Abstract
AbstractObjectiveTo quantify the background incidence rates of 15 prespecified adverse events
of special interest (AESIs) associated with covid-19 vaccines.DesignMultinational network cohort study.SettingElectronic health records and health claims data from eight countries:
Australia, France, Germany, Japan, the Netherlands, Spain, the United
Kingdom, and the United States, mapped to a common data model.Participants126 661 070 people observed for at least 365 days before 1 January 2017,
2018, or 2019 from 13 databases.Main outcome measuresEvents of interests were 15 prespecified AESIs (non-haemorrhagic and
haemorrhagic stroke, acute myocardial infarction, deep vein thrombosis,
pulmonary embolism, anaphylaxis, Bell’s palsy, myocarditis or pericarditis,
narcolepsy, appendicitis, immune thrombocytopenia, disseminated
intravascular coagulation, encephalomyelitis (including acute disseminated
encephalomyelitis), Guillain-Barré syndrome, and transverse myelitis).
Incidence rates of AESIs were stratified by age, sex, and database. Rates
were pooled across databases using random effects meta-analyses and
classified according to the frequency categories of the Council for
International Organizations of Medical Sciences.ResultsBackground rates varied greatly between databases. Deep vein thrombosis
ranged from 387 (95% confidence interval 370 to 404) per 100 000 person
years in UK CPRD GOLD data to 1443 (1416 to 1470) per 100 000 person years
in US IBM MarketScan Multi-State Medicaid data among women aged 65 to 74
years. Some AESIs increased with age. For example, myocardial infarction
rates in men increased from 28 (27 to 29) per 100 000 person years among
those aged 18-34 years to 1400 (1374 to 1427) per 100 000 person years in
those older than 85 years in US Optum electronic health record data. Other
AESIs were more common in young people. For example, rates of anaphylaxis
among boys and men were 78 (75 to 80) per 100 000 person years in those aged
6-17 years and 8 (6 to 10) per 100 000 person years in those older than 85
years in Optum electronic health record data. Meta-analytic estimates of
AESI rates were classified according to age and sex.ConclusionThis study found large variations in the observed rates of AESIs by age group
and sex, showing the need for stratification or standardisation before using
background rates for safety surveillance. Considerable population level
heterogeneity in AESI rates was found between databases.
Reference43 articles.
1. WHO COVID-19 Dashboard. Geneva: World Health Organization 2020; Available at https://covid19.who.int/ (accessed 11 Mar 2021).
2. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines
3. The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns
4. Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology. CBER Surveillance Program Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring Protocol. https://www.bestinitiative.org/wp-content/uploads/2021/02/C19-Vaccine-Safety-AESI-Background-Rate-Protocol-FINAL-2020.pdf (accessed 11 Mar 2021).
5. ACCESS. Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines. 2020. http://www.encepp.eu/encepp/viewResource.htm?id=37274 (accessed 11 Mar 2021).