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Presentation at the Immunization Summit 2011

Pneumococcal Conjugated
Vaccine (PCV) :
Is the introduction to the
National Immunization Program in
Sri Lanka justified ?
Dr. Pushpa Ranjan Wijesinghe, MD
Consultant Epidemiologist
Is introduction of PCV a dilemma for
National EPI managers ?
• Need for achieving MDGs and role of immunization
• Opportunities for introduction of appropriate new
vaccines to the NPI
• Are we going to use these opportunities ?
• Inequity
• public sector responsibility

• If so, will there be a place for pneumococcal vaccines?
• Is scientific evidence available for such a decision ?
• If the decision is made, is it self- sustainable in the
longer run ?
Consensus statement
The immunization stake holder's meeting -2007
• Pneumococcal vaccines :
• Current disease burden (2007) is inadequate for
decision making
• Due to high pneumonia specific morbidity, mortality and
high AB resistance of S.pneumoniae, consideration of
the pneumococcal vaccine in future given the financial
feasibility and GAVI support
• Extension of surveillance activities to more sentinel sites
to represent different geographical regions, further
strengthening and revisit in 2008
Does the disease burden warrant health
intervention ?

• Consensus statement –The immunization stake
holder's meeting -2007
“Current disease burden (2007) is inadequate for decision making “

•

Is the situation different in 2010 ?

“ High AB resistance of S.pneumonia “
• Is

this real in the Sri Lankan context ?
Pneumococcal Surveillance 2004-2008)
•

Syndromic surveillance of PMS patients aged 2-60 months at the LRH

Type of testing

No. tested (n)

positivity rate for S.pneumoniae

Blood cultures

2275

0.68%
( range - 0.57%-0.69%)

CSF cultures

9495

0.65%
( range – 0.23% - 1.1%)

Latex agglutination tests

1861

1 .9%
( range – 0.88% - 2.5%)

Higher detection by latex antigen test from CSF than CSF cultures
*Diminished growth of S.pneumoniae in cultures due to probable prior use of
antibiotics

Source : SAPNA
Incidence rate /100000 and estimates of PMS for
Colombo district and Sri Lanka
Syndrome

Incidence rate *
(per 100000)

Estimate for
Colombo district *

Estimate for
Sri Lanka

All cause
pneumonia

1342

2227

23551

All cause
meningitis

519

866

9030

All cause
sepsis

390

651

6786

3759

39167

All cause PMS 2251

•Epidemiological and economic analysis of pneumococcal disease in
Sri Lanka conducted by Dr. S.Kularatne for the Epidemiology Unit - 2009
Annual incidence rates of IPD/100000
in under 5 children
Country

Pneumococcal
meningitis

Pneumococcal
sepsis

Pneumococcal
pneumonia

IPD

Sri Lanka
( Colombo)

31.1
(95% CI= 20-42)

18.0
(95% CI= 10-26)

34.2
(95% CI= 23-46)

83.3
(95% CI= 65-101)

Spain

90.0

Germany

14.0

USA
Gambia

250
(500 - < I yr)

Kenya

597
Annual incidence rate/100000 and estimates of
IPD for Colombo district and Sri Lanka
Syndrome

Incidence rate *
(per 100000)

Estimate for
Colombo *

Estimate for
Sri Lanka

Pneumococcal
pneumonia

34.2
(95% CI -23-46)

57
(95% CI- 38-76)

595
(95% CI- 400 -800)

Pneumococcal
meningitis

31.1
(95% CI -20-42)

51
(95% CI - 33-70)

539
(95% CI -348 – 730)

Pneumococcal
sepsis

18
(95% CI -10-26)

30
(95% CI-17-4)

313
(95% CI -174-452)

83.3
(95% CI- 65-101)

139
(95% CI -108-169)

1449
(95% CI -1131-1757)

IPD

* Epidemiological and economic analysis of pneumococcal disease in
Sri Lanka conducted by Dr. S.Kularatne for the Epidemiology Unit - 2009
Pneumococcal surveillance ( 2004-2009)
Antibiotic sensitivity of Pneumococcal isolates ( n=125)

Antibiotic

Sensitive

Intermediate
resistant

Resistant

Penicillin

53 (42%)

41(33%)

31(25%)

Co-trimaxazole

33 (26%)

21(17%)

71(57%)

Chlorampenicol

99(79%)

00

26 (21%)

Erythromycin

42(33%)

01(1%)

82(66%)

Cefotaxime

94(75%)

25(20%)

06(5%)

Source : SAPNA
Is there an appropriate vaccine?
• PCV 7
– contains 7 sero -types
– 4, 6b,9v,14,18C, 19F, 23F

