Maternal immunization provides important health benefits to both pregnant women and to their fetus. Vaccine-preventable diseases cause significant morbidity and mortality among maternal, neonatal, and young infant. Some infections are so serious even they can waste pregnancy, harm her baby during pregnancy or after delivery. These complications can be protected with vaccination. This is why vaccinations are so important for pregnant mothers. Vaccines strengthen the immune systems of body that can fight off serious infectious diseases. A vaccine can help in protection of the mother's body from infections and this immunity passes to her baby during pregnancy. This immunity keeps the child safe during the first few months of life until baby gets his own vaccination. Vaccination also protects mothers from getting a serious disease that could affect future pregnancies. Fetus getting any risk after vaccination of the mother during pregnancy primarily is theoretical. Globally, no scientific study exist which shows the risk of fetus after vaccination of pregnant women with inactivated vaccines or bacterial vaccines or toxoids. Even live vaccines causing risk to fetus is theoretical. Benefits of vaccinating pregnant women usually outweigh potential risks when the likelihood of disease exposure is high, when infection would pose a risk to the mother or fetus, and when the vaccine is unlikely to cause harm. Not all vaccinations are safe during pregnancy but some of inactivated vaccines are considered safe which can be give to pregnant women who might be at risk of infection.

1. VACCINATION IN PREGNANCY
DR ALKA MUKHERJEE
MBBS DGO FICOG FICMCH PGDCR PGDMLS
MA(PSY)
DR APURVA MUKHERJEE
NAGPUR M.S.
INDIA
Dr Alka Mukherjee Nagpur 1

2. Why vaccinations during pregnancy are so important?
• Vaccine-preventable diseases cause significant morbidity
and mortality among maternal, neonatal, and young infant.
Some infections are so serious even they can waste
pregnancy, harm her baby during pregnancy or after
delivery. These complications can be protected with
vaccination.
• Vaccines strengthen the immune systems of body that can
fight off serious infectious diseases.
• The immunological changes occur during pregnancy which
may be responsible for the susceptibility of certain infectious
diseases that increases the risk of more serious outcomes.
• Immunization during pregnancy is a simple and effective
way - Maternal immunization provides important health
benefits to both pregnant women and to their fetus.

3. • Immunization during pregnancy can also directly protect the
fetus and infant via transferred of antibodies from the
mother to the fetus.
• A vaccine can help in protection of the mother's body from
infections and this immunity passes to her baby during
pregnancy. This immunity keeps the child safe during the
first few months of life until baby gets his own vaccination.
• Vaccination also protects mothers from getting a serious
disease that could affect future pregnancies.
Vaccination during pregnancy is a cost-effective
strategy to improve pregnancy outcomes

4. VACCINES ARE THE IMPORTANT PART OF HEALTHY PREGNANCY
• Inactivated virus or bacterial vaccines or toxoids –
 Risk to a developing foetus from vaccination of the mother during
pregnancy is theoretical
 No evidence exists of risk
• Live vaccines – Live attenuated virus is a vaccine that could cross the
placenta and result in viral infection to the fetus. That why, most of live
attenuated vaccines like Measles, Mumps, Rubella, Varicella,
Meningococcal, Human Papilloma Virus (HPV) vaccine and Pneumococcal
polysaccharide vaccine, Oral Polio Vaccine (OPV), Inactivated Polio
Vaccine (IPV), Typhoid vaccine, Cholera vaccine, Plague vaccine,
Japanese encephalitis vaccines are strongly contraindicated in pregnant
women.
Types of vaccines

5. Benefits of vaccinating pregnant women usually outweigh
potential risks
• when the likelihood of disease exposure is high,
• when infection would pose risk to the mother or foetus, and
when the vaccine is unlikely to cause harm,
• No known risk exists for the foetus from passive
immunisation of pregnant women with immune globulin
preparations.

