Maternal
Immunization
with Tdap Vaccine
Agenda
Pertussis:Key facts & Epidemiology
Who is at risk?
Source of Pertussis infection
What is Tdap vaccine?
Recommendations for Maternal Immunization with Tdap vaccine
Safety data on Maternal Immunisation with Tdap vaccine
Summary
4. Agenda
4
Pertussis:Key facts & Epidemiology
Who is at risk?
Source of Pertussis infection
What is Tdap vaccine?
Recommendations for Maternal Immunization with Tdap vaccine
Safety data on Maternal Immunisation with Tdap vaccine
Summary
1.
2.
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4.
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6.
7.
6. PERTUSSIS:KEY FACTS
• Highly contagious respiratory infection caused by
the Gram-negative bacterium Bordetella pertussis1,2
• Pertussis affects people of all ages3
• More commonly known as ‘whooping cough’1
• Transmission: airborne droplets or direct contact
with nasopharyngeal discharges from an infected
person1,3
• Reservoir: Humans are the only reservoir3
Bordetella pertussis
(Photograph sourced from the
CDC PHIL: ID 2121)
1. CDC. In: Epidemiology and Prevention of Vaccine-Preventable Diseases [Pink Book]. 2012:215–232; 2. Grant C. In: Oxford Textbook of Medicine. 2010:Section 7.6.14; 3. WHO. Wkly
Epidemiol Rec 2010;85:385–400
7. Despite high primary vaccination coverage of DTP,
a considerable number of pertussis cases are still
reported annually
7
Global distribution of 140,156 pertussis cases reported to the WHO in 2014
No data/0 cases
<10
≥10–100
≥100–1000
≥1000–10,000
≥10,000–20,000
≥20,000–50,000
Number of pertussis cases
Adapted from - World Health Organization. Data, statistics and graphics – Disease incidence time series.
http://apps.who.int/immunization_monitoring/globalsummary/timeseries/tsincidencepertussis.html. (accessed November 2017)
Map used for illustrative purpose
8. Pertussis cases in India (1980-2015)
8World Health Organization• SEARO/FGL/IVD • 31 August 2016 Immunization
WHO & UNICEF estimates of national immunization coverage Jul 2016
WHO vaccine –preventable disease monitoring system 2016
9. The real burden of pertussis is under estimated
9
However, WHO estimated that there were
1.6 crore cases of pertussis in the
same year2
In 2008, 148,095 cases globally were officially
reported1
1. World Health Organization. Data, statistics and graphics – Disease incidence time series. Available from:
http://apps.who.int/immunization_monitoring/globalsummary/timeseries/tsincidencepertussis.html (accessed November 2017); 2. World Health
Organization. Immunization, Vaccines and Biologicals - Pertussis. Available from: http://www.who.int/immunization/topics/pertussis/en/. (accessed
