TDAP Vaccination by Dr. Alka Mukherjee

1. TDAP VACCINE IN MATERNAL IMMUNIZATION
DR ALKA MUKHERJEE
MBBS DGO FICOG FICMCH PGDCR PGDMLS
MA(PSY)
Dr Alka Mukherjee Nagpur 1

2. VACCINATION IN PREGNANCY
WHY VACCINATE WOMEN?
Dr Alka Mukherjee Nagpur 2

3. Dr Alka Mukherjee Nagpur 3

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8. IMPORTANCE OF VACCINATION
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Source: 1. https://www.who.int/bulletin/volumes/86/2/07-040089/en/ (Accessed April,2019) 2.
http://www.searo.who.int/mediacentre/features/2015/maternal-and-neonatal-tetanus-elimination/en/ (Accessed April,2019)
3. https://www.who.int/bulletin/volumes/92/6/13-132597/en/ (Accessed April,2019)
Image source: Shutterstock
Vaccination greatly reduces disease, disability, death and
inequity worldwide
• Vaccines annually prevent almost 6 million
deaths worldwide
1.Control of
mortality,
morbidity and
complications1 • India has achieved the elimination of
maternal and neonatal tetanus by improving
access to immunizationEradication &
Elimination2
• Complete prevention of persistent vaccine-
type infection has been demonstrated for
human papillomavirus (HPV) vaccine
Prevention of
infection1
• Measles vaccination protects against
multiple complications such as dysentery,
bacterial pneumonia and malnutrition
Protection
against related
diseases1
• In India, the introduction of childhood
rotavirus vaccination is projected to save
nearly Rs 150 Cr in treatment costs per year
Societal and
other benefits3
Dr Alka Mukherjee Nagpur

9. 9
Vaccine Remarks
Strongly
advisable
MMR
• All women in the pre-conception period should be screened for rubella infection and vaccinated if non-immune. The
combination of MMR is preferred over rubella vaccine alone.
(Strength of recommendation: A, quality of evidence III)
Pregnancy should be deferred for 3 months after receiving the MMR vaccination.
Hep B
• HBV vaccination should be offered to those at high-risk of infection like household contacts and sex partners of HBsAg-positive
persons, HIV-positive women, those with a history of recent sexually transmitted infections, renal disease requiring
hemodialysis, those receiving blood products and healthcare workers. (Strength of recommendation: A,
quality of evidence III)
Desirable
Tetanus, Diphtheria,
Pertussis (Tdap)
• Tdap should be administered again during pregnancy in order to provide optimal protection to the baby during its first months
of life.
(Strength of recommendation: A, quality of evidence IV)
Influenza
• Influenza vaccine is recommended for women who would be pregnant in the influenza season especially in those who are at
high risk of influenza-related complications. Live intranasal vaccine in not recommended in pregnancy (Strength of
recommendation: A, quality of evidence III)
Varicella
• Women should be screened for varicella immunity in the pre-conceptional period by taking a history of past infection or
previous vaccination or by serology. All the non-immune women should be vaccinated.
(Strength of recommendation: A, quality of evidence III)
Pregnancy should be deferred for 1 month.
HPV
• HPV vaccination is recommended for all women and girls (9-26 years of age) if not completed earlier, for decreasing the
incidence of benign and malignant lesions of the cervix. *
(Strength of recommendation: B, quality of evidence III)
Vaccination for women – FOGSI Recommendations 20161
Dr Alka Mukherjee Nagpur

10. TDAP VACCINE IN MATERNAL IMMUNIZATION
DR ALKA MUKHERJEE
MBBS DGO FICOG FICMCH PGDCR PGDMLS
MA(PSY)
Dr Alka Mukherjee Nagpur 10

