Alternative Rotavirus Vaccine Candidates: Why should we bother?
|
|
- Deborah Nichols
- 5 years ago
- Views:
Transcription
1 Alternative Rotavirus Vaccine Candidates: Why should we bother? Duncan Steele Initiative for Vaccine Research, WHO 7 th International Rotavirus Symposium June 2006, Lisboa, Portugal
2 Rotavirus Vaccines in 2006
3 UN Millennium Development Goals Goal #4: Reduce child mortality Target: Reduce by two thirds, between 1990 and 2015, the under-five mortality rate (U5MR) Indicators: 13 Under-five mortality rate 14 Infant mortality rate
4 10.5m early childhood (<5y) deaths World Health Report (Annex table 2, unpublished data for 2002) 2004 and The Lancet, 2003; 361: countries account for 6,7 million (>60%) of childhood deaths 42 countries account for 90%
5 Global Mortality of Rotavirus Infection Each dot = 1,000 deaths Parashar et al, EID. 2005
6 Millennium Development Goals
7 Rotavirus Vaccine Introduction Rotarix vaccine introduction in Latin America Brazil, Panama, Venezuela: Price of approx $7 per dose for public health use Prices in private market though: approx 90 per dose in France > 120 per dose in Austria Roger Glass, personal communication RotaTeq vaccine introduction in USA: Price of $62.50 per dose
8 Traditional Vaccine Market Development Private Market Low vol High price Low vol High price Mid vol Mid price High Vol Low price capacity $ time R&D clinical manufacture Adapted from W. Vandersmissen, Vaccine 19, 2001
9 Public Sector needs: Rapid high capacity and "mature" price Private Market High Vol Low price Efficiency gained Fund research & clinical studies capacity Help create market $ time R&D clinical manufacture
10 Million doses 200 The Challenge: The Lessons from hepatitis B and Hib vaccines HepB -- all developing countries HepB available in the US The Vaccine Fund established Asian producers enter market GAVI forecasts* HepB -- all developing countries, excluding India, China, Indonesia Hib all developing countries
11 Capacity and Price Industrialised country manufacturers Emerging manufacturers Capacity Market Emerging manufacturers can contribute to: needed capacity (not necessarily always at lower prices) early "maturity" of price (which in turn could increase demand)
12 Rotavirus Vaccine Strains Upstream Rotavirus Vaccines Meeting Meeting in Geneva, March 2006 Vaccine Manufacturers GSK Bio and Merck Emerging Vaccine Manufacturers Rotavirus Vaccine Developers Regulatory authorities Rotavirus experts
13 Other Candidate Live Oral RV Vaccines Vaccine Name Company Strain(s) Lanzhou Lamb LLR Lanzhou Biologicals, China G10,P[12] LLR reassortants LLR + Kantai, China G10,P[12] reassort Indian Neonatal 116E Bharat Biotech Ltd, India G9, P[11] Australian RV3 QIMR/ Biofarma, Indonesia G2, P[6] neonatal Rhesus TV RRV-TV BIOVIRx / IDT, Germany Rhesus + G1,G2, G4 NIH Bovine Reassortant UK Butantan, Brazil Wuhan, Chengdu, China Serum Institute, Shanta Biologicals E, Bharat, India Bovine + G1,G2,G3, G4, ++ reassortant
14 The Return of RotaShield? Vaccine master seeds, dossiers, licenses acquired by BIOVIRx from Wyeth/NIH New safety figures suggested by re-analysis of IS - significantly lower than reported (~1 in 32,000) Most widely studied RV vaccine with full FDA regulatory profile/strains etc IDT- Tornau Germany, partner to produce pilot lots of vaccine Targeting clinical trials in the developing world Seeking FDA licensure Len Ruiz, Geneva, March 2006
15 Lanzhou Lamb Rotavirus (LLR) Lamb rotavirus - G10P[12] strain Licensed in China, 2000 >1,00,000 doses have been administered Single oral dose regimen Given to children up to 10 years of age ~$16 per dose in private market International concerns about safety This vaccine is not pre-qualified (GMP) Randomised, double-blinded efficacy trial is required (GCP) Lanzhou Institute plans to develop a reassortant lamb vaccine candidate (Bai et al, Beijing. October, 2003)
16 Bovine-human Rotavirus Reassortant Vaccine Developed by Al Kapikian, NIAID Tetravalent vaccine tested in Finland Less reactogenic than RRV-TV Efficacy comparable to RRV-TV Courtesy R Glass Possible designer vaccine for different strains Suggested neonatal immunizations Licensed by NIH to 7 companies/3 countries J Infect Dis Sep 1;192 Suppl 1:S22-9.