November 2017) 3.Miller E et al. Commun Dis Public Health 2000;3(2):132–134
WHO, World Health Organization
Thus, For every 1 case reported, an estimated 83
more people have evidence
of recent infection3
11. Who is at risk of Pertussis ?
1
1
Infants1 Adolescents1 Adults1
1.Tina Tan, MD et al. (Pediatr Infect Dis J 2005;24: S10–S18
12. Pertussis is a highly contagious and potentially serious respiratory disease1
Newborns are too young to be protected by currently available vaccination
schedules2
- Pertussis disease are highest in the period
between birth and 6–8 weeks of age3
- 76% of pertussis related deaths occur in
infants aged under 2 months4
- About 90% of pertussis-related deaths in
infants <6 months old5
1.CDC. In: Epidemiology and Prevention of Vaccine-Preventable Diseases [Pink Book]. 2012:215–232 2.Berti E, et al. Acta
Paediatr 2014;103:846–9.) 3.Meulen et al,CID,2016 .4.Healy CM etal Hum Vac Imm 5.Grant. In: Oxford Textbook of Medicine. 2010:
Section 7.6.14
Pertussis Disease
13. Pertussis- complications in young infants
1. Hong. Korean J Pediatr 2010;53(5):629–633
• Young infants (<2 months of age) are most at risk of pertussis-
associated complications and death1
Complications in young infants
(<2 months of age)1
Complication Rate, %
Hospitalisation >90
Pneumonia 15–25
Seizures 2–4
Encephalopathy 0.5–1
Death 0.5–1
15. 15
0
5
10
15
20
25
30
35
40
Mother Father Sibling Grandparent Other
Mothers are the most common source of pertussis infection1
Percentageoftotalsource
contactswithpertussis
37.3
17.6
26.8
4.2
14.9
1.Data derived from Wiley KE et al. Vaccine 2013;31:618–625
15
Pooled data from a maximum of 7 studies which included case infants less than 6 months old
Main source of infection
Sources of infant pertussis cases by contact category (%)
16. Adolescents AdultsChildren
Waning
immunity1,4
Vaccine-induced
protection1,4 Limited
immunity1,4
Transmissio
n
Elderly
Complicatio
ns
& death5
Older individuals represent a reservoir of infection, potentially transmitting
disease to unvaccinated or partially vaccinated infants1–3
Young infants
As per current practise only children are vaccinated with
DTP, starting at 6 weeks
1. Hewlett EL & Edwards EM. N Engl J Med 2005;352:1215–1222; 2. Wendelboe AM et al. Pediatr Infect Dis J 2007;26:293–299;
3. Zepp F et al. Lancet Infect Dis 2011;11(7):557–570; 4. Wendelboe AM et al. Pediatr Infect Dis J 2005;24(5 Suppl):S58–S61; 5. Dabrera G et al. Clin Infect Dis
2015;60(3):333–337
1
6
What happens when only children are vaccinated
17. Several vaccines have been found to be generally
well tolerated and immunogenic in pregnant
women and their neonates1
Some vaccines are routinely recommended
during pregnancy including inactivated influenza,
tetanus toxoid, Tdap(acellular pertussis
vaccines)*1
Maternal immunisation can help protect very
young infants
*Adequate human data on use of pertussis containing vaccine during pregnancy are not available. Therefore, Boostrix ® +/- IPV can be used during pregnancy only when
recommended by a physician
1. Chu HY & Englund JA. Clin Infect Dis 2014;59:560–568 1
7
19. What is Tdap vaccine ?
Boostrix Prescribing Inform.-Version BTX/PI/IN/2017/01 dated 04 Apr 2017
20. Boostrix Prescribing Inform.-Version BTX/PI/IN/2017/01 dated 04 Apr 2017
• A single 0.5 ml dose of the vaccine is
recommended from the age of 4 years
onwards
• BOOSTRIX should be administered in
accordance with official recommendations
and/or local practice regarding the use of
Tdap vaccines.
• BOOSTRIX is or deep intramuscular injection
preferably in the deltoid region
Posology and method of administration
21. Boostrix Prescribing Inform.-Version BTX/PI/IN/2017/01 dated 04 Apr 2017
Posology and method of administration
• The use of BOOSTRIX may be considered during
the 3rd trimester of pregnancy
• Human data from prospective clinical studies on
the use of BOOSTRIX during the 1st & 2nd trimester
of pregnancy are not available
• It is not expected that vaccination with BOOSTRIX
harms the foetus at any trimester of pregnancy.
The benefits versus the risks of administering BOOSTRIX during pregnancy
should be carefully evaluated. Limited data indicate that maternal antibodies may
reduce the magnitude of the immune response to some vaccines in infants born
from mothers vaccinated with BOOSTRIX during pregnancy. The clinical relevance of
this observation is unknown
23. Boostrix safety data in Maternal Immunisation1
2
3
1.Petousis-Harris H, et al. BMJ Open 2016;6:e010911. doi:10.1136/bmjopen-2015-010911
Vaccination with Boostrix in pregnant women was well
tolerated with no Serious AEFI likely to be caused by the
vaccine.
This is reassuring for pregnant women, vaccinators and
policymakers.
793 participants. The mean age was 32, with 61.4% of
participants aged between 25 and 35 years.
