology Pertussis (whooping cough), which is caused by Bordetella pertussis bacteria, is an easily spread respiratory
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versifel FeLV, suspension for injection for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
More informationEXPANDED PROGRAM OF IMMUNIZATION (EPI) Definition Program adopted by WHO since l974, it includes child immunization & vaccination of pregnant women.
EXPANDED PROGRAM OF IMMUNIZATION (EPI) Definition Program adopted by WHO since l974, it includes child immunization & vaccination of pregnant women. Strategy A. Child immunization Egyptian immunization
More informationYellow fever. Key facts
From: http://www.who.int/en/news-room/fact-sheets/detail/yellow-fever WHO/E. Soteras Jalil Yellow fever 14 March 2018 Key facts Yellow fever is an acute viral haemorrhagic disease transmitted by infected
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE CHMP GUIDELINE ON CLINICAL EVALUATION OF NEW VACCINES ANNEX: SPC REQUIREMENTS
European Medicines Agency London, 18 October 2006 EMEA/CHMP/VWP/382702/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE CHMP GUIDELINE ON CLINICAL EVALUATION OF NEW VACCINES ANNEX: SPC REQUIREMENTS
More informationA BULLETIN FOR PHARMACY SERVICE PROVIDERS FROM ALBERTA BLUE CROSS
Pharmacy Benefact A BULLETIN FOR PHARMACY SERVICE PROVIDERS FROM ALBERTA BLUE CROSS Number 757 September 2018 Alberta Public Health Activities Program (APHAP) Influenza Immunization Program 2018/2019 This
More informationThe Expanding Rotavirus Vaccine Landscape: Lessons learned from Influenza Vaccines
The Expanding Rotavirus Vaccine Landscape: Lessons learned from Influenza Vaccines Kathleen Neuzil, MD, MPH Director, Center for Vaccine Development University of Maryland School of Medicine September
More informationProgress and Challenges of Enteric Vaccines. Dr. Tajul Islam A Bari icddr,b Bangladesh
Progress and Challenges of Enteric Vaccines Dr. Tajul Islam A Bari icddr,b Bangladesh New enteric vaccines in use Cholera Rotavirus Typhoid Cholera- History During the 19th century, cholera spread across
More informationNHS public health functions agreement Service specification No. 31 Meningococcal group B (MenB) programme
NHS public health functions agreement 2017-18 Service specification No. 31 Meningococcal group B (MenB) programme Classification: official NHS public health functions agreement 2017-18 Service specification
More informationDevelopment of a Vaccine Multi-Dose Vial: Rationale and Strategy
Development of a Vaccine Multi-Dose Vial: Rationale and Strategy Nicholas Warne Lynn Phelan Barry Ballan Li Li WCBP 2018 Washington, DC Jan 30-Feb 1, 2018 Overview We have developed a multi-dose version
More informationTrends in Vaccine Presentations and Packaging
Trends in Vaccine Presentations and Packaging Developing Countries Vaccine Manufacturers Network Meeting 29 October 2014; Delhi, India Debra Kristensen Director, Vaccine and Pharmaceutical Technologies,
More informationHuman Hepatitis B Immunoglobulin, solution for intramuscular injection.
New Zealand Data Sheet Hepatitis B Immunoglobulin-VF NAME OF THE MEDICINE Human Hepatitis B Immunoglobulin, solution for intramuscular injection. DESCRIPTION Hepatitis B Immunoglobulin-VF is a sterile,
More informationUnderstanding vaccine development
Understanding vaccine development Firdausi Qadri Director, Centre for Vaccine Sciences International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) Outline of this talk 1. Understanding disease
More informationTYPHERIX PRODUCT INFORMATION (Salmonella typhi Vi polysaccharide)
TYPHERIX PRODUCT INFORMATION (Salmonella typhi Vi polysaccharide) DESCRIPTION TYPHERIX is a colourless, sterile liquid containing the cell surface Vi polysaccharide extracted from Salmonella typhi Ty2
More informationSummary of the October 2017 meeting of the Strategic Advisory Group of Experts on Immunization
Summary of the October 2017 meeting of the Strategic Advisory Group of Experts on Immunization The Strategic Advisory Group of Experts (SAGE) on Immunization 1 met on 17-19 October 2017 in Geneva, Switzerland.
More informationUNICEF Safe Injection Equipment Key highlights
Safe Injection Equipment VPPEF 03 October 2017 UNICEF Safe Injection Equipment Key highlights Nagwa Hasanin, HTC Vaccine Pharmaceutical form Route of administration Liquid Freeze- dried oral Inject Site
More informationNHS public health functions agreement
NHS public health functions agreement 2016-17 Service specification No. 31 Meningococcal group B (MenB) programme Classification: official NHS England INFORMATION READER BOX Directorate Medical Commissioning
More informationDevelopment of a heat-stable Rotavirus vaccine using innovative delivery technology
Development of a heat-stable Rotavirus vaccine using innovative delivery technology 1 HILLEMAN OPERATING MODEL IS UNIQUE WITH FOCUS ON TRANSLATIONAL SCIENCE AND GETTING AFFORDABLE VACCINES TO MARKET FASTER
More informationHealth Care Worker Vaccinations, 2011: EXTENDED CARE FACILITIES
Health Care Worker Vaccinations, 2011: EXTENDED CARE FACILITIES Karen K Hoffmann, RN, MS, CIC, FSHEA. Clinical Instructor, Division of Infectious Diseases University of North Carolina at Chapel Hill Associate
More informationNOTE: The first appearance of terms in bold in the body of this document (except titles) are defined terms please refer to the Definitions section.