17 Reassortant bovine-human rotavirus UK Bovine-human rotavirus reassortant strain (UK G6P[7]) Quadrivalent reassortant vaccine (with human rotavirus VP7 genes for G1-G4) Safe and non-reactogenic in phase I trials Satisfactory immunogenicity in phase II trials (Clements-Mann et al, Vaccine 1999; 17: ) Immunogenicity trial in infants administered concomitantly with childhood vaccines Safe and well tolerated after 3 doses at 10 5 ffu Non-inhibitory to other routine childhood vaccine immune responses 95% of infants developed serum neutralizing antibody responses (Clements-Mann et al, Vaccine 2001; 19: )
18 Human Neonatal Strain (RV3) Courtesy G Barnes RV3 neonatal strain Naturally attenuated strain in maternity units Infants followed for 3 years Protected against rotavirus disease G3P[6] - both human rotavirus immunogens Clinical trials with neonatal rotavirus Safe, but low immunogenicity Infants who sero-converted were protected in following year (Barnes et al, Vaccine, 2002) Further development of pilot lots at higher viral concentration with QIMR and transfer to Vero approved cell line Further development as a vaccine candidate with a local manufacturer in Indonesia (BioFarma)
19 Bovine-human rotavirus reassortant neonatal strains Bovine-human rotavirus reassortant strains (116E, I321) Naturally occurring strains in India Bovine / human rotavirus reassortants Collaboration between CDC & Stanford, USA and AIIMS & Bharat BioTech in India to develop this candidate for Indian sub-continent Development funded by PATH
20 Bovine-human rotavirus reassortant neonatal strains Phase I trial in Cincinnati 30 adults, 10 5 ffu of I321, 116E or placebo no virus shedding 2 x seroconversion (both 116E) 2 x mild diarrhoea 30 children 2-12 years 1 x virus shed 4 x seroconversion (all 116E) Glass et al JID 2005:192 (Suppl 1)
21 Parenteral Rotavirus Vaccines VP6 vaccine candidate (Dick Ward) VP7 VP4 VP6 Virus like particles (Margaret Conner) VP2 Inactivated approach (Baoming Jiang)
22 WHO Meeting Recommendations General recommendation that each candidate should be taken forward for clinical evaluation Minimum standard of global expectations for rotavirus vaccine clinical development to ensure that there is not a potential spill over effect of "unforeseen" problems or R&D processes Solid phase I and II development programmes encouraged to ensure international compliance Encourage development of inactivated approaches Recognise that there are National and Institutional prerogatives for rotavirus vaccine R&D Role of WHO DCVMN and DCVRN to alert, influence and assist the R&D process and ultimately prequalification
23 Rotavirus Vaccines Future Introduction and the MDG
New and Underused Vaccines, Rotavirus
New and Underused Vaccines, Rotavirus George Armah Noguchi Memorial Institute for Medical research University of Ghana 10th Annual African Vaccinology Course (VACFA) Cape town, South Africa 10 th to 14
More informationROTAVIRUS VACCINES. Virology
ROTAVIRUS VACCINES Virology Rotavirus is a triple-layers viral particle belonging to the Reoviridae family. It contains 11 segments of double-stranded RNA, of which 6 are structural and 5 are non-structural
More informationRotavirus Vaccines. Gagandeep Kang Christian Medical College Vellore
Rotavirus Vaccines Gagandeep Kang Christian Medical College Vellore Rotavirus disease burden Rotavirus vaccines and candidates Performance of vaccines in developed and developing countries Longitudinal
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 informationRoger I. Glass, M.D., Ph.D. Fogarty International Center, NIH Viral Gastroenteritis Unit, CDC
Roger I. Glass, M.D., Ph.D. Fogarty International Center, NIH Viral Gastroenteritis Unit, CDC International Rotavirus Symposia- A 30 year history 1-4. 1984, 1986, 1989, 1991 NIH Bethesda, MD USA 5. 1995
More informationdeveloping countries in Latin America?
. How have rotavirus vaccines worked in developing countries in Latin America? Brendan Flannery, Pan American Health Organization, Brazil and Lúcia De Oliveira, Immunization Unit/FCH, Washington, DC 9th
More informationCan we improve the performance of live oral rotavirus vaccines?
