Gilsenan AW, Sturkenboom MC, de Luise C, Cohet C, Anderson SA, Brown J, Foskett N, Perez-Gutthann S. COVID-19 vaccine safety monitoring: opportunities, challenges and lessons learned for pharmacoepidemiology. Presentation to be given at the 2022 ICPE Conference; August 27, 2022. Copenhagen, Denmark.

BACKGROUND: COVID-19 vaccines were authorized in record time. More than a year after first roll-out , more than 4 billion persons have been vaccinated. The rapid authorization, roll out and short follow-up in trials required extraordinary efforts to monitor and address safety issues around the vaccines.

OBJECTIVES: In this symposium we aim to discuss the lessons learned in a pandemic environment related to monitoring the safety of these vaccines from the perspective of vaccine manufacturers, regulators, and research organizations.

DESCRIPTION: This symposium will give attendees direct insight from those at the forefront of the COVID-19 Vaccine safety monitoring needs and challenges. To set the stage, attendees will hear a brief overview from various stakeholder experiences (lessons learned about collaborative work in a pandemic environment along with recommendations for handling future pandemics). Next a moderated panel discussion including additional stakeholder perspectives will be conducted to provide additional insights and recommendations for how we can be better prepared (research networks, data accessibility, expectations with regard to timeliness of results) to address safety questions for future pandemics.

5’ Welcome, setting the stage for the symposium - Chair (Alicia Gilsenan and TBD (European regulator invited)

60’ minutes – Stakeholder Perspective Presentations
• Perspective from Regulatory (EMA: Catherine Cohet, Netherlands) (10 min) (US FDA CBER: Steven Anderson) (10 min)
• Perspective from Research networks: VAC4EU (Miriam Sturkenbaum) (10 min), HPCHI (Jeffrey Brown ) (10 min)
• Perspective from Manufacturers (early roll out): Pfizer (Cynthia de Luise), 10 min) US, AstraZeneca (Nadia Foskett), UK (10 min)

20’ Discussion with panel - Moderated by Chairs
• Global responsibility and access to, and lack of availability of data in different regions, areas of successful collaboration, what should we do differently?
• The H1N1 pandemic had many lessons learned, what did we do better 10 years later, and what can still be improved
• Panel: Speakers; Susana Perez-Gutthann, plus 2 additional manufacturer representatives invited.

5’ Q&A with audience - Moderated by Chairs

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