Report to SAGE on achievement of previous recommendations ... · 19 | SAGE meeting, 27-29 October 2009 Are we on track to reach our coverage goals? Global DTP3 Coverage 1980-2008

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


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


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


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


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]


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


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


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


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


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


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


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


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


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


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


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.


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


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.


Countries with most unvaccinated infants DTP3, 2006-2008 (in millions)

Source: WHO/UNICEF coverage estimates 1980-2008, July 2009 193 WHO Member States.


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%)


193 WHO Member States.



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)


Source:WHO/UNICEFestimatesandWHO/IVBdatabase,July2009,193WHOMemberStates.


23.5 million infants not immunized (DTP3), 2008, 86 % lives in GAVI eligible countries


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


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


Financial outlook …

(1) Figures assume 14M assessed contribution level globally, still to be confirmed


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


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


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


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

Report to SAGE on achievement of previous recommendations ... · 19 | SAGE meeting, 27-29 October 2009 Are we on track to reach our coverage goals? Global DTP3 Coverage 1980-2008

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