Can we improve the performance of live oral rotavirus vaccines? Duncan Steele 9 th International Rotavirus Symposium 2 & 3 August 2010, Johannesburg, South Africa Vaccine efficacy against severe rotavirus
More informationHow and Why Vaccines Are Developed by Industry. Stanley A. Plotkin
How and Why Vaccines Are Developed by Industry Stanley A. Plotkin Merieux 2012 1 Why Vaccines are Different than Drugs 1) Given to healthy people, high safety required 2) Larger governmental role 3) Low
More informationStatus of Vaccine Research and Development of Next-generation Rotavirus Vaccines Prepared for WHO PD-VAC
Status of Vaccine Research and Development of Next-generation Rotavirus Vaccines Prepared for WHO PD-VAC I. About the Disease and Pathogen Basic information on pathogen, including transmission, estimated
More informationRotavirus Vaccines for Infants in Developing Countries in Africa and Asia: Considerations from a World Health Organization Sponsored Consultation
SUPPLEMENT ARTICLE Rotavirus Vaccines for Infants in Developing Countries in Africa and Asia: Considerations from a World Health Organization Sponsored Consultation A. Duncan Steele, 1,2 Manish Patel,
More informationA Human Rotavirus Vaccine
7th International Rotavirus Symposium Lisbon, Portugal, 12-13 June 2006 A Human Rotavirus Vaccine Dr. Béatrice De Vos GlaxoSmithKline Biologicals Rixensart, Belgium Rotarix is a trade mark of the GlaxoSmithKline
More informationCorrelates of efficacy for human rotavirus vaccines Value of anti-rotavirus immunoglobulin A antibody concentrations
Correlates of efficacy for human rotavirus vaccines Value of anti-rotavirus immunoglobulin A antibody concentrations Brigitte Cheuvart, Kathleen M. Neuzil, Duncan Steele, Nigel Cunliffe, Shabir A. Madhi,
More informationImpact of withholding breastfeeding around the time of Rotarix vaccination on the immunogenicity of Rotarix vaccine A Randomized Trial
Impact of withholding breastfeeding around the time of Rotarix vaccination on the immunogenicity of Rotarix vaccine A Randomized Trial S. Asad Ali, MD, MPH Department of Pediatrics and Child Health Aga
More informationINFORMATION SHEET OBSERVED RATE OF VACCINE REACTIONS ROTAVIRUS VACCINE
Global Vaccine safety Essential Medicines & Health Products 20, Avenue Appia, Ch- 1211 Geneva 27 INFORMATION SHEET OBSERVED RATE OF VACCINE REACTIONS ROTAVIRUS VACCINE June 2018 Types of vaccines Rotaviruses
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 informationVaccines for preventing rotavirus diarrhoea: vaccines in use (Review)
Vaccines for preventing rotavirus diarrhoea: vaccines in use (Review) Soares-Weiser K, MacLehose H, Bergman H, Ben-Aharon I, Nagpal S, Goldberg E, Pitan F, Cunliffe N This is a reprint of a Cochrane review,
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 informationAccelerating the Introduction of Rotavirus Vaccines into GAVI-Eligible Countries
Accelerating the Introduction of Rotavirus Vaccines into GAVI-Eligible Countries Investment Case for GAVI Secretariat Submitted by PATH s Rotavirus Vaccine Program in collaboration with WHO and the US
More informationA NEW PARADIGM FOR TRANSLATIONAL VACCINE DEVELOPMENT. Introducing the Gates Medical Research Institute
A NEW PARADIGM FOR TRANSLATIONAL VACCINE DEVELOPMENT Introducing the Gates Medical Research Institute MY JOURNEY A NEW PARADIGM FOR TRANSLATIONAL VACCINE DEVELOPMENT Introducing the Gates Medical Research
More informationVaccines against Rotavirus & Norovirus. Umesh D. Parashar CDC, Atlanta, GA
TM Vaccines against Rotavirus & Norovirus Umesh D. Parashar CDC, Atlanta, GA 1 Rotavirus is the Leading Cause Of Severe Diarrhea in Children
More informationReport of the Regulatory Forum on Update on Clinical Experience with Rotavirus Vaccines
Report of the Regulatory Forum on Update on Clinical Experience with Rotavirus Vaccines Held during the Sixth Meeting of the Developing Countries Vaccine Regulator's Network (DCVRN) 23 May 2007 Brasilia,
More informationWill live oral vaccines work in children in the developing world? Martin Friede Ph.D. Initiative for Vaccine Research
Will live oral vaccines work in children in the developing world? Martin Friede Ph.D. Initiative for Vaccine Research Estimated global distribution of the 600,000 annual deaths caused by rotavirus 2 1
More informationROTAVIRUS VACCINES FOR AUSTRALIAN CHILDREN: INFORMATION FOR GPS AND IMMUNISATION PROVIDERS
