2. Center for Communicable Diseases Control
New Vaccines
Hossein Masoumi Asl
Center for Communicable Diseases Control

3. Global Immunization Vision and Strategy (GIVS):
Implications for Immunization Policy Development

4. Realizing the vision Four strategic areas Reaching more people
Introducing new vaccines and technologies
Synergies with other interventions in health systems context
Global interdependence …
Context :
- Remarkable progress… but
* Coverage stagnation/disparities
* Fragmentation of EPI
- GIVS offers a unifying vision of
immunization main thrusts for

5. Goals
By 2010:
90% routine vaccination coverage nationally and % in all districts
90% reduction of global mortality due to measles (compared to 2000)
By 2015:
Maintain Coverage achievement (80%-90%)
2/3 reduction of global childhood mortality and morbidity due to VPDs (compared to 2000) [MDG4]

6. Under-Five Child Mortality
Global Distribution of Cause-Specific Child Deaths
Under-nutrition
(underlying cause)
IMMUNIZATION POTENTIAL:
~25% CHILD MORTALITY REDUCTION BY 2015
Source: World Health Report

7. Leading causes of vaccine-preventable deaths in children under 5 years old
Source/credits: The Global Burden of Disease: 2004 update,
* WHO/IVB estimates based on GBD estimates, deaths for 2000
** WHO/IVB estimates based on GBD estimates, 2004 update
As at February 2009

8. Preventable with (current) expected improvements in coverage
Preventable if coverage is scaled up to 90% and widespread use of new vaccines
60%-70% reduction in rate
GIVS GOAL by 2015:
Two-thirds reduction of global childhood morbidity and mortality due to VPDs compared to 2000 levels
Not preventable by 2015
Source: Lara's calculations on 22 Oct 2004, based on files developed for IFFI project.
Mortality averted based on "existing vaccines" includes tetanus (neonatal and other), pertussis, diphtheria, measles, YF, and Hib.
Polio is not shown (very little mortality), and Hepatitis B is also not shown (primarily causes mortality in adults; also, the impact of vaccination on HepB mortality will not really be seen by 2015).
Mortality based on "near term vaccines" includes JE, Mening A/C, Pneumo, and Rotavirus, based on expected date of introduction/availability, and assuming the vaccine is relatively effective (ie 80% efficacy).
Mortality curves are calculated based on expected improvements in coverage: The top line shows the expected mortality rate due to VPD if coverage stayed constant at 2003 levels; the yellow difference is obtained by projections of improvements in coverage, given current trends. The blue difference is if coverage is scaled up to 90% by Includes the impact of campaigns for measles, tetanus, and yellow fever.
We have not made big gains since 2000 in reducing the VPD mortality rate, but even in the year 2000, there were averting 2-3 million deaths per year from VPD.

9. WHO estimates 2.7M childhood deaths from vaccine preventable illnesses
Pneumococcal, Rota & Hib account for
two thirds
of the vaccine preventable deaths among children

10. GIVS Strategic Area 2: Introducing new vaccines and new technologies
OBJECTIVES
Empowerment for country decision making
Making vaccines available
New vaccines also for the disadvantaged
Research and development for needed vaccines
MAIN STRATEGIES
Country capacity for informed decision making
Effective and sustainable supply of new vaccines
Research & Development

12. What are the new vaccine in our country?

13. Hib Vaccine, 2008 No (21 countries or 11%) Yes (133 countries or 69%)
Highlight: India (IRC approved), Nigeria (IRC conditional approval)
Not introduced:
AFRO: Botswana, Cape Verde.
EMRO: Egypt, Iran, Iraq and Tunisia.
EURO: Bulgaria, Romania, Russian Federation, Turkmenistan.
SEARO: Maldives and Thailand.
WPRO: China, Cook Islands, Japan, Nauru, Philippines, Rep of Korea, Singapore, Tuvalu and Vanuatu.
Yes Part of the country are: Belarus, Pakistan and Sudan (only North Sudan introduced)
2009 and/or GAVI Approved: AFRO: Cameroon, Comoros, Congo, Côte d'Ivoire, DRC, Equatorial Guinea, Gabon, Mauritania, Mozambique, Namibia, Sao Tome Y Principe, Seychelles, Swaziland and United Rep. Of Tanzania. EMRO: Afghanistan. EURO: Albania, Armenia, Georgia, Kyrgyzstan, Rep. of Moldova and Uzbekistan. SEARO: Bangladesh, Bhutan and Nepal. WPRO: Lao and Vietnam.
In addition, Cambodia was approved and said they will introduce in January 2010.
Applied not yet approved is: Azerbaijan, India and Nigeria
Never applied is DPRK, Haiti, Indonesia, Myanmar, Somalia and Timor Leste
No (21 countries or 11%)
Yes (133 countries or 69%)
Yes-- part of country (3 countries--2%)
Intro 2009 or GAVI Approved (27 countries-4%)
Applied for GAVI Support (3 countries--2%)
Never Applied (6 countries--3%)
Source: WHO/IVB database, 193 WHO Member States. Data as of June 2009
Date of slide: 11 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 All rights reserved

