TY - JOUR
T1 - Risk of cardiac arrhythmia and cardiac arrest after primary and booster COVID-19 vaccination in England
T2 - A self-controlled case series analysis
AU - Stowe, Julia
AU - Whitaker, Heather J.
AU - Andrews, Nick J.
AU - FMedSci, Elizabeth Miller
N1 - Publisher Copyright:
© 2023 The Author(s)
PY - 2023/12
Y1 - 2023/12
N2 - Background: Various cardiac arrhythmias have been reported after COVID-19 infection and vaccination. We assessed the risk after primary immunisation with the ChAdOx1 adenovirus vectored vaccine, and primary and booster immunisation with an mRNA vaccine in 40 million vaccinated adults with 121 million doses (33.9% ChAdOx1 and 66.1% mRNA) in England. Methods: Hospital admissions for a cardiac arrhythmia and emergency care attendance for a cardiac arrest in individuals aged 18 years and older on the 31st March 2021 were linked to the national COVID-19 immunisation register. The incidence of events 1–14 and 15–28 days after vaccination relative to a post-vaccination control period was estimated using the self-controlled case series method modified for fatal events. Outcomes were stratified by arrhythmia type, vaccine type, age group and dose number (up to five). Elevated relative incidence (RI) estimates with p < 0.001 were considered strong evidence of an association. Findings: There was an increased risk of admission for arrhythmia events that were largely palpitations without myocarditis within 14 days of a second priming dose of an mRNA vaccine in 18–49 year olds with an RI of 1.66 (95 % confidence interval 1.47,1.86) for BNT162b2 and 3.75 (2.52,5.57) for mRNA-1273 (p < 0.001) and also after a first booster dose, 1.34 (1.17,1.53) and 1.75 (1.43,2.15) respectively (p < 0.001). No other cardiac arrhythmia, including cardiac arrest, showed an elevated incidence within 28 days of vaccination for any dose, age group or vaccine type. In contrast the risk of a cardiac arrhythmia of all types, including a cardiac arrest, was consistently elevated in those testing positive for SARS-CoV-2 infection. Interpretation: Our study provides reassuring evidence of the safety of the ChAdOx1 and mRNA COVID-19 vaccines with respect to serious cardiac arrhythmias and of the favourable risk benefit of mRNA booster vaccination.
AB - Background: Various cardiac arrhythmias have been reported after COVID-19 infection and vaccination. We assessed the risk after primary immunisation with the ChAdOx1 adenovirus vectored vaccine, and primary and booster immunisation with an mRNA vaccine in 40 million vaccinated adults with 121 million doses (33.9% ChAdOx1 and 66.1% mRNA) in England. Methods: Hospital admissions for a cardiac arrhythmia and emergency care attendance for a cardiac arrest in individuals aged 18 years and older on the 31st March 2021 were linked to the national COVID-19 immunisation register. The incidence of events 1–14 and 15–28 days after vaccination relative to a post-vaccination control period was estimated using the self-controlled case series method modified for fatal events. Outcomes were stratified by arrhythmia type, vaccine type, age group and dose number (up to five). Elevated relative incidence (RI) estimates with p < 0.001 were considered strong evidence of an association. Findings: There was an increased risk of admission for arrhythmia events that were largely palpitations without myocarditis within 14 days of a second priming dose of an mRNA vaccine in 18–49 year olds with an RI of 1.66 (95 % confidence interval 1.47,1.86) for BNT162b2 and 3.75 (2.52,5.57) for mRNA-1273 (p < 0.001) and also after a first booster dose, 1.34 (1.17,1.53) and 1.75 (1.43,2.15) respectively (p < 0.001). No other cardiac arrhythmia, including cardiac arrest, showed an elevated incidence within 28 days of vaccination for any dose, age group or vaccine type. In contrast the risk of a cardiac arrhythmia of all types, including a cardiac arrest, was consistently elevated in those testing positive for SARS-CoV-2 infection. Interpretation: Our study provides reassuring evidence of the safety of the ChAdOx1 and mRNA COVID-19 vaccines with respect to serious cardiac arrhythmias and of the favourable risk benefit of mRNA booster vaccination.
KW - Arrhythmia
KW - COVID-19 vaccine safety
KW - Cardiac arrest
KW - SARS-CoV-2 infection
UR - https://www.scopus.com/pages/publications/85179488717
U2 - 10.1016/j.jvacx.2023.100418
DO - 10.1016/j.jvacx.2023.100418
M3 - Article
AN - SCOPUS:85179488717
SN - 2590-1362
VL - 15
JO - Vaccine: X
JF - Vaccine: X
M1 - 100418
ER -