ROTAVIRUS VACCINES FOR AUSTRALIAN CHILDREN: INFORMATION FOR GPS AND IMMUNISATION PROVIDERS Summary Rotavirus is the most common cause of severe gastroenteritis in infants and young children, accounting
More information8 th INTERNATIONAL ROTAVIRUS SYMPOSIUM
PROCEEDINGS FROM THE 8 th INTERNATIONAL ROTAVIRUS SYMPOSIUM June 3 4, 2008 Istanbul, Acknowledgements The Symposium Organizing Committee wishes to thank the following organizations for support of the 8th
More informationGlobal Impact of Enteric Disease Deaths in young children
1 Global Impact of Enteric Disease Deaths in young children 2 Average of 2.2 million deaths per year worldwide Typhoid 600 000 Cholera 120 000 ETEC 380 000 Rotavirus 450 000 Shigella 670 000 WHO, 2000
More informationRotavirus: WHO Global Recommendations, Policy, and Surveillance
Rotavirus: WHO Global Recommendations, Policy, and Surveillance 9 th International Rotavirus Symposium 2 August 2010 Mary Agócs, MD, MSc Department of Immunization, Vaccines & Biologicals From 1999 2009:
More informationFrom development to delivery: Decision-making for the introduction of a new vaccine
From development to delivery: Decision-making for the introduction of a new vaccine Prince Mahidol Award Conference Bangkok, Thailand 1-2 February 2007 Dr. J.M. Okwo-Bele Department of Immunization, Vaccines
More information!!!!!! *+*,+-./+,.- 0+! 12! February 2005
!!!!!! "#!"#! $%&'(() *+*,+-./+,.- 0+! 12! February 2005 Disclaimer: This publication contains the collective views of an international group of experts 1 Summary WHO develops international technical specifications
More informationProtecting people against known and emerging infectious diseases globally
Protecting people against known and emerging infectious diseases globally 18 October 2017 SAGE Geneva By Mahima Datla President, DCVMN 1 Agenda Introduction to DCVMN DCVMN s contributions Suggested areas
More informationViral Agents of Paediatric Gastroenteritis
Viral Agents of Paediatric Gastroenteritis Dr Carl Kirkwood -------------------- Enteric Virus Research Group Murdoch Childrens Research Institute Royal Children s Hospital Victoria. WHO Collaborating
More informationTHE WITHDRAWL OF THE ROTASHIELD ROTAVIRUS VACCINATION DUE TO AN ASSOCIATION WITH INTUSSUSCEPTION: FACT OR FICTION?
THE WITHDRAWL OF THE ROTASHIELD ROTAVIRUS VACCINATION DUE TO AN ASSOCIATION WITH INTUSSUSCEPTION: FACT OR FICTION? Ramin Shadman, Vaccine Revolution, Stanford University, 2000 Abstract - Rotavirus exists
More informationUpdate on Pentavalent Human-Bovine Rotavirus Vaccine. Michelle Goveia, MD, MPH Medical Director MSD Vaccines India, September 2014
Update on Pentavalent Human-Bovine Rotavirus Vaccine Michelle Goveia, MD, MPH Medical Director MSD Vaccines India, September 2014 Outline Characteristics of RotaTeq and its worldwide use Recent data evaluating
More informationIndustry Perspective: Strategies and costs associated with increasing seasonal influenza vaccine. since 2006
Industry Perspective: Strategies and costs associated with increasing seasonal influenza vaccine use from high to low income countries since 2006 Dr. Michael Watson, sanofi-pasteur on behalf of WHO GAP
More informationA Briefing Paper on Rotavirus
COMMON VIRUS AND SENSELESS KILLER: A Briefing Paper on Rotavirus DIARRHEA KILLS. MOTHERS IN THE WORLD S POOREST COUNTRIES KNOW THIS ALL TOO WELL. It s a fact few people in wealthier nations realize. Rotavirus
More informationReport to the Board. Typhoid vaccines: WHO Position paper. Weekly epidemiological record. 2008; 6: ibid
Annex B: Background and Overview of Analyses Gavi s Historical Decisions on TCV In the 2008 VIS, the Board prioritised TCVs for Gavi s portfolio along with Rubella, HPV, and JE vaccines. Although no financial
More informationMedia Coverage World Health Organisation Grants Prequalification to Bharat Biotech s rotavirus vaccine, ROTAVAC(R)
Media Coverage World Health Organisation Grants Prequalification to Bharat Biotech s rotavirus vaccine, ROTAVAC(R) 1) Business Wire World Health Organization Grants Prequalification to Bharat Biotech s
More informationDengue Vaccine Butantan Institute. DCVMN, Bangkok, 2015
Dengue Vaccine Butantan Institute DCVMN, Bangkok, 2015 GENOME Dengue Viruses Dengue is a mosquito-borne RNA virus with 4 distinct serotypes: 1,2,3,and 4 3 structural proteins: C, prm, and E E protein is
More informationManaging cost considerations and access to technology for cost effective vaccine manufacture in developing countries.
