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Report to SAGE on Achievement of Previous Recommendations & Progress Highlights Report to SAGE on achievement of previous recommendations & Progress highlights SAGE Meeting, 27-29 October 2009 J.M. Okwo-Bele, WHO Outline Follow-up of previous meetings and recommendations Pneumococcal conjugate vaccines Japanese Encephalitis HPV vaccine Rotavirus vaccines Hepatitis B Lower middle-income countries (LMICs) financing Update on latest global developments Briefs on WHO/IVB Department activities State of the worlds vaccines and immunization 3rd Edition (SOWVI) Strategic plan 2010-15 Addressing Stakeholders' panel recommendations Technologies & Logistics Advisory Committee Topics on the horizon for SAGE meetings 2 | SAGE meeting, 27-29 October 2009 Pneumococcal Conjugate Vaccine, 2009 29 countries have introduced PCV7, including Rwanda in Apr 09 and the Gambia through Wyeth donation and GAVI support 14 countries (11 GAVI eligible) interested to introduce PCV10 or PCV13 9 new applications to GAVI in Oct 2009 * Honduras, Panama and Saudi Arabia **For Barbados, Costa Rica, have the vaccine in their schedule in Mexico, Micronesia, New Zealand 2008 for risk groups only and Sweden and Palau: data not confirmed. has it in parts of the country No (78 countries or 40%) Introduction in 2009 or GAVI Approved* (14 countries or 7%) Yes** (26 countries or 13%) Applied for GAVI Support – Not yet Approved (3 countries or 2%) Yes part of the country (3 countries or 2%) Never Applied for GAVI Support (58 countries or 31%) Yes risk groups (11 countries or 6%) The boundaries and names shown and the designations used on this map do Source: WHO/IVB database, 193 WHO Member States. Data not imply the expression of any opinion whatsoever on the part of the as of June 2009 World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of 3 | SAGE meeting, 27-29 October 2009 its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. © WHO 2009. All rights reserved Pneumococcal Vaccines Introduction… . Availability of Vaccines - GSK PCV10 licensed by EMEA, Canada, Australia; review for prequalification (PQ) nearing completion; concerns about risks of misuse of a 2-dose preservative free presentation - Wyeth PCV13 submitted for licensure to EMEA plus US FDA fast track designation; Submitted for WHO prequalification expected by Q3/2010 . GAVI support - Advanced Market Commitment (PCV10 and PCV13) signed 12th June 09 - Partnership efforts through Accelerated Vaccine Introduction Initiative . Global Action Plan for Pneumonia Prevention and Control (GAPP) - Launch planned for 2nd Nov 09 - Protect – Prevent – Treat 4 | SAGE meeting, 27-29 October 2009 SA 14‐14‐2 JE vaccine clinical trials overview Objecve Results Philippines, 2005, PATH/CDIBP Low, but stat. significant interference observed on MV GMT and sero‐ JE/MV co‐administraon conversion rates (4%, CI 1‐6) at 1 month; considered acceptable by GACVS; GMT differences disappear aer 1 year (PATH). Measles serology will be repeated and data will be available Dec 2009 for review. No safety concerns. Single dose SA‐14‐14‐2 immunogenic as of 8 months. Sri‐Lanka, 2007, PATH/CDIBP/MoH This co‐administraon study has less power than the above – suggest JE/MV co‐admin and boosng mouse similar immunogenicity and no safety concern (PATH). Single brain vaccine immunity dose SA 14‐14‐2 boosts pre‐exisng JE immunity (PATH) India, 2007 ‐ CDIBP Very low viraemia acvity post injecon Viraemia in adults (1+/24 at day 8) as expected from animal data (PATH). India, 2007 – Univ Lucknow 6 months post single dose vaccinaon, age 1‐15Y, effecveness 94.5% Case control effecveness (81.5–98.9) India, 2009 – ICMR 2 States India, 201 cases and 804 controls aged 1‐15Y post Case control effecveness vaccinaon campaign – results pending 5 | SAGE meeting, 27-29 October 2009 ChengDu Institute of Biological Products (CDIBP) Facility Construction • New production facility will ensure a sufficient, sustainable, and affordable SA 14-14-2 vaccine supply to meet growing regional demand (initial capacity >70 millions doses) • Training to build capacity on compliance with international standards for current Good Manufacturing Practices since last 2.5 years • Facility online and producing vaccine by Q2 2011, pending China NRA New JE vaccine production building in Chengdu functionality Source: Dr Mansour Yaïch [email protected] 6 | SAGE meeting, 27-29 October 2009 CHINA: Proposed Road Map towards meeting NRA critical indicators and pathway for prequalification of JE vaccines Task Force WHO Follow WHO Follow WHO Follow WHO established up visit up visit up visit formal assessment Workshop on Regulatory NRA Inspection Training assessment on risk based tools inspections Inventory of Training on quality Management system