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2.3 Groups with special vaccination requirements

2.3.2 Vaccination of women planning pregnancy, pregnant or breastfeeding women, and preterm infants - updated July 2009

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Please note: due to continuous updates being made to the Immunisation Handbook, the page number on the electronic version will not always match the hard copy version.

(i) Women planning pregnancy

The need for measles, mumps, rubella, varicella, diphtheria, tetanus and pertussis vaccination should be assessed as part of any pre-conception health check. Where previous vaccination history or infection is uncertain, relevant serological testing should be undertaken to ascertain immunity. Influenza vaccine is recommended routinely and pneumococcal vaccination is recommended for women with risk factors, including smokers. Women receiving live viral vaccines must be advised against falling pregnant within 28 days of vaccination. Please refer to individual disease chapters for more information about primary vaccination for these diseases.

(ii) Pregnancy

Although the use of most vaccines during pregnancy is not usually recommended on precautionary grounds, there is no convincing evidence that pregnancy should be an absolute contraindication to the use of any vaccine, particularly inactivated vaccines. The only exception is vaccinia virus (smallpox vaccination), which has been shown to cause fetal malformation. There is some evidence, however, that fever per se is teratogenic.^1,2 With the exception of the use of influenza vaccine, the NHMRC takes the conservative position that the use of vaccines during pregnancy might cause fever and should be avoided other than in situations of increased risk, where the benefits of protection from vaccination outweigh the risks. Eliminating the risk of exposure to vaccine-preventable diseases during pregnancy (eg. by changing travel plans, avoiding high-risk behaviours or occupational exposures) is an alternative to vaccination.

Live attenuated vaccines are contraindicated for pregnant women because of the hypothetical risk of harm to the fetus should transmission occur. If a live attenuated vaccine is inadvertently given to a pregnant woman, or if a woman becomes pregnant within 4 weeks of vaccination, she should be counselled about the potential transmission, albeit extremely unlikely, to the fetus. There is, however, no indication to consider termination of a pregnancy in this situation.

The following table may be used as a guide to the recommended use of vaccinations in pregnancy. Information regarding pregnancy status in women of reproductive age should be part of the routine pre-vaccination screening checklist (see Section 1.3.4, Pre-vaccination screening).

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Table 2.3.1: Vaccinations in pregnancy

Live attenuated vaccines

Bacterial

Recommendation

Comments

BCG vaccine
(Live attenuated strain
M. bovis )

Contraindicated.

Hypothetical risk only. BCG has not been shown to cause fetal damage.

Oral typhoid vaccine

Contraindicated.

Studies in animals are inadequate but available data show no evidence of an increased occurrence of fetal damage with oral live attenuated vaccine. Inactivated typhoid Vi polysaccharide vaccine is preferred.

Live attenuated vaccines

Viral

Recommendation

Comments

Measles-mumps-rubella (MMR) vaccine

Contraindicated.

Hypothetical risk only. Despite concerns that attenuated rubella vaccine virus might cause congenital abnormalities, rubella vaccine (either monovalent or as MMR) has been given to pregnant women (usually inadvertently) without harm to the fetus. Even though the rubella vaccine virus can infect the fetus if given in early pregnancy, there is no evidence that it causes congenital rubella syndrome in infants born to susceptible mothers vaccinated during pregnancy and, in particular, rubella vaccination during pregnancy is not an indication for termination.³

Women of child-bearing age should avoid pregnancy for 28 days after vaccination.

It is standard practice to test all pregnant women for immunity to rubella, and to vaccinate susceptible women as soon as possible after delivery (preferably using MMR).

Rotavirus vaccine

Contraindicated.

Not registered for use in adults.

Rotavirus vaccine can be safely administered to household contacts of pregnant women.

Smallpox vaccine

Contraindicated.

Should not be given to women who are pregnant or considering becoming pregnant. Pregnancy should be avoided for 3 months after vaccination.

Varicella vaccine

Contraindicated.

Hypothetical risk only. Congenital varicella syndrome has (to date) not been identified in women who have been inadvertently vaccinated in early pregnancy.⁴ This provides some reassurance of the safety of the vaccine.

Women of child-bearing age should avoid becoming pregnant for 28 days after vaccination.