14. Morbidity: Mortality: Disability
Global Burden of Hib diseases ( WHO Estimates - Children < 5 years old)
Morbidity:
3 million children with serious illness/ year
~20% of severe pneumonia
Mortality:
450,000 deaths/year
>1000 preventable deaths every day
1 in 25 child deaths
Disability
15-35% of survivors of Hib meningitis suffer lifelong consequences (paralysis, hearing loss, mental retardation, speech problems, learning problems)
Acute respiratory infections (2 million deaths each year) are the leading infectious cause of death in children 1mo to 5 years of age. S. pneumo causes approximately 800,000 of those deaths, Hib accounts for almost 400K. Diarrheal diseases are the second leading cause of death with 1.7M deaths – 500K are estimated to be due to rotavirus. Other leading causes of death include Malaria (853), Measles (395) HIV aids (321)

15. Estimated total Hib disease cases: Estimated total Hib deaths:
Burden of Hib disease in the EMR ( WHO Estimates - Children < 5 years old)
Estimated total Hib disease cases:
1,140,271 Hib cases/year
Estimated total Hib deaths:
49,457 deaths

16. Hib conjugate vaccines
Available since early 1990s
Excellent safety record
Over 95% efficacy against invasive disease
Compatible with EPI schedules
Vaccination Interrupts transmission and protects community (Indirect Effect or Herd Immunity)

17. discontinued (1 country) Plans not clear (3 countries)
Hib Vaccine introduction in the EMR
Palestine
Bahrain
introduced (17 countries)
discontinued (1 country)
Plans not clear (3 countries)
No plans (not eligible for GAVI support)

18. Estimated burden of Hib and pneumococcus for < 5 children

19. Lumbar Puncture for Detection of Meningitis in Age 2 m – 5 y /100,000 (Population: 491,891) Sep ,Mar IRAN
No. of highly suspicious
No. of
Other bacteria
N.meningitidis
No. of S.pneumoniae
No. of H.influenzae
Viral LP
No. of proven & H.S. Bacterial Men.
Abnormal LP
N0. of LP 63
45% 16
12% 6 4% 23
17% 30
22%
265
66%
138
34%
403
21%
1874
Incidence rate of H. influenzae Meningitis : 4/100,000/year in 2m-5y children

20. Estimation of budget needed for Hib vaccine integration
Total population: 70,000,000
# of children < 5y: 5,600,000
# of children < 1y: 1,200,000
# of H. influenza meningitis in <5y / Year: 290
# of other invasive H. influenza infections in <5y / Year: ?
Cost of vaccine for 3 doses per child: 10 USD
Annual budget only for vaccine: 14,000,000 USD

21. Rotavirus disease and Rotavirus vaccines

22. Selected hospitals in 5 cities , I.R.IRAN

23. Rotavirus Gastroenteritis Surveillance Data (Iran, 2006-2008)

24. Total Sentinel site (province/hospital)
Total number of hospitalizations for children <5 years
Total number of hospitalized diarrhoea cases*
# suspected cases of rotavirus gastroenteritis
# stool specimens collected
# stool specimens tested
Results %
Pos.
results
Neg.
Shiraz
Dastgheib
13330
4493
3725
1910
1031
(54)
782
Tabriz
Kodakan
21362
2095
1506
682
356(52)
318
Mashad
Sheikh
3629
944
525
443
423
160(38)
236
Bandarabas
16053
3337
1688
1623
1628
922(57)
634
Tehran Markaztebi
22430
2721
824
312(38)
415
Total
76804
13590
8268
5487
2781
(51)
2385

25. Morbidity of Rotavirus gastroenteritis
Rotavirus detection among AGE cases Hospital-based surveillance network, EMR

26. Burden of rotavirus disease
Estimated Rotavirus mortality for children <5 years, 2004 (as of 31 March 2006)
Global:
deaths annually
EMR: 61,164
Deaths annually

