Update on Pertussis with special reference to QUINVAXEM in India

Update on Pertussis
Dr Gaurav Gupta

Conflict of Interest
• Received grants from various vaccine
manufacturers including
– Sanofi Pasteur
– GSK
– Abbott
– Novartis

Noel Preston (1988)
‘There must be a few medical subjects that have
generated so much controversy & even outright
contradiction, as pertussis’
Today (2014)
25 years later than the above statement, pertussis has
become even more contentious, more controversial &
more balkanized …

Knowledge is the process of piling up facts,
wisdom lies in their simplification

Outline of Presentation
• Pertussis resurgence – background
• aP v/s wP – which is better & why
• choices amongst wP vaccines – why choose
one over others

Reported cases of pertussis in 2008 :: Top 10 countries
7
Australia & USA reported maximum number of cases following India ...
Source: 1. World Health Organization. http://www.who.int/whosis/2010/en/index.html accessed on 12 February, 2014.

Status of global pertussis
outbreaks …
8
Source: 1. Available at http://www.cfr.org/interactives/GH_Vaccine_Map/#map (accessed on 24th January, 2014)
2008

9
2009
outbreaks …

10
2010
outbreaks …

11
2011
outbreaks …
• Outbreaks also been reported from countries using wP vaccines like from Khairpur District of Sindh province of Pakistan
• However, study conducted between 2005 & 2009 found that B. parapertussis was responsible for outbreak
Source: 1. Mughal A, Kazi YF, Bukhari HA, Ali M. Pertussis resurgence among vaccinated children in Khairpur, Sindh, Pakistan. Public Health. 2012; 126:518-22. 2. Bokhari H, Said F, Syed MA, Mughal A, Kazi YF, Kallonen T, et al. Molecular typing of Bordetella parapertussis isolates
circulating in Pakistan. FEMS Immunol Med Microbiol. 2011; 63:373-80. 3. Available at http://www.cfr.org/interactives/GH_Vaccine_Map/#map (accessed on 24th January, 2014).

12
2012
outbreaks …

13
2013
outbreaks …

14
Source: 1. Ali Rowhani-Rahbar, Joan Bartlett, Roger Baxter, Nicola Klein. Pertussis Risk in Children as a Function of Time Since Receipt of
the 5th Dose of Acellular Pertussis Vaccine. 29th Annual ESPID Meeting The Hague, The Netherlands June 10, 2011.
Pertussis resurgence in USA
In 2010, California experienced largest pertussis outbreak in 50 years …
Pertussis declined
sharply with advent
of wP vaccines
Shift from DTwP to
DTaP emerged as the
major factor for
California outbreak
• Outbreak despite >80% coverage with 3 & 5 component DTaP
• ‘Coincident with this shift in vaccine type, pertussis incidence has
been gradually increasing…’

• In November 2012, SAGE expressed concern
about the apparent resurgence of pertussis in
some industrialized countries despite high
vaccine coverage with acellular pertussis (aP)
vaccines, which in some settings
was associated with an increase in infant
pertussis deaths.

• SAGE then established a pertussis working
group which presented its report to SAGE.
• Review of epidemiological data on pertussis
from 19 developing and industrialized
countries in various world regions which have
wP- or aP-based programs achieving
– high vaccine coverage rates,
– effective disease control,
– ability to provide high quality data.

MEETING OF THE STRATEGIC ADVISORY GROUP OF EXPERTS (SAGE)ON
IMMUNIZATION, APRIL 2014
• Pertussis epidemiology
• B. pertussis strains have evolved over time
• Inconsistent correlation with vaccine programs and
epidemiology
• No evidence to date for diminished effectiveness of
vaccines against different allelic variants
• No evidence of emergence of B. parapertussis in aP or wP
using countries
• Pertussis vaccination
• Main objective of pertussis vaccination is to reduce risk of severe
pertussis in infants
• wP and aP very effective in reducing disease with high coverage
• Drastic decline in global incidence and mortality in post-
vaccine era

FIMbriae
Filamentous Haem-Agglutinin
PeRrtactiN
Pertussis Toxin
Adenylate Cyclase Toxin
Dermo-Necrotic Toxin
Tracheal Cyto-Ttoxin
Bordetella resistance to
Killing genetic locus, frame A
Lipo-Oligo-Sachharide
These virulence factors are responsible for pathogenesis of
B. Pertussis …
Source: 1. He Q, Makinen J, Berbers G, Bordetella pertussis Protein Pertactin Induces Type-Specific Antibodies: One Possible Explanation for
the Emergence of Antigenic Variants? The Journal of Infectious Diseases 2003; 187:1200–5. 2. Crowcroft N. S., Pebody R. G. Recent
developments in pertussis. The Lancet 2006;367:1926-1936.
19

