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

Laura Andreoli, Daniele Lini, Karen Schreiber, Ioannis Parodis, Parikshit Sen, Naveen Ravichandran, Jessica Day, Mrudula Joshi, Kshitij Jagtap, Arvind Nune, Elena Nikiphorou, Vishwesh Agarwal, Sreoshy Saha, Ai Lyn Tan, Samuel Katsuyuki Shinjo, Nelly Ziade, Tsvetelina Velikova, Marcin Milchert, Abraham Edgar Gracia-Ramos, Lorenzo CavagnaMasataka Kuwana, Johannes Knitza, Ashima Makol, Aarat Patel, John D Pauling, Chris Wincup, Bhupen Barman, Erick Adrian Zamora Tehozol, Jorge Rojas Serrano, Ignacio García-De La Torre, Iris J Colunga-Pedraza, Javier Merayo-Chalico, Okwara Celestine Chibuzo, Wanruchada Katchamart, Phonpen Akarawatcharangura Goo, Russka Shumnalieva, Yi-Ming Chen, Leonardo Santos Hoff, Lina El Kibbi, Hussein Halabi, Binit Vaidya, Syahrul Sazliyana Shaharir, A T M Tanveer Hasan, Dzifa Dey, Carlos Enrique Toro Gutiérrez, Carlo V Caballero-Uribe, James B Lilleker, Babur Salim, Tamer Gheita, Tulika Chatterjee, COVAD Study Group

Research output: Contribution to journalJournal articleResearchpeer-review


OBJECTIVES: We investigated 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 (DF), and AID-related treatment modifications were analyzed upon diagnosis of AID versus 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 DF 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 DF 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 the fetus by passive immunization appear to outweigh potential risks.

Original languageEnglish
Issue number5
Pages (from-to)1341-1351
Publication statusPublished - 1. May 2024


  • COVID-19 vaccination
  • adverse events
  • autoimmune diseases
  • breastfeeding
  • disease flare
  • pregnancy
  • treatment
  • Vaccination/adverse effects
  • Humans
  • Breast Feeding
  • Pregnancy
  • SARS-CoV-2/immunology
  • Autoimmune Diseases
  • Adult
  • COVID-19/prevention & control
  • Female
  • COVID-19 Vaccines/adverse effects


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