The short term safety ofCOVID‐19 vaccines in Australia:AusVaxSafetyactive surveillance, February – August 2021

Abstract

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.

Rabdomiólise secundária a vacina contra COVID-19: relato de caso

“…Atualmente, os centros de vacinação COVID-19 encontram-se sob alçada da medicina geral e familiar e o centro de saúde é a principal porta de entrada do utente nos serviços de saúde, pelo que importa relembrar a rabdomiólise como um possível efeito adverso das vacinas contra a COVID-19. Efetivamente, podem surgir mialgias de ligeira intensidade e rápida resolução até três dias a seguir à vacinação [10][11] e o médico de família deverá estar apto a identificar a sintomatologia, que não se enquadra no padrão expectável, para agir em conformidade.…”

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“…In the largest published post‐marketing analysis of the safety of the Comirnaty and Vaxzevria vaccines, Lucy Deng and colleagues 13 analysed data from online AusVaxSafety surveys of more than three million people aged 16 years or more. The authors found that adverse events were more frequently reported by people with underlying medical conditions, including a history of anaphylaxis.…”

Vaccine safety: what systems are required to ensure public confidence in vaccines?

“…Australian data contribute to the international body of evidence regarding vaccine safety, adds information on specific groups in our country (including Indigenous Australians), and permits comparisons between the vaccines used locally. Both the rapid establishment of reactogenicity profiles and the awareness that AEFI are actively being sought facilitates public confidence in vaccines 10,13 …”

“…In the study reported in this issue of the MJA , 10 Deng and colleagues analysed AusVaxSafety data for more than three million vaccination episodes. While the response rate to the survey was relatively high (63%), the authors may have overestimated the frequency of adverse events because non‐responders are less likely to have experienced significant reactions.…”

“…Both the rapid establishment of reactogenicity profiles and the awareness that AEFI are actively being sought facilitates public confidence in vaccines. 10 , 13 …”