20
aP vaccines do not contain many crucial antigens while
wP vaccines contain entire complement of all antigens …
Source: 1. Crowcroft NS ,Pebody RG .Recent developments in pertussis.The Lancet 2006;367:1926-1936 2.Preston A. Bordetella pertussis : the intersection
of genomics and pathobiology.CMAJ 2005;173(1)55-62.

21
The natural immune response involve predominantly Th1 cells ...
Immune response to natural infection by B. pertussis…
Source: 1. Mills K.H.G., McGuirk P. Antigen-specific regulatory T cells: their induction & role in infection. Seminars in Immunology 16
(2004) 107–1.

22
Immunomodulatory responses to these immunogens are complex ...
Immune response induction by wP & aP vaccines …
Source: 1. Mills K. Immunity to Bordetella pertussis. Microbes and Infection, 3, 2001, 655−677.

Comparative efficacy of DTwP &
DTaP vaccines
23
Source: 1. Edwards & Decker. In: Vaccines, 4th Edition, 2004. 2. Plotkin & Cadoz. PIDJ, 1997; 16 (5).

Duration of immunity to pertussis
24
wP vaccines provide longer immunity than aP vaccines …
Source: 1. Pediatric Infectious Diseases Journal 2005;24(5) 58-61. 2. Wendelboe et al. PIDJ, 2005.
Duration of protection by wP vaccines

4
Acellular (aP) vs Whole cell (wP) Vaccines
• Acellular vaccines
• Lower initial efficacy
• Faster waning of immunity
• Possible reduced impact on transmission
• Likely to result in resurgence
• Magnitude and timing of resurgence difficult to predict
• Potential increased risk of death in those too young to be
vaccinated

4
Acellular (aP) vs Whole cell (wP) Vaccines
vaccinated
vaccinated
• Proposed mechanism
• aP vaccines induce different type of immune response
• Higher Th2-promoting antibody responses
• Lower Th1 and Th17 responses
• Less effective at limiting and clearing mucosal infections

Safety concerns – wP versus aP
• wP often cause minor (but troublesome) side effects
and rarely more serious adverse events. Relatively
high incidence of the former is sometimes
unacceptable to care-givers and care-providers; this is
what prompted the development of aP
• The incidence of frequent side effects (fever,
erythema, swelling, fretfulness, drowsiness) is
reported to be significantly less with aP as compared
to wP.

Frequency of Common Side Effects with Pertussis
Vaccines
Event Whole cell
pertussis vaccine
Acellular
pertussis vaccine
Average Average Range
Fever < 38.3°C 44.5% 20.8% 16-29.2%
Fever > 38.3°C 15.9% 3.7% 1.6-5.9%
Erythema 56.3% 31.4% 15-44%
> 2.0 cm 16.4% 3.3% 1.4-5.9%
Swelling 38.5% 20.1% 7.5-24.2%
Drowsiness 62.0% 42.7% 29.4-52.2%
There is a very wide range among various aP with varying frequencies for
individual side effects. Impossible to identify an aP with the most (or least)
favourable adverse event profile.
Mathew JL. Acellular Pertussis Vaccines: Pertinent Issues, Indian Pediatrics 2008;
45:727-729

Safety concerns – wP versus aP
• Meta-analysis of data from large randomized
controlled trials on serious adverse events shows that
although the relative risk for some events is less with
aP, the absolute risk difference is comparable to wP
because such events are very rare with both.

Meta-analysis of Serious Adverse Events with Pertussis
vaccines
Event Frequency
with aP
Frequency
with wP
Pooled RR
(95% CI)
Interpretation
High fever 227/99323 996/96879 0.18 RR is about
(>40°C) (0.23%) (1.03%) (0.08-0.44) 80% less with aP than
with wP, but the
absolute
difference is 2%.
Seizures 58/106204 224/103474 0.28 RR is about
(within 48 h) (0.05%) (0.22%) (0.13-0.61)
72% less with aP than
with wP, but the
absolute
difference is negligible.
Hypotensive- 20/106204 491/103474 0.04 RR is about
hyporesponsive
episode
(0.02%) (0.47%) (0.01-0.19)
96% less with aP than
with wP, but the
absolute
difference is negligible.
Mathew JL. Acellular Pertussis Vaccines: Pertinent Issues, Indian Pediatrics 2008; 45:727-729
Relative risk for some events is less with aP, the absolute risk difference is comparable to wP
because such events are very rare with both.