Managing cost considerations and access to technology for cost effective vaccine manufacture in developing countries. Amol R. Dindokar Serum Institute of India ltd. Overview Disease Control Priorities
More informationGSK VACCINES: KEY GROWTH DRIVERS
GSK VACCINES: KEY GROWTH DRIVERS Martin Andrews Senior Vice President, Global Vaccines Centre of Excellence, GSK Biologicals Millions of children die from infectious diseases Many of these deaths are preventable
More informationInnovations in Human Papillomavirus Vaccine
Oct 2014 Life Health Innovations in Human Papillomavirus Vaccine Innovation 1 Topics 1. Current HPV vaccines 2. New development 3. What s next? 2 PART I CURRENT HPV VACCINES 3 Worldwide incidence of cervical
More informationThis PDF is available for free download from a site hosted by Medknow Publications
252 Indian Journal of Medical Microbiology, (2006) 24 (4):252-7 Review Article ROTAVIRUS VACCINES G Kang Abstract Rotavirus, the most common cause of severe diarrhea and a leading cause of mortality in
More informationUpdates on Rotasiil development
Updates on Rotasiil development 13 th International Rotavirus Symposium Minsk, Belarus 30 August 2018 Dr Sajjad Desai MD Serum Institute of India Pvt Limited, Pune Rotasiil Bovine-human reassortant strains
More informationFecal shedding of rotavirus vaccine in premature babies in the neonatal unit
Fecal shedding of rotavirus vaccine in premature babies in the neonatal unit Dr. Manish Sadarangani Director, Vaccine Evaluation Center, BC Children s Hospital Research Institute Assistant Professor, Division
More informationBuilding the Evidence for Rotavirus Immunization
Roger Glass Lecture Building the Evidence for Rotavirus Immunization Duncan Steele Bill & Melinda Gates Foundation 11 th International Rotavirus Symposium Delhi, India. 3-5 September, 2014 Building the
More informationNVI Experience and Concept of Central Technology Hub
NVI Experience and Concept of Central Technology Hub Jan Hendriks Netherlands Vaccine Institute (NVI) MSF/Oxfam Consultation improving access and stimulating vaccine development for use in resource pour
More informationDengue Vaccines: current status of development
Dengue Vaccines: current status of development ISID-NTD 2011 International Meeting, Boston Satellite Symposium on Dengue Control, 10 July 2011 Pem Namgyal WHO/IVB/IVR 1 Presentation Outline! Summary of
More informationConclusions and Recommendations of the Experts Meeting on Rotavirus Genotypes in the Region of the Americas
Conclusions and Recommendations of the Experts Meeting on Rotavirus Genotypes in the Region of the Americas Eyal Leshem December 9, 2013 National Center for Immunization & Respiratory Diseases Division
More informationProspective Models of Vaccine Security Collaborations in Research and Development
Prospective Models of Vaccine Security Collaborations in Research and Development Georges Thiry, PhD IVI (International Vaccine Institute) Phuket, Oct 01, 2014 Content R&D Examples of collaborations from
More informationRoger I. Glass, M.D., Ph.D. Director, Fogarty International Center Associate Director for International Research, NIH
Rotavirus Vaccines: Prioritization for Introductions- National & International Case Studies Fondation Merieux Conference Center November 27, 2012 Roger I. Glass, M.D., Ph.D. Director, Fogarty International
More informationTraining in Infectious Diseases Modeling. A reflection on vaccination as a disease control measure
Training in Infectious Diseases Modeling A reflection on vaccination as a disease control measure -Example of Rotavirus disease- Participant s Guide Adapted by Nathalie Elomeiri; Camelia Savulescu; Fernando
More informationPneumococcal Symposium
3 rd Regional Pneumococcal Symposium 13-14 14 February 2008 Istanbul, Turkey Dr. Akira Homma Bio-Manguinhos, Fiocruz DCVMN Developing Countries Vaccine Manufacturers Network -DCVMN- Formed in 2000, Bandung,
More informationBurden of Rotavirus in India - Is Rotavirus Vaccine an Answer to It?
