TY - JOUR
T1 - Risk factors associated with short-term adverse events after SARS-CoV-2 vaccination in patients with immune-mediated inflammatory diseases
AU - Wieske, Luuk
AU - Kummer, Laura Y. L.
AU - van Dam, Koos P. J.
AU - Stalman, Eileen W.
AU - van der Kooi, Anneke J.
AU - Raaphorst, Joost
AU - Löwenberg, Mark
AU - Takkenberg, R. Bart
AU - Volkers, Adriaan G.
AU - D'Haens, Geert R. A. M.
AU - Tas, Sander W.
AU - Spuls, Phyllis I.
AU - Bekkenk, Marcel W.
AU - Musters, Annelie H.
AU - Post, Nicoline F.
AU - Bosma, Angela L.
AU - Hilhorst, Marc L.
AU - Vegting, Yosta
AU - Bemelman, Frederike J.
AU - Killestein, Joep
AU - van Kempen, Zoé L. E.
AU - Voskuyl, Alexandre E.
AU - Broens, Bo
AU - Sanchez, Agner Parra
AU - Wolbink, Gertjan
AU - Boekel, Laura
AU - Rutgers, Abraham
AU - de Leeuw, Karina
AU - Horváth, Barbara
AU - Verschuuren, Jan J. G. M.
AU - Ruiter, Annabel M.
AU - van Ouwerkerk, Lotte
AU - van der Woude, Diane
AU - Allaart, Cornelia F.
AU - Teng, Y. K. Onno
AU - van Paassen, Pieter
AU - Busch, Matthias H.
AU - Jallah, B. Papay
AU - Brusse, Esther
AU - van Doorn, Pieter A.
AU - Baars, Adája E.
AU - Hijnen, Dirkjan
AU - Schreurs, Corine R. G.
AU - van der Pol, W. Ludo
AU - Goedee, H. Stephan
AU - Steenhuis, Maurice
AU - Rispens, Theo
AU - ten Brinke, Anja
AU - Verstegen, Niels J. M.
AU - Zwinderman, Koos A. H.
AU - van Ham, S. Marieke
AU - T2B! immunity against SARS-CoV-2 study group
AU - Kuijpers, Taco W.
AU - Eftimov, Filip
N1 - Funding Information:
We would like to thank ZonMw (The Netherlands Organization for Health Research and Development, grant 10430072010007) for the funding of the study and the T2B partners, including the patient groups and Health Holland for the support in this study. Also, we would like to thank E.P. Moll van Charante, J.A Bogaards and R.A. Scholten for their guidance in the data safety monitoring board.
Funding Information:
We would like to thank ZonMw (The Netherlands Organization for Health Research and Development, grant 10430072010007) for the funding of the study and the T2B partners, including the patient groups and Health Holland for the support in this study. Also, we would like to thank E.P. Moll van Charante, J.A Bogaards and R.A. Scholten for their guidance in the data safety monitoring board.
Funding Information:
This study was supported by ZonMw (The Netherlands Organization for Health Research and Development, 10430072010007). The sponsor had no role in the design, analyses or reporting of the study.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: Studies have suggested incremental short-term adverse events (AE) after repeated vaccination. In this report, we assessed occurrence and risk factors for short-term AEs following repeated SARS-CoV-2 vaccination in patients with various immune-mediated inflammatory diseases (IMIDs). Methods: Self-reported daily questionnaires on AEs during the first 7 days after vaccination were obtained of 2259 individuals (2081 patients and 178 controls) participating in an ongoing prospective multicenter cohort study on SARS-CoV-2 vaccination in patients with various IMIDs in the Netherlands (T2B-COVID). Relative risks were calculated for potential risk factors associated with clinically relevant AE (rAE), defined as AE lasting longer than 2 days or impacting daily life. Results: In total, 5454 vaccinations were recorded (1737 first, 1992 second and 1478 third vaccinations). Multiple sclerosis, Crohn’s disease and rheumatoid arthritis were the largest disease groups. rAEs were reported by 57.3% (95% CI 54.8–59.8) of patients after the first vaccination, 61.5% (95% CI 59.2–63.7) after the second vaccination and 58% (95% CI 55.3–60.6) after the third vaccination. At day 7 after the first, second and third vaccination, respectively, 7.6% (95% CI 6.3–9.1), 7.4% (95% CI 6.2–8.7) and 6.8% (95% CI 5.4–8.3) of patients still