Safety of Four COVID-19 Vaccines across Primary Doses 1, 2, 3 and Booster: A Prospective Cohort Study of Australian Community Pharmacy Vaccinations

Abstract

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.

Association between adverse events after COVID-19 vaccination and anti-SARS-CoV-2 antibody concentrations, the Netherlands, May 2021 to November 2022: a population-based prospective cohort study

“…Our findings on AE for which medical care was sought are consistent with previous findings by a prospective cohort study performed in Australia [23]. In our study, headache, fatigue and fever were the most commonly reported AE.…”

Association between common adverse events after COVID-19 vaccination and anti-SARS-CoV-2 antibody concentrations in a population-based prospective cohort study in the Netherlands

“…Our findings on AE for which medical care was sought are in correspondence with previous findings by a prospective cohort study performed in Australia (17). In our study, headache, fatigue and fever were most commonly reported AE.…”

Burden and Impact of Reactogenicity among Adults Receiving COVID-19 Vaccines in the United States and Canada: Results from a Prospective Observational Study

“…Notably, some are calling for healthcare workers and certain other professionals to receive vaccines of lower reactogenicity [35]. Based on the findings of this and prior studies [37,[39][40][41][42][43][44], NVX-CoV2373 may provide a less reactogenic option for these individuals.…”

“…Notably, the referenced clinical studies were small and not designed to compare vaccine-associated side effects by vaccine type. Despite this, the consistency of reported reactogenicity event trends across various booster and primary series studies is clear [ 37 , 39 , 40 , 41 , 43 , 44 ]. Here, 2019nCoV-406 offers new real-world insights and an examination of human behavior associated with differences in reactogenicity.…”