6. PRENATAL SCREENING
• Pregnant women –
• Should be evaluated for immunity to RUBELLA AND VARICELLA
• Should be tested for the presence of HBSAG during every pregnancy.
• Women susceptible to rubella and varicella should be vaccinated
immediately after delivery.
• Pregnant women , babies and infants are at risk of serious problems
from the influenza virus.
• Data regarding anthrax vaccination during are very limited but show
no confirmed effect on the foetus
• Toxoids : toxoids appear safe during pregnancy , e.g TETANUS
• Immune globulins : immune globulins are used for post – exposure
prophylaxis and not associated with reports that harm is done to the
foetus . such agents are considered in pregnant women exposed to
hepatitis B, rabies , tetanus , varicella , and hepatitis A.

7. TETANUS VACCINE
• Tetanus can cause severe morbidity in the mother and mortality in
the neonate.
• Tetanus is a life-threatening bacterial disease that is caused by the
toxin of a bacterium called Clostridium tetani which is often found
in soil.
• Tetanus bacteria enter the body through an open wound. It could
well be a tiny prick or scratch on the skin, although Tetanus
infection is more common when there is a deep puncture wound
such as a bite, cut, burn or an ulcer. Tetanus affects a person's
nervous system and can be fatal if left untreated.
• Neonatal tetanus usually occurs in newborns through infection of
the unhealed umbilical stump, especially when the stump is cut
with a non-sterile instrument.
• Tetaus is prevented only through vaccination. The tetanus vaccine
contains noninfectious toxoids.

8. • Tetanus toxoids appear safe during pregnancy and are
administered in many countries of the world to prevent
neonatal tetanus.
• To maximize the maternal antibody response and passive
antibody transfer to the infant, the national immunization
schedule in India recommends the 2 doses of tetanus toxoid
(TT) for unknown immunization status of pregnant women
i.e the first dose of tetanus toxoid should be administered as
soon as pregnancy is detected, second dose of tetanus
toxoid is administered after 4 weeks and if a mother
received 2 TT doses in the last pregnancy and mother gets
again pregnant with in 3 y than only one dose of TT is
recommended and that dose is called booster dose.

9. • The World Health Organization (WHO) reported that
neonatal tetanus kills over 200,000 newborns each year;
almost all these deaths occur in developing countries while
it is very rare in developed nations.
• The WHO also recommends that a third vaccine be given 6
months after the second one to provide protection for at
least 5 y
• After TT vaccination, the antibodies formed in mother are
transferred to baby and protect baby for a few months after
birth.
• TT vaccination also helps to prevent premature birth or
delivery.
• The American Congress of Obstetricians and Gynecologists
recommends use of tetanus immune globulin, as there is no
evidence of any adverse effects to the fetus from the tetanus
immunoglobin.

10. TDAP VACCINATION
• Pertussis is on the rise and outbreaks are happening across
the World
• 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 of life are when infants are at the
greatest risk of contracting pertussis and having severe,
potentially life-threatening complications from the infection.
To help protect babies during this time when they are most
vulnerable, women should get the tetanus toxoid, reduced
diphtheria toxoid, and acellular pertussis vaccine (Tdap)
during each pregnancy.
• A strong recommendation from Doctor - VITAL

11. 5 Facts about Tdap and Pregnancy
1. Tdap during pregnancy provides the best protection for
mother and infant.Recommend and administer OR recommend
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.

12. 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.

13. 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.

14. 6. 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.

15. 5. 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.
•

16. Hepatitis B Infection
• Hepatitis B infection is a serious infection that causes inflammation of
the liver.
• Hepatitis B infection in a pregnant woman might result in severe
morbidity for the mother and may increase the chance of preterm birth;
but- no study which shows that hepatitis B infection is not associated
with increased abortion rates, stillbirth, or congenital malformation in
fetus.
• Therefore, the biggest concern is the vertical transmission i.e from
mother to child and as 70% to 90% of babies will remain chronically
infected with hepatitis B into adult life and later on can develop liver
cirrhosis and hepatocellular carcinoma.
• Because of such high risks and the safety and efficacy (seroconversion 90
to 100%) of Hepatitis B vaccine in preventing Hepatitis B infection, it is
recommended that Hepatitis B vaccine be given to pregnant women at
high risk.