Yellow fever vaccine

Contraindicated, unless travelling to yellow fever endemic area.

Hypothetical risk only. Yellow fever vaccine has been given to a large number of pregnant women with no adverse outcomes.⁵ Pregnant women who travel to a yellow fever-endemic area against medical advice should receive yellow fever vaccine.

The administration of yellow fever vaccine in early pregnancy is not an indication for termination.

Zoster vaccine Contraindicated. Hypothetical risk only. Women of child-bearing age are unlikely to be eligible for zoster vaccination. The zoster vaccine is registered for use in persons ≥50 years of age. If women of child-bearing age have been vaccinated, they should avoid becoming pregnant for 28 days after vaccination (see Chapter 3.26, Zoster).

Inactivated vaccines

Bacterial

Recommendation

Comments

Cholera (oral) vaccine

Not recommended.

Inadequate information on safety of oral cholera vaccine in pregnancy.

Adolescent/adult formulation dTpa vaccine

Recommended for pregnant women who work in close contact with infants eg. childcare, neonatal units.

Data on use of adult/adolescent formulation dTpa during pregnancy are not available, so it should be given in pregnancy only when the possible advantages outweigh the possible risks to the fetus. All women who are planning pregnancy should be encouraged to receive a single dose of dTpa before pregnancy; if not given before pregnancy, it should be given as soon as possible after delivery.

Haemophilus influenzae type b (Hib) vaccine

Recommended for pregnant women at increased risk of Hib disease (eg. hyposplenia, asplenia).

Available clinical data suggest that it is unlikely that use of Hib vaccine in pregnant women would have any deleterious effects on the pregnancy.

Meningococcal C conjugate vaccine (MenCCV)

Recommended for pregnant women at increased risk of meningococcal disease (eg. hyposplenia, asplenia), or possible exposure to serogroup C.

Although no clinical study data are available on the use of MenCCV in pregnant women, it is unlikely that it would have any deleterious effects on the pregnancy.

Meningococcal polysaccharide vaccine (4vMenPV)

Recommended for pregnant women at increased risk of meningococcal disease who have not been vaccinated with 4vMenPV in the past 3 years (eg. hyposplenia, asplenia), or possible exposure to serogroup A, W 135 or Y.

No documented adverse events in either pregnant women or their newborns when vaccinated with 4vMenPV administered in the second and third trimesters of pregnancy. The number of pregnant vaccinees reported in the literature is small.

7-valent pneumococcal conjugate vaccine (7vPCV)

Not recommended.

Vaccination during pregnancy has not been evaluated for potential harmful effects to mother or fetus. Although unlikely to result in adverse effects, the vaccine is currently only registered for use in children ≤9 years of age.

23-valent pneumococcal polysaccharide vaccine (23vPPV)

Recommended for pregnant women at increased risk of invasive pneumococcal disease (IPD) (eg. asplenia, impaired immunity, chronic illness, CSF leak) who have not received 23vPPV in the past 5 years (and provided they have not received 2 previous doses).

No adverse effects when administered in pregnancy. Data are limited to clinical trials and deferral of vaccine is recommended unless there is an increased risk of IPD. Women of reproductive age with known risk factors for IPD (including smokers) should be vaccinated before planned pregnancy.

Q fever vaccine

Not recommended.

Safety of use in pregnancy has not been established.

Typhoid Vi polysaccharide vaccine

In pregnant women travelling to endemic countries where water quality and sanitation is poor.

There is no evidence of risk to the fetus from vaccination with Vi polysaccharide vaccine.

Viral

Recommendation

Comments

Hepatitis A vaccine

Recommended for susceptible pregnant women travelling to areas of moderate to high endemicity or who are at increased risk of exposure through lifestyle factors, or where severe outcomes may be expected (eg. pre-existing liver disease).

Hepatitis A vaccine should only be given to pregnant women who are non-immune and where there is a clear indication. As for any inactivated viral vaccines, although data are limited, no adverse effects on the developing fetus are expected.

Hepatitis B vaccine

Recommended for susceptible pregnant women for whom this vaccine would otherwise be recommended.