Special Article Burden of Rotavirus in India - Is Rotavirus Vaccine an Answer to It? *Davendra K. Taneja 1, Akash Malik 2 1 Professor, 2 P.G.T, Department of Community Medicine, Maulana Azad Medical College,
More informationRotavirus vaccines: Issues not fully addressed in efficacy trials
Rotavirus vaccines: Issues not fully addressed in efficacy trials TM Umesh D. Parashar Lead, Viral Gastroenteritis Team CDC, Atlanta, USA uparashar@cdc.gov 1 Two New Rotavirus Vaccines Licensed in 2006
More informationMonitoring For Rotavirus Serotypes In The Americas. Jon Gentsch
Monitoring For Rotavirus Serotypes In The Americas Jon Gentsch Centers for Disease Control and Prevention, Atlanta, USA * The findings and conclusions in this presentation are those of the authors and
More informationMVP as an example of a project managed approach to develop a needed vaccine
MVP as an example of a project managed approach to develop a needed vaccine Marc LaForce, MVP/PATH MSF/Oxfam consultation: improving access and stimulating vaccine development Geneva, January 26, 2010
More informationApproaches to Assessing Intussusception Risk in Developing Countries
Approaches to Assessing Intussusception Risk in Developing Countries Jacqueline Tate Centers for Disease Control and Prevention Atlanta, GA, USA National Center for Immunization & Respiratory Diseases
More informationChikungunya Vaccines in the Pipeline
Chikungunya Vaccines in the Pipeline Health impact Public health burden : 1.3 billion people live in areas endemic for Chikungunya. Prevalent in ~60 countries over the world Has high attack rates and the
More informationOutline. Role of Developing Country Vaccine Industry For Meeting Global Vaccine Needs. Immunization Landscape ADVAC 2013
Role of Developing Country Vaccine Industry For Meeting Global Vaccine Needs ADVAC 2013 Dr. Suresh Jadhav Executive Director Serum Institute of Limited Maharashtra,, 411028 ssj@seruminstitute.com France,
More informationCommon Virus and Senseless Killer: A Briefing Paper on Rotavirus
Common Virus and Senseless Killer: A Briefing Paper on Rotavirus Diarrhea kills. Mothers in the world s poorest countries know this all too well. It s a fact few people in wealthier nations realize. Rotavirus
More informationNew vaccine technologies: Promising advances may save more lives
New vaccine technologies: Promising advances may save more lives Vaccine Technology III June 10, 2010 PATH s vision A world where innovation ensures that health is within reach for everyone. 2 PATH s mission
More informationDealing with Post-market Issues: PCV Case Study
Dealing with Post-market Issues: PCV Case Study CASE STUDY: Adventitious agent in raw material ISSUE: Presence of porcine circovirus (PCV-1) DNA detected in marketed rotavirus vaccine by an independent
More informationStatus of SII Bovine Rotavirus Pentavalent Vaccine (BRV-PV)
Status of SII Bovine Rotavirus Pentavalent Vaccine (BRV-PV) Dr Prasad Kulkarni, MD Serum Institute of India Limited Pune Rotavirus symposium, 03 September 2014, New Delhi 03 September 2014 1 Origins of
More informationQuestions and answers relating to finding of DNA fragments of a porcine circovirus in Rotarix vaccine
21 April 2010 Questions and answers relating to finding of DNA fragments of a porcine circovirus in Rotarix vaccine What is the issue? A United States academic research team discovered the presence of
More informationValue of post-licensure data to assess public health value Example of rotavirus vaccines
Value of post-licensure data to assess public health value Example of rotavirus vaccines TM Umesh D. Parashar Lead, Viral Gastroenteritis Team CDC, Atlanta, USA uparashar@cdc.gov 1 Two New Rotavirus Vaccines
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 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 informationECONOMICS OF THE VACCINE MARKET: SIZE, GROWTH AND REVENUES
ECONOMICS OF THE VACCINE MARKET: SIZE, GROWTH AND REVENUES 1 Relationship between research funding and burden of disease Source: Global Forum for Health Research Monitoring Financial Flows for Health Research
More informationRotarix : Global Efficacy against Severe RV GE due to G1 and non-g1 (G2, G3, G4, G9) RV Types
Rotarix : Global Efficacy against Severe RV GE due to G1 and non-g1 (G2, G3, G4, G9) RV Types 8 th International Rotavirus Symposium Istanbul, 3 rd June 2008 Dr. Norman Begg, Vice President, Clinical Development