11. INTRODUCTION
• Worldwide, Pertussis remains a major health problem.
• Children outbreaks are happening across the World.
• On average, about 1,000 infants are hospitalized and
typically between five and 15 infants die each year in
the United States due to Pertussis. Most of these
deaths are among infants who are too young to be
protected by the childhood Pertussis vaccine series
that starts when infants are 2 months old.
• These first few months are the period when infants are
at greatest risk of developing Pertussis infection and
serious complications such as pneumonia, seizures or
brain damage, any of which could ultimately be fatal
Dr Alka Mukherjee Nagpur 11

12. DESPITE HIGH DTP COVERAGE, PERTUSSIS
CASES REPORTED
Number of pertussis cases
Global distribution of 139,535 pertussis cases reported to the WHO in 2016
Adapted from - World Health Organization. Data, statistics and graphics – Disease incidence time series.DTP-
Diphtheria,Tetanus,Pertussis
http://apps.who.int/immunization_monitoring/globalsummary/timeseries/tsincidencepertussis.html. (accessed Feb 2018)Dr Alka Mukherjee Nagpur 12

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15. PERTUSSIS CASES IN INDIA (2000-2016)
• Pertussis in adults can be a source of infection
for infants under 2 months of age who have not
yet been vaccinated.
India is the top country by pertussis cases
in the world1
0
10000
20000
30000
40000
50000
60000
70000
20002001 200220032004 200520062007 2008 20092010 2011 2012 20132014 2015 2016
Pertussiscases
http://apps.who.int/immunization_monitoring/globalsummary/timeseries/tsincidencepertussis.html (accessed on 26 Feb
2018) Dr Alka Mukherjee Nagpur 15

16. PERTUSSIS IS UNDER ESTIMATED
In 2008, 148,095 pertussis cases globally were
reported1
However, WHO estimated 1.6 crore cases
in the same year2
The true incidence of pertussis is likely to be higher
in both developed and developing countries3,4 due
to under-diagnosing and under-reporting5,6
World Health Organization(WHO)- 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. Wood N, McIntyre P. Pertussis: review of epidemiology, diagnosis, management and prevention. Paediatr Respir Rev 2008;9(3):201–
211.4-Zepp F, Heininger U, Mertsola J, et al. Rationale for pertussis booster vaccination throughout life in Europe. Lancet Infect Dis 2011;11(7):557–570
5-Tan T, Trindade E, Skowronski D. Epidemiology of pertussis. Pediatr Infect Dis J 2005;24(5 Suppl):S10–S18
6-World Health Organization (WHO). Pertussis vaccines: WHO position paper. Wkly Epidemiol Rec 2010;85(40):385–400
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19. PERTUSSIS DISEASE
• Newborns are too young to be protected by currently
available vaccination schedules
• Pertussis disease are highest in the period
between birth and 6–8 weeks of age2,4
• > 90% of infants under 2months with pertussis
infection are hospitalized3
• 76% of pertussis related deaths occur in
infants aged under 2 months4
-
1-Berti E, et al. Acta Paediatr 2014;103:846–9.) 2.Meulen et al,CID,2016 3
Hong JY. Update on pertussis and pertussis immunization. Korean J Pediatr
2010;53(5):629–633. 4.Healy CM et al Hum Vac Imm 2016
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20. PERTUSSIS- COMPLICATIONS IN YOUNG
INFANTS
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
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21. MOTHERS ARE THE MOST COMMON SOURCE OF
PERTUSSIS INFECTION FOR NEWBORNS1
0
5
10
15
20
25
30
35
40
Mother Father Sibling Grandparent Other
Sources of infant pertussis cases by contact category (%)
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22. AS PER CURRENT PRACTISE ONLY CHILDREN ARE
VACCINATED WITH DTP, STARTING AT 6 WEEKS
Dr Alka Mukherjee Nagpur 22