AEFI = adverse event following immunisation
The largest number of pregnancy exposures in
prospective observational study with Boostrix that have
been actively followed up for safety outcomes
24. Safety of Boostrix + Influenza (FLU) vaccinations
in Pregnancy1
2
4
1.Sukumaran L,et al. OBSTETRICS & GYNECOLOGY 2015VOL. 126, NO. 5, NOVEMBER 2015
• No statistically significant increased risk of fever or any medically
attended AE was found in pregnant women vaccinated
concomitantly.
• No difference in preterm delivery, LBW, or small –for-gestational –
age neonates between women vaccinated concomitantly
compared with sequentially in pregnancy
Among 36,844 pregnancies in which Tdap & Flu vaccines were
administered, the vaccines were administered concomitantly in 8,464
(23%) pregnancies and sequentially in 28,380 (77%) pregnancies
Retrospective, cohort study of pregnant women using the Vaccine
Safety Datalink from 2007 to 2015, to access safety of Tdap and Flu
vaccines administered concomitantly during pregnancy.
25. More evidence supports the generally well tolerated
profile of Tdap vaccines in Maternal Immunisation
25
No increased risks for any pre-specified maternal
safety outcomes within 42 days of vaccination1
1. Kharbanda EO Vaccine. 2016;34(7):968-73; 2. Morgan et al. Obstet Gynecol 2015;125:1433–8) . 3, Vizzotti C et al. Vaccine 2015;33:6413-19
Tdap vaccines safety cohort
included 53,885 vaccinated
pregnant women1
1,258,723 doses of
Boostrix and Adacel
have been administered
since strategy started3
Both vaccines demonstrated a suitable safety profile.
No serious adverse effects or fatalities have been
reported4
A cohort including 1,229
women who received Tdap
vaccine more than once in
consecutive pregnancies2
Antepartum Tdap vaccination does not lead to excess
pregnancy related morbidity, even with repetitive
dosing in serial pregnancies.2*
27. FOGSI Recommendation
1.http://www.fogsi.org/wp-content/uploads/2015/11/vaccination_women.pdf, accessed on 08/11/2017
2.http://www.fogsi.org/gcpr-preconception-care/accessed on 08/11/2017
Tetanus diphtheria acellular pertussis (T-dap) vaccination
can be considered instead of the second dose of tetanus
toxoid(TT) to offer protection against diphtheria and
pertussis in addition to tetanus1.
FOGSI Good Clinical Practice Recommendations on PRECONCEPTION CARE - 2015
"Tdap should be administered again during pregnancy in order to
provide optimal protection to the baby during its first months of
life2. (Strength of recommendation: A)”
The Federation of Obstetric & Gynecological Societies of India
28. IAP recommendation
1. http://acvip.org/professional/columns/detailed-recommendations-iap-immunization-schedule-2016 accessed on 07-11-2017
“One dose of Tdap vaccine to pregnant mothers during each
pregnancy (preferred during 27 through 36 weeks gestation)
regardless of number of years from prior Td or Tdap
vaccination”
IAP/ACVIP Recommended Immunization Schedule & Update in
Immunization 2016
IAP-Indian Academy of Pediatrics, ACVIP-Advisory Committee on Vaccines and Immunization Practices
29. Countriesthatimplementorrecommend*pertussisbooster
vaccineinMaternalImmunisation
Country with maternal immunisation recommendation
Country without maternal immunisation recommendation
> 31 countries have
Recommendation/implementation
*India, South Korea and Canada do not have UMV programmes for pertussis as MI
29
UK
S Korea
India
Australia
New Zealand
Italy
Taiwan
Greece
Qatar
Colombia
Suriname
Switzerland
USA
Canada
Spain#
Belgium
Israel
Ireland
El Salvador
Panama
Brazil
Argentina
Paraguay
Costa Rica
World Health Organization. Vaccinationschedules. Availableat: http://apps.who.int/immunization_monitoring/globalsummary/schedules. Accessed April 2016,Australian GovernmentDepartment of Health. The Australian ImmunisationHandbook 10th Edition 2013. Availableat:
http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home(updated January 2014; Pertussis updated March 2015). Accessed April 2016,Belgian Conseil Supérieur de la Santé (CSS). Vaccination anticoquelucheuse. Vaccinationde l'adulte. 2013.