More informationEPIDEMIOLOGICAL STUDIES
EPIDEMIOLOGICAL STUDIES EPIDEMIOLOGIC STUDIES EPIDEMIOLOGIC STUDIES 8 Clinical Trial sites in Brasil (NICHD) Transfusion recipient study (NHLBI) Prospective study in Brasil (Yale) Natural history population
More informationSUPPLEMENT ARTICLE. of Africa and Asia. The highest rates of rotavirus-associated mortality occur in sub-saharan Africa, where
SUPPLEMENT ARTICLE Comparison of 2 Different Regimens for Reactogenicity, Safety, and Immunogenicity of the Live Attenuated Oral Rotavirus Vaccine RIX4414 Coadministered with Oral Polio Vaccine in South
More informationVaccine Research Center, University of Tampere Medical School, Tampere, Finland; 2 Wyeth Vaccine Research, Pearl River, New York; 3
MAJOR ARTICLE Safety, Efficacy, and Immunogenicity of 2 Doses of Bovine-Human (UK) and Rhesus Rhesus-Human Rotavirus Reassortant Tetravalent s in Finnish Children Timo Vesikari, 1 Aino V. Karvonen, 1 Jukka
More informationDevelopment of Vaccine Security at the Regional Level
Workshop among ASEAN countries on Opportunities for Regional Vaccine Security September 30 to October 3, 2014, Cape Panwa, Phuket, Thailand Development of Vaccine Security at the Regional Level Stephane
More informationExperience of Pentavalent Human-bovine Reassortant Rotavirus Vaccine Among Healthy Infants in Taiwan
ORIGINAL ARTICLE Experience of Pentavalent Human-bovine Reassortant Rotavirus Vaccine Among Healthy Infants in Taiwan Chien-Chih Chang, 1 Mei-Hwei Chang, 1 * Tzou-Yen Lin, 2 Hong-Chang Lee, 3 Wu-Shiun
More informationShabir A. Madhi. Progress and Challenges of Immunization Contributing Toward Attaining the MDG Goal to Reduce under-5 Childhood Mortality.
Shabir A. Madhi Progress and Challenges of Immunization Contributing Toward Attaining the MDG Goal to Reduce under-5 Childhood Mortality. National Institute for Communicable Diseases & University of Witwatersrand,
More informationThe Pentavalent Rotavirus Vaccine, RotaTeq : From Development to Licensure and Beyond
The Pentavalent Rotavirus Vaccine, RotaTeq : From Development to Licensure and Beyond Max Ciarlet, PhD Vaccines Clinical Research Department Merck Research Laboratories North Wales, Pennsylvania, United
More informationDr Michelle Groome MBBCh (Wits) DCH(SA) MScMed (Epi & Biostats) Department of Science and Technology/National Research Foundation: Vaccine
Dr Michelle Groome MBBCh (Wits) DCH(SA) MScMed (Epi & Biostats) Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases; Medical Research Council: Respiratory and
More informationDCVMN AND VACCINE SECURITY IN ASEAN REGION. ASEAN Countries on Opportunities for Regional Vaccine Security 1-3 October, 2014.
DCVMN AND VACCINE SECURITY IN ASEAN REGION ASEAN Countries on Opportunities for Regional Vaccine Security 1-3 October, 2014. Phuket - Thailand Developing Countries Vaccine Manufacturers Network (DCVMN)
More informationVaccines, Not Just for Babies
Vaccines, Not Just for Babies Meg Fisher, MD Medical Director Disclosures I have no relevant financial relationships with the manufacturers of any commercial products or commercial services discussed in
More informationROTAVIRUS COMMON, SEVERE, DEVASTATING, PREVENTABLE [ ] THE LATEST EVIDENCE & WHAT S NEEDED TO STOP ILLNESSES AND DEATHS
ROTAVIRUS COMMON, SEVERE, DEVASTATING, PREVENTABLE [ ] THE LATEST EVIDENCE & WHAT S NEEDED TO STOP ILLNESSES AND DEATHS ROTACOUNCIL.ORG Table of contents Introduction...4 What is rotavirus?... 5 Vaccines:
More informationVaccine Development in the Developing World; past, present and future: SEAR Perspective
Speech by Dr Samlee Plianbangchang Regional Director, WHO South-East Asia Vaccine Development in the Developing World; past, present and future: SEAR Perspective 15 June 2010 Bangkok, Thailand Vaccine
More informationWHO VACCINE SUPPLY & QUALITY SUPPORT FOR NATIONAL IMMUNIZATION PROGRAMMES
WHO VACCINE SUPPLY & QUALITY SUPPORT FOR NATIONAL IMMUNIZATION PROGRAMMES Immunization and vaccine development in the last decade Since the Millennium Summit in 2000, immunization substantial international
More informationLicensed Vaccines That Are Not Being Used Widely in LDCs
Licensed Vaccines That Are Not Being Used Widely in LDCs Cholera: rbs-wc, WC Hepatitis A: Inactivated Hib: PRP-conjugates HPV: VLP JE: Inactivated, live-attenuated MMR: Live-attenuated Meningococcal: Conjugate