– a licensed product
• PCV 9
– Contains additional serotypes – 1 & 5
– unlicensed product

• PCV 10
– contains additional serotype - 7

• PCV 13
– contains additional serotypes- 3,6A,9A
Is there an appropriate vaccine?
Type of
vaccine

No. of
Serotypes
contained

Serotypes

PCV 7

7

PCV 9

9

1 & 5 (additionally)

PCV 10

10

7(additionally)

In production

PCV 13

13

3,6A,9A(additionally)

In production

4, 6b,9v,14,18C, 19F, 23F

Status

licensed
product
unlicensed
product
Pneumococcal surveillance ( 2004-2009)
Distribution of serotypes in Sri Lanka ( LRH & 5 sites)
35

30

Coverage of PCV 7 = 62.2%
Coverage of PCV 7 = 62.2%
Coverage of PCV 10=63.1%
Coverage of PCV 10=63.1%
Coverage of PCV 13= 69.7%
Coverage of PCV 13= 69.7%

29

25

20

15
11
8

9V

9N

19c

6B

18F

1
6A

18A

5

4

1
47f

17f

Type

1

0

35,42

1

33b

1

4

23f

1

23a

1

22

1

19f

1

16a

1

15c

20

1

15b

16

0

11c

15

2

11a

1

38

1

23

1
14

1
13

0

1
3

1

5

4

4

4

5

7

NT

10

1

Number

22
Are the globally available
safety and efficacy data
conclusive ?
Is there a need for
local immunogenicity/efficacy and
safety data ?
End points
evaluated

Individual
randomized
(direct effect)

Cluster
randomized ( +
herd immunity)

Individually RCT

Individual

Efficacy (95% CI)

Efficacy (95% CI)

Efficacy (95% CI)

Efficacy (95% CI)

IPD –vaccine
sero types

94% (80-99%)

83% (21-96%)

71%(46-86%)

IPD-all pneumococal
types

89% ( 74-96%)

52 % (-7-79%)

45%(19-62%)

Radiologically
confirmed
pneumonia

26% ( 7-41%)

-21% ( -62-9%)

35%(26-43%)

Well defined clinical
pneumonia

6% ( 1-11%)

Severe clinical
pneumonia

-

Hospital admissions

13% (6-19%)

Mortality (all cause)

14%(2-24%)

Vaccine type acute
Otitis media
All cause acute otitis
media

54% (41-64%)

6%(4-9%)

6% ( -4-16%)

Source : WHO
Safety – key points
• Generally safe and well tolerated
• even among children infected with HIV

• Post marketing surveillance
• No significant serious AE among 30 million users in USA

• Most common reported adverse events
• Injection site reactions (slight soreness and swelling)
• Transient fever above 38.5 C

• Rare adverse events
• Febrile seizures
• Hypotonic-Hypo responsive Episodes (HHE)

• Very rare adverse events
• Urticarea, angioneurotic oedema, erythema multiforme and
hypersensitivity including anaphylaxis
Preventable number of cases by PCV 7
in Sri Lanka
Non
vaccinated
scenario

Vaccinated –
vaccine
recipients
(90%)

Vaccinated –
vaccine non
recipients
(10%)

Total cases
prevented by
vaccine

IPD

1444

120

25

1299

Non Pnc
PMS

38280

25417

5206

7657

Efficacy – 83% for IPD
Can the vaccine be incorporated in to the
current EPI schedule ?
• Currently 2 recommended schedules of 3
doses
– 6 weeks, 10 weeks and 14 weeks
– 2 months, 4 months and 6 months
• Compatible with pentavalent 3 doses
• No need for an additional clinic visit
What are the costs involved ?
Approximate cost for
vaccines

5$
per a dose

(376843 X 5 $ X 3)

56 52645 $
per year

Treatment cost in a
non vaccinated
scenario

Per Pnc PMS
&
other PMS
cases

(25714 RS X1444)
+
(12495 Rs X 38280)

45 56221 $
per year

Treatment cost in a
vaccinated scenario

Per Pnc PMS
&
other PMS
cases

(25714 Rs X 145)
+
(12495 Rs X 30623)

34 49668 $
per year

Treatment cost
saved from
vaccination
Additional space due Volume per
to increasing Cold
dose
chain requirements
59.7cm3/dose *

11 06553 $
per year

(1130529 X 59.7)

67.5 m3
Is the suggested vaccine cost effective ?
GAVI’s economic
analysis

GAVI’s estimated
Cost effectiveness ratio
for
Sri Lanka

Estimated
Cost effectiveness ratio
based on
Sri Lankan study

Cost effective in
71/72
GAVI eligible
countries
( including Sri
Lanka )