• Quinvaxem components:
– Diphtheria toxoid - ≥30 IU
– Tetanus toxoid - ≥60 IU
– Whole-cell pertussis - ≥4 IU
– HBsAg - 10 mg
– Hib (PRPT-CRM197)- 10 mg
- 25 μg of CRM 197
– No thiomersal
– No preservatives1
†Thiomersal may be present in traces as a residue of the manufacturing process
Quinvaxem is a fully liquid, pentavalent vaccine
that helps to protect against
diphtheria, tetanus, pertussis, hepatitis B & Haemophilus influenzae type b1
Source: 1. Quinvaxem PI 2006. 2. Data on file 2012.
Quinvaxem
Fully liquid pentavalent (DTwP-Hep B-Hib) vaccine ...
32

Summary
• Only pentavalent vaccine with CRM197 Hib conjugate – better tolerability & titers
than TT conjugate
• The only pentavalent with no preservative / no added thiomersal in India
• Optimal aluminum phosphate (adjuvant) levels
• Extensive clinical database (>4000 subjects) across different schedules &
interchangeability
• Well documented immunogenicity & safety profile & low post injection
reactogenicity including Indian data
• 1st WHO pre-qualified, fully liquid pentavalent vaccine, with sustained WHO PQ
since 2006
• The most widely used pentavalent vaccine globally (>418 million doses :: till Sep
2012)
• Protecting 25% of the global newborn cohort from 5 deadly disease every year#
• Registered in >30 countries & distributed by UNICEF & PAHO in > 90 countries
Quinvaxem

Evolution of Hib conjugates2
CRM197 is a modern Hib conjugate ...
Tetanus Toxoid
(TT)
Diphtheria Toxoid
(DT)
Outer Membrane Protein
of meningitidis (OMP)
Cross Reactive Material
of C. diptheria (CRM197)
 Derived from
Clostridium tetani
 Inactivated with
formalin
 Purified with
ammonium sulfate
and filter sterilized
prior to conjugation
process
 Derived from C.
diphtheriae
 Detoxified with
formaldehyde
 Purified by
ammonium sulfate
fractionation &
filtration
Outer membrane protein
complex derived from
N. meningitidis serogroup
B strain11
Purified by detergent
extraction,
ultracentrifugation,
filtration & sterile
filtration
 Enzymatically
inactive, nontoxic
mutant of diphtheria
toxin
 Requires no
formaldehyde
detoxification
 Obtained at near
100% purity
* M.Wt. 140 kD 63 kD 37 kD 63 kD
35

Experience of CRM197 conjugated vaccines
 used in modern conjugate vaccines2
• Prevnar, Menveo
• demonstrated efficacy & safety
 positive effect on preexisting immunity
of CRM197 & TT than DT and TT which
have negative effect to pre- or
concomitant immunization with other
conjugate vaccines3
 shows highest immune responses after
the 3rd dose5
 better tolerated than TT conjugate4
Hib CRM197 vs Hib TT
Better local reactogenecity profile
than Hib-TT Conjugate Vaccines6,7
P <0.05
P <0.05
Source: 1. Based on: Harrison LH. Clin Microbiol Rev. 2006;19:142-164. 2. Bröker M, et al. Vaccine 2009; 27:5574–5580. 3. M. Tontini et al. / Vaccine 31 (2013) 4827– 4833.
4. Decker MD et al. J Pediatr. 1992; 120 (2 pt 1):184-9. 5. Kanra G, Viviani S, Yurdakok K, Özmert E et. al. Clinical Microbiology and Infection. Vol.6 Sup 1.2000. Abstract
WeP 296 p.236-7. 6. Decker MD, et al. J Pediatr. 1992;120(2 pt 1):184-189. 7. Knuf M et al. Vaccine 2011; 29: 4881-90 based on: Decker MD et al. J Pediatr 1992; 120 (2 pt
1) 184-189.
36
CRM197 conjugate protein
CRM 197 demonstrates better local reactogenicity than TT conjugate ...