27. Two Rotavirus Vaccines
Human G1P[8],
lyophilized,
orally administered
Two dose schedule with EPI
Bovine-human pentavalent human G1, G2, G3 and G4; bovine G6, P[8] reassortant,
Liquid
Three dose schedule with EPI
Rotarix®
GSK
RotaTeq®
Merck

28. Rotavirus vaccine introduction in the EMR
Palestine
Bahrain
Introduced (2)
introduction 2010/2011 (4)
Applying to GAVI for (4)
Considered (2)
No plans (10)

29. Estimation of budget needed for Rotavirus vaccine integration
Percent of admitted diarrheal cases attribute to rotavirus: 32%
Estimation of annual admission: *
Total number of rotavirus death/year: ?
Annual budget only for vaccine: 24,000,000 US$
Need to cold chain will be 4 fold (due to Hib & rotavirus vaccines
*: Parashar UD, et al, Global illness and death caused by rotavirus disease in children, Emerging Infectious Diseases . Vol. 9, No. 5, May 2003

30. Pneumococcal diseases and Pneumococcal conjugate vaccines

31. Morbidity: ~ 14 million cases
Global Burden of pneumococcal diseases ( WHO Estimates - Children < 5 years old)
Morbidity: ~ 14 million cases
Most common cause of bacterial pneumonia among children
Mortality: ~ 840,000 deaths
WHO Estimates 2008

32. Regional of pneumococcal diseases ( WHO Estimates - Children < 5 years old)
Morbidity: ~ 1.5 million cases
Mortality: ~ 100,000 deaths
WHO Estimates 2008

33. Incidence of IPDs (per 100,000 Children under Age 5)
<1000
1000-<2000
2000-<3000
> 3000
The boundaries in the map doesn’t represent official WHO position

34. S. pneumoniae Mortality (per 100,000 Children under Age 5)
<10
10- <100
100-<300
* HIV+ deaths excluded
300-<500
>500
The boundaries in the map doesn’t represent official WHO position

35. Estimated burden of Hib and pneumococcus for < 5 children

36. Pneumococcal Conjugate Vaccines
Safe and effective: over 95% efficacy against invasive disease
Compatible with EPI schedules, suitable for < 2 years children
Vaccination Interrupts transmission and protects community (Indirect Effect or Herd Immunity)
Available vaccines
7-valent: serotypes 4, 6B, 9V, 14, 18C, 19F, 23F
10-valent: 7-valent + 1, 5, 7F
In the pipelines
13-valent: 10-valent + 3, 6A, 19A

37. WHO position on use of 7 valent pneumococcal vaccine
Recognizing the heavy burden of pneumococcal disease occurring in young children and the safety and efficacy of PCV-7 in this age group, WHO considers that it should be a priority to include this vaccine in national immunization programmes, particularly in countries where mortality among children aged <5 years is >50/1000 live births or where > children die annually.
Despite the absence of some serotypes that are important causes of pneumococcal disease in developing countries, PCV-7 can prevent substantial mortality and morbidity in these countries. Once other pneumococcal vaccines offering similar or wider protection become available, countries will be able to decide whether to switch to a different formulation.

38. Pneumococcal vaccine introduction in the EMR
Palestine
Bahrain
Introduced (6)
introduction 2010(1)
Planned 2010/2011(2)
Applying for (3)
Plans not clear/no plans (10)

39. Status of AAP/CDC recommendations*** DTaP-IPV/Hib (PENTACEL™)
Vaccine
Manufacturer
BLA submitted to FDA
BLA age indications**
FDA licensure
Status of AAP/CDC recommendations***
DTaP-IPV (KINRIX)
GlaxoSmithKline (GSK)
Jun-2007
4 through 6 years of age
Licensed 24-Jun-08
AAP: aapnews.aappublications.org/cgi/content/full/29/8/20 CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5739a4.htm
DTaP-IPV/Hib (PENTACEL™)
sanofi pasteur
Jul-2005
2, 4, 6, and 15 through 18 months of age
Licensed 20-Jun-08
AAP: aapnews.aappublications.org/cgi/content/full/29/8/1-b CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5739a5.htm
Hib(Hiberix)
Mar-2009
Booster dose in children 15 months through 4 years of age
Licensed 19-Aug-09
CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5836a5.htm
Hepatitis A (VAQTA®)
Merck
Supplement to original BLA
Greater than or equal to 12 months of age
Licensed 11-Aug-05
AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;120/1/189 CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm CDC for post-exposure and for international travelers cdc.gov/mmwr/preview/mmwrhtml/mm5641a3.htm
Hepatitis A (HAVRIX®)
Licensed 17-Oct-05