PMS/AEFI Gathering evidence for NRA indicators and Uploading information onto sharepoint WHO GMP observed audits Septept 0ct Nov Dec Jan Feb March Apr May June Jul Aug Sept 2009 2010 7 | SAGE meeting, 27-29 October 2009 Other Japanese Encephalis Vaccines Biken: BK‐VJE strain Beijing‐1 on Vero cells inacvated Licensed 2009 in Japan, producon for domesc use only Three dose primary immunizaon Intercell: Ixiaro, strain SA‐14‐14‐2 on Vero cells, adjuvanted inacvated Licensed 2009 US, EU, Australia for travellers market; Endemic country market in Joint Venture with Biological E Ltd of India, licensure 2010‐2011? Two dose primary immunizaon Sanofi: Imojev, chimeric YF17D/SA‐14‐14‐2 on Vero cells, live License applicaon submied 2009 in Thailand and Australia Joint Venture for producon in Thailand Single dose primary immunizaon 8 | SAGE meeting, 27-29 October 2009 HPV Vaccine Status . HPV vaccine Implementation: - 22 countries using HPV (up from 10 in 2007) - GSK Cervarix vaccine WHO prequalified since July 2009 - PATH reports on demonstration projects India, Peru, Uganda and VietNam (http://www.path.org/publications/) - Merck & Qiagen donation of vaccine (5M doses) and screening kits (1.5M) . HPV Monitoring & Surveillance Meetings (May & Nov 2009): . WHO/UNFPA/GAVI High-level Meeting (1 Dec 2009): - Commitment for comprehensive approach (vaccine, screening , treatment) - Programmatic and Financing considerations 9 | SAGE meeting, 27-29 October 2009 HPV Research: Malmö International Conference on HPV (May 2009) HIV and HPV vaccination: – Preliminary data from immunogenicity/safety study with the bivalent vaccine in HIV positive 7-12-year old boys and girls receiving optimal antiretroviral treatment showed that at 7 months follow-up: • no evidence of a lower antibody response • no safety concerns • no negative impact on the HIV viral load or T-cell count Alternative schedules: – Preliminary data which compared a 2-dose regimen with a 3-dose regimen for the quadrivalent vaccine showed no difference in antibody levels at 7 months follow-up 10 | SAGE meeting, 27-29 October 2009 Rotavirus Vaccines : Clinical trials of in Asia and Africa Included over 12,000 children Conducted in populations from 7 countries with diversity in regard to socioeconomic parameters, HIV prevalence and circulating rotavirus strains Mali Trials designed to simulate “real world conditions” with no restrictions Ghana Kenya on OPV co-administration and breastfeeding Malawi GSK-RVP partnership South Merck-RVP partnership Africa 11 | SAGE meeting, 27-29 October 2009 Efficacy against severe rotavirus gastroenteritis in the first year of life, by region Region Vaccine VE 95% CI Countries RotarixTM Malawi, South 61.7 44.0, 73.2 Africa Africa Africa RotaTeq® Ghana, Kenya, 64.2 40.2, 79.4 Mali Asia RotaTeq® Bangladesh, 51.0 12.8, 73.3 Vietnam WER No. 23, 5th June 2009 5th International Conference on Vaccines for Enteric Diseases, Malaga, Spain, September 9, 2009 12 | SAGE meeting, 27-29 October 2009 Efficacy against severe rotavirus gastroenteritis in the first year of life, by mortality quartile WHO Under-5 child Countries where studies mortality Efficacy Estimates mortality performed strata Highest HIGH 50-64% Ghana, Kenya, Malawi, Mali (top 25%) INTER- High mid Bangladesh, South Africa 46-72% MEDIATE (next 25%) Low mid Vietnam 72 - 85% (next 25%) Multiple countries in Americas LOW Least Multiple countries in 85 – 100% (lowest 25%) Americas, Europe, WPRO 13 | SAGE meeting, 27-29 October 2009 Integrated approach to diarrhoea control . Vaccine efficacy against severe GE episodes due to any cause: 23% - 59% . Release of the UNICEF/WHO report “Diarrhoea: Why Children Are Still Dying and What Can Be Done” - Low osmolarity ORS and zinc - Rotavirus vaccine - Exclusive breastfeeding - Vitamin A supplementation - Handwashing with soap - Household water treatment and safe storage systems - Stop community-wide open defecation 14 | SAGE meeting, 27-29 October 2009 Other SAGE Recommendations Hepatitis B vaccines – EB review of a technical paper with input from 5 clusters (January 2010) – In October 2009, Regional Committee in EMR adopted target of reduction in the prevalence of chronic hepatitis B virus infection to <1% among children >5 years by 2015 Access to new vaccines in lower middle-income countries – New initiative of pooled procurement under discussions for EMR – BMGF funded study on LMICs and new vaccines to be launched in November (WHO coordinating), with results and recommendations to SAGE in 2010 – GAVI eligibility criteria and tiered-pricing issues // healthy market discussions 15 | SAGE meeting, 27-29 October 2009 RV144: HIV-1 Prime-Boost Vaccine Trial Source: Dr Jerome Kim from Walter Reed Trial Description Vaccine
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