report to sage on achievement of previous recommendations ... · 19 | sage meeting, 27-29 october...
TRANSCRIPT
Report to SAGE on achievement of previous recommendations
& Progress highlights
SAGE Meeting, 27-29 October 2009
J.M. Okwo-Bele, WHO
SAGE meeting, 27-29 October 2009 2 |
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
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Pneumococcal Conjugate Vaccine, 2009
Source: WHO/IVB database, 193 WHO Member States. Data as of June 2009
The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of 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
No (78 countries or 40%)
Yes** (26 countries or 13%)
Yes part of the country (3 countries or 2%)
Yes risk groups (11 countries or 6%)
Introduction in 2009 or GAVI Approved* (14 countries or 7%)
Applied for GAVI Support – Not yet Approved (3 countries or 2%)
Never Applied for GAVI Support (58 countries or 31%)
* Honduras, Panama and Saudi Arabia have the vaccine in their schedule in 2008 for risk groups only and Sweden has it in parts of the country
**For Barbados, Costa Rica, Mexico, Micronesia, New Zealand and Palau: data not confirmed.
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
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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
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SA14‐14‐2JEvaccineclinicaltrialsoverview
ResultsObjec,ve
Low,butstat.significantinterferenceobservedonMVGMTandsero‐conversionrates(4%,CI1‐6)at1month;consideredacceptablebyGACVS;GMTdifferencesdisappearaOer1year(PATH).MeaslesserologywillberepeatedanddatawillbeavailableDec2009forreview.Nosafetyconcerns.SingledoseSA‐14‐14‐2immunogenicasof8months.
Philippines,2005,PATH/CDIBPJE/MVco‐administra,on
Thisco‐administraZonstudyhaslesspowerthantheabove–suggestsimilarimmunogenicityandnosafetyconcern(PATH).SingledoseSA14‐14‐2boostspre‐exisZngJEimmunity(PATH)
Sri‐Lanka,2007,PATH/CDIBP/MoHJE/MVco‐adminandboos,ngmouse
brainvaccineimmunity
VerylowviraemiaacZvitypostinjecZon(1+/24atday8)asexpectedfromanimaldata(PATH).
India,2007‐CDIBPViraemiainadults
6monthspostsingledosevaccinaZon,age1‐15Y,effecZveness94.5%(81.5–98.9)
India,2007–UnivLucknowCasecontroleffec,veness
2StatesIndia,201casesand804controlsaged1‐15YpostvaccinaZoncampaign–resultspending
India,2009–ICMRCasecontroleffecZveness
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ChengDu Institute of Biological Products (CDIBP) Facility Construction
New JE vaccine production building in Chengdu
• 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 functionality
Source: Dr Mansour Yaïch [email protected]
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CHINA: Proposed Road Map towards meeting NRA critical indicators and pathway for prequalification of JE vaccines
WHO Follow up visit
WHO Follow up visit
WHO Follow up visit
WHO GMP observed audits
Workshop on NRA
assessment tools
Inventory of PMS/AEFI
Sept Nov Dec Jan Feb March Apr May June Jul Aug Sept 0ct
2009 ept
2010
Regulatory Inspection Training
on risk based inspections
Training on quality Management system
WHO formal
assessment
Gathering evidence for NRA indicators and Uploading information onto sharepoint
Task Force established
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OtherJapaneseEncephali,sVaccines
Biken:BK‐VJEstrainBeijing‐1onVerocellsinacZvatedLicensed2009inJapan,producZonfordomesZcuseonlyThreedoseprimaryimmunizaZon
Intercell:Ixiaro,strainSA‐14‐14‐2onVerocells,adjuvantedinacZvatedLicensed2009US,EU,Australiafortravellersmarket;EndemiccountrymarketinJointVenturewithBiologicalELtdofIndia,
licensure2010‐2011?TwodoseprimaryimmunizaZon
Sanofi:Imojev,chimericYF17D/SA‐14‐14‐2onVerocells,liveLicenseapplicaZonsubmiied2009inThailandandAustraliaJointVentureforproducZoninThailandSingledoseprimaryimmunizaZon
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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
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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
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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
Trials designed to simulate “real world conditions” with no restrictions on OPV co-administration and breastfeeding
South Africa
Malawi
Ghana
Mali
Kenya
GSK-RVP partnership
Merck-RVP partnership
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Efficacy against severe rotavirus gastroenteritis in the first year of life, by region
Region Vaccine Countries VE 95% CI
Africa RotarixTM Malawi, South Africa
61.7 44.0, 73.2
Africa RotaTeq® Ghana, Kenya, Mali
64.2 40.2, 79.4
Asia RotaTeq® Bangladesh, Vietnam
51.0 12.8, 73.3
WER No. 23, 5th June 2009
5th International Conference on Vaccines for Enteric Diseases, Malaga, Spain, September 9, 2009
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Efficacy against severe rotavirus gastroenteritis in the first year of life, by mortality quartile
WHO mortality
strata
Under-5 child mortality Efficacy Estimates Countries where studies
performed
HIGH Highest (top 25%) 50-64% Ghana, Kenya, Malawi, Mali
INTER-MEDIATE
High mid (next 25%) 46-72% Bangladesh, South Africa
LOW
Low mid (next 25%) 72 - 85% Vietnam
Multiple countries in Americas Least
(lowest 25%) 85 – 100% Multiple countries in Americas, Europe, WPRO
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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
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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
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RV144: HIV-1 Prime-Boost Vaccine Trial Source: Dr Jerome Kim from Walter Reed
Trial Description RV144: A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-uninfected Thai Adults
Co-Development Partners Ministry of Public Health (MOPH), Thailand
Vaccine Trials Centre, Mahidol University Data Management Unit, Mahidol University
Royal Thai Army Division of AIDS, National Institute of Allergy &
Infectious Diseases (NIAID), NIH Global Solutions for Infectious Diseases (VaxGen) Sanofi pasteur
Sponsor Surgeon General, US Army; IND is held by USAMMDA; MHRP and USAMC-AFRIMS execute for Sponsor
Clinical Development Stage Phase IIb (Test of Concept, TOC) Trial
Vaccine Regimen
• Prime: ALVAC® HIV (vCP1521) • Schedule: 0, 1, 3, 6 mo • subtype B (LAI) gag/pro • subtype E (92TH023) env; gp41-TM (LAI)
• Boost: AIDSVAX® B/E • Schedule: 3, 6 mo • subtype B (MN) gp120 env • subtype E (A244) gp120 env
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Results
ALVAC-HIV + AIDSVAX B/E prevents HIV infection – VE = 31.2% (two-tailed p = 0.039, OBF 95% CI 1.1, 52.1) – There may be a waning of efficacy over time
No effect on setpoint viral load
No safety issues apparent
HIV risk behaviors were balanced between arms and did not increase during trial.
