Background Rates of 41 Adverse Events of Special Interest for COVID-19 Vaccines in 10 European Healthcare Databases - an ACCESS Cohort Study

Willame, C; Carlos, Durán; Durán, Carlos M.G.; Roel, Elbers; Gini, Rosa; Bartolini, Claudia; Paoletti, Olga; Wang, Lei; Ehrenstein, Véra; Kahlert, Johnny; Haug, Ulrike; Schink, Tania; Díez‐Domingo, Javier; Mira‐Iglesias, Ainara; Vergara-Hernández, Carlos; Giaquinto, Carlo; Barbieri, Elisa; Stona, Luca; Huerta, Consuelo; García-Poza, P; Martín-Pérez, Mar; González, Airam de Burgos; Martínez-González, María T; Bryant, Verónica; Villalobos, Felipe; Pallejà-Millán, Meritxell; Aragón, María; Jose, Carreras Juan; Souverein, Patrick C.; Thurin, Nicolas; Nicolas, Thurin; Olaf, Klungel; Sturkenboom, Miriam

doi:10.2139/ssrn.4055926

Cited by 3 publications

(3 citation statements)

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“… 63 64 For instance, a recent comprehensive study by the European Medicines Agency estimated the incidence rate to be in the range of 10–200 cases per 1 000 000 person-years of follow-up. 65 By incorporating these background incidence rates into our analysis, we can better contextualise the risk of myo/pericarditis following mRNA vaccination. To illustrate, consider two groups of 1 000 000 individuals each, with one group receiving an mRNA vaccine and the other remaining unvaccinated.…”

Section: Discussionmentioning

confidence: 99%

Risk of myocarditis and pericarditis in mRNA COVID-19-vaccinated and unvaccinated populations: a systematic review and meta-analysis

et al. 2023

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ObjectiveTo summarise the available evidence on the risk of myocarditis and/or pericarditis following mRNA COVID-19 vaccination, compared with the risk among unvaccinated individuals in the absence of COVID-19 infection.DesignSystematic review and meta-analysis.Data sourcesElectronic databases (Medline, Embase, Web of Science and WHO Global Literature on Coronavirus Disease), preprint repositories (medRxiv and bioRxiv), reference lists and grey literature were searched from 1 December 2020 until 31 October 2022.Study selectionEpidemiological studies of individuals of any age who received at least one dose of an mRNA COVID-19 vaccine, reported a risk of myo/pericarditis and compared the risk of myo/pericarditis to individuals who did not receive any dose of an mRNA COVID-19 vaccine.Data extraction and synthesisTwo reviewers independently conducted screening and data extraction. The rate of myo/pericarditis among vaccinated and unvaccinated groups was recorded, and the rate ratios were calculated. Additionally, the total number of individuals, case ascertainment criteria, percentage of males and history of SARS-CoV-2 infection were extracted for each study. Meta-analysis was done using a random-effects model.ResultsSeven studies met the inclusion criteria, of which six were included in the quantitative synthesis. Our meta-analysis indicates that within 30-day follow-up period, vaccinated individuals were twice as likely to develop myo/pericarditis in the absence of SARS-CoV-2 infection compared to unvaccinated individuals, with a rate ratio of 2.05 (95% CI 1.49–2.82).ConclusionAlthough the absolute number of observed myo/pericarditis cases remains quite low, a higher risk was detected in those who received mRNA COVID-19 vaccinations compared with unvaccinated individuals in the absence of SARS-CoV-2 infection. Given the effectiveness of mRNA COVID-19 vaccines in preventing severe illnesses, hospitalisations and deaths, future research should focus on accurately determining the rates of myo/pericarditis linked to mRNA COVID-19 vaccines, understanding the biological mechanisms behind these rare cardiac events and identifying those most at risk.