CRM197 conjugate protein
Pentavalent Vaccine Hib conjugate Hib GMT’s µg/ml
(1 month after
3rd dose)
Pentavac1
(Serum Institute of India)
TT
(Tetanus Toxoid)
7.55
Comvac
(Bharat Biotech)2
TT
(Tetanus Toxoid)
7.01
Pentaxim3
(Sanofi Pasteur)
TT
(Tetanus Toxoid)
4.17*
Quinvaxem4
(Novartis Vaccines)
CRM197
(Cross Reactive Material 197)
15
*In aP pentavalent vaccine aP antigens interfere with Hib response, leading to lower GMTs
compared with monovalent Hib vaccines5
Source: 1. Sharma HJ et al. Human Vaccines 7:4, 451-457; April 2011; c 2011. 2. SPC Comvac 2012. 3. Ortiz et al. INDIAN PEDIATRICS.
VOLUME 46__NOVEMBER 17, 2009. 4. Eregowda A et al. Human Vaccines & Immunotherapeutics 9:9, 1903–1909; September 2013; c 2013 5.
Plotkin SA et al. Expert Rev. Vaccines 10(7), 981–1005 (2011).
37
CRM 197 demonstrate better Hib immune response than TT conjugate ...

Quinvaxem
• The world is moving away from Thiomersal1
• Growing global trends towards thiomersal-free vaccine usage
– European Medicines Agency in 2007 recommends reducing exposure to
mercury2
– The US FDA is continuing its efforts to reduce the exposure to Thiomersal3
– AAFP, AAP, ACIP and PHS recommend vaccines free from Thiomersal3
Quinvaxem is the only pentavalent vaccine which is preservative-
free with no added Thiomersal
USA: 30 &
France: 2
childhood vaccines
with thiomersal
1999 2002
USA & Europe
All childhood
vaccines are
thiomersal free or
contain only traces
2012
USA & Europe
Almost all vaccines
are thiomersal-free
Source: 1. Hessel L. Bull Acad Natl Med. 2003;187(8):1501-10. 2. The European Medicines Agency Evaluation of Medicines for Human Use , London, 11
January 2007 EMEA/CHMP/VWP/19541/2007; CHMP Position Paper on Thiomersal Implementation of the Warning Statement Relating to Sensitisation.
3. http://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228.htm (accessed Aug. 2013).
39
The only pentavalent vaccine which is preservative-free ...

Safety Profile2 :
Adverse reactions that have been
reported with high aluminum containing
vaccines include
 Sterile abscesses
 Erythema
 Subcutaneous nodules
 Granulomatous inflammation
 Contact hypersensitivity
 Production of IgE antibodies
Regulations
 US FDA (21 CFR 610.15)
• aluminum content of a vaccine
shall not exceed 0.85 mg of
aluminum per dose
 WHO technical guidelines
• aluminum content of a vaccine
shall not exceed 1.25 mg of
aluminum per dose
Optimal aluminium adjuvant content for favourable tolerability ...
Quinvaxem
Quinvaxem contains 0.3 mg aluminium adjuvant
for desired immunogenicity & low local reactogenicity1
Source: 1. Quinvaxem prescribing Information 2013. 2. Krewski, Yokel, Nieboer, et al. Human Health Risk Assessment for Aluminum,
Aluminum Oxide, and Aluminium Hydroxide. JJ Toxicol Environ Health B Crit Rev. 2007; 10(Suppl 1): 1–269.
41

