Frontiers in Drug Safety and Regulation | Vaccine Safety and Regulation

Review

Published on 01 Dec 2025

The use of observed-to-expected analyses as a signal detection tool in COVID-19 vaccine safety surveillance: lessons learned from an industry perspective

in Vaccine Safety and Regulation

Laurence Serradell
Antonella Fretta
Jenny Nachbar
Jill Dreyfus
Diana Garofalo
Arianna Lucini
Susan Mather
Daina Esposito
Anne-Laure Chabanon
Vincent Bauchau

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1650992

1,211 views
1 citation

Policy and Practice Reviews

Published on 01 Dec 2025

Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices

in Vaccine Safety and Regulation

Sonja Gandhi-Banga
Laurence Serradell
Deborah Layton
Jill Dreyfus
Nicolas Praet
Diana C. Garofalo
Vincent Bauchau
Scott P. Kelly
Lin Li

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1651090

1,312 views
1 citation

Policy and Practice Reviews

Published on 26 Nov 2025

Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence

in Vaccine Safety and Regulation

Sarah C. MacDonald
Adrienne P. Guignard
Flor M. Munoz
Eileen O. Dareng
Kourtney J. Davis
Marina Amaral de Avila Machado
Shahar Shmuel
Laura Taddei
Lydie Marcelon

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1648854

1,177 views

Perspective

Published on 25 Nov 2025

The role of MedDRA in global pharmacovigilance and public health during COVID-19: pandemic preparedness and response

in Vaccine Safety and Regulation

Brian O’Hare
Heba Ibrahim
Patrick Revelle

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1607642

960 views

Original Research

Published on 14 Nov 2025

Reporting rates of abnormal uterine bleeding after COVID-19 vaccination in South Korea

in Vaccine Safety and Regulation

Jae Min Lee
Seung Geun Yeo
Sung Soo Kim
Dong Choon Park

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1658412

1,164 views

Perspective

Published on 15 Aug 2025

A national pharmacovigilance centre perspective on pandemic preparedness - lessons learned from the COVID-19 pandemic

in Vaccine Safety and Regulation

Florence van Hunsel
Agnes Kant

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1644680

3,842 views
1 citation

Original Research

Published on 12 Aug 2024

Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group”

in Vaccine Safety and Regulation

Nicoletta Luxi
Chiara Bellitto
Francesco Ciccimarra
Emiliano Cappello
Luca L’Abbate
Marco Bonaso
Chiara Ajolfi
Paolo Baldo
Roberto Bonaiuti
Claudio Costantino

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1363086

3,342 views

Systematic Review

Published on 31 Jan 2024

Menstrual disorders following COVID-19 vaccination: a review using a systematic search

in Vaccine Safety and Regulation

Veerle R. Smaardijk
Rana Jajou
Agnes Kant
Florence P. A. M. van Hunsel

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1338466

39,708 views
10 citations

8 articles

articles

The use of observed-to-expected analyses as a signal detection tool in COVID-19 vaccine safety surveillance: lessons learned from an industry perspective

Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices

Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence

The role of MedDRA in global pharmacovigilance and public health during COVID-19: pandemic preparedness and response

Reporting rates of abnormal uterine bleeding after COVID-19 vaccination in South Korea

A national pharmacovigilance centre perspective on pandemic preparedness - lessons learned from the COVID-19 pandemic

Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group”

Menstrual disorders following COVID-19 vaccination: a review using a systematic search