Hepatitis B vaccine should only be given to pregnant women who are non-immune and where there is a clear indication. As for any inactivated viral vaccines, although data are limited, no adverse effects on the developing fetus are expected.

Human papillomavirus (HPV) vaccine

Not recommended.

There are no concerns that HPV vaccines are teratogenic and animal studies have found no evidence of teratogenicity or adverse fetal outcomes. However, where vaccine has inadvertently been administered during pregnancy, further doses should be deferred until after delivery.

Influenza vaccine

Recommended for all pregnant women who will be in the second or third trimester during the influenza season, including those in the first trimester at the time of vaccination.

There is no evidence of congenital defects or adverse effects on the fetus of women who are vaccinated against influenza in pregnancy.

Japanese encephalitis (JE) vaccine

Recommended for pregnant women at risk of acquiring JE.

No adverse effects on pregnancy have been attributed to JE vaccine, whereas JE infection is associated with miscarriage.

Inactivated polio vaccine (IPV)

Recommended for pregnant women at risk of poliovirus exposure (eg. travel to endemic countries).

IPV should only be given to pregnant women when clearly indicated. There is no convincing evidence of risk to the fetus from IPV administered in pregnancy.

Rabies vaccine

Recommended for pregnant women for whom this vaccine would otherwise be recommended (eg. travellers to rabies endemic countries).

Pregnancy is never a contraindication to rabies vaccination in situations where there is a significant risk of exposure (related to occupation or travel), or where there has been a possible exposure to rabies virus or Australian bat lyssavirus.

Toxoids and immunoglobulins

Tetanus/diphtheria toxoid

Recommended for pregnant women.

Toxoids are safe in pregnancy.

Pooled or hyperimmune immunoglobulins

Recommended for susceptible pregnant women exposed to: measles, hepatitis A, hepatitis B, rabies or Australian bat lyssavirus, varicella viruses and tetanus.

There is no known risk to the fetus from passive immunisation of pregnant women with immunoglobulins.

