Title: COVID-19 Vaccination Safety and associated Health Care Utilization among Adults with
Inflammatory Bowel Disease – A population-based self-controlled case series analysis
Version: 1 Date: 12 Feb 2024
Reviewer's report:
Lee and colleagues performed a population-based study using a clever self-controlled case series
design to assess the safety of sequential COVID-19 vaccines in patients with IBD compared to
self over time, and healthy controls. These data are reassuring that COVID-19 was not associated
with an increase in AESIs (adverse events of special interest) or IBD health care utilization,
demonstrating the safety of COVID-19 vaccines on a population level.
Major Comments
1) Was any difference seen between which vaccines a patient received? Some data has shown
a higher rate of certain adverse events, such as myocarditis after the mRNA-1273 as compared
to BNT162n2, and Guillain-Barre after the J&J vaccine (JNJ-78436735 in the USA) compared
to the mRNA vaccines. This would also be pertinent given the finding of increased ED visits
after the 2nd dose (as the mRNA-1273 vs BNT162n2 have 3 vs 2 shot regimens) Can consider
stratifying the findings based on vaccine type in a supplementary table to assess the difference
2) Were medication prescriptions not available in the database used for this study? Would be
useful to help stratify baseline IBD disease severity and as a IBD-related healthcare outcome
(e.g. use of corticosteroids or change in biologic)
3) Was timeframe of vaccination and correlation to “waves” of the pandemic in Canada
considered? This would be important to account for, given that surges of COVID-19 during the
pandemic and subsequent lockdowns may have greatly impacted rates of certain outcomes such
as outpatient or ED visits.
Title: COVID-19 Vaccination Safety and associated Health Care Utilization among Adults with
Inflammatory Bowel Disease – A population-based self-controlled case series analysis
Version: 1 Date: 12 Feb 2024
Reviewer's report:
Lee and colleagues performed a population-based study using a clever self-controlled case series
design to assess the safety of sequential COVID-19 vaccines in patients with IBD compared to
self over time, and healthy controls. These data are reassuring that COVID-19 was not associated
with an increase in AESIs (adverse events of special interest) or IBD health care utilization,
demonstrating the safety of COVID-19 vaccines on a population level.
Major Comments
1) Was any difference seen between which vaccines a patient received? Some data has shown
a higher rate of certain adverse events, such as myocarditis after the mRNA-1273 as compared
to BNT162n2, and Guillain-Barre after the J&J vaccine (JNJ-78436735 in the USA) compared
to the mRNA vaccines. This would also be pertinent given the finding of increased ED visits
after the 2nd dose (as the mRNA-1273 vs BNT162n2 have 3 vs 2 shot regimens) Can consider
stratifying the findings based on vaccine type in a supplementary table to assess the difference
2) Were medication prescriptions not available in the database used for this study? Would be
useful to help stratify baseline IBD disease severity and as a IBD-related healthcare outcome
(e.g. use of corticosteroids or change in biologic)
3) Was timeframe of vaccination and correlation to “waves” of the pandemic in Canada
considered? This would be important to account for, given that surges of COVID-19 during the
pandemic and subsequent lockdowns may have greatly impacted rates of certain outcomes such
as outpatient or ED visits.
Please review this paper.
user
Title: COVID-19 Vaccination Safety and associated Health Care Utilization among Adults with
Inflammatory Bowel Disease – A population-based self-controlled case series analysis
Version: 1 Date: 12 Feb 2024
Reviewer's report:
Lee and colleagues performed a population-based study using a clever self-controlled case series
design to assess the safety of sequential COVID-19 vaccines in patients with IBD compared to
self over time, and healthy controls. These data are reassuring that COVID-19 was not associated
with an increase in AESIs (adverse events of special interest) or IBD health care utilization,
demonstrating the safety of COVID-19 vaccines on a population level.
Major Comments
1) Was any difference seen between which vaccines a patient received? Some data has shown
a higher rate of certain adverse events, such as myocarditis after the mRNA-1273 as compared
to BNT162n2, and Guillain-Barre after the J&J vaccine (JNJ-78436735 in the USA) compared
to the mRNA vaccines. This would also be pertinent given the finding of increased ED visits
after the 2nd dose (as the mRNA-1273 vs BNT162n2 have 3 vs 2 shot regimens) Can consider
stratifying the findings based on vaccine type in a supplementary table to assess the difference
2) Were medication prescriptions not available in the database used for this study? Would be
useful to help stratify baseline IBD disease severity and as a IBD-related healthcare outcome
(e.g. use of corticosteroids or change in biologic)
3) Was timeframe of vaccination and correlation to “waves” of the pandemic in Canada
considered? This would be important to account for, given that surges of COVID-19 during the
pandemic and subsequent lockdowns may have greatly impacted rates of certain outcomes such
as outpatient or ED visits.
assistant