Vaccine Landscape Implications for 202X May 2, 2011

1920s1930s1940s1950s1960s1970s1980s1990s2000s2010s2020s Yellow Fever (1948) BCG (1926) IPV (1955) OPV (1963) Rabies (1880s) Measles (1963) DTP (1948) Rubella (1969) Mumps (1967) EPI Introduced (BCG, DTP, Measles, OPV) (1974) <5% of infants immunized globally each year Vaccine Characteristics Relatively low price for most vaccines (<$1.00/treatment) Large multi-dose vial sizes (minimize cost/dose and immunization logistics impact) Typically high wastage (25 – 70%) Vaccine Characteristics Relatively low price for most vaccines (<$1.00/treatment) Large multi-dose vial sizes (minimize cost/dose and immunization logistics impact) Typically high wastage (25 – 70%) FIRST Vx LICENSURE EPI catalyzed the strengthening of country supply logistics systems 2 Smallpox (1903) MMR (1971) Vaccine Landscape (1920 – 1979)

1920s1930s1940s1950s1960s1970s1980s1990s2000s2010s2020s Yellow Fever (1948) BCG (1926) IPV (1955) OPV (1963) Rabies (1880s) Measles (1963) DTP (1948) Rubella (1969) Mumps (1967) Vaccine Characteristics Hib 1 st of the higher priced vaccines (>$3.00/dose) High wastage comes at a higher cost  trend toward smaller multi-dose vials Shift to pentavalent combination vaccine Vaccine Characteristics Hib 1 st of the higher priced vaccines (>$3.00/dose) High wastage comes at a higher cost  trend toward smaller multi-dose vials Shift to pentavalent combination vaccine HepB (1981) Hib (1988) FIRST Vx LICENSURE EPI Introduced (BCG, DTP, Measles, OPV) (1974) <5% of infants immunized globally each year DTP-HepB+Hib Pentavalent Vaccine (1998) Smallpox (1903) MMR (1971) Vaccine Landscape (1980 – 1999) 3

Health Systems Investments ( ) Medical Products, Vaccines, and Technologies Health Information System Health Service Delivery Leadership and Governance Health Financing Health Workforce CCL training modules Equipment info sheets WHO PQ established VVMs available Joint statement on AD syringes TechNet e-Forum PAHO Revolving Fund established UNICEF Vaccine Independence Initiative established WHO GAG established SAGE established TechNet established Building Blocks of a Highly Functional Health System* WHO standardized immunization schedules BMGF established EPI introduced GPV established * Everybody’s Business: Strengthening Health System's to Improve Health Outcomes, WHO’s Framework for Action,

Source: WHO Global Atlas Investment = Impact (1980 – 2000)

1920s1930s1940s1950s1960s1970s1980s1990s2000s2010s2020s Yellow Fever (1948) BCG (1926) HepB (1981) Hib (1988) IPV (1955) OPV (1963) Rabies (1880s) Measles (1963) DTP (1948) Rubella (1969) Mumps (1967) Cholera (2009) MenA (2009) DTP-HepB+Hib Pentavalent Vaccine (1998) PCV7 (2000) Cervarix (2007) PCV 10 (2009) Smallpox (1903) PCV 13 (2009) MMR (1971) 6 Vaccine Landscape (2000 – 2010) FIRST Vx LICENSURE Vaccine Characteristics Multinational suppliers targeting low income markets earlier than in past Prices >$3.00 per dose becoming the norm Different product profiles for vaccines targeting the same disease Vaccine Characteristics Multinational suppliers targeting low income markets earlier than in past Prices >$3.00 per dose becoming the norm Different product profiles for vaccines targeting the same disease JE (2010) RotaRix (2006) Gardasil (2006) RotaTeq (2006)

