Safety of heterologous primary and booster schedules with ChAdOx1-S and BNT162b2 or mRNA-1273 vaccines: nationwide cohort study

AbstractObjectiveTo assess the risk of adverse events associated with heterologous primary (two dose) and booster (three dose) vaccine schedules for covid-19 with Oxford-AstraZeneca’s ChAdOx1-S priming followed by mRNA vaccines (Pfizer-BioNTech’s BNT162b2 or Moderna’s mRNA-1273) as compared with hom...

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Published in:BMJ (Online) 2022-07, Vol.378, p.e070483
Main Authors: Andersson, Niklas Worm, Thiesson, Emilia Myrup, Laursen, Mona Vestergaard, Mogensen, Stine Hasling, Kjær, Jesper, Hviid, Anders
Format: Article
Language:English
Subjects:
2019-nCoV Vaccine mRNA-1273 - adverse effects
Adult
Adverse events
BNT162 Vaccine - adverse effects
Cohort analysis
Cohort Studies
Coronaviruses
COVID-19 - epidemiology
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Drug dosages
Guillain-Barre syndrome
Heart diseases
Hemostatics
Humans
Immunization
Immunization, Secondary
Ischemia
mRNA
mRNA vaccines
mRNA Vaccines - adverse effects
Myocarditis
Patient safety
Pericarditis
RNA, Messenger
Schedules
Severe acute respiratory syndrome coronavirus 2
Sleep disorders
Thrombocytopenia
Thromboembolism
Thromboembolism - etiology
Vaccination - adverse effects
Vaccines, Synthetic
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Summary:AbstractObjectiveTo assess the risk of adverse events associated with heterologous primary (two dose) and booster (three dose) vaccine schedules for covid-19 with Oxford-AstraZeneca’s ChAdOx1-S priming followed by mRNA vaccines (Pfizer-BioNTech’s BNT162b2 or Moderna’s mRNA-1273) as compared with homologous mRNA vaccine schedules for covid-19.DesignNationwide cohort study.SettingDenmark, 1 January 2021 to 26 March 2022.ParticipantsAdults aged 18-65 years who received a heterologous vaccine schedule of priming with ChAdOx1-S and one or two mRNA booster doses (with either the BNT162b2 or mRNA-1273 vaccine) were compared with adults who received a homologous BNT162b2 or mRNA-1273 vaccine schedule (ie, two dose v two dose, and three dose v three dose schedule).Main outcome measuresThe incidence of hospital contacts for a range of adverse cardiovascular and haemostatic events within 28 days after the second or third vaccine dose, comparing heterologous versus homologous vaccine schedules. Secondary outcomes included additional prioritised adverse events of special interest. Poisson regression was used to estimate incidence rate ratios with adjustment for selected covariates.ResultsIndividuals who had had a heterologous primary vaccine (n=137 495) or a homologous vaccine (n=2 688 142) were identified, in addition to those who had had a heterologous booster (n=129 770) or a homologous booster (n=2 197 213). Adjusted incidence rate ratios of adverse cardiovascular and haemostatic events within 28 days for the heterologous primary and booster vaccine schedules in comparison with the homologous mRNA vaccine schedules were 1.22 (95% confidence interval 0.79 to 1.91) and 1.00 (0.58 to 1.72) for ischaemic cardiac events, 0.74 (0.40 to 1.34) and 0.72 (0.37 to 1.42) for cerebrovascular events, 1.12 (0.13 to 9.58) and 4.74 (0.94 to 24.01) for arterial thromboembolisms, 0.79 (0.45 to 1.38) and 1.09 (0.60 to 1.98) for venous thromboembolisms, 0.84 (0.18 to 3.96) and 1.04 (0.60 to 4.55) for myocarditis or pericarditis, 0.97 (0.45 to 2.10) and 0.89 (0.21 to 3.77) for thrombocytopenia and coagulative disorders, and 1.39 (1.01 to 1.91) and 1.02 (0.70 to 1.47) for other bleeding events, respectively. No associations with any of the outcomes were found when restricting to serious adverse events defined as stay in hospital for more than 24 h.ConclusionHeterologous primary and booster covid-19 vaccine schedules of ChAdOx1-S priming and mRNA booster doses as both second and third dos
ISSN:1756-1833
0959-8138
1756-1833
DOI:10.1136/bmj-2022-070483