TITLE INFLUENZA IMMUNIZATION SCOPE Provincial APPROVAL AUTHORITY Vice-President and Chief Health Operations Officer, Central and Southern Alberta SPONSOR Population, Public and Indigenous Health PARENT
More informationVaccine Innovation Lexicon
Vaccine Innovation Lexicon October 2016 VACCINE INNOVATION LEXICON Abbreviations ACIP BFS CDC cpad CTC gppp GTIN GVAP IPAC LMICs MAP MDVP PDVAC PPC PSPQ RUP SAGE SIP TPP UNICEF VVM WHO Advisory Committee
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICAL PRODUCT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Registration No.: 1C 10/54 (NBC) Importer / Manufacturer: MSD (Thailand) Ltd. / Merck Sharp & Dohme Corp., West Point, Pennsylvania 19486, USA SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICAL
More informationMeasles Immunization Catch-up Campaign
Measles Immunization Catch-up Campaign What is measles? Measles is one of the most infectious diseases. Measles is an acute viral illness caused by a virus from the paramyxovirus family. Almost all children
More informationPrioritized research questions for adolescent HIV testing, treatment and service delivery
Prioritized research questions for adolescent HIV testing, treatment and service delivery The World Health Organization (WHO) and the Collaborative Initiative for Paediatric HIV Education and Research
More informationFrom Vaccine Development to Policy: A Brief Review of WHO Vaccine-Related Activities and Advisory Processes (2017)
1. Introduction From Vaccine Development to Policy: A Brief Review of WHO Vaccine-Related Activities and Advisory Processes (2017) To help achieve the implementation of the Global Vaccine Action Plan (GVAP),
More informationRotavirus Vaccine. Supply and Procurement Roadmap. The Market Shaping Goal. Public Summary. Rotavirus Supply and Procurement Roadmap UPDATE 2016
The Market Shaping Goal Shape markets for vaccines and other immunisation products to achieve moderate or high levels of healthy markets dynamics. Supply and Procurement Roadmap Rotavirus Vaccine Public
More informationIntroduction of Haemophilus influenzae type b vaccine into immunization programmes
WHO/V&B/00.05 ORIGINAL: ENGLISH DISTR.: GENERAL Introduction of Haemophilus influenzae type b vaccine into immunization programmes Management guidelines, including information for health workers and parents
More informationVaccine Decision-Making
Key Points Vaccine Decision-Making * Decisions on introducing new vaccines have long-term implications for immunization costs as well as logistics systems and service delivery. The choice of vaccine presentation
More informationPost Licensure Communication on Vaccine Safety among Regulator, Industry and Stakeholder
Post Licensure Communication on Vaccine Safety among Regulator, Industry and Stakeholder Lucky S Slamet DCVMN International Annual General Meeting, New Delhi, India, 8-10 July 2014 1 Disclaimer The information
More informationHealth Products Regulatory Authority
1 NAME OF THE VETERINARY MEDICINAL PRODUCT VANGUARD CPV-L 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Quantity per 1 ml dose Active substance(s): Live attenuated canine Parvovirus, strain NL-35-D, low passage,
More informationPriorix TM Measles, mumps and rubella vaccine
Priorix TM Measles, mumps and rubella vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION Priorix is a lyophilised mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn
More informationJinchang Wu, Ph.D. Director of International Affairs, Changchun BCHT March, 2013 Dubai
Jinchang Wu, Ph.D. Director of International Affairs, Changchun BCHT March, 2013 Dubai Established in March 2004 at Changchun High-tech Zone, Jilin Province, Northeast China Research, development, production
More informationCOMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP) <DRAFT>
European Medicines Agency London, 24 July 2006 Doc. Ref. EMEA/CHMP/VWP/263499/2006 COMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP) GUIDELINE ON DOSSIER STRUCTURE AND CONTENT OF MARKETING AUTHORISATION
More informationPLAGUE OUTBREAK. Madagascar. External Situation Report 04. Grade
PLAGUE OUTBREAK Madagascar External Situation Report 04 Date of issue: 17 October 2017 1. Situation update Grade 2... Cases... Deaths 849 67... CFR 7.9% Madagascar is experiencing a large outbreak of plague
More informationAnti-Viral Prophylaxis Target Product Profile Guidelines
Anti-Viral Prophylaxis Target Product Profile Guidelines February 24, 2009 Report Documentation Page Form Approved OMB No. 0704-0188 Public reporting burden for the collection of information is estimated
More information