key: cord-0849361-yw4yr871
authors: Sciascia, Savino; Costanzo, Piera; Radin, Massimo; Schreiber, Karen; Pini, Massimo; Vaccarino, Antonella; Cecchi, Irene; Baldovino, Simone; Roccatello, Dario
title: Safety and tolerability of mRNA COVID-19 vaccines in people with antiphospholipid antibodies
date: 2021-10-20
journal: Lancet Rheumatol
DOI: 10.1016/s2665-9913(21)00320-9
sha: 58b9bbf76615add7abb97358948637b1b3496dab
doc_id: 849361
cord_uid: yw4yr871

nan

Vaccines represent a cornerstone in controlling the COVID-19 pandemic. The availability of data on the immunogenicity and safety of vaccines in patients with autoimmune diseases is progressively increasing. [1] [2] [3] However, some concerns have been raised regarding the safety of the vaccines in patients with antiphospholipid antibodies, as these antibodies have been reported to appear following both infection and vaccination and have been identified in patients with COVID-19. 4 Although a few cases of thrombocytopenia and thrombotic events with clinical features resembling antiphospholipid syndrome have been reported in recipients of either adenoviral vectorbased or mRNA-based COVID-19 vaccines, 5 a pathogenic link and, more critically, the clinical relevance of antiphospholipid antibodies in these clinical settings have yet to be fully elucidated. 78 (76%) of 102 patients had at least one side-effect: 45 (44%) reported pain at the injection site, 37 (36%) fatigue, and 29 (28%) headache. Symptoms were transient and selflimiting within 10 days. There were no differences in frequencies of systemic side-effects between the two mRNA vaccines. Symptoms were reported as mild in 72 (71%) patients and moderate in 30 (29%). No symptoms compatible with new thrombotic events were reported. The rate of reactions was not different when comparing those after the first and second doses. Only one patient with thrombotic antiphospholipid syndrome and a known history of mild thrombocytopenia (110 000/mm³), who was on longterm vitamin K antagonist therapy, reported the occurrence of selflimiting purpuric lesions on her calves 10 days after the second dose. Blood tests were unremarkable except for a single transient fluctuation of platelet count (88 000/mm³). Consequent investigations (during an observation time of 5 months) showed a platelet count persistently above 100 000/mm³.

Although more data are needed, including from long-term follow-up, immunogenicity data from our survey show that mRNA COVID-19 vaccines seem to have an acceptable safety and tolerability profile in patients with antiphospholipid antibodies. No major adverse effects nor thrombotic events were reported. Side-effects seem frequent, but mild and transient in nature.

We declare no competing interests. 

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Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial

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Antibody development after COVID-19 vaccination in patients with autoimmune diseases in the Netherlands: a substudy of data from two prospective cohort studies

Preliminary data on post market safety profiles of COVID 19 vaccines in rheumatic diseases: assessments on various vaccines in use, different rheumatic disease subtypes, and immunosuppressive therapies: a twocenters study