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Key Messages
First vaccine study to reduce the risk of HIV infection in humans
The vaccine regimen is safe and, at 31.2% efficacy, is modestly protective; however more
research is needed
Additional studies needed to better
understand how the vaccine regimen
reduced the risk of HIV infection
Study has important implications for future
HIV vaccine design and testing
A major scientific achievement, this study provides first evidence that development of a
safe and effective preventive vaccine is possible
Outstanding example of international and
interagency collaboration
Trial collaborators, along with outside experts, are already determining next
steps
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Are we on track to reach our coverage goals? Global DTP3 Coverage 1980-2008 and projections 2009-2010
Source: WHO/UNICEF coverage estimates 1980-2008, July 2009
193 WHO Member States.
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Countries with most unvaccinated infants DTP3, 2006-2008 (in millions)
Source: WHO/UNICEF coverage estimates 1980-2008, July 2009 193 WHO Member States.
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Immunization coverage with DTP3 vaccines in infants, 2008
<50% (6 countries or 3%)
80-89% (31 countries or 16%)
50-79% (36 countries or 19%)
>=90% (120 countries or 62%)
Source: WHO/UNICEF coverage estimates 1980-2008, July 2009
193 WHO Member States.
The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of 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
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No data (24 countries or 16%) (DTP3 estimated coverage for 2007 16 countries > 90%; 8 countries< 90)
“Developing”* countries with all districts achieving at least 80% DTP3 coverage, 2008
* 155 developing countries and economies in transition per UN World Economic & Social Survey, 2008 classification
No (90 countries or 58%) Yes (41 countries or 26%)
Not applicable (38 countries)
The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of 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
Source:WHO/UNICEFestimatesandWHO/IVBdatabase,July2009,193WHOMemberStates.
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23.5 million infants not immunized (DTP3), 2008, 86 % lives in GAVI eligible countries
Source: WHO/UNICEF coverage estimates 1980-2008, July 2009
Non GAVI eligible, 3.3 million
Ethiopia, 0.5 million
Chad, 0.3 million China, 0.5 million
Nigeria, 2.5 million Pakistan, 1.3 million Indonesia, 0.9 million DR Congo, 0.8 million
GAVI eligible, 20.2 million
India, 8.7 million
Rest of GAVI eligible, 4.7 million
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WHO Immunization Strategic Plan Light touch from current strategic plan (Innovation, Quality &
Safety, Access and Policy)
Priority areas of work Immunization Systems Strengthening (Reaching the un-
immunized) Integrated delivery of childhood preventive & curative Vaccine of assured quality
Strengthened advocacy in support of immunization
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Financial outlook …
(1) Figures assume 14M assessed contribution level globally, still to be confirmed
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State of the World's Vaccines and Immunization – 3rd Edition
WHO/UNICEF/World Bank publication Previous editions in 1996 & 2003
Two main sections Progress report Diseases and their vaccines
Launching event – 21 Oct 09: National Press Club – Wash DC Good Media Coverage
Lancet Editorial
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Addressing Recommendations from Mid-Term Evaluation Report of Stakeholders' Panel
Plan of action drafted and under implementation - Improved communications (summaries, web, e-mailing,
WER enhancements, expansion of target groups, synergies, media)
- Monitoring plan - Development of criteria for agenda item selection and
longer term horizon
Additional resources requirements Strengthening of National Technical Advisory
Groups on Immunization Adjustment of TLAC to address system barriers
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Immunization Practices Advisory Committee
Background – Post TLAC – Need to encompass other components of immunization programmes
Overall purpose: To support and advise WHO/IVB to formulate the immunization practices, norms and standards necessary
– to reach and sustain high level immunization coverage as stated in GIVS – to provide immunization services of high quality to the recipients of vaccines
Relation to SAGE – Committee has as main focus the recommendations on practices at
operational and procedural level and will report to SAGE regularly. Recommendations of strategic nature will need to be endorsed by SAGE
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2010-2012 SAGE Meetings: Topics on the Horizon
Cross-cutting and strategic issues Immunization schedules Target product profiles Reinforcing surveillance networks Measles: feasibility of global measles
elimination Impact of introduction of new vaccines
on strengthening of immunization and health systems
Strategic options for older age group vaccination
Low-middle income countries: financing
Vaccine specific policy recommendations and updates
Rubella Hepatitis A Meningitis Tick-borne encephalitis Seasonal and pandemic
influenza Polio Typhoid vaccine: feed-back
from regions HIV