Question Number: 255
PDR Number: SQ22-000625
Date Submitted: 21/11/2022
Department or Body: Department of Health
260. Vaccination with primary and recommended booster doses is the best way to reduce the higher risk of severe COVID-19 in unvaccinated pregnant women. The United Kingdom Joint Committee on Vaccination and Immunisation (JCVI) advice is that pregnant women are more at risk of severe COVID-19 disease and the Royal College of Obstetricians and Gynaecologists, the Royal College of Midwives and the UK National Health Service strongly recommends COVID-19 vaccination for pregnant and breastfeeding women. In the United Kingdom, an autumn booster is being offered to those at high risk of the complications from COVID-19 infection, who may not have been boosted for a few months. This includes pregnant women. Information on these recommendations can be found here: www.gov.uk/government/publications/covid-19-vaccination-women-ofchildbearing-age-currently-pregnant-planning-a-pregnancy-or-breastfeeding/covid19-vaccination-a-guide-on-pregnancy-and-breastfeeding – www.nhs.uk/pregnancy/keeping-well/pregnancy-and-coronavirus/. A BBC News article from 1 September 2022 outlines the misleading claim that the UK government had suspended vaccination for pregnant women came from a now out-of-date document from 2020. available at www.bbc.com/news/health-62739554. This is supported by the COVID-19 vaccination decision guide for women who are pregnant, breastfeeding or planning pregnancy, which notes that pregnant women were not included in the first clinical trials for COVID-19 vaccines, so at the time of initial guidance there was limited evidence confirming the safety of COVID-19 vaccines during pregnancy. The initial advice from immunisation expert groups was therefore cautious, and COVID-19 vaccines were not routinely recommended in pregnancy. Over time, real-world evidence from other countries has accumulated and reports show that the mRNA COVID-19 vaccines Pfizer and Moderna are effective and very safe to use in pregnancy. On 9 June 2021, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) released a joint statement with Australian Technical Advisory Group on Immunisation (ATAGI) recommending that pregnant women be routinely offered Pfizer mRNA vaccine (Comirnarty) at any stage of pregnancy, due to the risk of severe outcomes from COVID-19 is significantly higher for pregnant women and their unborn baby. The COVID-19 vaccination decision guide for women who are pregnant, breastfeeding or planning pregnancy is available on www.health.gov.au using the search term “pregnancy decision guide”. 264. The safety of the Australian population has always been the Australian Governments highest priority. For this reason, decisions regarding COVID-19 vaccines have been, and continue to be, based on the expert medical advice of ATAGI and the Therapeutic Goods Administration (TGA). The development of ATAGI’s advice is based on a thorough review of all the current and emerging evidence on COVID-19 vaccines, including data on effectiveness, waning of immunity, international program settings, national vaccination coverage and operational flexibility where appropriate. ATAGI continuously monitors and reviews all emerging evidence on COVID-19 vaccinations and adverse events and updates its recommendations as required. The TGA collects adverse event reports directly from health professionals and consumers, as well as through state and territory health departments, other Australian vaccine safety organisations and vaccine sponsors. Adverse events reported to the TGA may not be caused by the vaccine. Adverse events are suspected by the reporter of possibly being related to the vaccine, but this relationship is usually not certain – the event may be coincidental. The TGA reviews adverse event reports to look for any patterns that indicate a possible safety issue that should be investigated. This includes thoroughly investigating these issues to determine what action is required, if any, to maintain public safety.??? Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination far outweigh the potential risks. Like all medicines, COVID-19 vaccines may cause some side effects. The most frequently reported include injection-site reactions (such as a sore arm) and more general symptoms, like headache, muscle pain, fever and chills. This reflects what was seen in the clinical trials. TGA is publishing regular COVID-19 vaccine safety reports including information about reported suspected side effects and other safety information from Australia and overseas. These are available at: https://www.tga.gov.au/news/covid-19-vaccine-safety-reports The most recent TGA COVID-19 vaccine safety report shows an adverse event reporting rate of 2.1 per 1,000 COVID-19 vaccine doses as at 13 November 2022. TGA collaborates closely with national stakeholders on COVID-19 vaccine safety activities and issues, including the ATAGI, the National Centre for Immunisation Research and Surveillance (NCIRS), the Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) and the Adverse Events Following Immunisation – Clinical Assessment Network (AEFI-CAN).?? NCIRS publishes regular reports of findings from active post-vaccination surveillance through AusVaxSafety, available at: www.ncirs.org.au/ncirs-covid-19-response/covid-19- vaccine-safety-monitoring-ausvaxsafety The issue of fever and febrile convulsions in children under five who received trivalent influenza vaccination in 2010 was thoroughly investigated by the TGA and the department. A number of public communications about this topic are available on the TGA website.
