Tdap vaccination During PregnancyBased on commonly asked questions by Gynaecologists Dr Sharda Jain Dr Jyoti Agarwal

1. Tdap
Dr Sharda Jain
Dr Jyoti Agarwal
Vaccination
During Pregnancy
…Caring hearts, healing hands
Based on commonly asked questions
by Gynaecologists

2. What is the Tdap Vaccine ?

3. The Tdap vaccine is a combination vaccine
which offers TRIPLE PROTECTION against three bacterial infections –
TETANUS DIPPHTHERIA & PERTUSSIS in a single shot.
The three vaccine components are
tetanus (T) , diphtheria (d)& acellular pertussis (ap).
“T” refers to a standard dose of tetanus antigen ,
whereas the lowercase letters “d” & “p” are used to indicate to the
Pediatric vaccine (Tdap)

4. How is the Tdap vaccine different
from the TT/Td vaccine which is
generally given
during PREGNANCY ??

5. • Tetanus toxoid (TT) / tetanus & diphtheria toxoid
(Td)vaccine help protect the newborn & young
infants only against tetanus & diphtheria.
• The Tdap vaccine additionally provides
protection against pertussis through trans
placental transfer of antibodies from mother to
foetus.

6. • Since 2011 , various bodies like ACIP & ACOG
have been recommending a single dose of
Tdap vaccine during LATE pregnancy
• In India , FOGSI has recommended the use of
Tdap vaccine during pregnancy since 2014

7. WHAT IS PERTUSSIS ?

8. • PERTUSSIS
is a highly contagious respiratory infection
caused by the gram – negative bacterium
Bordetella pertussis . It is more commonly
known as “Whooping Cough”.
• Pertussis is transmitted through airborn droplets
or direct contact with nasopharyngeal discharge
from an infected person.
• It affects people of all ages but newborn are at
a higher risk of infection & serious complications
like hospitalization, pneumonia , seizure & even
death

9. What is the incidence of
pertussis in India ?

10. DID YOU KNOW ?
India ranks no. 1 globally
with – 24000 pertussis cases reported by
WHO in 2017.
However, pertussis continues to be an under
diagnosed disease & under reported disease.
It is estimated that for 1 reported case of
pertussis , 83 more infections may go undetected.

11. Why are NEWBORN at a higher risk of
neonatal pertussis ?

12. • In India , newborn infants do not begin their primary
vaccination series against pertussis with DTP vaccines
until at least 6 weeks of age.
This leaves the newborn vulnerable to contract serious pertussis
infection from family members & especially mothers
• Mother have been identified as the source of infection in
37% of neonatal pertussis cases & are the most common
source of pertussis infection for newborn infants .

13. Why is Tdap vaccination
recommended during pregnancy ?

14. • Tdap vaccination during pregnancy is one of
the most cost- effective strategies in
protecting the newborn / young infants from
neonatal pertussis.
• Tdap vaccine when administered during
pregnancy result in trans- placental transfer of
antibodies from mother to fetus.
• These antibodies offer protection during first
few months of life when newborn are most
vulnerable to pertussis disease & its
complications

15. When is the OPTIMAL TIME during
pregnancy to administer Tdap vaccine?

16. Recent data support that the optimal time to vaccinate with Tdap
vaccine is during 27-36 weeks of gestation because higher antibody
concentrations are likely to be achieved in the foetus .
These protective antibodies that are transferred in the foetus
protect the newborn until they begin their own DTP
vaccination series.
Several global & local authorities like ACOG, RCOG & IAP
recommend single dose of Tdap vaccine during 27-36 weeks of
gestation

17. Is it necessary to vaccinate pregnant
women with Tdap during every
pregnancy even if she has been
vaccinated in the past ?

18. In October 2012 , a critical new data on the lack of persistance of
maternal pertussis antibodies was reviewed by ACIP .
It Was Found That There Was Rapid Wanning Of Antibody Level 2-
3 Years Post Vaccination.
This indicated that maternal antibodies generated from the Tdap vaccine during
one pregnancy would not be sufficient to provide protection to the newborn
during subsequent pregnancies.
Both ACIP & ACOG recommend that all pregnant women received single
dose of Tdap vaccine during each pregnancy , preferably during 27-36 weeks
of gestation

19. Can the Tdap vaccine be
recommended to pregnant women
who have received TT vaccination in
the same pregnancy ?

20. • TDAP VACCINATION CAN BE CONSIDERED INSTEAD OF THE
SECOND DOSE OF TETANUS TOXOID.
• A prospective study involving healthy Thai pregnant women (370
enrolled in year April 2015 – September 2016) , were offered Tdap
between 26-26 weeks of gestation. Of the 370 , ninety – eight women
received at least one extra dose of tetanus – containing vaccine during
this current pregnancy (1 dose in 37 women ,2 dosed in 60 women , 3
dose in 1 women)
• No reported increase in the severity or duration of adverse events
associated with the administration of an extra tetanus containing vaccine
was observed.

21. Can Tdap & influenza vaccine be
given to pregnant women in the
same visit ?

22. In a retrospective study 36,844 pregnant women were
administered with Tdap & Flu vaccines concomitantly in
8,464 (23%) & sequentially in 28,380 (77%) pregnancies.
No statistically significant increased risk of fever or
any medically attended adverse effect was found when
Flu & Tdap were co-administered during pregnancy.

