COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study-Reference-Cited by-同舟云学术

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

Published:2023-07-28 Issue: Volume: Page:
ISSN:1462-0324
Container-title:Rheumatology
language:en
Short-container-title:

Author:

Andreoli Laura¹^ORCID,Lini Daniele¹,Schreiber Karen²³⁴,Parodis Ioannis⁵⁶^ORCID,Sen Parikshit⁷^ORCID,Ravichandran Naveen⁸^ORCID,Day Jessica⁹¹⁰¹¹^ORCID,Joshi Mrudula¹²^ORCID,Jagtap Kshitij¹³^ORCID,Nune Arvind¹⁴^ORCID,Nikiphorou Elena¹⁵¹⁶^ORCID,Agarwal Vishwesh¹⁷^ORCID,Saha Sreoshy¹⁸^ORCID,Tan Ai Lyn¹⁹²⁰^ORCID,Shinjo Samuel Katsuyuki²¹^ORCID,Ziade Nelly²²²³^ORCID,Velikova Tsvetelina²⁴^ORCID,Milchert Marcin²⁵^ORCID,Gracia-Ramos Abraham Edgar²⁶^ORCID,Cavagna Lorenzo²⁷^ORCID,Kuwana Masataka²⁸^ORCID,Knitza Johannes²⁹^ORCID,Makol Ashima³⁰^ORCID,Patel Aarat³¹,Pauling John D³²³³^ORCID,Wincup Chris³⁴³⁵^ORCID,Barman Bhupen³⁶,Zamora Tehozol Erick Adrian³⁷^ORCID,Serrano Jorge Rojas³⁸^ORCID,De La Torre Ignacio García³⁹^ORCID,Colunga-Pedraza Iris J⁴⁰^ORCID,Merayo-Chalico Javier⁴¹^ORCID,Chibuzo Okwara Celestine⁴²,Katchamart Wanruchada⁴³^ORCID,Akarawatcharangura Goo Phonpen⁴⁴,Shumnalieva Russka⁴⁵^ORCID,Chen Yi-Ming⁴⁶⁴⁷^ORCID,Hoff Leonardo Santos⁴⁸^ORCID,El Kibbi Lina⁴⁹^ORCID,Halabi Hussein⁵⁰^ORCID,Vaidya Binit⁵¹^ORCID,Shaharir Syahrul Sazliyana⁵²^ORCID,Hasan A T M Tanveer⁵³^ORCID,Dey Dzifa⁵⁴,Toro Gutiérrez Carlos Enrique⁵⁵^ORCID,Caballero-Uribe Carlo V⁵⁶,Lilleker James B⁵⁷⁵⁸^ORCID,Salim Babur⁵⁹^ORCID,Gheita Tamer⁶⁰^ORCID,Chatterjee Tulika⁶¹^ORCID,Saavedra Miguel A⁶²^ORCID,Distler Oliver⁶³^ORCID,Chinoy Hector⁵⁷⁶⁴^ORCID,Agarwal Vikas⁸^ORCID,Aggarwal Rohit⁶⁵^ORCID,Gupta Latika⁵⁷⁶⁶⁶⁷^ORCID,Griger Zoltán,Kardes Sinan,Vince Melinda Nagy,Singh Yogesh Preet,Ranjan Rajiv,Jain Avinash,Pandya Sapan C,Pilania Rakesh Kumar,Sharma Aman,Manesh Manoj M,Gupta Vikas,Kavadichanda Chengappa G,Patro Pradeepta Sekhar,Ajmani Sajal,Phatak Sanat,Goswami Rudra Prosad,Chowdhury Abhra Chandra,Mathew Ashish Jacob,Shenoy Padnamabha,Asranna Ajay,Bommakanti Keerthi Talari,Shukla Anuj,Pande Arunkumar R,Chandwar Kunal,Ghodke Akanksha,Boro Hiya,Fazal Zoha Zahid,Vaidya Binit,Cansu Döndü Üsküdar,Yıldırım Reşit,Gasparyan Armen Yuri,Del Papa Nicoletta,Sambataro Gianluca,Fabiola Atzeni,Govoni Marcello,Parisi Simone,Bocci Elena Bartoloni,Sebastiani Gian Domenico,Fusaro Enrico,Sebastiani Marco,Quartuccio Luca,Franceschini Franco,Sainaghi Pier Paolo,Orsolini Giovanni,De Angelis Rossella,Danieli Maria Giovanna,Venerito Vincenzo,Grignaschi Silvia,Giollo Alessandro,Alunno Alessia,Iannone Florenzo,Fornaro Marco,Traboco Lisa S,Wibowo Suryo Anggoro Kusumo,Loarce-Martos Jesús,Prieto-González Sergio,Gonzalez Raquel Aranega,Yoshida Akira,Nakashima Ran,Sato Shinji,Kimura Naoki,Kaneko Yuko,Gono Takahisa,Tomaras Stylianos,Proft Fabian Nikolai,Holzer Marie-Therese,Gromova Margarita Aleksandrovna,Aharonov Or,Griger Zoltán,Hmamouchi Ihsane,El bouchti Imane,Baba Zineb,Giannini Margherita,Maurier François,Campagne Julien,Meyer Alain,Langguth Daman,Limaye Vidya,Needham Merrilee,Srivastav Nilesh,Hudson Marie,Landon-Cardinal Océane,Zuleta Wilmer Gerardo Rojas,Arbeláez Álvaro,Cajas Javier,Silva José António Pereira,Fonseca João Eurico,Zimba Olena,Bohdana Doskaliuk,Ima-Edomwonyi Uyi,Dedeke Ibukunoluwa,Airenakho Emorinken,Madu Nwankwo Henry,Yerima Abubakar,Olaosebikan Hakeem,Becky A,Koussougbo Oruma Devi,Palalane Elisa,So Ho,Ugarte-Gil Manuel Francisco,Chinchay Lyn,Bernaola José Proaño,Pimentel Victorio,Fathi Hanan Mohammed,Mohammed Reem Hamdy A,Harifi Ghita,Fuentes-Silva Yurilís,Cabriza Karoll,Losanto Jonathan,Colaman Nelly,Cachafeiro-Vilar Antonio,Bautista Generoso Guerra,Ho Enrique Julio Giraldo,Nunez Lilith Stange,Cristian Vergara M,Báez Jossiell Then,Alonzo Hugo,Pastelin Carlos Benito Santiago,Salinas Rodrigo García,Obiols Alejandro Quiñónez,Chávez Nilmo,Ordóñez Andrea Bran,Llerena Gil Alberto Reyes,Sierra-Zorita Radames,Arrieta Dina,Hidalgo Eduardo Romero,Saenz Ricardo,Idania Escalante M,Calapaqui Wendy,Quezada Ivonne,Arredondo Gabriela,