23. Dr Alka Mukherjee Nagpur 23

24. ADVANTAGES & BENEFITS OF MATERNAL
IMMUNIZATION
• 1. Maternal immunization offers an ideal “2-for one” strategy
a) It offers direct protection of the infant through the induction of
maternal antibodies that can be transported across the placenta to
protect the infant from birth
b) Indirectly protecting the infant through preventing infection in and
thus transmission from their mother.
• 2. Tdap is an inactivated vaccine so there are no theoretical
concerns regarding safety in pregnant women.
• Vaccination later in pregnancy also has the advantage that
maternal antibodies are highest when placental transport is most
efficient (from approximately 34 weeks gestation). This timing
theoretically optimizes levels of maternally-derived antibodies in
the newborn infant leading to more sustained protection.
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25. • 3. Unlike influenza, Pertussis is not known to increase
morbidity in pregnant women –
Tdap administration can be delayed until later in pregnancy -
a) Avoiding concerns about interference with fetel development
b) Mistaken association with pregnancy loss - the first trimester.
• 4. Unlike antibodies induced by polysaccharide antigens
(IgG2) where placental transport is less efficient, Tdap induces
antibodies of the immunoglobulin G1 subclass - both actively
and passively transported across the placenta - increased
infant levels.
• 5. As the first dose of the primary immunization series is
given early in life -- is likely that antibody levels need to
persist for relatively short periods of time to protect against
severe and fatal infant disease
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26. SAFETY OF PERTUSSIS IMMUNIZATION IN PREGNANCY
 Studies - maternal vaccinations at an early stage of pregnancy
are small in number - evidence, if any for or against
vaccination at an early stage of pregnancy - scarce.
 Minor injection site reactions- pain associated with the
vaccine injection.
 Numerous studies - assessed the safety and immunogenicity
of acellular pertussis vaccines in infants and children,
adolescents and adults.
 These studies invariably demonstrated that acellular pertussis
vaccines are well-tolerated with lower rates of adverse events
than whole cell pertussis vaccines.
 Available data – Tdap – NO pregnancy loss or poor neonatal
outcomes
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27. IMMUNE RESPONSE FOLLOWING PERTUSSIS
IMMUNIZATION IN PREGNANCY
• Prior to implementation, there was indirect evidence
that Pertussis immunization in pregnancy was likely to
be immunogenic and effective - natural infection in
mothers prior to delivery, may have protected them in
early life.
• During the 1940s and 1950s small numbers of women
received whole cell pertussis vaccine during the third
trimester of pregnancy.
• No adverse events
• Increased antibody levels in mother and baby with
enhanced in vitro killing of B. pertussis were reported.
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28. • Concerns that high maternal antibody levels –
suppress infant immune response to pertussis vaccines
– But studies - no significant interference - both
naturally and vaccine-induced Pertussis-specific IgG in
mothers were efficiently transported across the placenta
• Studies - Van Savage et al. - the half-life of naturally-
induced maternal antibody to be 36 - 40 days which is
similar to that of natural antibody - expect that high
maternal antibody levels in infants following
immunization in pregnancy would persist at “sufficient”
levels to protect infants from acquiring infection in the
early months of life.
IMMUNE RESPONSE FOLLOWING PERTUSSIS
IMMUNIZATION IN PREGNANCY
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29. • RCTs and by the prospective cohort study in Belgium -
Despite this rapid waning - “high” levels of antibodies
present at delivery - “sufficient” for protection through
the start of the primary immunization series
• Immunization during one pregnancy would be unlikely
to protect infants of subsequent pregnancies.
IMMUNE RESPONSE FOLLOWING PERTUSSIS
IMMUNIZATION IN PREGNANCY
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30. CDC RECOMMENDATION
• 5 Facts about Tdap and Pregnancy
1. Tdap during pregnancy provides the best protection for
mother and infant.
– Recommend and administer or refer your patients to
receive Tdap during every pregnancy.
– Optimal timing is between 27 and 36 weeks
gestation (preferably during the earlier part of this
period) to maximize the maternal antibody response
and passive antibody transfer to the infant.
– Fewer babies will be hospitalized for and die from
pertussis when Tdap is given during pregnancy
rather than during the postpartum period.
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31. 2.POSTPARTUM TDAP ADMINISTRATION IS
NOT OPTIMAL.
– Postpartum Tdap administration does not provide
immunity to the infant, who is most vulnerable to
the disease’s serious complications.
– Infants remain at risk of contracting Pertussis from
others, including siblings, grandparents, and other
caregivers.
– It takes about 2 weeks after Tdap receipt for the
mother to have protection against Pertussis, which
means the mother is still at risk for catching and
spreading the disease to her newborn baby during
this time
Dr Alka Mukherjee Nagpur 31