17. • The Hepatitis B vaccine is an inactivated (recombinant) virus
vaccine; and because the vaccine is composed of
noninfectious Hepatitis B surface antigen particles, it should
theoretically cause no increased risk.
• Globally, many studies confirmed that there are no adverse
pregnancy outcomes reported after vaccinated with HepB
vaccine during pregnancy.
• Pregnancy is therefore not considered a contraindication to
vaccination, however the Hepatitis B vaccine should be
offered for pregnant women who are at high risk for
acquiring Hepatitis B infection during pregnancy.

18. • A woman found to be HBSAG positive
• Should be monitored carefully to ensure that the infant
receives hepatitis B immune globulin (HBIG) and
• Begins the hepatitis B vaccine series no later than 12 hours
after birth and
• Infant completes the recommended hepatitis B vaccine
series B infection can be passed from mother to baby at
birth .
• Chronic hepatitis B can result in liver cancer - much more
common in low – income countries . it has been suggested
that vaccinating mothers against hepatitis B in pregnancy
may reduce the risk of the baby becoming infected.
• At the moment , there is nor enough research to show that
the hepatitis b vaccination is safe in pregnancy but is
recommended if there is high – risk of exposure

19. HEPATITIS B VIRUS INFECTION IN PREGNANCY
• It poses a serious risk to infants at birth. When babies become infected with
hepatitis B, they have a 90% chance of developing a life-long, chronic infection
• One in four people with chronic hepatitis B develop serious health problems
including liver damage, liver disease, and liver cancer.8'9
• Centres for Disease Control and Prevention (CDC) recommendations endorse
vaccination during pregnancy of women who are at high-risk of contracting
hepatitis B
• CDC & ACOG RECOMMENDATION:
Universal
screening of all
pregnant
women
Those at higher
risk – test for
antibody to
hepatitis B
surface Ag(anti-
HBs)
Persons who are
negative for both
markers & are at
risk – should be
vaccinated
Babies to get
HBIG SHOT & the
1st dose of
hepatitis vaccine
within 12 hours of
birth

20. VARICELLA INFECTION IN PREGNANCY
• Congenital Varicella Syndrome
• Varicella infection in the first or early second trimester of
pregnancy could lead to 'congenital varicella syndrome' in
the foetus.
• Primary varicella zoster virus (VZV) infection during
pregnancy may result in intrauterine infection in about 25%
of the cases and congenital anomalies can be expected in
approximately 12% of infected foetuses

22. VARICELLA INFECTION
• Maternal pneumonia is a complication in about 10-20% of
cases of varicella infection during pregnancy, resulting in a
higher mortality and morbidity than in non-pregnant adults.
• Pregnant women with VZV pneumonia should be
hospitalized for monitoring and administered antiviral
therapy, because up to 40% of women may need mechanical
ventilation. Mortality in severe cases is estimated to be 3-
14%.
• The risk for pneumonia also increases with increasing
gestational age. Newborns whose mothers develop
chickenpox rash from 5 before to 2 days after delivery are at
risk for chickenpox shortly after birth, with the chance of
death as high as 30%

23. PREVENTION OF VARICELLA INFECTION
Women of childbearing
age
Pregnant women not
protected against chickenpox
Postpartum women
Best way
chicken-pox vaccine
1-3 months prior to
pregnancy
Most effective way
Vaccination of close contacts
To protect a pregnant
woman
Against chickenpox
Asap post delivery
vaccinate with 1st dose
& 2nd dose 6-8 weeks
postpartum visit
Varicella vaccination –
Offers 100% seroconversion with 2 doses of Varilrix in healthy adults
One dose – 85% seroconversion
Two doses- 100% seroconversion & > or = to 4-fold rise in GMTs
Proven safety & efficacy in 53 clinical trials in > 10,000 individuals