4211 $ per
DALY averted

7397 Rs per
DALY averted

Benchmark – WHO CHOICE
Where are we compared to the previous
summit ?
• Availability of an estimate of the disease burden for the
Colombo district as a model for decision making
• Availability of an estimate of treatment cost
• More comprehensive collection of sero types from
LRH and 5 other hospitals
• Wide representativeness
• Antibiotic resistance data
• Circulating serotypes ( n=125)
Where are we compared to the previous
summit ?
•

Availability of a vaccine ( 7,10,13 valent) with a high coverage for
available serotypes

•

Comprehensive data on safety and immunogenicity of the intended
vaccine

•

Availability of results of an economic analysis as a guiding tool for
decision making

•

Established infra structure ,expertise on and experience in post
introduction surveillance of new vaccines

•

Availability and delivery of the intended vaccine in the private sector

•

WHO support for continued surveillance ( disease and laboratory)
Points for the discussion
•

•

•
•
•

Is
–
–
–

introduction of pneumococcal vaccine justifiable ?
Disease burden, economic burden
Competing priorities (MMR, typhoid)
Financial sustainability
• SL- no longer being GAVI eligible
• Self financing potential
Can a tentative timeline be determined ?
– consideration of the pneumococcal vaccine in future given the financial
feasibility and GAVI support – immunization stake holder's meeting 2007
What are the other constraints ?
How can we overcome them?
Any concerns of participants ?
Acknowledgement
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Dr. Nihal Abeysinghe for vision and guidance
Dr. Paba Palihawadana and Dr T.S.R.Pieris for continued vision & support
Dr.Ranjit Batuwanthdawe for the pioneering work
Dr. Malka Dissanayake & Dr.Kumudu Karunaratne for enabling
information generation
Dr.Sanjeewa Kuaratne for initiating epidemiological and economic analysis
All microbiologists at the SPnSN for their contributions
MLTs at the LRH microbiology lab for the excellent work
All pediatricians at the LRH for their precious contributions
Dr. Mark Stein Hoff, Prof. Kurian Thomas, Professor Lalitha Kesewan
Microbiology team @ the Christian Medical College , Vellore, Tamil Nadu
GAVI’s Pneumo ADIP, John Hopkins University, USA
International Clinical Epidemiological Network (INCLEN)
All research assistants of the SAPNA ( Sri Lanka) for the hard work
Iresha, Roshan, Priyangika for coordinating all the work

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Immunization summit pneumo finalr