More informationSummaries of Complementary Presentations on Agenda Item:
Summaries of Complementary Presentations on Agenda Item: WHO s Role in Supporting Emerging Vaccine Manufacturers To inform the SAGE discussion on this agenda item, four presentations have been solicited
More informationProgress under GAP Pillar 2 "Increase Production Capacity" Contribution of the WHO Technology Transfer Programme. Martin Friede
Progress under GAP Pillar 2 "Increase Production Capacity" Contribution of the WHO Technology Transfer Programme Martin Friede Global influenza vaccine production capacity since 2006 Cantacuzino Romania
More informationGAVI ALLIANCE: UPDATE AND FUTURE DIRECTIONS FOR GLOBAL VACCINES AND IMMUNISATIONS
GAVI ALLIANCE: UPDATE AND FUTURE DIRECTIONS FOR GLOBAL VACCINES AND IMMUNISATIONS Ranjana Kumar International Rotavirus Symposium Istanbul, 3 4 June 2008 The GAVI Alliance Public-private partnership bringing
More informationThe Pediatric Dengue Vaccine Initiative (PDVI) Thailand, 2007
The Pediatric Dengue Vaccine Initiative (PDVI) Thailand, 2007 The Vaccine Enterprise-the the disease Clinical data Surveillance data Laboratory data/diagnostics Input, analysis and reporting The Vaccine
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 informationMichel BAIJOT Vice President, WW Business Development & Strategic Alliances
Technology Transfer and Vaccines: The GSK Experience WHO Workshop on Technology Transfer for Local Manufacturing Capacity of Vaccines Geneva, November 30th, 2010 Michel BAIJOT Vice President, WW Business
More informationRotavirus Vaccines: an Overview
CLINICAL MICROBIOLOGY REVIEWS, Jan. 2008, p. 198 208 Vol. 21, No. 1 0893-8512/08/$08.00 0 doi:10.1128/cmr.00029-07 Copyright 2008, American Society for Microbiology. All Rights Reserved. Rotavirus Vaccines:
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 informationcorrespondence Rotavirus Vaccines
correspondence Rotavirus Vaccines To the Editor: The rotavirus vaccines in the clinical trials reported on by Ruiz-Palacios and colleagues and Vesikari and colleagues (Jan. 5 issue) 1,2 may reduce mortality
More informationBangladesh: How to move from data to implementation. K. Zaman, MBBS, PhD Senior Scientist and Epidemiologist icddr,b
Bangladesh: How to move from data to implementation K. Zaman, MBBS, PhD Senior Scientist and Epidemiologist icddr,b Rotavirus in Bangladesh Estimated 2.4 million cases of rotavirus diarrhoea annually in
More informationGSK s Candidate Influenza A (H5N1) Virus Monovalent Vaccine
GSK s Candidate Influenza A (H5N1) Virus Monovalent Vaccine Regulatory Pathway for Licensure VRBPAC, February 29, 2012 Katalin Abraham, Director, US Regulatory Affairs GSK Biologicals GSK s Influenza Vaccines
More informationYellow Fever Vaccine: Current Outlook. UNICEF Supply Division
Yellow Fever Vaccine: Current Outlook UNICEF Supply Division March 2015 0 Yellow Fever Vaccine - Current Outlook March 2015 This update provides revised information on the continued constrained 2014-2017
More informationIntroduction and overview of the program; new vaccine pipeline and prioritization process
Immunization for the Modern Family: Western Canada Immunization Forum 2011 Introduction and overview of the program; new vaccine pipeline and prioritization process Monika Naus, MD, MHSc, FRCPC, FACPM
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 informationQuality assurance for essential medicines and health products: moving towards an harmonized approach
Quality assurance for essential medicines and health products: moving towards an harmonized approach Prequalification of vaccines David Wood QSS/EMP/WHO 12 December 2012 A growing portion of vaccines procured
More informationDisease Control Priorities. Presentation Sub-title Seventh International Rotavirus Symposium Lisbon June 12, 2006
Disease Control Priorities and Rotavirus Presentation Vaccines Title Presentation Sub-title Seventh International Rotavirus Symposium Lisbon June 12, 2006 1 What is the DCPP? DCPP is an alliance of organizations
More informationNew Vaccines in SA. Regulatory Perspectives James Southern 2015
New Vaccines in SA Regulatory Perspectives James Southern 2015 Outline Regulatory Environment of new vaccines Clinical Trials Application procedures HIV Vaccines Other new vaccines in development Ongoing
More information