Not your mothers vaccines Using new vaccines against the old enemies of Diarrheal Disease and Pneumonia
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Not Your Mother’s Vaccines Using new vaccines against old enemies of pneumonia and diarrheal disease Rebecca Fields, IMMUNIZATIONbasics & AED Angela Weaver, USAID/Global/HIDN USAID Mini-University - October 5, 2007 Immunization 101: “Traditional” vaccines in national immunization programs BCG – against Tb DTP - diphtheria, tetanus, pertussis (whooping cough) Polio Measles [Hepatitis B] [Yellow fever] WHO “Standard” Schedule for Routine Immunization Age of Contact Birth 6 weeks 10 weeks 14 weeks Vaccine BCG, OPV-0, Hep B* DTP1, OPV1, Hep B* DTP2, OPV2, Hep B* DTP3, OPV3, Hep B* 9 months Measles, Hep B*, YF * total of 3 doses with timing dependent upon local epidemiology Three New Vaccines Against Old Enemies to Child Survival Haemophilus influenzae type b (Hib) vaccine Pneumococcal vaccine Rotavirus vaccine WHO Criteria for Large-scale Introduction of New Vaccines: Features of vaccine Meet current WHO quality standards Safe and have significant impact against the actual disease in target populations Minimal interference with immune response to other vaccines given simultaneously Program compatibility Be easily adapted to existing vaccination schedules Meet common limitations, e.g. storage space Be appropriately priced Global Alliance for Vaccines and Immunization (GAVI) – a public-private partnership Improve access to sustainable immunization services Assure injection safety for immunization Expand use of all existing cost-effective vaccines (including Hib) Accelerate R&D and introduction of new vaccines (including pneumo + rota) snapshot: Burden of disease Hib vaccine (1) 386,000 deaths/year pneumonia, meningitis, “invasive Hib disease” 3 million cases of serious disease, including sequelae Vaccine efficacy -- >95% effective with 3 doses & safety -- Research on need for booster -- Efficacy in HIV+ children? WHO position Should be included in all routine infant immunization programs snapshot: Vaccine availability Where introduced? Introduction issues Hib vaccine (2) Multiple conjugate vaccines now available, including in combination with DTP vaccine 106 countries as of mid-2007 --3 doses, e.g., 6, 10, 14 weeks --Should not be frozen --Cost of $3.50/dose likely to decline after 2008 with new suppliers snapshot: Burden of disease Pneumococcal Vaccine (1) > 710,000 deaths in children <5 pneumonia, meningitis, sepsis -->95% effective in U.S. --Gambia trial (PCV-9): 7 deaths prevented per 1000 vaccinated -- Induces Herd immunity -- Optimal serotypes? --Serotype replacement? Vaccine efficacy & Safety WHO position Priority to include PCV-7 in national immunization programs, esp where <5MR is >50 or high HIV prevalence snapshot: Vaccine availability Where introduced? Introduction issues Pneumococcal Vaccine (2) Limited supply through 2010 when new suppliers will come on board 13 countries to date; another 5 developing countries by end 2008 --3 doses, fits current EPI schedule -- Current bulky product presentation -- one-time start-up campaign? --Price of >$5/dose may decline to $2/dose if commitments to purchase made now --surveillance: serotype replacement? Pneumococcal vaccine demonstrates considerable herd effect MMWR September 16, 2005 / 54(36);893-897 snapshot: Burden of disease Vaccine efficacy & Safety WHO position Rotavirus Vaccine (1) 530,000 deaths/year globally - 90-100% protection against severe rotavirus; 74-85% against any rotavirus - Increased intussusception not detected - Strongly recommended where vaccine efficacy data suggest impact; -Not yet recommended for Africa, Asia -- GAVI will support only in EURO & PAHO regions until 2010 snapshot: Vaccine availability Where introduced? Introduction issues Rotavirus Vaccine (2) Sufficient supply with two licensed manufacturers Latin America -- 2 or 3 doses of oral vaccine -- Particular need for timely vaccination --Bulky product presentation -- Surveillance for impact and possible adverse events PAHO countries introducing Rotavirus Vaccine, 2006 USA: recommended by ACIP Mexico: June Rotateq Rotarix Possibillty ELS: October Nicaragua: October Pop < 1 yr: Venezuela: April Pop < 1yr :590,000 Panama: March Pop < 1 yr:70,000 Brasil: March Pop <1 yr: 3,711,000 Rotavirus Vaccines Zinc Treatment Enhanced Diarrheal Disease Control Sanitation/ Hygiene ORT/ Breastfeeding Source: Rotavirus ADIP website Sustainable Immunization System Financing Community Action Practices Support Policies Supervision Management Supplies & Logistics Training Monitoring & Surveillance Advocacy & Communications Directions Break into pairs With the sheet you are assigned, brainstorm two issues that need to be addressed in introducing a new vaccine into a child health program You have four minutes When you are finished, use the tape provided to attach your paper on the wall Sustainable Immunization System Financing Community Action Practices Support Policies Supervision Management Supplies & Logistics Training Monitoring & Surveillance Advocacy & Communications Packaged volumes of vaccines, per dose (source: PATH, GAVI) Vaccine BCG (diluent outside cold chain) Diphtheria-Tetanus-Pertussis (DTP) Oral polio Measles (diluent outside cold chain) Administration Reconstitution Liquid Liquid Reconstitution Vial size 10 10 10 10 Volume (cm3) 1.2 3.0 2.5 3.0 Tetanus toxoid Hepatitis B DTPw-Hib combined DTPw-HepB liquid + Hib DPTw-HepB + Hib Liquid Liquid Liquid Reconstitution Reconstitution 10 10 10 10 2 3.0 3.8 2.3 5.3 9.7 Packaged volumes of vaccines, per dose (source: PATH, GAVI) Vaccine BCG (diluent outside cold chain) Diphtheria-Tetanus-Pertussis (DTP) Oral polio Measles (diluent outside cold chain) Administration Reconstitution Liquid Liquid Reconstitution Vial size 10 10 10 10 Volume (cm3) 1.2 3.0 2.5 3.0 Tetanus toxoid Hepatitis B DTPw-Hib combined DTPw-HepB liquid + Hib DPTw-HepB + Hib Liquid Liquid Liquid Reconstitution Reconstitution 10 10 10 10 2 3.0 3.8 2.3 5.3 9.7 Pneumococcal 7-valent (pre-filled syringe) Rotarix® (25 mono-dose pack, diluent in cold chain) Rotarix® (25 mono-dose pack, diluent OUTSIDE cold chain) Liquid Reconstitution Reconstitution 1 1 1 59.7 111.6 11.4 RotaTeq (in 2 mono-dose pack) RotaTeq (in 10 mono-dose pack) Liquid Liquid 1 1 85.2 80.9 Impact on cold chain Rotavirus vaccine Source: PAHO GAVI Support for Financing New Vaccines Minimum country co-payment/dose of 1st co-financed vaccine 2008 2009 2010 2011 2012 2013 2014 2015 Poorest countries $0.20 $0.20 $0.20 $0.30 $0.30 $0.30 $0.30 $0.30 Intermediate $0.30 $0.30 $0.30 $0.40 $0.40 $0.40 $0.40 $0.40 Least poor $0.30 $0.35 $0.40 $0.46 $0.53 $0.61 $0.70 $0.80 Fragile $0.10 $0.10 $0.10 $0.15 $0.15 $0.15 $0.15 $0.15 “Pearls” What are your ideas?