  • 1. Presentation at the Immunization Summit 2011 Pneumococcal Conjugated Vaccine (PCV) : Is the introduction to the National Immunization Program in Sri Lanka justified ? Dr. Pushpa Ranjan Wijesinghe, MD Consultant Epidemiologist
  • 2. Is introduction of PCV a dilemma for National EPI managers ? • Need for achieving MDGs and role of immunization • Opportunities for introduction of appropriate new vaccines to the NPI • Are we going to use these opportunities ? • Inequity • public sector responsibility • If so, will there be a place for pneumococcal vaccines? • Is scientific evidence available for such a decision ? • If the decision is made, is it self- sustainable in the longer run ?
  • 3. Consensus statement The immunization stake holder's meeting -2007 • Pneumococcal vaccines : • Current disease burden (2007) is inadequate for decision making • Due to high pneumonia specific morbidity, mortality and high AB resistance of S.pneumoniae, consideration of the pneumococcal vaccine in future given the financial feasibility and GAVI support • Extension of surveillance activities to more sentinel sites to represent different geographical regions, further strengthening and revisit in 2008
  • 4. Does the disease burden warrant health intervention ? • Consensus statement –The immunization stake holder's meeting -2007 “Current disease burden (2007) is inadequate for decision making “ • Is the situation different in 2010 ? “ High AB resistance of S.pneumonia “ • Is this real in the Sri Lankan context ?
  • 5. Pneumococcal Surveillance 2004-2008) • Syndromic surveillance of PMS patients aged 2-60 months at the LRH Type of testing No. tested (n) positivity rate for S.pneumoniae Blood cultures 2275 0.68% ( range - 0.57%-0.69%) CSF cultures 9495 0.65% ( range – 0.23% - 1.1%) Latex agglutination tests 1861 1 .9% ( range – 0.88% - 2.5%) Higher detection by latex antigen test from CSF than CSF cultures *Diminished growth of S.pneumoniae in cultures due to probable prior use of antibiotics Source : SAPNA
  • 6. Incidence rate /100000 and estimates of PMS for Colombo district and Sri Lanka Syndrome Incidence rate * (per 100000) Estimate for Colombo district * Estimate for Sri Lanka All cause pneumonia 1342 2227 23551 All cause meningitis 519 866 9030 All cause sepsis 390 651 6786 3759 39167 All cause PMS 2251 •Epidemiological and economic analysis of pneumococcal disease in Sri Lanka conducted by Dr. S.Kularatne for the Epidemiology Unit - 2009
  • 7. Annual incidence rates of IPD/100000 in under 5 children Country Pneumococcal meningitis Pneumococcal sepsis Pneumococcal pneumonia IPD Sri Lanka ( Colombo) 31.1 (95% CI= 20-42) 18.0 (95% CI= 10-26) 34.2 (95% CI= 23-46) 83.3 (95% CI= 65-101) Spain 90.0 Germany 14.0 USA Gambia 250 (500 - < I yr) Kenya 597
  • 8. Annual incidence rate/100000 and estimates of IPD for Colombo district and Sri Lanka Syndrome Incidence rate * (per 100000) Estimate for Colombo * Estimate for Sri Lanka Pneumococcal pneumonia 34.2 (95% CI -23-46) 57 (95% CI- 38-76) 595 (95% CI- 400 -800) Pneumococcal meningitis 31.1 (95% CI -20-42) 51 (95% CI - 33-70) 539 (95% CI -348 – 730) Pneumococcal sepsis 18 (95% CI -10-26) 30 (95% CI-17-4) 313 (95% CI -174-452) 83.3 (95% CI- 65-101) 139 (95% CI -108-169) 1449 (95% CI -1131-1757) IPD * Epidemiological and economic analysis of pneumococcal disease in Sri Lanka conducted by Dr. S.Kularatne for the Epidemiology Unit - 2009
  • 9. Pneumococcal surveillance ( 2004-2009) Antibiotic sensitivity of Pneumococcal isolates ( n=125) Antibiotic Sensitive Intermediate resistant Resistant Penicillin 53 (42%) 41(33%) 31(25%) Co-trimaxazole 33 (26%) 21(17%) 71(57%) Chlorampenicol 99(79%) 00 26 (21%) Erythromycin 42(33%) 01(1%) 82(66%) Cefotaxime 94(75%) 25(20%) 06(5%) Source : SAPNA
  • 10. Is there an appropriate vaccine? • PCV 7 – contains 7 sero -types – 4, 6b,9v,14,18C, 19F, 23F – a licensed product • PCV 9 – Contains additional serotypes – 1 & 5 – unlicensed product • PCV 10 – contains additional serotype - 7 • PCV 13 – contains additional serotypes- 3,6A,9A
  • 11. Is there an appropriate vaccine? Type of vaccine No. of Serotypes contained Serotypes PCV 7 7 PCV 9 9 1 & 5 (additionally) PCV 10 10 7(additionally) In production PCV 13 13 3,6A,9A(additionally) In production 4, 6b,9v,14,18C, 19F, 23F Status licensed product unlicensed product
  • 12. Pneumococcal surveillance ( 2004-2009) Distribution of serotypes in Sri Lanka ( LRH & 5 sites) 35 30 Coverage of PCV 7 = 62.2% Coverage of PCV 7 = 62.2% Coverage of PCV 10=63.1% Coverage of PCV 10=63.1% Coverage of PCV 13= 69.7% Coverage of PCV 13= 69.7% 29 25 20 15 11 8 9V 9N 19c 6B 18F 1 6A 18A 5 4 1 47f 17f Type 1 0 35,42 1 33b 1 4 23f 1 23a 1 22 1 19f 1 16a 1 15c 20 1 15b 16 0 11c 15 2 11a 1 38 1 23 1 14 1 13 0 1 3 1 5 4 4 4 5 7 NT 10 1 Number 22
  • 13. Are the globally available safety and efficacy data conclusive ? Is there a need for local immunogenicity/efficacy and safety data ?
