Cohort monitoring of 29 Adverse Events of Special Interest prior to and after COVID-19 vaccination in four large European electronic healthcare data sources

Sturkenboom, Miriam; Messina, Davide; Paoletti, Olga; Burgos-Gonzalez, Airam de; García-Poza, Patricia; Huerta, Consuelo; García, Ana Llorente-; Martín-Pérez, Mar; Martínez, María Teresa; Martin, Ivonne; Overbeek, Jetty A.; Padros-Goossens, Marc; Souverein, Patrick C.; Swart, Karin M. A.; Klungel, Olaf H.; Gini, Rosa

doi:10.1101/2022.08.17.22278894

Cited by 2 publications

(2 citation statements)

References 35 publications

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“…In January 2020, the EMA launched an early hypothesisgenerating, active surveillance study to monitor the first vaccinations. 20,21 It included primary data collection in 7 countries and parallel cohort monitoring of AESIs and COVID-19 diagnoses before and after vaccination in large healthcare databases. The study provided a framework for further readiness and generation of new background rates and pharmacoepidemiological analyses.…”

Section: Observational Studiesmentioning

confidence: 99%

“…In addition, independent observational studies were commissioned by the EMA ( Figure ). In January 2020, the EMA launched an early hypothesis‐generating, active surveillance study to monitor the first vaccinations 20,21 . It included primary data collection in 7 countries and parallel cohort monitoring of AESIs and COVID‐19 diagnoses before and after vaccination in large healthcare databases.…”

Section: Monitoring Toolkitmentioning

confidence: 99%

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Safety Monitoring of COVID‐19 Vaccines: Perspective from the European Medicines Agency

Durand

Dogné

Cohet

et al. 2023

Clin Pharma and Therapeutics

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Prior to deployment of COVID‐19 vaccines in the European Union (EU) in 2021, a high vaccine uptake leading to an unprecedented volume of safety data from spontaneous reports and real‐world evidence, was anticipated. The European Medicines Agency (EMA) implemented specific activities to ensure enhanced monitoring of emerging vaccine safety information, including intensive monitoring of reports of adverse events of special interest (AESIs) and the use of observed‐to‐expected (O/E) analyses. EMA also commissioned several independent observational studies using a large network of electronic healthcare databases and primary data collection via mobile and web‐based applications. This preparedness was key for two high‐profile safety signals: thrombosis with thrombocytopenia syndrome (TTS), a new clinical entity associated with adenovirus‐vectored vaccines, and myocarditis/pericarditis with messenger RNA (mRNA) vaccines. With no existing case definition nor background rates, the signal of TTS posed particular challenges. Nevertheless, it was rapidly identified, evaluated, contextualised and the risk minimised thanks to close surveillance and an efficient use of available evidence, clinical expertise and flexible regulatory tools. The two signals illustrated the complementarity between spontaneous and real‐world data, the former enabling rapid risk identification and communication, the latter enabling further characterisation. The COVID‐19 pandemic has tremendously enhanced the development of tools and methods to harness the unprecedented volume of safety data generated for the vaccines. Areas for further improvement include the need for better and harmonised data collection across Member States (e.g., stratified vaccine exposure) to support signal evaluation in all population groups, risk contextualisation and safety communication.

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Section: Observational Studiesmentioning

confidence: 99%

Section: Monitoring Toolkitmentioning

confidence: 99%

Safety Monitoring of COVID‐19 Vaccines: Perspective from the European Medicines Agency

Durand

Dogné

Cohet

et al. 2023

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

show abstract

Expert review of global real-world data on COVID-19 vaccine booster effectiveness and safety during the omicron-dominant phase of the pandemic

Solante

Álvarez-Moreno

Burhan

et al. 2022

Expert Review of Vaccines

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Introduction: COVID-19 vaccines have been highly effective in reducing morbidity and mortality during the pandemic. However, the emergence of the Omicron variant and subvariants as the globally dominant strains have raised doubts about the effectiveness of currently available vaccines and prompted debate about potential future vaccination strategies. Areas covered: Using the publicly available IVAC VIEW-hub platform, we reviewed 52 studies on vaccine effectiveness (VE) after booster vaccinations. VE were reported for SARS-CoV-2 symptomatic infection, severe disease and death and stratified by vaccine schedule and age. In addition, a nonsystematic literature review of safety was performed to identify single or multi-country studies investigating adverse event rates for at least two of the currently available COVID-19 vaccines. Expert opinion: Booster shots of the current COVID-19 vaccines provide consistently high protection against Omicron-related severe disease and death. Additionally, this protection appears to be conserved for at least 3 months, with a small but significant waning after that. The positive risk-benefit ratio of these vaccines is well established, giving us confidence to administer additional doses as required. Future vaccination strategies will likely include a combination of schedules based on risk profile, as overly frequent boosting may be neither beneficial nor sustainable for the general population.

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Cohort monitoring of 29 Adverse Events of Special Interest prior to and after COVID-19 vaccination in four large European electronic healthcare data sources

Cited by 2 publications

References 35 publications

Safety Monitoring of COVID‐19 Vaccines: Perspective from the European Medicines Agency

Safety Monitoring of COVID‐19 Vaccines: Perspective from the European Medicines Agency

Expert review of global real-world data on COVID-19 vaccine booster effectiveness and safety during the omicron-dominant phase of the pandemic

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