24. CONGENITAL RUBELLA SYNDROME
• The most serious feature of rubella.
• It arises when pregnant women become infected with the rubella
virus in the early stages of pregnancy, infection of the foetus
occurs when the rubella virus spreads from the placenta and
enters the foetal circulation,
• The CRS is estimated to affect up to 85% of infants born to women
infected with rubella (luring the first trimester of pregnancy.
• Over 100,000 cases per year of crs occur in the developing world
alone.
• It causes abortion, miscarriage, stillbirth and foetal anomalies.
• The manifestations of crs include: deafness, eye defects (e.G.
Cataracts), heart defects, neurological abnormalities (e.G.
Microcephaly and mental retardation), liver and spleen damage

25. MMR VACCINE OR JUST RUBELLA VACCINE
• Centres for Disease Control and Prevention emphasizes on the use
of combined MMR vaccine for any indication as this provides
potential additional benefit Of protection against measles and
mumps.
• Measles illness during pregnancy leads to increased rates of
premature labour, spontaneous abortion, and low birth weight
among affected infants and also birth defects,
• Mumps developed in women during the first trimester of
pregnancy, leads to an increased risk for fetal death
• MMR vaccine is highly Immunogenic after one (lose, with
reported seroconversion rates of
 98.7% for measles,
 95.5% for mumps and
 99.5% rubella,

26. INFLUENZA IN PREGNANCY
• Influenza is an acute respiratory tract infection which typically presents
with constitutional symptoms such fever, my malaise, headache, fatigue
and upper respiratory tract symptoms such cough, sore throat and
rhinitis
• Caused by influenza virus strains A, and C, out of which; types A and B
are associated with seasonal epidemics and only type A viruses are
known to cause pandemics
• In India influenza case are seen throughout the year , but a clear peak in
the influenza activity is observed during the monsoon season and a
smaller peak during winter months.
• Physiological and immunological changes associated with pregnancy put
pregnant women at greater risk of infections and complications .
• As compared to non – pregnant women , pregnant women with
influenza are at higher risk of severe complications
• death and adverse pregnancy outcomes such as low birth weight ,
preterm delivery , emergency caesarean sections , stillbirth and neonatal
deaths.

27. Influenza vaccine
• Can be given any time during pregnancy.
• Influenza vaccination in pregnancy causes trans-placental transfer of
antibodies and protects infants in first 6 months of life.
• In a literature review by steinhoffet al. Efficacy and safety of influenza
vaccines among pregnant women has been demonstrated in
observational studies and randomized clinical trials.
• In a clinical trial conducted in bangladesh among 340 healthy pregnant
women , at 24 weeks follow up ,inactive influenza vaccine among
pregnant mothers led to 63 % reduction of laboratory – confirmed
influenza and 29 % reduction in febrile respiratory illness among infants
and 36 % reduction in febrile respiratory illness among mothers.
• Well tolerated with no reports of serious adverse event among monthers
or their infants
• Recommended by the world health organization, US centres for disease
control. American college of obstetricians and gynaecologists, and Indian
academy of paediatrics.

28. HUMAN PAPILLOMA VIRUS VACCINE IN
PREGNANCY
• Human papilloma virus (HPV) vaccination is not
recommended in pregnancy, neither is routine pregnancy
testing before vaccination.
• Available Safety data regarding the inadvertent
administration of the vaccine during pregnancy are
reassuring;
• If a ',vaccine series is started and a patient then becomes
pregnant. completion of the vaccine series should be
delayed until that pregnancy completed. Lactating women
can receive any HPV vaccine vaccines HPV do not affect the
safety of breastfeeding for mothers or infants

29. TYPES OF VACCINES
• Live/attenuated vaccines: Containing virus or bacteria are
contraindicated in pregnancy, e.g. BCG vaccine
• Inactivated bacterial vaccine:
1. Inactivated bacterial vaccine is used during pregnancy for
women, who have a specific risk of exposure and
contracting the disease
2. Vaccination against Pneumococcal or Meningococcal
infections or typhoid fever show no confirmed side effects
regarding the foetus, however, data are limited.

