Not your mothers vaccines Using new vaccines against the old enemies of Diarrheal Disease and Pneumonia

							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?