Pharmacovigilance challenges of COVID-19 vaccine safety monitoring during the pandemic - a narrative review

Dagmara Mirowska-Guzel; Magdalena Niedzielko; Barbara de Bernardi; Antonella Fretta; Marcin Kruk; Weronika Lepionka; Kavita Ramji; Patrick Caubel

doi:10.56782/pps.739

Published : 2026-06-15

Vol. 24 No. 2 (2026)

Pharmacovigilance challenges of COVID-19 vaccine safety monitoring during the pandemic - a narrative review

Dagmara Mirowska-Guzel

Magdalena Niedzielko

Barbara de Bernardi

Antonella Fretta

Marcin Kruk

Weronika Lepionka

Kavita Ramji

Patrick Caubel

DOI: https://doi.org/10.56782/pps.739

Abstract

This article explores the challenges related to the immense workload associated with pharmacovigilance during the COVID-19 pandemic as well as strategies and solutions employed by key stakeholders, including regulators, industry, and academia. The rapid development and rollout of COVID-19 vaccines was accompanied by increased public interest in their safety, resulting in the collection and analysis of an unprecedented volume of safety data. Requests from regulators worldwide for the accelerated preparation and submission of aggregate safety reports, as well as ad hoc data requests, presented additional challenges. The academic community voluntarily contributed by summarizing emerging evidence on vaccine safety, conducting research to clarify potential mechanisms underlying adverse events, and examining factors associated with vaccine hesitancy. An effective pharmacovigilance system played a crucial role in gathering and rapidly analyzing large amounts of data to identify signals, refine the safety profile of a new medicinal product, and respond promptly to any emerging concerns to ensure that patients are not exposed to medications with an unfavourable benefit–risk balance.

Keywords:

Vaccine, COVID-19, pandemic, pharmacovigillance, adverse drug reaction

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Mirowska-Guzel, D., Niedzielko, M., de Bernardi, B., Fretta, A., Kruk, M., Lepionka, W., … Caubel, P. (2026). Pharmacovigilance challenges of COVID-19 vaccine safety monitoring during the pandemic - a narrative review. Prospects in Pharmaceutical Sciences, 24(2), 149–160. https://doi.org/10.56782/pps.739

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Dagmara Mirowska-Guzel

dagmara.mirowska-guzel@wum.edu.pl

Affiliation:

Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Banacha 1b, 02-097, Warsaw, Poland Poland

Magdalena Niedzielko

magdalena.niedzielko@wum.edu.pl
https://orcid.org/0000-0001-5869-1340

Affiliation:

Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Banacha 1b, 02-097, Warsaw, Poland Poland

Barbara de Bernardi

barbara.debernardi@pfizer.com

Affiliation:

Worldwide Medical and Safety, Pfizer Italia srl, Via Anna Maria Mozzoni, 12, 20152 Milan, Italy Italy

Antonella Fretta

antonella.fretta@pfizer.com
https://orcid.org/0009-0007-0074-341X

Affiliation:

Worldwide Medical and Safety, Pfizer Italia srl, Via Anna Maria Mozzoni, 12, 20152 Milan, Italy Italy

Marcin Kruk

marcin.kruk@pfizer.com
https://orcid.org/0009-0008-4073-8233

Affiliation:

Worldwide Medical and Safety, Pfizer Polska, Żwirki i Wigury 16b, 02-092, Warsaw, Poland Poland

Weronika Lepionka

weronika.lepionka@pfizer.com
https://orcid.org/0009-0002-6366-3832

Affiliation:

Worldwide Medical and Safety, Pfizer Polska, Żwirki i Wigury 16b, 02-092, Warsaw, Poland Poland

Kavita Ramji

kavita.ramji@pfizer.com

Affiliation:

Worldwide Medical and Safety, Pfizer Polska, Żwirki i Wigury 16b, 02-092, Warsaw, Poland Poland

Patrick Caubel

patrick.caubel@pfizer.com

Affiliation:

Worldwide Medical and Safety, Pfizer Inc, 500 Arcola Rd Collegeville, Pennsylvania, United States United States