  • 14. End points evaluated Individual randomized (direct effect) Cluster randomized ( + herd immunity) Individually RCT Individual Efficacy (95% CI) Efficacy (95% CI) Efficacy (95% CI) Efficacy (95% CI) IPD –vaccine sero types 94% (80-99%) 83% (21-96%) 71%(46-86%) IPD-all pneumococal types 89% ( 74-96%) 52 % (-7-79%) 45%(19-62%) Radiologically confirmed pneumonia 26% ( 7-41%) -21% ( -62-9%) 35%(26-43%) Well defined clinical pneumonia 6% ( 1-11%) Severe clinical pneumonia - Hospital admissions 13% (6-19%) Mortality (all cause) 14%(2-24%) Vaccine type acute Otitis media All cause acute otitis media 54% (41-64%) 6%(4-9%) 6% ( -4-16%) Source : WHO
  • 15. Safety – key points • Generally safe and well tolerated • even among children infected with HIV • Post marketing surveillance • No significant serious AE among 30 million users in USA • Most common reported adverse events • Injection site reactions (slight soreness and swelling) • Transient fever above 38.5 C • Rare adverse events • Febrile seizures • Hypotonic-Hypo responsive Episodes (HHE) • Very rare adverse events • Urticarea, angioneurotic oedema, erythema multiforme and hypersensitivity including anaphylaxis
  • 16. Preventable number of cases by PCV 7 in Sri Lanka Non vaccinated scenario Vaccinated – vaccine recipients (90%) Vaccinated – vaccine non recipients (10%) Total cases prevented by vaccine IPD 1444 120 25 1299 Non Pnc PMS 38280 25417 5206 7657 Efficacy – 83% for IPD
  • 17. Can the vaccine be incorporated in to the current EPI schedule ? • Currently 2 recommended schedules of 3 doses – 6 weeks, 10 weeks and 14 weeks – 2 months, 4 months and 6 months • Compatible with pentavalent 3 doses • No need for an additional clinic visit
  • 18. What are the costs involved ? Approximate cost for vaccines 5$ per a dose (376843 X 5 $ X 3) 56 52645 $ per year Treatment cost in a non vaccinated scenario Per Pnc PMS & other PMS cases (25714 RS X1444) + (12495 Rs X 38280) 45 56221 $ per year Treatment cost in a vaccinated scenario Per Pnc PMS & other PMS cases (25714 Rs X 145) + (12495 Rs X 30623) 34 49668 $ per year Treatment cost saved from vaccination Additional space due Volume per to increasing Cold dose chain requirements 59.7cm3/dose * 11 06553 $ per year (1130529 X 59.7) 67.5 m3
  • 19. Is the suggested vaccine cost effective ? GAVI’s economic analysis GAVI’s estimated Cost effectiveness ratio for Sri Lanka Estimated Cost effectiveness ratio based on Sri Lankan study Cost effective in 71/72 GAVI eligible countries ( including Sri Lanka ) 4211 $ per DALY averted 7397 Rs per DALY averted Benchmark – WHO CHOICE
  • 20. Where are we compared to the previous summit ? • Availability of an estimate of the disease burden for the Colombo district as a model for decision making • Availability of an estimate of treatment cost • More comprehensive collection of sero types from LRH and 5 other hospitals • Wide representativeness • Antibiotic resistance data • Circulating serotypes ( n=125)
  • 21. Where are we compared to the previous summit ? • Availability of a vaccine ( 7,10,13 valent) with a high coverage for available serotypes • Comprehensive data on safety and immunogenicity of the intended vaccine • Availability of results of an economic analysis as a guiding tool for decision making • Established infra structure ,expertise on and experience in post introduction surveillance of new vaccines • Availability and delivery of the intended vaccine in the private sector • WHO support for continued surveillance ( disease and laboratory)
  • 22. Points for the discussion • • • • • Is – – – introduction of pneumococcal vaccine justifiable ? Disease burden, economic burden Competing priorities (MMR, typhoid) Financial sustainability • SL- no longer being GAVI eligible • Self financing potential Can a tentative timeline be determined ? – consideration of the pneumococcal vaccine in future given the financial feasibility and GAVI support – immunization stake holder's meeting 2007 What are the other constraints ? How can we overcome them? Any concerns of participants ?
  • 23. Acknowledgement • • • • • • • • • • • • • • Dr. Nihal Abeysinghe for vision and guidance Dr. Paba Palihawadana and Dr T.S.R.Pieris for continued vision & support Dr.Ranjit Batuwanthdawe for the pioneering work Dr. Malka Dissanayake & Dr.Kumudu Karunaratne for enabling information generation Dr.Sanjeewa Kuaratne for initiating epidemiological and economic analysis All microbiologists at the SPnSN for their contributions MLTs at the LRH microbiology lab for the excellent work All pediatricians at the LRH for their precious contributions Dr. Mark Stein Hoff, Prof. Kurian Thomas, Professor Lalitha Kesewan Microbiology team @ the Christian Medical College , Vellore, Tamil Nadu GAVI’s Pneumo ADIP, John Hopkins University, USA International Clinical Epidemiological Network (INCLEN) All research assistants of the SAPNA ( Sri Lanka) for the hard work Iresha, Roshan, Priyangika for coordinating all the work