30. FOOD AND DRUG ADMINISTRATION PREGNANCY
• Pregnancy category B :
• Pregnancy category C :
• Pregnancy category D :
• Human Papillomavirus Influenza
Japanese Encephalitis,
Meningococcal , Tdap
• Hepatitis A , Hepatitis B , Mmr
Meningococcal , Pneumococcal ,
Polio , Td , Tdap , Varicella ,
Zoster ,Bcg , Rabies , Typhoid ,
Yellow Fever.
• Anthrax, Vaccinia
Regulation required that each product be classified under one of five pregnancy
categories on the basis of risk of reproductive and developmental adverse effects or
for certain categories , on the basis of such , risk weighted against potential benefits

31. BREASTFEEDING AND VACCINATION
• Neither inactivated nor live – virus vaccines administered to a
lactating woman affect the safety of breastfeeding for women or
their infants.
• Although live viruses in vaccines can replicate in vaccine recipients
the majority of live virus in vaccines have been demonstrated not
be excreted in human milk.
• Varicella vaccine virus has not been found in human milk.
• Although rubella vaccine virus might be excreted in human milk ,
the virus usually does not infect the infant . If infection does occur
, it is well tolerated because the virus is attenuated.
• Inactivated , recombinant , subunit , polysaccharide , and
conjugate vaccines , as well as toxoids , pose no risk for mothers ,
who are breastfeeding or for their infants

32. BARRIERS IN VACCINATION IN PREGNANCY
• There are several scientific , social and structural barriers to
developing vaccines for pregnant women.
• These barriers challenge the ability to prepare and respond
to epidemics and are particularly highlighted during a public
health emergency that has pregnant women and their
unborn fetuses as the primary affected population.
• Lack of a broadly accepted ethical framework for guiding
clinical research during pregnancy e.g. the term minimal risk
– a concept that not well defined
• We should consider both: Risk & benefit to fetus & risk &
benefit to mother

33. Focus on later part of pregnancy:
• Pregnancy is a physiologically dynamic state.
• The immune profile of a pregnant woman is responsive to
the changing levels of sex hormones and evolves through
the course of pregnancy.
• Most of the current knowledge base for vaccine response is
derived from observational studies conducted in the latter
part of pregnancy, with limited data available from the first
and early second trimester or from randomized clinical trials.
• The clinical, practical, and public health considerations
require that vaccine use not be restricted to women with
advanced gestational age.

34. Lack of standardization:
• Robust safety evaluation is a cornerstone of any vaccine
development and deployment program.
• There has been an increase in the number of studies
evaluating the safety of currently recommended maternal
vaccines, such as influenza and pertussis vaccines. Despite
increased attention on the evaluation of safety of
immunization in pregnancy, barriers remain.

35. RECENT GLOBAL OUTBREAKS AND NEED FOR
VACCINATION IN PREGNANCY
• There recent infection disease outbreaks of global
importance – H1N1 influenza , Ebola , and now Zika – have
had specific implications for pregnant women.
• For the H1N1 pandemic , pregnant women and their infants -
high risk groups for severe complications and death.
• During the Ebola Outbreak - concerns about worse
outcomes amongst pregnant women and specific concerns
regarding vertical transmission of infection to newborns .
• The current Zika outbreak , with its ostensible association
with microcephaly , has direct and highly concerning
implications for pregnant women , in particular , and women
of reproductive age in general

36. • Pregnant women planning international travel should be advised that
country's recommended immunization or CDC travel website; which
provides up-to-date country-specific immunization recommendations
and aids in risk factor determination.
• Three travel-related vaccine-preventable diseases
1. YELLOW FEVER
• No obvious safety data on yellow fever – but inadvertent administration
during pregnancy – No adverse side effects
• CDC recommends yellow fever vaccine during pregnancy if a woman
must travel and her risk of exposure and infection is high enough (based
on location, season, and activities planned during travel) to outweigh
any potential theoretical risks of vaccination.
• Non-pregnant women of childbearing potential should be counselled to
avoid conception for 4 weeks post-vaccination.
TRAVEL VACCINATIONS FOR PREGNANT WOMEN

37. 2. JAPANESE ENCEPHALITIS - CDC recommendation - Japanese
encephalitis vaccination should be considered for pregnant
women planning longer-duration travel (about more than a
month) to endemic areas when the theoretical risk of
immunization is outweighed by the risk of infection,
3. TYPHOID FEVER - Typhoid vaccine is given after analysing the
risk of exposure and is not routinely advocated.

