COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study

Andreoli, L; Ravichandran, N; Lini, D; Gracia-Ramos, AE; Schreiber, K; De La Torre, IG; Parodis, I; Shaharir, SS; Sen, P; Toro Guti&#233;rrez, CE; Chinoy, H; Day, J; Joshi, M; Jagtap, K; Nune, A; Nikiphorou, E; Agarwal, V; Saha, S; Tan, AL; Shinjo, SK; Ziade, N; Velikova, T; Milchert, M; Cavagna, L; Kuwana, M; Knitza, J; Makol, A; Patel, A; Pauling, JD; Wincup, C; Barman, B; Zamora Tehozol, EA; Serrano, JR; Colunga-Pedraza, IJ; Merayo-Chalico, J; Chibuzo, OC; Katchamart, W; Akarawatcharangura Goo, P; Shumnalieva, R; Chen, YM; Hoff, LS; El Kibbi, L; Halabi, H; Vaidya, B; Hasan, Atmt; Dey, D; Caballero-Uribe, CV; Lilleker, JB; Salim, B; Gheita, T; Chatterjee, T; Saavedra, MA; Distler, O; Agarwal, V; Aggarwal, R; Gupta, L

Author(s): Andreoli, L; Ravichandran, N; Lini, D; Gracia-Ramos, AE; Schreiber, K; De La Torre, IG; Parodis, I; Shaharir, SS; Sen, P; Toro Gutiérrez, CE; Chinoy, H; Day, J; Joshi, M; Jagtap, K; Nune, A; Nikiphorou, E; Agarwal, V; Saha, S; Tan, AL; Shinjo, SK; Ziade, N; Velikova, T; Milchert, M; Cavagna, L; Kuwana, M; Knitza, J; Makol, A; Patel, A; Pauling, JD; Wincup, C; Barman, B; Zamora Tehozol, EA; Serrano, JR; Colunga-Pedraza, IJ; Merayo-Chalico, J; Chibuzo, OC; Katchamart, W; Akarawatcharangura Goo, P; Shumnalieva, R; Chen, YM; Hoff, LS; El Kibbi, L; Halabi, H; Vaidya, B; Hasan, Atmt; Dey, D; Caballero-Uribe, CV; Lilleker, JB; Salim, B; Gheita, T; Chatterjee, T; Saavedra, MA; Distler, O; Agarwal, V; Aggarwal, R; Gupta, L;
Details: Publication Year 2024-05-02,Volume 63,Issue #5,Page 1341-1351
Journal Title: Rheumatology
Abstract: OBJECTIVES: We investigated coronavirus disease 2019 (COVID-19) vaccine safety in pregnant and breastfeeding women with autoimmune diseases (AID) in the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. METHODS: Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares and AID-related treatment modifications were analysed upon diagnosis of AID vs healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine. RESULTS: Among the 9201 participants to the self-administered online survey, 6787 (73.8%) were women. Forty pregnant and 52 breastfeeding patients with AID were identified, of whom the majority had received at least one dose of COVID-19 vaccine (100% and 96.2%, respectively). AE were reported significantly more frequently in pregnant than in non-pregnant patients (overall AE 45% vs 26%, P = 0.01; minor AE 40% vs 25.9%, P = 0.03; major AE 17.5% vs 4.6%, P < 0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC with respect to AE. Post-vaccination disease flares were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18.3% of age- and disease-matched non-pregnant and non-breastfeeding patients (n = 262). All pregnant/breastfeeding patients who experienced a disease flare were managed with glucocorticoids; 28.6% and 20% of them required initiation or change in immunosuppressants, respectively. CONCLUSION: This study provides reassuring insights into the safety of COVID-19 vaccines administered to women with AID during the gestational and post-partum periods, helping overcome hesitant attitudes, as the benefits for the mother and for the fetus by passive immunization appear to outweigh potential risks.
Publisher: Oxford Academic
Keywords: Humans; Female; Pregnancy; *Breast Feeding; Adult; *Autoimmune Diseases; *COVID-19 Vaccines/adverse effects; *COVID-19/prevention & control; SARS-CoV-2/immunology; Vaccination/adverse effects; COVID-19 vaccination; adverse events; autoimmune diseases; breastfeeding; disease flare; treatment
Research Division(s): Inflammation
PubMed ID: 37505460
Publisher's Version: https://doi.org/10.1093/rheumatology/kead382
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2024-01-16 09:40:52

Last Modified: 2024-05-09 09:00:51