Transcript Slide 1

Pneumococcal Vaccines
Update 2011
Prepared for the COI meeting 24th Dec 2011
Dr Suhas V. Prabhu
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Burden of disease - recent updates based on
review of literature (national & global);
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Brief report of any cost-effective analysis
published in last 6-12 months;
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Clinical trials: ongoing/planned/completed;
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New recommendations from other agencies;
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Contentious issues, if any.
Burden of Disease –Pneumonet Data*
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2 year prospective study
Based in 3 Bengaluru
hospitals
Study of IPD (culture of
S. pneumoniae from a
normally sterile site) and
pneumonia as defined
clinically and on X-ray
Interim data for 1 year
Poster at ESPID- June
2011
Age
group
(months)
No. of No. in
cases group
Incidence
rate per
1,00,000
population
1 to 6
3
8,186
36.35
6 to 12
6
13,040
46.01
12 to 24
3
22,777
13.17
24 to 36
4
22,470
17.80
36 to 60
1
46,010
2.17
Overall
17
112,483
15.10
Incidence of IPD in children < 2 years is
15.91(pn) + 6.82(pyomen) + 5.55(bact)
= 28.28/1,00,000 population
* Study Funded by Wyeth, a division of Pfizer Inc.
Burden of Disease –Pneumonet Data
Age
group
(months)
Clinical
Pneumonia
No. of cases
Incidence
rates per
1,00,000 pop.
X-ray
Pneumonia
No. of cases
Incidence
rates per
1,00,000 pop.
1 to 6
393
4,800.88
145
1,771.32
6 to 12
499
3,826.69
214
1,641.10
12 to 24
627
2,752.78
318
1,396.15
24 to 36
384
1,708.95
175
778.82
36 to 60
468
1,017.17
254
552.05
Overall
2,371
2,107.87
1,106
983.26
These are total pneumonia cases. Incidence of Pneumococcal pneumonia
has to be by extrapolation on possible fraction of S. pneumonae as a
cause of pneumonia in this age groups
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Burden of disease - recent updates based on
review of literature (national & global);
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Brief report of any cost-effective analysis
published in last 6-12 months;
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Clinical trials: ongoing/planned/completed;
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New recommendations from other agencies;
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Contentious issues, if any.
Cost Effectiveness data -Issues
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Cost effectiveness will depend on whether restricted
to “serious diseases” only (IPD) or others like AOM
Assumed incidence rates for AOM varied highly in
different studies from 20,952 to 118,000 per
1,00,000 children aged 0 – 10 years
PCV7 efficacy rates for AOM in 2 early studies were
only 6-8%
Other studies had rates varying from 12% to 57%
depending on vaccine used and whether direct
effects alone or additionally herd immunity effects
were included
Boonacker CV et.al. Pharmacoeconomics 2011 Mar 29(3):199-211 doi: 102165/11584930-000000000-00000
Cost-effectiveness data – Singapore*
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PCV-13 prevented 834 cases and 7 deaths due to IPD in
the vaccinated population, and 952 cases and 191
deaths in the unvaccinated population (herd effect) over
the 5-year time horizon.
Including herd effects, the cost-effectiveness ratio for
PCV-13 was USD $37,644 per QALY. Without herd
effect, the ratio was USD $204,535 per QALY.
The PCV-7 cost per QALY including herd effects was
USD $43,275 and for PHiD-10 the ratios were USD
$45,100
* Tyo K et. al. Vaccine 29 (2011) 6686– 6694
Cost- effectiveness data – Australia*
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Potential benefits estimated for PHiD-CV were due primarily
to prevention of otitis media and for PCV-13 due to a further
reduction in IPD.
At equivalent total cost to vaccinate an infant, compared to no
PCV the base-case cost per QALY saved were estimated at
A$64,900 (for PCV-7; 3 + 0), A$50,200 (for PHiD-CV; 3 + 1)
and A$55,300 (for PCV-13; 3 + 0), resp.
Assumptions regarding herd protection, serotype protection,
otitis media efficacy, and vaccination cost changed the
relative cost-effectiveness of alternative PCV programs.
The high proportion of current invasive disease caused by
serotype 19A (as included in PCV-13) may be a decisive
factor in determining vaccine policy in Australia.
* Newell AT et. al. Vaccine 29 (2011) 8077– 8085
Cost - Effectiveness data – Mexico*
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Strategy based on PCV13 prevented 16.205 deaths,
gained 332.006 QALYs and saved US$1,307/child
vaccinated.
Strategies based on PCV7 or PCV10 prevented 13.806
and 5.589 deaths, gained 282.969 and 114.972 QALYs
& saved US$ 1,084 and US$ 731/child vaccinated, resp.
These results were robust to variations in herd immunity
and lower immunogenicity of 10-valent vaccine.
Conclusion: Strategies based on 7, 10 & 13-valent
PCVs would be cost-saving interventions, with highest
health outcomes and savings of the strategy based on
13-valent vaccine.
* Mucino-Ortega E et. al. Value in Health (2011) S65 – 70
Cost-effectiveness – Valencia (Spain) *
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Universal PCV-13 vaccination would decrease the no. of
hospital admitted pneumonia by 4571 cases while avoiding
310 cases of IPD and 82,596 cases of AOM throughout the
cohort lifetime.
A total of 190 S. pneumoniae related deaths would be averted
over the same period.
Total medical costs of non-vaccinating the cohort of newborns
would reach up to € 403,850.859 compared to € 438,762.712
for vaccinating the cohort.
The incremental cost of vaccinating the children was
estimated in € 12,794 per QALY.
Conclusion: Universal PCV-13 vaccination would be a cost
effective intervention for preventing pneumococcal infections
and its associated mortality and morbidity.
* Diez-Dominigo J. et. al. Vaccine 29 (2011) 9640–9648