41. FOGSI RECOMMENDATIONS FOR VACCINATION
DURING PREGNANCY
• Federation of Obstetric and Gynaecological Societies of India (FOGSI)
recommends immunization against
1. Tetanus - Two doses of tetanus toxoid injection at least 28 days apart
are to be given to all pregnant mothers commencing from second
trimester
Subsequent pregnancy occurs within 5 years – 1 Booster
• In contrast to developed nations where tetanus is rare, it remains
endemic in the developing world. The incidence often increases
following natural disasters such as earthquakes and Tsunamis. In 2012,
there were 2,404 cases of tetanus reported to the WHO from India
• Tetanus diphtheria Acellular pertussis (Tdap) vaccination can be
considered instead of the second dose of tetanus toxoid to offer
protection against diphtheria and pertussis in addition to tetanus.

42. 2. Diphtheria - Tetanus diphtheria Acellular pertussis (Tdap)
vaccination can be considered instead of the second dose of
tetanus toxoid to offer protection against diphtheria and
pertussis in addition to tetanus.
The regular pertussis vaccine is contraindicated in
pregnancy.
(Td-vac) tetanus and diphtheria vaccination can be an
alternative if T-dap is not available.
3. Pertussis and
4. Influenza

43. • In 2012, a total of 2,525 new cases of respiratory diphtheria
were reported from India. For reasons that are not well
understood, pockets of diphtheria are reappearing primarily
in developing countries.
• The IAP suggests immunization of pregnant women with
single dose of T-dap during the third trimester (preferred 27-
36 weeks gestation) regardless of the interval between
previous T or T-dap vaccination. T-dap has to be repeated in
every pregnancy irrespective of the status of previous
immunization (with T-dap).

44. • Influenza vaccination is recommended for mothers from 26
weeks onwards,
• In case of a pandemic, the influenza vaccine can be given
earlier to protect the mother.

45. CONTEXT-3
• Both influenza A and B viruses are important as respiratory
pathogens. Influenza occurs all over the world with the
annual global attack rate estimated at 5-10% in adults and
20-30% in children. Most of the infections globally are
caused by influenza A (HINI), influenza A (H3N2) and
influenza B viruses.
• 'Antigenic drift' results in seasonal epidemics and is due to
point mutations that occur during viral replication. The
inactivated influenza vaccine (as opposed to live attenuated
vaccine) is recommended in pregnancy. This offers
protection to the mother (pregnant women are at a higher
risk of ARDS) and to the newborn who cannot be vaccinated
for the first 6 months of life.

46. • Higher rates of influenza-associated complications recorded
among pregnant women during the 2009 H INI pandemic
resulted in recognizing pregnancy as a high-risk group and,
therefore, vaccination is recommended in this group.
• Studies have demonstrated a 63% reduction in influenza
illness among infants up to 6 months, whose mothers
received influenza vaccination during pregnancy.

47. POSTNATAL VACCINATION
• FOGSI recommends
• postnatal rubella,
• hepatitis B,
• varicella,
• influenza,
• tetanus and
• HPV vaccinations to all non-immunized postnatal mothers

48. CONTEXT
• Postnatal period is a good window of opportunity which
should not be missed to protect the mother and her future
progeny.
• Influenza vaccination of the pregnant and parturient women
reduces the risk of respiratory illness including laboratory-
confirmed influenza in their infants up to 6 months as a
result of both trans-placental maternal antibodies and
increased anti – influenza antibodies in breast milk.
• Vaccines such as rubella can be safely administered in
concurrence with postnatal contraception