Safety profile of pfizer-biontech COVID-19 vaccine in patients with rheumatic diseases: Preliminary assessment

ABSTRACT

Background: Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19, administered as 2 doses separated by 21 days (1) On December 27, 2020, Italy started use of Pfizer-BioNTech COVID-19 vaccine and initial doses were reserved for health care personnel Objectives: The primary end points were the safety of each administered dose in patients with Rheumatic diseases (RD's) Methods: In this multicenter, observational study, we interviewed by phone 27 patients with rheumatic diseases (RDs) and 30 healthy subjects receiving the Pfizer-BioNTech vaccine (0.3 ml i.m. in two doses 21 days apart, time 0 and 3 weeks). Results: As of 30 January 2021, 57 subjects (27 patients and 30 healthy subjects) were interviewed. The epidemiological and clinical features of the 27 patients are reported in Table 1. Among the whole population, 35 subjects (16 patients and 19 healthy subjects) complained of an adverse event after the first vaccine dose, with symptom onset occurring within 1 day of vaccination. All adverse events (100%) were classified as nonserious and included injection site pain (17), fatigue (5), headache (16), fever (3), tachycardia (2), and paresthesia (2). After 21 days, 6 patients and 11 healthy subjects received the second vaccine dose. Fifteen (5 patients and 10 healthy subjects) of them (88%) reported adverse events, again categorized as nonserious. Specifically, injection site pain (7), fatigue (10), headache (10), fever (10), paresthesia (1), cutaneous vasculitis (1), itchy and scratchy throat (1), diarrhea (4), lymph node enlargement (1) were recorded. No differences were noted between patients with RDs and healthy subjects in terms of adverse events. Conclusion: This preliminary study shows that the Pfizer-BioNTech COVID-19 vaccine is as safe in patients with RDs as in healthy subjects. Whether patients with RDs will develop protective titers of anti-SARS-CoV-2 antibodies as compared to healthy subjects will be evaluated in further, ongoing studies.