Pregnant women are recommended to receive an RSV vaccine during each pregnancy to protect their infant
A single dose of Abrysvo is recommended for all pregnant women (including those aged <18 years) to protect their infant. It is recommended in each pregnancy from 28 weeks gestation.
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. See Vaccine recommendations for pregnant women – a guide for health professionals.
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.
There is limited evidence to inform additional doses of RSV vaccine during subsequent pregnancies. The recommendation to receive RSV vaccine in each pregnancy is based on immunologic principles and experience with other vaccines recommended in pregnancy. There are currently no safety concerns regarding additional doses of RSV vaccine during subsequent pregnancies. Further data from clinical trials and additional epidemiological and safety data from countries with maternal RSV vaccine programs are expected in the future.
Women who are breastfeeding but not pregnant are not recommended to receive an RSV vaccine. There are no theoretical safety concerns to either the non-pregnant breastfeeding mother or to the breastfed child, but there is also limited evidence that vaccination would protect their infant through breastfeeding alone.
Timing of vaccination during pregnancy
Timing of vaccination during pregnancy
The recommended time for RSV vaccination during pregnancy is from 28 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 data for women vaccinated at this gestation and their newborn infants.
If a pregnant woman is not vaccinated by the end of 36 weeks gestation, they should receive the vaccine as soon as possible. An immune response to the vaccine develops within weeks after vaccination and transplacental antibody transfer to their infant increases progressively from the time of vaccination. However, protection will be significantly reduced if the infant is born less than 2 weeks after the mother received the vaccine.13
If birth occurs <2 weeks after the mother received the RSV vaccine, their infant is recommended to receive nirsevimab (a long-acting RSV-specific monoclonal antibody) to provide additional protection. See Neonates and infants aged <8 months whose mothers were not vaccinated at least 2 weeks before giving birth, or who are at increased risk of severe disease, are recommended to receive passive immunisation with a long-acting RSV-specific monoclonal antibody.
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) or Rh(D) immunoglobulin (Anti-D).
Abrysvo can be given at any time of the year, regardless of when in the year a pregnant woman is expected to give birth.
Pregnant women recommended to receive the vaccine, who have previously had an RSV infection, can receive it once they are recovered.
Maternal RSV vaccination is recommended during each pregnancy, including pregnancies that are closely spaced, to provide maximal protection to every infant.
Abrysvo is funded through the NIP for all pregnant women (including those <18 years of age) from 28 weeks gestation. For details see the National Immunisation Program schedule.