PMID- 35908834 OWN - NLM STAT- MEDLINE DCOM- 20220802 LR - 20220923 IS - 2056-5933 (Electronic) IS - 2056-5933 (Linking) VI - 8 IP - 2 DP - 2022 Jul TI - SARS-CoV-2 vaccine safety in adolescents with inflammatory rheumatic and musculoskeletal diseases and adults with juvenile idiopathic arthritis: data from the EULAR COVAX physician-reported registry. LID - 10.1136/rmdopen-2022-002322 [doi] LID - e002322 AB - BACKGROUND: There is a lack of data on SARS-CoV-2 vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs). Current vaccination guidance is based on data from adults with RMDs or CYP without RMDs. OBJECTIVES: To describe the safety of SARS-COV-2 vaccination in adolescents with inflammatory RMDs and adults with juvenile idiopathic arthritis (JIA). METHODS: We described patient characteristics, flares and adverse events (AEs) in adolescent cases under 18 with inflammatory RMDs and adult cases aged 18 or above with JIA submitted to the European Alliance of Associations for Rheumatology COVAX registry. RESULTS: A total of 110 cases were reported to the registry. Thirty-six adolescent cases were reported from four countries, most with JIA (42%). Over half (56%) reported early reactogenic-like AEs. One mild polyarthralgia flare and one serious AE of special interest (malaise) were reported. No CYP reported SARS-CoV-2 infection postvaccination.Seventy-four adult JIA cases were reported from 11 countries. Almost two-thirds (62%) reported early reactogenic-like AEs and two flares were reported (mild polyarthralgia and moderate uveitis). No serious AEs of special interest were reported among adults with JIA. Three female patients aged 20-30 years were diagnosed with SARS-CoV-2 postvaccination; all fully recovered. CONCLUSIONS: This is an important contribution to research on SARS-CoV-2 vaccine safety in adolescents with RMDs and adults with JIA. It is important to note the low frequency of disease flares, serious AEs and SARS-CoV-2 reinfection seen in both populations, although the dataset is limited by its size. CI - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Lawson-Tovey, Saskia AU - Lawson-Tovey S AUID- ORCID: 0000-0002-8611-162X AD - Centre for Genetics and Genomics Versus Arthritis, The University of Manchester, Manchester, UK. AD - National Institute of Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK. FAU - Machado, Pedro M AU - Machado PM AUID- ORCID: 0000-0002-8411-7972 AD - Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, UK. AD - National Institute for Health Research (NIHR) University College London Hospitals Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK. FAU - Strangfeld, Anja AU - Strangfeld A AUID- ORCID: 0000-0002-6233-022X AD - Epidemiology Unit, German Rheumatism Research Center Berlin, Berlin, Germany. FAU - Mateus, Elsa AU - Mateus E AD - Portuguese League Against Rheumatic Diseases (LPCDR), Lisbon, Portugal. AD - Standing Committee of People with Arthritis/Rheumatism in Europe (PARE), European League Against Rheumatism, Zurich, Switzerland. FAU - Gossec, Laure AU - Gossec L AUID- ORCID: 0000-0002-4528-310X AD - INSERM, Institut Pierre Louis d'Epidemiologie et de Sante Publique, Sorbonne Universite, Paris, France. AD - APHP, Rheumatology Department, Hopital Universitaire Pitie Salpetriere, Paris, France. FAU - Carmona, Loreto AU - Carmona L AUID- ORCID: 0000-0002-4401-2551 AD - Instituto de Salud Musculoesqueletica, Madrid, Spain. FAU - Raffeiner, Bernd AU - Raffeiner B AD - Department of Rheumatology, Central Hospital of Bolzano, Bolzano, Italy. FAU - Bulina, Inita AU - Bulina I AD - Rheumatology Department, Paul Stradins Clinical University Hospital, Riga, Latvia. AD - Riga Stradins University, Riga, Latvia. FAU - Clemente, Daniel AU - Clemente D AD - Paediatric Rheumatology Department, Hospital Nino Jesus, Madrid, Spain. FAU - Zepa, Julija AU - Zepa J AD - Riga Stradins University, Riga, Latvia. AD - Paul Stradins Clinical University Hospital, Riga, Latvia. FAU - Rodrigues, Ana M AU - Rodrigues AM AD - Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisboa, Portugal. AD - EpiDoC unit, CEDOC, Nova Medical School, Lisboa, Portugal. FAU - Mariette, Xavier AU - Mariette X AUID- ORCID: 0000-0002-4244-5417 AD - Rheumatology, Universite Paris-Saclay, Assitance Publique-Hopitaux de Paris, INSERM UMR1184, Hopital Bicetre, Le Kremlin-Bicetre, France. FAU - Hyrich, Kimme L AU - Hyrich KL AD - National Institute of Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK kimme.hyrich@manchester.ac.uk. AD - Centre for Epidemiology Versus Arthritis, The University of Manchester, Manchester, UK. CN - EULAR COVAX LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - RMD Open JT - RMD open JID - 101662038 RN - 0 (COVID-19 Vaccines) SB - IM MH - Adolescent MH - Adult MH - Arthralgia MH - *Arthritis, Juvenile/epidemiology MH - *COVID-19/epidemiology/prevention & control MH - *COVID-19 Vaccines/adverse effects MH - Child MH - Female MH - Humans MH - *Musculoskeletal Diseases/epidemiology/etiology MH - *Physicians MH - Registries MH - SARS-CoV-2 PMC - PMC9344592 OTO - NOTNLM OT - Arthritis, Juvenile OT - COVID-19 OT - Vaccination COIS- Competing interests: SL-T and BR have nothing to disclose. PMM reports consulting/speaker's fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript, and is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC). AS reports personal fees from lectures for AbbVie, MSD, Roche, BMS, and Pfizer. EM reports LPCDR received support for specific activities: grants from Abbvie, Novartis, Janssen-Cilag, Lilly Portugal, Sanofi, Grunenthal S.A., MSD, Celgene, Medac, Pharmakern, GAfPA; grants and non-financial support from Pfizer; non-financial support from Grunenthal, outside the submitted work. LG reports Amgen, Galapagos, Lilly, Pfizer, Sandoz; consulting fees: AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, all unrelated to this manuscript. LC reports fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme Espana, S.A., Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, Astellas Pharma, Actelion Pharmaceuticals Espana, Grunenthal, and UCB Pharma. IB reports speaker fees from AbbVie, Pfizer, Janssen, Boehringer Ingelheim, all unrelated to this manuscript. DC reports speakers fees from Novartis, GSK, all unrelated to this manuscript. JZ reports speaker fees from Abbvie, Novartis, Janssen/Johnson & Johnson, all unrelated to this manuscript. AR reports research grants and consultant fees from Amgen and Pfizer, all unrelated to this manuscript. KLH reports non-personal speaker's fees from Abbvie and grant income from BMS, UCB, and Pfizer, all unrelated to this manuscript, and is supported by the NIHR Manchester Biomedical Research Centre. XM is an Associate Editor for this journal. FIR - Stenova, Emoke IR - Stenova E FIR - Dimitroulas, Theodoros IR - Dimitroulas T FIR - Roux, Nicolas IR - Roux N FIR - Durez, Patrick IR - Durez P FIR - Leurs, Amelie IR - Leurs A FIR - Carbone, Anna IR - Carbone A FIR - Hachulla, Eric IR - Hachulla E FIR - Toussirot, Eric IR - Toussirot E FIR - Yardimci, Gozde Kubra IR - Yardimci GK FIR - Puerta, Jose Ag IR - Puerta JA FIR - Rubio, Natalia de la Torre IR - Rubio NT FIR - Masaryk, Pavol IR - Masaryk P FIR - Queyrel, Viviane IR - Queyrel V FIR - Jeffrey, Rachel IR - Jeffrey R FIR - Seror, Raphaele IR - Seror R FIR - Floyd, Sharon IR - Floyd S FIR - Rednic, Simona IR - Rednic S FIR - Strakova, Eva IR - Strakova E FIR - Kalyoncu, Umut IR - Kalyoncu U FIR - Mylnarikova, Vanda IR - Mylnarikova V EDAT- 2022/08/01 06:00 MHDA- 2022/08/03 06:00 PMCR- 2022/07/29 CRDT- 2022/07/31 21:04 PHST- 2022/03/08 00:00 [received] PHST- 2022/07/15 00:00 [accepted] PHST- 2022/07/31 21:04 [entrez] PHST- 2022/08/01 06:00 [pubmed] PHST- 2022/08/03 06:00 [medline] PHST- 2022/07/29 00:00 [pmc-release] AID - rmdopen-2022-002322 [pii] AID - 10.1136/rmdopen-2022-002322 [doi] PST - ppublish SO - RMD Open. 2022 Jul;8(2):e002322. doi: 10.1136/rmdopen-2022-002322.