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Live attenuated vaccines
Bacterial	Recommendation	Comments
BCG vaccine (Live attenuated strain M. bovis )	Contraindicated.	Hypothetical risk only. BCG has not been shown to cause fetal damage.
Oral typhoid vaccine	Contraindicated.	Studies in animals are inadequate but available data show no evidence of an increased occurrence of fetal damage with oral live attenuated vaccine. Inactivated typhoid Vi polysaccharide vaccine is preferred.
Live attenuated vaccines
Viral	Recommendation	Comments
Measles-mumps-rubella (MMR) vaccine	Contraindicated.	Hypothetical risk only. Despite concerns that attenuated rubella vaccine virus might cause congenital abnormalities, rubella vaccine (either monovalent or as MMR) has been given to pregnant women (usually inadvertently) without harm to the fetus. Even though the rubella vaccine virus can infect the fetus if given in early pregnancy, there is no evidence that it causes congenital rubella syndrome in infants born to susceptible mothers vaccinated during pregnancy and, in particular, rubella vaccination during pregnancy is not an indication for termination.³ Women of child-bearing age should avoid pregnancy for 28 days after vaccination. It is standard practice to test all pregnant women for immunity to rubella, and to vaccinate susceptible women as soon as possible after delivery (preferably using MMR).
Rotavirus vaccine	Contraindicated. Not registered for use in adults.	Rotavirus vaccine can be safely administered to household contacts of pregnant women.
Smallpox vaccine	Contraindicated.	Should not be given to women who are pregnant or considering becoming pregnant. Pregnancy should be avoided for 3 months after vaccination.
Varicella vaccine	Contraindicated.	Hypothetical risk only. Congenital varicella syndrome has (to date) not been identified in women who have been inadvertently vaccinated in early pregnancy.⁴ This provides some reassurance of the safety of the vaccine. Women of child-bearing age should avoid becoming pregnant for 28 days after vaccination.
Yellow fever vaccine	Contraindicated, unless travelling to yellow fever endemic area.	Hypothetical risk only. Yellow fever vaccine has been given to a large number of pregnant women with no adverse outcomes.⁵ Pregnant women who travel to a yellow fever-endemic area against medical advice should receive yellow fever vaccine. The administration of yellow fever vaccine in early pregnancy is not an indication for termination.
Zoster vaccine	Contraindicated.	Hypothetical risk only. Women of child-bearing age are unlikely to be eligible for zoster vaccination. The zoster vaccine is registered for use in persons ≥50 years of age. If women of child-bearing age have been vaccinated, they should avoid becoming pregnant for 28 days after vaccination (see Chapter 3.26, Zoster).
Inactivated vaccines
Bacterial	Recommendation	Comments
Cholera (oral) vaccine	Not recommended.	Inadequate information on safety of oral cholera vaccine in pregnancy.
Adolescent/adult formulation dTpa vaccine	Recommended for pregnant women who work in close contact with infants eg. childcare, neonatal units.	Data on use of adult/adolescent formulation dTpa during pregnancy are not available, so it should be given in pregnancy only when the possible advantages outweigh the possible risks to the fetus. All women who are planning pregnancy should be encouraged to receive a single dose of dTpa before pregnancy; if not given before pregnancy, it should be given as soon as possible after delivery.
Haemophilus influenzae type b (Hib) vaccine	Recommended for pregnant women at increased risk of Hib disease (eg. hyposplenia, asplenia).	Available clinical data suggest that it is unlikely that use of Hib vaccine in pregnant women would have any deleterious effects on the pregnancy.
Meningococcal C conjugate vaccine (MenCCV)	Recommended for pregnant women at increased risk of meningococcal disease (eg. hyposplenia, asplenia), or possible exposure to serogroup C.	Although no clinical study data are available on the use of MenCCV in pregnant women, it is unlikely that it would have any deleterious effects on the pregnancy.
Meningococcal polysaccharide vaccine (4vMenPV)	Recommended for pregnant women at increased risk of meningococcal disease who have not been vaccinated with 4vMenPV in the past 3 years (eg. hyposplenia, asplenia), or possible exposure to serogroup A, W 135 or Y.	No documented adverse events in either pregnant women or their newborns when vaccinated with 4vMenPV administered in the second and third trimesters of pregnancy. The number of pregnant vaccinees reported in the literature is small.
7-valent pneumococcal conjugate vaccine (7vPCV)	Not recommended.	Vaccination during pregnancy has not been evaluated for potential harmful effects to mother or fetus. Although unlikely to result in adverse effects, the vaccine is currently only registered for use in children ≤9 years of age.
23-valent pneumococcal polysaccharide vaccine (23vPPV)	Recommended for pregnant women at increased risk of invasive pneumococcal disease (IPD) (eg. asplenia, impaired immunity, chronic illness, CSF leak) who have not received 23vPPV in the past 5 years (and provided they have not received 2 previous doses).	No adverse effects when administered in pregnancy. Data are limited to clinical trials and deferral of vaccine is recommended unless there is an increased risk of IPD. Women of reproductive age with known risk factors for IPD (including smokers) should be vaccinated before planned pregnancy.
Q fever vaccine	Not recommended.	Safety of use in pregnancy has not been established.
Typhoid Vi polysaccharide vaccine	In pregnant women travelling to endemic countries where water quality and sanitation is poor.	There is no evidence of risk to the fetus from vaccination with Vi polysaccharide vaccine.
Viral	Recommendation	Comments
Hepatitis A vaccine	Recommended for susceptible pregnant women travelling to areas of moderate to high endemicity or who are at increased risk of exposure through lifestyle factors, or where severe outcomes may be expected (eg. pre-existing liver disease).	Hepatitis A vaccine should only be given to pregnant women who are non-immune and where there is a clear indication. As for any inactivated viral vaccines, although data are limited, no adverse effects on the developing fetus are expected.
Hepatitis B vaccine	Recommended for susceptible pregnant women for whom this vaccine would otherwise be recommended.	Hepatitis B vaccine should only be given to pregnant women who are non-immune and where there is a clear indication. As for any inactivated viral vaccines, although data are limited, no adverse effects on the developing fetus are expected.
Human papillomavirus (HPV) vaccine	Not recommended.	There are no concerns that HPV vaccines are teratogenic and animal studies have found no evidence of teratogenicity or adverse fetal outcomes. However, where vaccine has inadvertently been administered during pregnancy, further doses should be deferred until after delivery.
Influenza vaccine	Recommended for all pregnant women who will be in the second or third trimester during the influenza season, including those in the first trimester at the time of vaccination.	There is no evidence of congenital defects or adverse effects on the fetus of women who are vaccinated against influenza in pregnancy.
Japanese encephalitis (JE) vaccine	Recommended for pregnant women at risk of acquiring JE.	No adverse effects on pregnancy have been attributed to JE vaccine, whereas JE infection is associated with miscarriage.
Inactivated polio vaccine (IPV)	Recommended for pregnant women at risk of poliovirus exposure (eg. travel to endemic countries).	IPV should only be given to pregnant women when clearly indicated. There is no convincing evidence of risk to the fetus from IPV administered in pregnancy.
Rabies vaccine	Recommended for pregnant women for whom this vaccine would otherwise be recommended (eg. travellers to rabies endemic countries).	Pregnancy is never a contraindication to rabies vaccination in situations where there is a significant risk of exposure (related to occupation or travel), or where there has been a possible exposure to rabies virus or Australian bat lyssavirus.
Toxoids and immunoglobulins
Tetanus/diphtheria toxoid	Recommended for pregnant women.	Toxoids are safe in pregnancy.
Pooled or hyperimmune immunoglobulins	Recommended for susceptible pregnant women exposed to: measles, hepatitis A, hepatitis B, rabies or Australian bat lyssavirus, varicella viruses and tetanus.	There is no known risk to the fetus from passive immunisation of pregnant women with immunoglobulins.