40. Vaccine
Manufacturer
BLA submitted to FDA
BLA age indications**
FDA licensure
Status of AAP/CDC recommendations***
Hepatitis A and Hepatitis B (TWINRIX®)
GlaxoSmithKline (GSK)
Supplement to original BLA: accelerated dosing
Greater than or equal to 18 years of age 0, 7, and 21 through 30 days and 12 month booster
Licensed 28-Mar-07
CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5640a5.htm
Herpes zoster vaccine (ZOSTAVAX®)
Merck
Apr-2005
Greater than or equal to 60 years of age
Licensed 25-May-06
ACIP: cdc.gov/mmwr/preview/mmwrhtml/rr57e0515a1.htm
HPV4 (GARDASIL®)
Dec-2005
Females 9 through 26 years of age (3 doses)
Licensed 8-Jun-06
ACIP: cdc.gov/mmwr/preview/mmwrhtml/rr56e312a1.htm ACIP Provisional: cdc.gov/vaccines/recs/provisional/downloads/hpv-vac-dec pdf AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;120/3/666
Supplement to original BLA
Males 9 through 26 years of age
Licensed 16-Oct-09
ACIP Provisional: cdc.gov/vaccines/recs/provisional/downloads/hpv-vac-dec pdf
27 through 45 years of age
To be reviewed
Pending FDA licensure
HPV2 (Cervarix™)
Mar-2007
10 through 25 years of age
Influenza vaccines - TIV
varies
n/a
See recommendations
AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;124/4/1216 CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5808a1.htm CDC Seasonal: cdc.gov/flu CDC H1N1: cdc.gov/h1n1
Influenza - LAIV-T (FluMist®)
MedImmune
24 months to 49 years of age
Licensed 19-Sep-07

41. Vaccine
Manufacturer
BLA submitted to FDA
BLA age indications**
FDA licensure
Status of AAP/CDC recommendations***
Japanese Encephalitis (IXIARO)
Intercell Biomedical
Dec-2007
Greater than or equal to 17 years of age
Licensed 30-Mar-09
ACIP Provisional: cdc.gov/vaccines/recs/provisional/downloads/je-july pdf
MCV4 (Menactra®)
sanofi pasteur
Dec-2003
11 through 55 years of age
Licensed 14-Jan-05
AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;116/2/496 CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm
Supplement to original BLA March 2005
2 through 10 years of age only for children at high risk
Licensed 18-Oct-07
ACIP: cdc.gov/mmwr/preview/mmwrhtml/mm5717a4.htm
MCV4 (Menveo™)
Novartis
Aug-2008
To be reviewed
Pending FDA licensure
MenCY-Hib (MenHibrix™)
GlaxoSmithKline (GSK)
2009
2, 4, 6 and 12 months of age
MMRV (ProQuad®)
Merck
Aug-2004
Same as for MMR dose 1 or dose 2; 12 months through 12 years of age
Licensed 6-Sep-05
CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5447a4.htm CDC Update: cdc.gov/vaccines/recs/provisional/downloads/mmrv-oct pdf

42. Vaccine
Manufacturer
BLA submitted to FDA
BLA age indications**
FDA licensure
Status of AAP/CDC recommendations***
PCV13 (Prevnar 13®)
Wyeth
Mar-2009
2 months through 5 years of age
To be reviewed
Pending FDA licensure
Rotavirus (ROTATEQ®)
Merck
Apr-2005
2, 4, and 6 months of age
Licensed 3-Feb-06
AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;123/5/1412 ACIP: cdc.gov/mmwr/PDF/rr/rr5802.pdf
Rotavirus (ROTARIX®)
GlaxoSmithKline (GSK)
Jun-2007
2 and 4 months of age
Licensed 3-Apr-08
Tdap (BOOSTRIX®)
Jul-2004
10 through 18 years of age
Licensed 3-May-05
AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;117/3/965 CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5503a1.htm
Supplement to original BLA
19 through 64 years of age
Licensed 4-Dec-08
CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5814a5.htm
Tdap (ADACEL™)
sanofi pasteur
Aug-2004
11 through 64 years of age
Licensed 10-Jun-05
AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;117/3/965 CDC Adolescent: cdc.gov/mmwr/preview/mmwrhtml/rr5503a1.htm CDC Adult: cdc.gov/mmwr/preview/mmwrhtml/rr5517a1.htm ACIP in Pregnancy: cdc.gov/mmwr/preview/mmwrhtml/rr5704a1.htm
Varicella virus second dose (Varivax®)
Supplement to original BLA: second dose
12 months to 12 years of age (3 month minimum interval)
Licensed 5-Apr-05
AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;120/1/221 CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5604a1.htm