23. How many countries
recommended Tdap
vaccination during pregnancy ?

24. “Tdap vaccination during pregnancy has been recommended by
global authorities like ACIP & ACOG since 2011”
Till March 2018
>35 countries recommended Tdap vaccination during pregnancy .
This includes countries like UK , USA , Canada, Spain , Australia &
New Zealand.
In India , FOGSI has recommended the use of Tdap vaccine during
pregnancy since 2014.

25. RECOMMENDATIONS for
Tdap Vaccination During Pregnancy
ACIP 2012 Women are recommended to received a single dose of tdap during each
pregnancy , which should be administered from 27 – 36 weeks of gestation ,
regardless of previous receipt of tdap
RCOG 2012 Women are recommended to received a dose of Tdap during each pregnancy ,
which should be administered from 27 through 36 weeks gestation , regardless
of previous receipt of Tdap
IAP, 2013 One dose of Tdap vaccine to pregnant mother / adolescent during each
pregnancy (preferred during 27 through 36 weeks gestation) regardless of
number of year from prior td or tdap vaccination
WHO, 2015 Vaccination of pregnant women is likely to be one of the most cost – effective
additional strategies for preventing disease in infant too young to be vaccinated
FOGSI 2016 Tdap should be administered during pregnancy in order to proved optimal
protection to the baby during its first month of life strength or
recommendation “A”
ACOG 2017 Administer tdap vaccine to all pregnant women as easily as 27-36 weeks

26. REFERENCE
ACIP Advisory committee on immunization practices
ACOG The American college of obstetricians & gynecologists
CDC Centers for disease control & prevention
WHO World health organization
RCOG Royal college of obstetrician & gynecologists
IAP Indian academy of pediatrics
FOGSI Federation of obstetric & gynecological; societies of India

27. What is Boostrix?

28. • Boostrix – GSK’s Tdap vaccine – is a
combination vaccine which offers triple
protection against diphtheria , tetanus &
pertussis “
• The use of Boostrix may be considered during
the third trimester of pregnancy
CONTENTS BOOSTRIX (0.5ML)
DIPHTJERIA TOXOID 2iu
TETANUS TOXOID 20 iu
pt 8 mcg
fha 8 mcg
prn 2.5 mcg

29. How is Boostrix administered ?

30. Boostrix is available as 0.5 ml dose in pre-
filled syringe which should be given as a deep
intramuscular injection preferable in the
deltoid region.

31. What is the effectiveness of boostrix?

32. Boostrix in pregnancy has demonstrated high effectiveness
against neonatal pertussis disease & it’s hospitalization across
countries like Australia , Spain , Columbia
Country Surveillance
period
Time vaccine
given during
pregnancy
Evaluated End
points
Vaccine
Effectiveness
(VE%)
Spain
Valencia
Prospective ,
matched
casecontrol study
march 2015
Feb 2016
(Tdap)
Between 27 & 36
weeks
Reduction in
pertussis disease in
infants < 3 months
of age
90.9%
Australia Matched
casecontrol
August 2015 &
August 2016
(Tdap)
Since 2015 new
south wales health
has funded boostrix
vaccination in the
3rd trimester of
pregnancy
Reduction in
hospitalization
cases due to
pertussis in infants
< 6 months of age
94%
Columbia
Bogota
Study assessing
impact of boostrix
Using data from the
national
surveillance system
from 2005 to 2015
2014 – 2015 (Tdap)
Not specified
Reduction in death
rates in infants <12
months of age
100%

33. What is the safety data available
with Boostrix ?

34. • Evidence supports the favorable safety profile of
Boostrix when administered during the 3rd trimester
of pregnancy .
• Safety data from a prospective observational study where
Boostrix was administered to pregnant women during the third
trimester (793 pregnancy outcomes) as well as data from passive
surveillance where pregnant women were exposed to Boostrix in
the 3rd & 2nd trimester have shown no vaccine related adverse
effect on pregnancy or on the health of the foetus / newborn child

35. Safety Profile of Boostrix
• Adverse events in adults
Very common : injection site
redness swelling , pain, malaise,
fatigue , headache.
• Common : Fever >37.5 c ,
Dizziness, nausea , injection site
mass / sterile abscess.
• Uncommon : URTI , diarrhea ,
vomiting lymphadenopathy ,
rash, pruritic, arthralgia, myagia
Adverse events during pregnancy in
clinical trials
Mild & moderate pain (79%)
Injection site induration (12%)
• Swelling (7.96% )
• Redness (5.8%)
Severe pain (2.6%), fever (2.1%)
Other , headache , nausea /
vomiting fatigue , myalgia /
arthralgia

36. TAKE HOME MESSAGE
• Tdap offers triple protection against diphtheria tetanus &
pertussis
Boostrix prescribing inform – version BTX/PI/IN/2017/01 DATED 04 APRIL 2017
• Tdap offer protection to both mother & new born infant
Boostrix prescribing inform – version BTX/PI/IN/2017/01 DATED 04 APRIL 2017
BOOSTRIX PI (IRELAND)(ACCESSED MAY 2019)
• FOGSI recommends Tdap vaccination during pregnancy
FO0GSI ,2014
Tdap Vaccination
During 3rd Trimester of pregnancy

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