Contact between pregnant women and individuals who have recently received live vaccines

Although there is no risk of transmission of the MMR vaccine viruses (MMR vaccine viruses are not transmissible), and an almost negligible risk of transmission of VZV (varicella or zoster) vaccine virus, there is a very small risk of transmission of the rotavirus vaccine viruses to a susceptible pregnant woman. However, there is no evidence that there is any risk to the fetus if pregnant women are in contact with recently vaccinated individuals. Therefore, it is safe to administer varicella vaccine, zoster vaccine and rotavirus vaccine to household contacts of pregnant women.

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(iii) Breastfeeding and vaccination

The rubella vaccine virus may be secreted in human breast milk and transmitted to breastfed infants but, where infection has occurred in an infant, it has been mild. Otherwise, there is no evidence of risk to the breastfeeding baby if the mother is vaccinated with any of the live or inactivated vaccines described in this Handbook. Breastfeeding does not adversely affect immunisation and is not a contraindication for the administration of any vaccine to the baby.

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(iv) Preterm babies

Preterm (premature) infants have a special need for protection and, despite their immunological immaturity, they generally respond well to vaccines. Provided they are well and there are no contraindications to vaccination they should be vaccinated according to the recommended schedule at the usual chronological age^.6-14

Routine childhood vaccines can cause an increase in apnoea in preterm babies vaccinated in hospital, particularly babies still requiring special care, but these are generally self-limiting and do not affect the clinical course.⁸Preterm babies in hospital should be monitored for apnoea or bradycardia for up to 48 hours post vaccination.^6-8 Vaccinations have not caused an increase in apnoeas in babies at home, and are not associated with an increased risk of SIDS.^6-8

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Vaccines as recommended on the National Immunisation Program (NIP) schedule

Preterm babies produce good antibody responses to most vaccines in the NIP. They should be vaccinated at the standard recommended ages without correction for prematurity.¹⁴

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Pneumococcal vaccines

All preterm babies born at less than 28 weeks’ gestation or with chronic lung disease should be offered the 7-valent pneumococcal conjugate vaccine at 2, 4 and 6 months of age, with a fourth dose at 12 months of age, and a 23-valent pneumococcal polysaccharide vaccine booster at 4–5 years of age (see Chapter 3.15, Pneumococcal disease).

Haemophilus influenzae type b vaccine

Some smaller preterm babies do not respond as well as term babies to PRP-OMP (Liquid PedvaxHIB or COMVAX) Hib vaccine.^9-14 When PRP-OMP is used in an extremely preterm baby (<28 weeks’ gestation or <1500 g birth weight), an extra dose of vaccine should be given at 6 months of age (ie. doses should be given at 2, 4, 6 and 12 months of age) (see Chapter 3.4, Haemophilus influenzae type b).

