Introduction: Active vaccine safety surveillance will be critical to COVID-19 vaccine deployment. Pharmacists have been identified as potential immunisers in COVID-19 policies, yet there are no reported active surveillance systems operating in pharmacies. We integrated an established participant-centred active vaccine safety surveillance system with a cloud-based pharmacy immunisation-recording program. We measured adverse events following immunisation (AEFI) reported via the new surveillance system in pharmacies, and compared these to AEFI reported via an existing surveillance system in non-pharmacy sites (general practice and other clinics).
Methods: A prospective cohort study of individuals>10 years receiving influenza immunisations from 22 pharmacies and 90 non-pharmacy sites between March and October, 2020, in Australia. Active surveillance was conducted using SMS and smartphone technology, via an opt-out system. Multivariable logistic regression (including a subgroup analysis of participants over 65 years) was used to assess differences in proportions of AEFI between participants immunised in pharmacies compared to non-pharmacy sites, adjusting for confounders of age, sex, and influenza vaccine brand.
Results: Of 101,440 influenza immunisation participants (6,992 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 an AEFI, compared with 6.0% (n=4,356) non-pharmacy participants (adjusted odds ratio: 0.87; 95% confidence interval: 0.76 to 0.99; p=0.039). Similar proportions of AEFIs were reported in pharmacy (5.8%; n=31) and non-pharmacy participants (6.0; n=1617) aged over 65 years (adjusted odds ratio: 0.94, 95% confidence interval: 0.65 to 1.35; p=0.725).
Conclusion: 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 to non-pharmacy immunisations, with no difference in older adults, suggests different cohorts attend pharmacy and non-pharmacy immunisers. The integrated pharmacy system is rapidly scalable across Australia with global potential.