QuinvaxemSummary of clinical evidence ...
Study Phase Design Primary objective Schedule Quinvaxem (n) Comparator
Kanra et al.
(Turkey)
II
Open label,
randomized,
comparative
Compare immunogenicity of HBV component of
Quinvaxem® with that of a separate HepB vaccine
(Hepavax-Gene®) when concomitantly administered with
Quattvaxem®
2-3-4
(months)
152
151
(separate
DTwP-Hib &
Hep B)
Gentile et al.
(Argentina)
II
Open label, single
center, non-
randomized
Evaluate immunogenicity of HBV component of
Quinvaxem® given to infants who may or may not have
received 1 dose of HepB vaccine at birth
2-4-6
(months) 218 -
Aspinall et al.
(South Africa)
III
Double blind,
multicenter,
randomized
Demonstrate clinical equivalence of 3 consecutive
production lots of Quinvaxem® given to infants with
regard to seroprotection rates for HepB
6-10-14
(weeks)
360 -
Aspinall et al.
(South Africa)
III
Open label,
multicentric,
randomized
Evaluate antibody responses to HBsAg, PRP, Bordetella
pertussis, diphtheria, and tetanus after a booster
vaccination in infants receiving the booster dose of
Quinvaxem® 1 month prior to, or concomitantly with, a
measles vaccine
18 ± 3
(months)
(booster)
227 -
Suárez et al.
(El Salvador)
III
Open label,
multicentric,
randomized,
parallel group
Demonstrate that antibody response to PRP (anti-PRP
titer >1.0 μg/mL) 1 month after booster dose of
Quinvaxem® is as good as after separate administration
of DTwP and Hib vaccines when received as a primary
immunization course with the commercially available
DTwP-HepB/Hib vaccine
15–24
(months)
(booster)
150
149
(separate
DTwP & Hib)
Asturias et al.
(Guatemala)
IV
Open label,
observational,
post-authorization
safety study
Investigate the incidence of clinically relevant AEs and all
serious AEs in infants vaccinated with Quinvaxem®,
administered according to the national schedule for
routine vaccination
2-4-6
(months) 3000 -
Eregowda et al.
(India)
III
Open label,
multicenter,
randomized
Demonstrate immunogenicity and safety of three doses
of Quinvaxem® in Indian infants
6-10-14
(weeks)
175 -
AE = adverse event; DTP = diphtheria, tetanus, pertussis; DTwP = diphtheria, tetanus, whole-cell pertussis; HBsAg = hepatitis B surface antigen; HBV =
hepatitis B virus; HepB = hepatitis B; Hib = Haemophilus influenzae type b; PRP = polyribosylribitol phosphate
43

Investigators:
Dr. Sanjay Lalwani, HoD, Dept. of Pediatrics, Bharati Vidyapeeth Medical College, Pune
Dr. Sukanta Chatterjee, HoD, Dept. of Pediatrics, Medical College, Kolkata
Dr. Adarsh Eregowda, HoD, Dept. of Pediatrics, Rajarajeshwari Medical College and Hospital, Bangalore
45
Quinvaxem – Indian study
Source: 1. Human Vaccines and Immunotherapeutics 2013;9(9):1-7. (Sept 2013 issue)

0
20
40
60
80
100
2%
Tetanus
100%100%
Diphtheria
99%
18%
Hepatitis B
98%
11%
Hib
(Long Term
Protection)
95%
23%
Hib
(Short Term
Protection)
100%
68%
Pertussis
99%
Post VaccinationBaseline N = 161
Minimum Protective Levels:
• D : ≥ 0.1 IU/mL
• T : ≥ 0.1 IU/mL
• wP : 4-fold increase or 20 EIU/mL
• Hib : Short term: ≥ 0.15 mcg/mL
• Long term: ≥ 1.00 mcg/mL
• Hep B : ≥ 10 mIU/mL
46
Seroprotection rates at Baseline & 1 month after 3rd vaccine dose ...
Quinvaxem – Indian study
Source: 1. Human Vaccines and Immunotherapeutics 2013;9(9):1-7. (Sept 2013 issue)

 Most of the solicited local
reactions were mild to moderate
in intensity
 Most of the unsolicited AEs were
also mild to moderate in intensity.
 There were no vaccine-related
serious adverse events (SAEs) or
deaths reported during the study
period
Results – Safety (4)
13
10
4
11
0
20
40
60
80
100
Fever ≥ 38°CErythema TendernessInduration
3rd Vaccination (N = 165)
ADR(%)

