Pregnant women are recommended to receive an RSV vaccine during pregnancy to protect the infant
A single dose of Abrysvo is recommended for pregnant women at 28–36 weeks gestation to protect the infant.
Abrysvo is the only RSV vaccine approved for use in pregnant women. Arexvy should not be given to pregnant women. See precautions.
See Table. Vaccines that are routinely recommended in pregnancy: inactivated vaccines in Vaccination for women who are planning pregnancy, pregnant or breastfeeding for more details.
RSV infection in infants often causes lower respiratory tract disease, such as bronchiolitis. It is most likely to be severe during the first 6 months of life, frequently requiring hospitalisation. Maternal immunisation reduces the risk of severe RSV disease in infants <6 months of age by around 70% (see Vaccine information). This is the result of passive protection by transplacental transfer of RSV-specific antibodies from the mother to the fetus during pregnancy.
Maternal RSV vaccine is administered mainly to protect newborn infants. Vaccination may also protect pregnant women against RSV disease, but this is usually mild in women of child-bearing age and clinical trials did not study protection to the mother from vaccination.
Advice on potential repeat vaccination during subsequent pregnancies will be provided in the future as more data become available. The need for vaccination during each pregnancy is anticipated based on immunologic principles and experience with other vaccines recommended in pregnancy.
Women who are breastfeeding but not pregnant are not recommended to receive an RSV vaccine. There are no theoretical safety concerns, but there is also no evidence that vaccination would protect the infant through breastfeeding alone.
Timing of vaccination during pregnancy
Timing of vaccination during pregnancy
The recommended time for RSV vaccination during pregnancy is between 28 and 36 weeks gestation. Although Abrysvo is registered from 24 to 36 weeks gestation, administration from 24 to <28 weeks of gestation is not routinely recommended until there are more safety and efficacy data for women vaccinated at this gestation and their newborn infants.
RSV vaccine can be given at any time of the year, regardless of when a pregnant woman is expected to deliver. Pregnant women who have previously had an RSV infection are recommended to receive an RSV vaccine once recovered.
If a pregnant woman is not vaccinated before 36 weeks gestation, they should receive the vaccine as soon as possible after 36 weeks gestation. An immune response to the vaccine develops within the weeks after vaccination and transplacental antibody transfer to the infant increases progressively from the time of vaccination. However, infants are not expected to be adequately protected unless they are born at least 2 weeks after the mother received the vaccine.1
If delivery occurs within 2 weeks of the mother receiving the RSV vaccine, the infant is recommended to receive nirsevimab (a long-acting RSV-specific monoclonal antibody) to provide additional protection.
If a pregnant woman inadvertently receives RSV vaccine earlier than 28 weeks gestation, a repeat dose during the same pregnancy is not recommended.
The recommended timing of vaccination during pregnancy considers that:
- further safety data on vaccination at an earlier gestational age than 28 weeks will be reviewed as these data become available (see Precautions – women who are pregnant or breastfeeding)
- RSV is a seasonal disease in most parts of Australia, but severe disease can occur outside of peak seasons as RSV circulation continues year-round. Seasonality differs by jurisdiction in Australia, particularly in the tropical regions
- RSV vaccines can be given at the same time as, or separate to, dTpa, influenza and COVID-19 vaccines (see Co-administration with other vaccines).
Abrysvo is funded through the NIP for all pregnant women. For details see the National Immunisation Program schedule.