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Section: Discussionmentioning

confidence: 99%

Risk of myocarditis and pericarditis in mRNA COVID-19-vaccinated and unvaccinated populations: a systematic review and meta-analysis

et al. 2023

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“…We included 27 different adverse events, adapted from prioritized lists of adverse events of special interest for the Covid-19 vaccines. [20][21][22] During follow-up, we identified outcome events as any hospital visits where an outcome diagnosis was recorded as the primary reason for seeking hospital care (see Table S2 for specific International Classification of Diseases, 10th revision-codes). 16 We included only incident events by excluding individuals who had a history of the respective studied outcome during a washout period from 1 January 2018 to day 28 after the third dose.…”

Section: Discussionmentioning

confidence: 99%

Safety of bivalent omicron-containing mRNA-booster vaccines: a nationwide cohort study

Andersson

Thiesson

Hansen

et al. 2023

Preprint

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Background: Safety data to support bivalent omicron-containing mRNA-booster vaccination are lacking. Methods: In a Danish nationwide cohort study from 1 January 2021 to 10 December 2022, we examined the association between bivalent omicron-containing mRNA-booster vaccination as a fourth Covid-19 vaccine dose and risk of adverse events in individuals aged ≥50 years. Using incidence rate ratios estimated with Poisson regression, we compared the rates of hospital visits for 27 different adverse events in a 28-day main risk period following vaccination with a bivalent omicron-containing mRNA-booster vaccine as a fourth dose to reference period rates from day 29 after the third or fourth vaccine dose and onward. Secondary analyses included stratifying by sex, age, and vaccine type and assessing the associations using self-controlled case series and observed vs. expected cohort analyses. Results: 1,740,417 individuals (mean age 67.8 years, standard deviation 10.7) received a bivalent omicron-containing mRNA-booster vaccine as a fourth dose. Fourth dose vaccination with a bivalent omicron-containing booster did not statistically significantly increase the rate of any of the 27 adverse outcomes within 28 days, nor when analyzed according to age, sex, vaccine type, or using alternative analytical approaches. However, post-hoc analysis detected signals for myocarditis (statistically significantly so in females), although the outcome was very rare and findings were based on few cases. No risk of cerebrovascular infarction was found. Conclusions: Bivalent omicron-containing mRNA-booster vaccination as a fourth dose was not associated with an increased risk of 27 different adverse events in 50+-year-olds.

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“…recognized as clinical manifestations of myo/pericarditis. In many instances, these manifestations have been reported to be the main initial symptoms prompting cardiac magnetic resonance referrals following COVID-19 vaccine-associated acute myocarditis[63][64][65]. Furthermore, our analysis revealed notable distinctions in the reporting of myo/pericarditis cases based on age and gender, with males having the highest re-ported number of cases in the 12-17 and 18-24 years old age groups.…”

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confidence: 62%

A Pharmacoepidemiological Approach For Evaluating The Risk Of Myocarditis And Pericarditis Following Mrna COVID-19 Vaccination

Alami

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ObjectivesThis thesis evaluates the risk of myocarditis and pericarditis (myo/pericarditis) post-mRNA COVID-19 vaccination. MethodsThree complementary approaches were employed: disproportionality analysis using Vaccine Adverse Event Reporting System (VAERS) for early safety signals, analysis of observed-to-expected reporting rates, and a systematic review and meta-analysis comparing the rate of myo/pericarditis among vaccinated relative to unvaccinated individuals. ResultsAnalysis of VAERS and observed-to-expected reporting rates identified a signal for myo/pericarditis following mRNA COVID-19 vaccination, predominantly in young males post second doses. The meta-analysis further corroborated the findings, indicating a higher risk in those who received mRNA COVID-19 vaccinations compared to unvaccinated individuals in the absence of COVID-19 infection. ConclusionThe multi-faceted approach adopted in this study indicates a potential risk of myo/pericarditis following mRNA COVID-19 vaccination. However, further research is needed to explore co-factors, genetic predisposition, and risks in special populations, to inform public health decisions and shape vaccine recommendations.

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Background Rates of 41 Adverse Events of Special Interest for COVID-19 Vaccines in 10 European Healthcare Databases - an ACCESS Cohort Study

Cited by 3 publications

References 21 publications

Risk of myocarditis and pericarditis in mRNA COVID-19-vaccinated and unvaccinated populations: a systematic review and meta-analysis

Risk of myocarditis and pericarditis in mRNA COVID-19-vaccinated and unvaccinated populations: a systematic review and meta-analysis

Safety of bivalent omicron-containing mRNA-booster vaccines: a nationwide cohort study

A Pharmacoepidemiological Approach For Evaluating The Risk Of Myocarditis And Pericarditis Following Mrna COVID-19 Vaccination

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