Catherine Glover1, Nigel Crawford2, Alan Leeb3, Nicholas Wood4, Kristine Macartney5. 1. National Centre for Immunisation Research and Surveillance, Children's Hospital at Westmead, Westmead, New South Wales, Australia. Electronic address: Catherine.glover1@health.nsw.gov.au. 2. Murdoch Children's Research Institute, Parkville, Victoria, Australia; Royal Children's Hospital, Melbourne, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia. Electronic address: nigel.crawford@mcri.edu.au. 3. SmartVax, Illawarra Medical Centre, Ballajura, Western Australia, Australia; Illawarra Medical Centre, Ballajura, Western Australia, Australia. Electronic address: alan@illawarramedical.com.au. 4. National Centre for Immunisation Research and Surveillance, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Discipline of Child and Adolescent Health, University of Sydney, Sydney, Australia. Electronic address: nicholas.wood@health.nsw.gov.au. 5. National Centre for Immunisation Research and Surveillance, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Discipline of Child and Adolescent Health, University of Sydney, Sydney, Australia; Department of Microbiology and Infectious Disease, Children's Hospital at Westmead, Westmead, New South Wales, Australia. Electronic address: kristine.macartney@health.nsw.gov.au.
Abstract
BACKGROUND: Maternal immunisation is important to protect both mother and baby, but safety concerns can lead to low uptake. AusVaxSafety participant-based surveillance actively monitors adverse events following immunisation (AEFI) in Australia. We aimed to analyse AEFI in the days following vaccination with seasonal inactivated influenza vaccine (IIV) and/or reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa) in pregnant women in Australia. METHODS: De-identified AEFI reports were solicited from vaccine recipients via automated SMS survey (using SmartVax software) following routine vaccination with IIV and/or dTpa at 219 national sentinel surveillance sites from 2015 to 2018. AEFI rates were compared by vaccine group (IIV alone, dTpa alone, or IIV and dTpa together), vaccine brand, trimester (IIV only) and vaccination period (April to August 2016-2018; IIV only). Women who had two vaccination encounters during surveillance were identified and AEFI rates compared for each dose. RESULTS: Among 13,758 participants, overall AEFI rates were lower following IIV (4.9%) than dTpa (6.4%) or IIV and dTpa given concomitantly (7.4%). The AEFI profile was similar for both vaccines, with injection site reactions, tiredness, and headache most commonly reported. Injection site pain and swelling/redness were significantly more common in women who received dTpa than IIV. Reports of medical attendance following immunisation were similar (0.3%) for each vaccine group. AEFI rates did not differ by IIV brand (FluQuadri®, Fluarix® Tetra), dTpa brand (Boostrix®, Adacel®), or by trimester. Among women with sequential dTpa vaccinations, 6.0% (7/116) had an AEFI following their second dTpa dose. CONCLUSIONS: Self-reported AEFI rates did not differ by trimester (IIV), or by vaccine brand (IIV or dTpa). Concomitant influenza and pertussis vaccination was associated with more frequent, but low rates of minor, expected AEFI. These real world 'citizen science-based' data provide further reassuring evidence of the safety of maternal vaccination.
BACKGROUND: Maternal immunisation is important to protect both mother and baby, but safety concerns can lead to low uptake. AusVaxSafety participant-based surveillance actively monitors adverse events following immunisation (AEFI) in Australia. We aimed to analyse AEFI in the days following vaccination with seasonal inactivated influenza vaccine (IIV) and/or reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa) in pregnant women in Australia. METHODS: De-identified AEFI reports were solicited from vaccine recipients via automated SMS survey (using SmartVax software) following routine vaccination with IIV and/or dTpa at 219 national sentinel surveillance sites from 2015 to 2018. AEFI rates were compared by vaccine group (IIV alone, dTpa alone, or IIV and dTpa together), vaccine brand, trimester (IIV only) and vaccination period (April to August 2016-2018; IIV only). Women who had two vaccination encounters during surveillance were identified and AEFI rates compared for each dose. RESULTS: Among 13,758 participants, overall AEFI rates were lower following IIV (4.9%) than dTpa (6.4%) or IIV and dTpa given concomitantly (7.4%). The AEFI profile was similar for both vaccines, with injection site reactions, tiredness, and headache most commonly reported. Injection site pain and swelling/redness were significantly more common in women who received dTpa than IIV. Reports of medical attendance following immunisation were similar (0.3%) for each vaccine group. AEFI rates did not differ by IIV brand (FluQuadri®, Fluarix® Tetra), dTpa brand (Boostrix®, Adacel®), or by trimester. Among women with sequential dTpa vaccinations, 6.0% (7/116) had an AEFI following their second dTpa dose. CONCLUSIONS: Self-reported AEFI rates did not differ by trimester (IIV), or by vaccine brand (IIV or dTpa). Concomitant influenza and pertussis vaccination was associated with more frequent, but low rates of minor, expected AEFI. These real world 'citizen science-based' data provide further reassuring evidence of the safety of maternal vaccination.
Authors: Lucy Deng; Catherine Glover; Michael Dymock; Alexis Pillsbury; Julie A Marsh; Helen E Quinn; Alan Leeb; Patrick Cashman; Thomas L Snelling; Nicholas Wood; Kristine Macartney Journal: Med J Aust Date: 2022-07-04 Impact factor: 12.776