reported AEs impacting daily life. Hospital admissions and allergic reactions were uncommon (<0.7%). Female sex (aRR 1.43, 95% CI 1.32–1.56), age below 50 (aRR 1.14, 95% CI 1.06–1.23), a preceding SARS-CoV-2 infection (aRR 1.14, 95% CI 1.01–1.29) and having an IMID (aRR 1.16, 95% CI 1.01–1.34) were associated with increased risk of rAEs following a vaccination. Compared to the second vaccination, the first vaccination was associated with a lower risk of rAEs (aRR 0.92, 95% CI 0.84–0.99) while a third vaccination was not associated with increased risk on rAEs (aRR 0.93, 95% CI 0.84–1.02). BNT162b2 vaccines were associated with lower risk on rAEs compared to CX-024414 (aRR 0.86, 95% CI 0.80–0.93). Conclusions: A third SARS-CoV-2 vaccination was not associated with increased risk of rAEs in IMID patients compared to the second vaccination. Patients with an IMID have a modestly increased risk of rAEs after vaccination when compared to controls. Most AEs are resolved within 7 days; hospital admissions and allergic reactions were uncommon. Trial registration: NL74974.018.20, Trial ID: NL8900. Registered on 9 September 2020.
AB - Background: Studies have suggested incremental short-term adverse events (AE) after repeated vaccination. In this report, we assessed occurrence and risk factors for short-term AEs following repeated SARS-CoV-2 vaccination in patients with various immune-mediated inflammatory diseases (IMIDs). Methods: Self-reported daily questionnaires on AEs during the first 7 days after vaccination were obtained of 2259 individuals (2081 patients and 178 controls) participating in an ongoing prospective multicenter cohort study on SARS-CoV-2 vaccination in patients with various IMIDs in the Netherlands (T2B-COVID). Relative risks were calculated for potential risk factors associated with clinically relevant AE (rAE), defined as AE lasting longer than 2 days or impacting daily life. Results: In total, 5454 vaccinations were recorded (1737 first, 1992 second and 1478 third vaccinations). Multiple sclerosis, Crohn’s disease and rheumatoid arthritis were the largest disease groups. rAEs were reported by 57.3% (95% CI 54.8–59.8) of patients after the first vaccination, 61.5% (95% CI 59.2–63.7) after the second vaccination and 58% (95% CI 55.3–60.6) after the third vaccination. At day 7 after the first, second and third vaccination, respectively, 7.6% (95% CI 6.3–9.1), 7.4% (95% CI 6.2–8.7) and 6.8% (95% CI 5.4–8.3) of patients still reported AEs impacting daily life. Hospital admissions and allergic reactions were uncommon (<0.7%). Female sex (aRR 1.43, 95% CI 1.32–1.56), age below 50 (aRR 1.14, 95% CI 1.06–1.23), a preceding SARS-CoV-2 infection (aRR 1.14, 95% CI 1.01–1.29) and having an IMID (aRR 1.16, 95% CI 1.01–1.34) were associated with increased risk of rAEs following a vaccination. Compared to the second vaccination, the first vaccination was associated with a lower risk of rAEs (aRR 0.92, 95% CI 0.84–0.99) while a third vaccination was not associated with increased risk on rAEs (aRR 0.93, 95% CI 0.84–1.02). BNT162b2 vaccines were associated with lower risk on rAEs compared to CX-024414 (aRR 0.86, 95% CI 0.80–0.93). Conclusions: A third SARS-CoV-2 vaccination was not associated with increased risk of rAEs in IMID patients compared to the second vaccination. Patients with an IMID have a modestly increased risk of rAEs after vaccination when compared to controls. Most AEs are resolved within 7 days; hospital admissions and allergic reactions were uncommon. Trial registration: NL74974.018.20, Trial ID: NL8900. Registered on 9 September 2020.
UR - https://www.scopus.com/pages/publications/85125612390
U2 - 10.1186/s12916-022-02310-7
DO - 10.1186/s12916-022-02310-7
M3 - Article
C2 - 35236350
SN - 1741-7015
VL - 20
SP - 100
JO - BMC medicine
JF - BMC medicine
IS - 1
M1 - 100
ER -
SDG 3 Good Health and Well-being