http://www.health.belgium.be/internet2Prd/groups/public/@public/@shc/documents/ie2divers/13036470_fr.pdf[Accessed February 2016]Public Health Agency of Canada. Canadian ImmunizationGuide; Part 4: Pertussis Vaccine (February2014). Available at: http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-pert-coqu-eng.php.Accessed April
2016Vashishtha VMV, et al. Indian Academy of Pediatrics (IAP) recommendedimmunization schedule for children aged 0 through 18 years – India, 2013 and updates on immunization. Indian pediatrics 2013; 50:1095–1108. http://www.indianpediatrics.net/oct2014/785.pdf,Health Service Executive (HSE), Ireland. Whooping cough vaccine for pregnant
women. September 2014. http://www.hse.ie/eng/health/immunisation/hcpinfo/OtherVaccines/pertussis/pertussisengleaf.pdf[Accessed February 2016]Stateof Israel Ministry of Health.WhoopingCough Vaccinationin Pregnant Women. http://www.health.gov.il/English/Topics/Pregnancy/during/Pages/Vaccination-Whooping_cough.aspx [Accessed
April 2016]Spanish Ministry of Health vaccination programme.Available at: http://www.msssi.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/docs/Adenda_TosFerinaEmbarazo.pdf[Accessed February 2016]MexicoConsejo de Salubridad General. Availableat:
http://www.cenetec.salud.gob.mx/descargas/gpc/CatalogoMaestro/580_GPC_Vacunacixnenlaembarazada/580GER.pdf[Accessed February 2016]Ulloa-Gutierrez R, GentileA, Avila-AgueroML. Pertussis cocoon strategy: would it be useful for Latin America and other developingcountries. Expert Rev Vaccines 2012; 11: 1393–96Choi WS, Choi J-H, Kwon
KT et al. Revised Adult ImmunizationGuidelineRecommended by the Korean Society of Infectious Diseases, 2014. Infect Chemother 2015; 47: 68–79Health Council of the Netherlands. Vaccinationagainst pertussis: aims and strategy. The Hague: Health Council of the Netherlands, 2015; publicationno. 2015/29. availableat:
http://www.gezondheidsraad.nl/sites/default/files/summary_201529_vaccinatie_tegen_kinkhoest_doel_en_strategie_0.pdf. Accessed April 2016Public Health England. Vaccinationagainst pertussis (Whooping cough) for pregnant women - 2014. Information for
healthcareprofessionals.July2014.https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/338567/PHE_pertussis_in_pregnancy_information_for_HP_2014_doc_V3.pdf[Accessed April 2016]Uruguay Ministry of Health. Comunicado a personal de salud. Vacunación con dpaT a embarazadas. Available at:
http://www.msp.gub.uy/sites/default/files/archivos_adjuntos/vacunacion%20embarazadas.pdf[Accessed February 2016]Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheriatoxoid, and acellularpertussis vaccine (Tdap) in pregnant women--Advisory Committeeon Immunization
Practices (ACIP), 2012. MMWR Morb Mortal Wkly Rep 2013;62(7):131–5,ECDC Shortage of acellularpertussis-containing vaccines and impact on immunisationprogrammes in the EU/EEA (first update). 2 February 2016. http://ecdc.europa.eu/en/publications/Publications/RRA-shortage-of-aP-containing-vaccines.pdf(Accessed February 2016)
Map used for illustrative purpose
30. Summary
30
The use of BOOSTRIX may be considered during
the third trimester of pregnancy 2
BOOSTRIX in the 3rd trimester have shown no
vaccine related adverse effect on pregnancy or on
the health of the foetus/newborn child2
Maternal immunisation is recommended by
several authorities3,4
Newborns are too young to be protected by
currently available vaccination schedules1
IN/BOO/0025/17
DateofPreparationOct’2017
Maternal immunisation with Tdap vaccine
1.Berti E, et al. Acta Paediatr 2014;103:846–9)2.Boostrix PI-Version BTX/PI/IN/2017/01 dated 04 Apr 2017,3.http://www.fogsi.org/gcpr-preconception-care/ accessed on
08/11/2017, 4.http://acvip.org/professional/columns/detailed-recommendations-iap-immunization-schedule-2016 accessed on 07-11-2017