Medical Products, Vaccines, and Technologies Health Information System Health Service Delivery Leadership and Governance Health Financing Health Workforce Effective Vx Stores Mgmt rollout CCL training modules WHO PQ established VVMs available WHO PQS devices and equip specs TechNet e-Forum cMYP rollout Effective Vx Mgmt rollout CCEM rollout GAVI ISS GAVI HSS Project Optimize initiated PAHO Revolving Fund established UNICEF Vaccine Independence Initiative established GAVI Alliance established WHO GAG established SAGE established TechNet established VPPAG established CCL Task Force established IPAC established Building Blocks of a Highly Functional Health System* WHO standardized immunization schedules EPI introduced GPV established FSP rollout VMA rollout UNICEF includes VVMs in tender & bundles AD syringe for each dose * Everybody’s Business: Strengthening Health System's to Improve Health Outcomes, WHO’s Framework for Action, Global Health Workforce Alliance created 7 Health Systems Investments (2000 – 2010) Equipment info sheets Joint statement on AD syringes BMGF established

8 *2009 and 2010 forecasted data for Pol3 not available 8 Investment = Impact ( )

1920 – 1939: 1 vaccine 1940 – 1959: 3 vaccines 1960 – 1979: 4 vaccines 1980 – 1999: 3 vaccines 2000 – 2019: >13 vaccines s1930s1940s1950s1960s1970s1980s1990s2000s2010s2020s Yellow Fever (1948) BCG (1926) HepB (1981) Hib (1988) IPV (1955) OPV (1963) Rabies (1880s) Measles (1963) DTP (1948) Rubella (1969) Mumps (1967) Rota (2006) HPV (2006) JE (2010) Cholera (2009) Typhoid Conjugate (~2013) Malaria (~ ) rBCG (~ ) MenA (2009) Dengue (~ ) ETEC (~ ) Shigella (~ ) FIRST Vx LICENSURE DTP-HepB+Hib Pentavalent Vaccine (1998) Pneumo (2000) Smallpox (1903) MMR (1971) 9 Vaccine Landscape (2000 – 2019) Typhoid PS (2011) Leishmaniasis (~ )

CharacteristicChangeImplication Price Many have higher costs (> $10/treatment) Impacts affordability & vaccination sustainability Presentation Many have smaller vial sizes (1-2 dose vials) Minimizes vaccine wastage, increases cold chain needs & waste disposal costs Target Population Birth Doses, Infants, Adolescents, & Adults More vaccines delivered outside the EPI system Vaccination Strategy Routine + catch-up, mass campaigns, school-based routine, school-based mass campaigns Significant immunization logistics implications Product Profile Not all vaccines the same – differ by dose schedule, serotypes, route of administration, preservative use Country preferences become a greater factor, immunization logistics need to be managed Intervention Portfolio More interventions available at the same time than ever before Country decision-making in face of much greater complexity (which disease, which product, what timeframe, what trade-offs) 10 New Vaccine Characteristics

11 Currently At Scale Being Scaled Up Waiting for Scale Up Currently Under Development Licensed or WHO PQ’d prior to Hib Pneumo Rotavirus MenA HPV Cholera Typhoid conjugate JE Pneumo (common protein) Rotavirus (116E) Pneumo (Killed whole cell) Pneumo (conjugates) Lower priced IPV Hexavalent DTwP-HepB-Hib-IPV BCG OPV MCV DTP-HepB YF Td / TT Rotavirus (BRV) Malaria (RTS,S) Dengue ETEC Hookworm BCG Boost Shigella Flu (Lentigen) Leishmaniasis 11 CURRENT VACCINE LANDSCAPE rBCG

AD– Auto disposable cMYP – Comprehensive Multi-year Plan (WHO) CCL – Cold Chain and Logistics CCEM – Cold Chain Equipment Manager (WHO) FSP – Financial Sustainability Plan for a national immunization program GAG – Global Advisory Group (WHO) GPV – Global Program for Vaccines and Immunization (WHO) IPAC – Immunization Practices Advisory Committee (WHO) PQ – Pre-Qualification (WHO) PQS– Performance, Quality, and Safety SAGE – Strategic Advisory Group of Experts on Immunization (WHO) VMA – Vaccine Management Assessments (WHO) VPPAG – Vaccine Presentation and Packaging Advisory Group (WHO) VVMs– Vaccine Vial Monitors 12 Acronyms