Affiliation:

1. Rheumatology and Clinical Immunology Unit, ASST Spedali Civili Brescia, Department of Clinical and Experimental Sciences, University of Brescia , Brescia, Italy

2. Danish Centre for Expertise in Rheumatology, Danish Hospital for Rheumatic Diseases , Sønderborg, Denmark

3. Department of Regional Health Research (IRS), University of Southern Denmark , Odense, Denmark

4. Department of Thrombosis and Haemostasis, Guys and St Thomas’ NHS Foundation Trust , London, UK

5. Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital , Stockholm, Sweden

6. Department of Rheumatology, Faculty of Medicine and Health, Örebro University , Örebro, Sweden

7. Maulana Azad Medical College, 2-Bahadurshah Zafar Marg , New Delhi, Delhi, India

8. Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences , Lucknow, India

9. Inflammatory Division, Walter and Eliza Hall Institute of Medical Research , Parkville, VIC, Australia

10. Department of Medical Biology, University of Melbourne , Parkville, VIC, Australia

11. Department of Rheumatology, Royal Melbourne Hospital , Parkville, VIC, Australia

12. Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals , Pune, India

13. Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital , Mumbai, Maharashtra, India

14. Department of Rheumatology, Southport and Ormskirk Hospital NHS Trust , Southport, UK

15. Centre for Rheumatic Diseases, King’s College London , London, UK

16. Rheumatology Department, King’s College Hospital , London, UK

17. Mahatma Gandhi Mission Medical College , Navi Mumbai, Maharashtra, India

18. Mymensingh Medical College , Mymensingh, Bangladesh

19. NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust , Leeds, UK

20. Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds , Leeds, UK

21. Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo , Sao Paulo, SP, Brazil

22. Rheumatology Department, Saint-Joseph University , Beirut, Lebanon

23. Rheumatology Department, Hotel-Dieu de France Hospital , Beirut, Lebanon

24. Department of Clinical Laboratory and Clinical Immunology, Medical Faculty, Sofia University St Kliment Ohridski , Sofia, Bulgaria

25. Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin , Szczecin, Poland

26. Department of Internal Medicine, General Hospital, National Medical Center “La Raza”, Instituto Mexicano del Seguro Social , Mexico City, Mexico

27. Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli studi di Pavia , Pavia, Lombardy, Italy

28. Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine , Bunkyo-ku, Tokyo, Japan

29. Medizinische Klinik 3—Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg , Erlangen, Deutschland

30. Division of Rheumatology, Mayo Clinic , Rochester, MN, USA

31. Bon Secours Rheumatology Center and Division of Pediatric Rheumatology, Department of Pediatrics, University of Virginia School of Medicine , Charlottesville, VA, USA

32. Bristol Medical School Translational Health Sciences, University of Bristol , Bristol, UK

33. Department of Rheumatology, North Bristol NHS Trust , Bristol, UK

34. Department of Rheumatology, Division of Medicine, Rayne Institute, University College London , London, UK

35. Centre for Adolescent Rheumatology Versus Arthritis at UCL, UCLH, GOSH , London, UK

36. Department of General Medicine, All India Institute of Medical Sciences (AIIMS) , Guwahati, India

37. Rheumatology, Medical Care & Research, Centro Medico Pensiones Hospital, Instituto Mexicano del Seguro Social Delegación Yucatán , Yucatán, Mexico

38. Rheumatologist and Clinical Investigator, Interstitial Lung Disease and Rheumatology Unit, Instituto Nacional de Enfermedades Respiratorias , Mexico City, Mexico

39. Departamento de Inmunología y Reumatología, Hospital General de Occidente and Universidad de Guadalajara , Guadalajara, Jalisco, Mexico

40. Rheumatology, Hospital Universitario Dr Jose Eleuterio Gonzalez , Monterrey, Mexico

41. Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico

42. Department of Medicine, University of Nigeria Teaching, Hospital, Ituku-Ozalla/University of Nigeria , Enugu Campus, Enugu, Nigeria

43. Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok, Thailand

44. Department of Medicine, Queen Savang Vadhana Memorial Hospital , Chonburi, Thailand

45. Department of Rheumatology, Clinic of Rheumatology, University Hospital “St Ivan Rilski”, Medical University-Sofia , Sofia, Bulgaria

46. Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital , Taichung City, Taiwan

47. Department of Medical Research, Taichung Veterans General Hospital , Taichung, Taiwan

48. Department of Clinical Medicine, School of Medicine, Universidade Potiguar (UnP) , Potiguar, Brazil

49. Rheumatology Unit, Internal Medicine Department, Specialized Medical Center , Riyadh, Saudi Arabia

50. Department of Internal Medicine, Section of Rheumatology, King Faisal Specialist Hospital and Research Center , Jeddah, Saudi Arabia

51. Department of Rheumatology, National Center for Rheumatic Diseases (NCRD) , Ratopul, Kathmandu, Nepal

52. Faculty of Medicine, Universiti Kebangsaan Malaysia , Cheras, Kuala Lumpur, Malaysia

53. Department of Rheumatology, Enam Medical College & Hospital , Dhaka, Bangladesh

54. Rheumatology Unit, Department of Medicine and Therapeutics, University of Ghana Medical School, College of Health Sciences , Korle-Bu, Accra, Ghana

55. Reference Center for Osteoporosis, Rheumatology and Dermatology, Pontifica Universidad Javeriana Cali , Cali, Colombia

56. Department of Medicine, Hospital Universidad del Norte , Barranquilla, Atlantico, Colombia

57. Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester , Manchester, UK

58. Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust , Salford, UK

59. Rheumatology Department, Fauji Foundation Hospital , Rawalpindi, Pakistan

60. Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University , Cairo, Egypt

61. Department of Internal Medicine, University of Illinois College of Medicine , Peoria, IL, USA

62. Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS , Mexico City, Mexico

63. Department of Rheumatology, University Hospital Zurich, University of Zurich , Zurich, Switzerland

64. Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust , Salford, UK

65. Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine , Pittsburgh, PA, USA

66. Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust , Wolverhampton, UK

67. Department of Rheumatology, City Hospital, Sandwell and West Birmingham Hospitals NHS Trust , Birmingham, UK

Abstract

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.

Funder

National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Rheumatology

Link

https://academic.oup.com/rheumatology/advance-article-pdf/doi/10.1093/rheumatology/kead382/51171485/kead382.pdf

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