ABSTRACT
Introduction Limited data exist regarding safety of COVID19 vaccinations for patients with cancer. Methods SerOzNET (ACTRN12621001004853) is a large prospective study of adults and children with cancer undergoing Sars-CoV-2 vaccination. Participants undertake a validated hesitancy survey at enrolment (Oxford COVID-19 Vaccine Confidence and Complacency Scale) and prior to the 3rd vaccine dose. Quality of life is assessed with serial EORTC QLQ-C30 (adults) or PedsQL (children). Patient- reported vaccine toxicity is assessed by patient-reported CTCAE items for common vaccine related AEs and patient-reported impact of vaccination on cancer treatment . Medically ascertained vaccine toxicity is assessed by study investigators one month after the 3rd vaccination dose. Results Five hundred and four participants have been enrolled (403 adults (80%) and 101 children (20%)). Baseline hesitancy surveys have been completed by 349 adults (87%), 58 parents (57%) and 51/86 eligible children (59%). Patient toxicity surveys have been returned post dose 1 for 445 (88%), post dose 2 for 417 (83%) and post dose 3 for 280 (56%). Incidence of any AEs was high (77-100% depending on age and dose), however the incidence of severe AEs (patient reported) was low (0-10% depending on age and dose). Interruptions to cancer treatment after vaccination were uncommon (2-12%). Conclusions Data to date are reassuring that severe adverse events and interruptions to cancer therapy post COVID19 vaccination are uncommon.