Comparison of available
pentavalent vaccines
Pentavalent
Vaccine
Composition
Seroprotection (%) Reactogenecity (%)
Remark
Diphtheria
Pertussis
Tetanus
Hib
HepatitisB
Pain
Redness
Swelling
Fever
Quinvaxem1
• Hib conjugated to
CRM197*
• No Thiomersal#,
• Optimal aluminum
content$
99 99 100 100 98 10 11 4 13
• Sustained WHO prequalification since
2006
• Most widely used pentavalent vaccine
globally (>418 million doses till Sep
2012)
• Extensive Clinical database (>11000
doses in >4000 infants & toddlers)
demonstrating high immunogenicity &
safety
Pentavac2
• Hib conjugated to TT
• Contains thiomersal
• High content of
alumInum
100 95 100 100 100 22 39 20 18
• Estimated 40 million doses
• Poor reactogenecity profile
Comvac3
• Optimal aluminum
content
98 76 98 100 98 9.2 4 4 24
• Not WHO prequalified
• Hep B component WHO delisted
• No supply to UNICEF
• No published clinical data
Easyfive-TT4
• Optimum aluminum
content
95
66 -
76
99 95 94 NA NA 42 73
• WHO delisted in 2011 & relisted in
2013
• No published clinical data
Pentaxim5
Hib conjugated to TT,
Preservative added and
optimal content of
alum
100
PT -
85
FHA -
93
100 99
IPV
100%
For all
strain 14 4 5 17
• Extensive clinical database
• > 85 Million doses distributed since
last 15 years
Source: 1. *CRM197 : Better immunogenicity & tolerability profile than TT conjugate # Thiomersal: absence of scientific consensus on safety of thiomersal $ Alum adjuvant forms depot at site of injection and causes increased local
reactogenecity. 1. Eregowda A et al, Human Vaccines & Immunotherapeutics Sep 2013: Vol 9(9), 1903–1909, 2.Sharma H et al.Vaccine 29 (2011) 2359–2364 3.Comvac prescribing information 4.Easyfive TT prescribing information. 5.
Pentaxin prescribing information. ****They are independent studies and Definitions/ Scales used may differ
48

Product
Manufacturer
2006 2007 2008 2009 2010 2011 2012 2013
# of doses
supplied
Quinvaxem Crucell /
Novartis
WHO -
PQ
418 million
(till Sep 2012)
Shan 5
Shantha Biotechnics
WHO - PQ Delisted X
SII Penta / Pentavac
Serum Institute of
India
WHO -
PQ
40 million doses
Easyfive TT
Panacea Biotec
WHO - PQ Delisted Delisted Relisted
55 million
doses
Combi Five
Biological Evans
WHO -
PQ
Data not
available
Comvac
Bharat biotech
No WHO prequalification
No supply to
international
agencies
Pentaxim
Sanofi Pasteur
No WHO prequalification
No supply to
international
agencies
Quinvaxem®: Only pentavalent vaccine sustained WHO
prequalification status since introduction in 2006
Demonstrating consistent quality & safety profile ...
Source: 1. Source: http://www.who.int/immunization_standards/vaccine_quality/pq_consultation_2013/en/index.html.
50

Summary
• Only pentavalent vaccine with CRM197 Hib conjugate – better tolerability & titers
than TT conjugate
• The only pentavalent with no preservative / no added thiomersal in India
• Optimal aluminum phosphate (adjuvant) levels
• Extensive clinical database (>4000 subjects) across different schedules &
interchangeability
• Well documented immunogenicity & safety profile & low post injection
reactogenicity including Indian data
• 1st WHO pre-qualified, fully liquid pentavalent vaccine, with sustained WHO PQ
since 2006
• The most widely used pentavalent vaccine globally (>418 million doses :: till Sep
2012)
• Protecting 25% of the global newborn cohort from 5 deadly disease every year#
• Registered in >30 countries & distributed by UNICEF & PAHO in > 90 countries
Quinvaxem: A new perspective in pentavalent vaccines ...

15
General Recommendations (1)
• All children should be immunized against
pertussis
• Maintain high levels of coverage (≥90%)
• Minor reductions can lead to an increase in incidence
• Goal is early and timely vaccination in all countries
• As soon as possible ≥ 6 weeks of age
• ≥ 3 doses of assured quality vaccine
• 1 dose (~50%+) 2 doses (~ 80%+) effective against severe disease

• wP vaccines preferred when:
• Program target is prevention of infant disease
• Limited number of pertussis doses delivered /
affordable
• aP vaccines should only be considered when:
• Program objectives include older children and adults
• Large numbers of doses may be included in a
national immunization schedule
• Cost implications (higher unit cost & number of required
doses)
53

Supplemental Strategies may be considered to
Prevent Infant Mortality
• Maternal immunization
• aP vaccines safe & effective (via transfer of maternal
antibodies)
• Cocooning
• Potential reduction in severe morbidity; timing crucial;
requires high coverage
• Adolescent/adult boosters
• Health care workers should be priority group
54

Update on Pertussis with special reference to QUINVAXEM in India

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