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Hepatitis B vaccine

Preterm babies do not respond as well to hepatitis B-containing vaccines as term babies.^7,12,13,15 Thus, for babies born at <32 weeks’ gestation or <2000 g birth weight, it is recommended to give vaccine at 0, 2, 4 and 6 months of age and either:

(a) measure anti-HBs at 7 months of age and give a booster at 12 months of age if antibody titre is <10 mIU/mL, or

(b) give a booster at 12 months of age without measuring the antibody titre.

(See Chapter 3.6, Hepatitis B.)

Influenza vaccine

Preterm infants with ongoing problems at 6 months of age, particularly respiratory, cardiac or neurological disease, should receive influenza vaccine.

References

1. Moretti ME, Bar-Oz B, Fried S, Koren G. Maternal hyperthermia and the risk for neural tube defects in offspring: systematic review and meta-analysis. Epidemiology 2005;16:216-9.

2. Chambers CD, Johnson KA, Dick LM, Felix RJ, Jones KL. Maternal fever and birth outcome: a prospective study. Teratology 1998;58:251-7.

3. Hamkar R, Jalilvand S, Abdolbaghi MH, et al. Inadvertent rubella vaccination of pregnant women: evaluation of possible transplacental infection with rubella vaccine. Vaccine 2006;24:3558-63.

4. Shields KE, Galil K, Seward J, et al. Varicella vaccine exposure during pregnancy: data from the first 5 years of the pregnancy registry. Obstetrics & Gynecology 2001;98:14-9.

5. Suzano CE, Amaral E, Sato HK, Papaiordanou PM, Campinas Group on Yellow Fever Immunization during Pregnancy. The effects of yellow fever immunization (17DD) inadvertently used in early pregnancy during a mass campaign in Brazil. Vaccine 2006;24:1421-6.

6. Ellison VJ, Davis PG, Doyle LW. Adverse reactions to immunization with newer vaccines in the very preterm infant. Journal of Paediatrics & Child Health 2005;41:441-3.

7. Saari TN, American Academy of Pediatrics Committee on Infectious Diseases. Immunization of preterm and low birth weight infants. Pediatrics 2003;112:193-8.

8. Pfister RE, Aeschbach V, Niksic-Stuber V, Martin BC, Siegrist CA. Safety of DTaP-based combined immunization in very-low-birth-weight premature infants: frequent but mostly benign cardiorespiratory events. Journal of Pediatrics 2004;145:58-66.

9. Washburn LK, O'Shea TM, Gillis DC, Block SM, Abramson JS. Response to Haemophilus influenzae type b conjugate vaccine in chronically ill premature infants. Journal of Pediatrics 1993;123:791-4.

10. Slack MH, Schapira D, Thwaites RJ, et al. Immune response of premature infants to meningococcal serogroup C and combined diphtheria-tetanus toxoids-acellular pertussis-Haemophilus influenzae type b conjugate vaccines. Journal of Infectious Diseases 2001;184:1617-20.

11. Losonsky GA, Wasserman SS, Stephens I, et al. Hepatitis B vaccination of premature infants: a reassessment of current recommendations for delayed immunization. Pediatrics 1999;103:e14.

12. Golebiowska M, Kardas-Sobantka D, Chlebna-Sokól D, Sabanty W. Hepatitis B vaccination in preterm infants. European Journal of Pediatrics 1999;158:293-7.

13. Blondheim O, Bader D, Abend M, et al. Immunogenicity of hepatitis B vaccine in preterm infants. Archives of Disease in Childhood. Fetal & Neonatal Edition 1998;79:F206-8.

14. Omeñaca F, Garcia-Sicilia J, García-Corbeira P, et al. Response of preterm newborns to immunization with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio and Haemophilus influenzae type b vaccine: first experiences and solutions to a serious and sensitive issue. Pediatrics 2005;116:1292-8.

15. Belloni C, Chirico G, Pistorio A, et al. Immunogenicity of hepatitis B vaccine in term and preterm infants. Acta Paediatrica 1998;87:336-8.

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