TY - JOUR
T1 - The short term safety of COVID-19 vaccines in Australia
T2 - AusVaxSafety active surveillance, February – August 2021
AU - Deng, Lucy
AU - Glover, Catherine
AU - Dymock, Michael
AU - Pillsbury, Alexis
AU - Marsh, Julie A.
AU - Quinn, Helen E.
AU - Leeb, Alan
AU - Cashman, Patrick
AU - Snelling, Thomas L.
AU - Wood, Nicholas
AU - Macartney, Kristine
N1 - Funding Information:
AusVaxSafety surveillance is funded under a contract with the Australian Department of Health. Thomas Snelling and Nicholas Wood are supported by Career Development Fellowships from the National Health and Medical Research Council. We acknowledge the participants and staff at the surveillance sites, state and territory health departments, and the contribution of the surveillance tools SmartVax, Vaxtracker, and Microsoft COVID Vaccine Management System.
Publisher Copyright:
© 2022 The Authors. Medical Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of AMPCo Pty Ltd.
PY - 2022/8/15
Y1 - 2022/8/15
N2 - Objective:: To assess the short term safety of the COVID-19 vaccines Comirnaty (Pfizer–BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia. Design:: Prospective observational cohort study; online surveys by AusVaxSafety, a national active vaccine safety surveillance system, three and eight days after vaccination. Setting, participants:: People aged 16 years or more who received COVID-19 vaccines at sentinel vaccination hubs, general practices, or Aboriginal Community Controlled Health Organisation clinics, 22 February – 30 August 2021. Main outcome measures:: Primary outcome: proportion of respondents who reported any adverse event following immunisation (AEFI) 0–3 days after vaccination. Secondary outcomes: proportions of respondents who reported specific adverse events or medical review for AEFI within seven days of vaccination; impact on usual daily activities; recovery. Results:: 4 851 480 people received COVID-19 vaccines at participating sentinel sites during the study period (25% of all COVID-19 vaccine doses administered in Australia to 30 August 2021). 3 035 983 people responded to both surveys (response rate, 62.6%); 35.9% of respondents reported one or more AEFI 0–3 days after Comirnaty dose 1, 54.7% after Comirnaty dose 2, 52.8% after Vaxzevria dose 1, and 22.0% after Vaxzevria dose 2. Local pain, fatigue, headache, and myalgia were the most frequently reported symptoms. After adjusting for demographic characteristics, vaccination site type, jurisdiction, and self-reported medical conditions, the odds of reporting any AEFI were higher for women than men (range of adjusted odd ratios [aORs], by vaccine and dose, 1.53–1.84), for people with a history of anaphylaxis (aOR range, 1.28–1.45), and for people reporting certain underlying conditions, including obesity (aOR range, 1.15–1.75), immunodeficiency (aOR range, 1.04–2.24), or chronic inflammatory disease (aOR range, 1.05–1.75). 0.9% of respondents sought medical advice in the three days following vaccination, most frequently after Comirnaty dose 2 (1.4%) and Vaxzevria dose 1 (1.2%). Conclusion:: AusVaxSafety active surveillance affirms the short term safety profile of Comirnaty and Vaxzevria vaccines in a large population sample during the first six months of the Australian COVID-19 vaccination program.
AB - Objective:: To assess the short term safety of the COVID-19 vaccines Comirnaty (Pfizer–BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia. Design:: Prospective observational cohort study; online surveys by AusVaxSafety, a national active vaccine safety surveillance system, three and eight days after vaccination. Setting, participants:: People aged 16 years or more who received COVID-19 vaccines at sentinel vaccination hubs, general practices, or Aboriginal Community Controlled Health Organisation clinics, 22 February – 30 August 2021. Main outcome measures:: Primary outcome: proportion of respondents who reported any adverse event following immunisation (AEFI) 0–3 days after vaccination. Secondary outcomes: proportions of respondents who reported specific adverse events or medical review for AEFI within seven days of vaccination; impact on usual daily activities; recovery. Results:: 4 851 480 people received COVID-19 vaccines at participating sentinel sites during the study period (25% of all COVID-19 vaccine doses administered in Australia to 30 August 2021). 3 035 983 people responded to both surveys (response rate, 62.6%); 35.9% of respondents reported one or more AEFI 0–3 days after Comirnaty dose 1, 54.7% after Comirnaty dose 2, 52.8% after Vaxzevria dose 1, and 22.0% after Vaxzevria dose 2. Local pain, fatigue, headache, and myalgia were the most frequently reported symptoms. After adjusting for demographic characteristics, vaccination site type, jurisdiction, and self-reported medical conditions, the odds of reporting any AEFI were higher for women than men (range of adjusted odd ratios [aORs], by vaccine and dose, 1.53–1.84), for people with a history of anaphylaxis (aOR range, 1.28–1.45), and for people reporting certain underlying conditions, including obesity (aOR range, 1.15–1.75), immunodeficiency (aOR range, 1.04–2.24), or chronic inflammatory disease (aOR range, 1.05–1.75). 0.9% of respondents sought medical advice in the three days following vaccination, most frequently after Comirnaty dose 2 (1.4%) and Vaxzevria dose 1 (1.2%). Conclusion:: AusVaxSafety active surveillance affirms the short term safety profile of Comirnaty and Vaxzevria vaccines in a large population sample during the first six months of the Australian COVID-19 vaccination program.
KW - COVID-19
KW - Drug-related side effects and adverse reactions
KW - Vaccination
UR - http://www.scopus.com/inward/record.url?scp=85133309762&partnerID=8YFLogxK
U2 - 10.5694/mja2.51619
DO - 10.5694/mja2.51619
M3 - Article
C2 - 35781813
AN - SCOPUS:85133309762
SN - 0025-729X
VL - 217
SP - 195
EP - 202
JO - Medical Journal of Australia
JF - Medical Journal of Australia
IS - 4
ER -