32. 3.COCOONING ALONE MAY NOT BE
EFFECTIVE AND IS HARD TO IMPLEMENT.
– The term “cocooning” means vaccinating anyone
who comes in close contact with an infant.
– Cocooning is difficult and it can be costly to make
sure that everyone who is around an infant is
vaccinated.
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33. 4. TDAP SHOULD NOT BE OFFERED AS PART OF
ROUTINE PRECONCEPTION CARE.
– Protection from Pertussis vaccines does not last as
long as vaccine experts would like, so Tdap is
recommended during pregnancy in order to provide
optimal protection to the infant.
– If Tdap is administered at a preconception visit, it
should be administered again during pregnancy
between 27 and 36 weeks gestation.
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34. TDAP CAN BE SAFELY ADMINISTERED
EARLIER IN PREGNANCY IF NEEDED
– Pregnant women should receive Tdap anytime
during pregnancy if it is indicated for wound care or
during a community pertussis outbreak.
– If Tdap is administered earlier in pregnancy, it should
not be repeated between 27 and 36 weeks
gestation; only one dose is recommended during
each pregnancy.
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35. GLOBAL AND LOCAL BODIES RECOMMEND TDAP
VACCINATION DURING PREGNANCY
US-ACOG,2011: Administer Tdap vaccine to all pregnant woman as
early as 27–36 weeks3
UK-RCOG,2012 : Women are recommended to receive a dose of
Tdap during each pregnancy, which should be administered from
27 through 36 weeks’ gestation, regardless of previous receipt of
Tdap.4
WHO,2015: Vaccination of pregnant women is likely to be one of the
most cost- effective additional strategy for preventing disease in
infants too young to be vaccinated1
FOGSI, 2016 : "Tdap should be administered during pregnancy in
order to provide optimal protection to the baby during its first
months of life.
Strength of recommendation “A” 2
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37. TAKE HOME
• Pertussis remains a serious public health problem and an extremely serious
life-threatening problem for young infants who become infected.
• Currently available vaccines do not give life-long immunity and acellular
pertussis vaccines used in resource-rich countries have less durable immunity
than previously thought.
• There is likely no single paradigm to effectively control Pertussis, which will
likely require a combination of efforts.
• Pertussis vaccination in pregnancy offers the best opportunity to prevent
pertussis-related deaths in young infants.
• This approach has proven safety, immunogenicity and effectiveness in
preventing Pertussis in young infants in countries where acellular pertussis
vaccines are used, although questions remain as to the optimal gestation to
administer vaccine and whether observed immune
• The optimal window of vaccination to confer the highest level of pertussis
antibody protection to the infant appears to be between 28-32 weeks’
gestation
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38. WHAT IS TDAP VACCINE ?
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39. POSOLOGY AND METHOD OF
ADMINISTRATION
• A single 0.5 ml dose recommended from the age of 4
years onwards1 (IM preferably in the deltoid region)
• The use of BOOSTRIX may be considered during the 3rd
trimester of pregnancy1
• Boostrix has shown no vaccine related adverse effect on
pregnancy or on the health of the foetus/newborn child
in the 3rd & 2nd trimester1(Including Boostrix+IPV)
• It is not expected that vaccination with BOOSTRIX harms
the foetus at any trimester of pregnancy1
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40. THANK YOU
Dr Alka Mukherjee Nagpur 40