Burden of disease - recent updates based on
review of literature (national & global);

Brief report of any cost-effective analysis
published in last 6-12 months;

Clinical trials: ongoing/planned/completed;

New recommendations from other agencies;

Contentious issues, if any.
Ongoing clinical trials
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COMPAS study
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Being conducted in 24,000 children in 3 Latin
American Countries; 4 year follow-up
Aim is to study the efficacy in preventing clinical and
radiological pneumonia in study group
PCV10 (with NTHi D protein) in study arm with control
(Hep. B and Hep. A)
Interim data – vaccine efficacy rate of 22% (clinical
pneumonia i.e. features of LRTI with CRP > 40 mg/L)
and 25.7% (Consolidation on X-ray Chest)
Likely to be officially published in March/June 2012
Other Efficacy data
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PHiDCV (PCV10) introduced in Brazil from 2010
1284 children randomly selected from Central Brazil
from Dec 2010 to Mar 2011
Effectiveness of pneumococcal NP carriage for
incomplete and completely vaccinated children were
26% (95% CI: 0%-50%) and 36%(95% CI: 12%53%), respectively.
For CAP, the effectiveness for complete vaccinated
children was 40% (95% CI: 1.4%-63%).
Andrade AL et al. Presented at WSPID, Melbourne, Nov 2011
PCV7 and PCV13 prevents meningitis
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Municipality of Campos (Rio de Janeiro) introduced free
PCV7 in children under one year old from 05/29/2009,
until 10/24/2010, when it was replaced by PCV13.
Primary doses at 3, 5, 7 months, with booster dose at 13
months age. After 19 months of vaccination, at least
6,440 children received 4 doses of vaccine, with 92% of
coverage vaccination status (7.000 births/year).
There was no suspect or confirmed pneumococcal
meningitis case in 2010, when compared with 2009,
when there were notified 5 cases, and 1 death.
Kury CM et al. Presented at WSPID Melbourne Nov 2011
Acute Bacterial Core surveillance data (US)*
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Rates of IPD with all serotypes per 1,00,000 pop.
In children < 2 years of age (Total 15980 cases)
Effect of switch to PCV13 in Feb 2010
All
serotypes
Vaccine
serotypes
Quarter/Year
Baseline
2010
2006-2008
Baseline
2006-2008
2010
Jan-Mar
43.4
48.4
27.0
31.8
Apr-Jun
37.1
27.8
22.9
18.4
Jul-Sept
22.0
17.5
10.7
11.2
Oct-2010
40.3
18.8*
24.1
8.5*
Conclusion: These preliminary findings are consistent
with early effects of PCV13 on IPD among young children
*Presented at ICAAC of ASM at Chicago Sept. 2011
* P < 0.0001

Burden of disease - recent updates based on
review of literature (national & global);

Brief report of any cost-effective analysis
published in last 6-12 months;

Clinical trials: ongoing/planned/completed;

New recommendations from other agencies;

Contentious issues, if any.
New recommendations for PCV 10
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Iceland – PCV10
EMA(CMPH) – PCV10
April 20111
June 20112
(extension of use for 2 to 5 year age group)
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Brazil, Chile, Mexico, Colombia
Finland, Sweden, Netherlands
Albania, Bulgaria, Austria, Cyprus
Kenya
1. EPI-ICE 7:2 Apr-Jun 2011 2. NELM News Service June 2011
New recommendations – PCV10 vs PCV13
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Switch from PCV 10 to PCV 13
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Hong Kong
Australia
Canada
Nov 20111
Aug 20112
Sep 20103
Simultaneous use of PCV10 and PCV 13
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Korea
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No comment of superiority or otherwise of either vaccine
No special recommendation for use of either vaccine in any
specific group
New Zealand
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Apr 20114
May 20115
Use of PCV10 routinely and PCV13 for “high-risk” group
1. Press Release: Health Dept. HK. Nov 29, 2011. 2. Dept. Memo dated 30th Aug, 2011
3. CCDR: Nov 2010. 4. Korean J Pediatr 2011;54(4):146-151 5. IAC – Univ. of Auckland
New recommendations – schedules of
vaccination
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2 + 1 schedule
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3 + 1 schedule
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Colombia (Bogotá), Finland, Mexico, Sweden (3 provinces)
U.K., France, Belgium
Australia (Northern Territories), Austria (high-risk groups),
Albania, Brazil, Bulgaria, Cyprus (high-risk groups), Hong
Kong, Taiwan (Taipei), The Netherlands, Germany
3 + 0 schedule
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Kenya
N.B. PCV13 now recommended for adults aged 50 years and over
Are 2 primary doses adequate?
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Review of 8 RCTs on PCV7 in 10 countries
Immunological data: 3p schedules result in
slightly higher antibody levels than 2p
schedules both before and after a booster
dose, particularly for serotypes 6B and 23F.
There is an absence of clinical outcome data
Limited data re: nasopharyngeal carriage
from direct comparisons of any 2p to any 3p
schedule.
P. Scott et al. Vaccine 29 (2011) 9711–9721

Burden of disease - recent updates based on
review of literature (national & global);

Brief report of any cost-effective analysis
published in last 6-12 months;

Clinical trials: ongoing/planned/completed;

New recommendations from other agencies;

Contentious issues, if any.
Contentious Issues – Additional categories
in high risk group
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Prematurity and VLBW babies
Up to 9 fold higher incidence of IPD in VLBW
babies compared to full size babies*
Is included as high risk category by many
advisory bodies incl. ACIP (USA), New Zealand
IAP COI recommendations 2010 do not include
this category as “high-risk”
Need to correct this lacuna in next publication
* Shinefield H et al. Pediatr Infect Dis J.2002;21:182-6
Thank You