RESUMEN
BACKGROUND: Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax), and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine the type and management of immediate adverse events following immunisation (I-AEFI) after COVID-19 vaccination. METHODS: Retrospective review of I-AEFI recorded between July 2021 and June 2022 in 314 community pharmacies in Australia. RESULTS: I-AEFI were recorded in 0.05% (n = 526/977,559) of all COVID-19 vaccinations (highest: AstraZeneca (n = 173/161,857; 0.11%); lowest: Pfizer (n = 50/258,606; 0.02%)). The most common reactions were: (1) syncope, after the first dose of AstraZeneca (n = 105/67,907; 0.15%), Moderna (n = 156/108,339; 0.14%), and Pfizer (n = 22/16,287; 0.14%); and (2) Nausea/vomiting after the first dose of Pfizer (n = 9/16,287; 0.06%), Moderna (n = 55/108,339; 0.05%), and AstraZeneca (n = 31/67,907; 0.05%) vaccines. A total of 23 anaphylactic reactions were recorded (n = 23/977,559; 0.002%), and 59 additional I-AEFI were identified using MedDRA® terminology. Pharmacists primarily managed syncope by laying the patient down (n = 227/342; 66.4%); nausea/vomiting was managed primarily by laying the patient down (n = 62/126; 49.2%), giving water (n = 38/126; 30.2%), or monitoring in the pharmacy (n = 29/126; 23.0%); anaphylactic reaction was treated with adrenaline (n = 18/23; 78.3%) and n = 13/23 (56.5%) anaphylactic reactions were treated with the combination of: administered adrenaline, called ambulance, and laid patient down. CONCLUSION: The most commonly recorded I-AEFI was syncope after COVID-19 vaccination in pharmacy; I-AEFI are similar to those previously reported. Pharmacists identified and managed serious and non-serious I-AEFI appropriately and comprehensively.
RESUMEN
Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax) and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine adverse events following immunisation (AEFI) at days 3 and 42 after primary doses 1, 2, 3 and booster. We conducted active vaccine safety surveillance from 130 community pharmacies in Australia integrated with AusVaxSafety, between August 2021-April 2022. Main outcomes: AEFI at 0-3 days post-vaccination; medical review/advice at 3 days and 42 days post-vaccination; SARS-CoV-2 breakthrough infection by day 42. Of 110,024 completed day 3 surveys (43.6% response rate), 50,367 (45.8%) reported any AEFI (highest proportions: Pfizer 42%, primary dose 3; AstraZeneca 58.3%, primary dose 1; Moderna 65.4% and Novavax 58.8%, both primary dose 2). The most common AEFI reported across all doses/vaccines were local reactions, systemic aches and fatigue/tiredness. Overall, 2172/110,024 (2.0%) and 1182/55,329 (2.1%) respondents sought medical review at days 3 and 42, respectively, and 931/42,318 (2.2%) reported breakthrough SARS-CoV-2 infection at day 42. We identified similar AEFI profiles but at lower proportions than previously reported for Pfizer, AstraZeneca, Moderna and Novavax COVID-19 vaccines. Moderna vaccine was the most reactogenic and associated with higher AEFI proportions across primary doses 2, 3, and booster.
RESUMEN
OBJECTIVES: We integrated an established participant-centred active vaccine safety surveillance system with a cloud-based pharmacy immunisation-recording program in order to measure adverse events following immunisation (AEFI) reported via the new surveillance system in pharmacies, compared with AEFI reported via an existing surveillance system in non-pharmacy sites (general practice and other clinics). DESIGN: A prospective cohort study. PARTICIPANTS AND SETTING: Individuals >10 years receiving influenza immunisations from 22 pharmacies and 90 non-pharmacy (general practice and other clinic) sites between March and October 2020 in Western Australia. Active vaccine safety surveillance was conducted using short message service and smartphone technology, via an opt-out system. OUTCOME MEASURES: Multivariable logistic regression was used to assess the primary outcome: differences in proportions of AEFI between participants immunised in pharmacies compared with non-pharmacy sites, adjusting for confounders of age, sex and influenza vaccine brand. A subgroup analysis of participants over 65 years was also performed. RESULTS: Of 101 440 participants (6992 from pharmacies; 94 448 from non-pharmacy sites), 77 498 (76.4%) responded; 96.1% (n=74 448) within 24 hours. Overall, 4.8% (n=247) pharmacy participants reported any AEFI, compared with 6% (n=4356) non-pharmacy participants (adjusted OR: 0.87; 95% CI: 0.76 to 0.99; p=0.039). Similar proportions of AEFIs were reported in pharmacy (5.8%; n=31) and non-pharmacy participants (6; n=1617) aged over 65 years (adjusted OR: 0.94; 95% CI: 0.65 to 1.35; p=0.725). The most common AEFIs in pharmacy were: pain (2%; n=104), tiredness (1.9%; n=95) and headache (1.7%; n=88); and in non-pharmacy sites: pain (2.3%; n=1660), tiredness (1.9%; n=1362) and swelling (1.5%; n=1121). CONCLUSIONS: High and rapid response rates demonstrate good participant engagement with active surveillance in both pharmacy and non-pharmacy participants. Significantly fewer AEFIs reported after pharmacist immunisations compared with non-pharmacy immunisations, with no difference in older adults, may suggest different cohorts attend pharmacy versus non-pharmacy immunisers. The integrated pharmacy system is rapidly scalable across Australia with global potential.