COVID-19 Vaccine Safety Monitoring: Opportunities, Challenges and Lessons Learned for Pharmacoepidemiology

Saturday, August 27, 2022

4:15 PM – 5:45 PM CEST

Location: Congress Hall D5

Publication Number: 202

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 - Chairs Alicia Gilsenan and TBD (European regulator invited)

60' minutes — Stakeholder Perspective Presentations
·Perspective from Regulatory (EMA: Catherine Cohet, Netherlands) (10 min) (US FDA CBER: Patricia Lloyd) (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 (Joseph Kim), 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, Daina Esposito (Moderna), and Kourtney Davis (Janssen).

5' Q&A with audience - Moderated by Chairs

Presenting Author(s)

Alicia W. Gilsenan, PhD, RPh, FISPE

Vice President, Epidemiology
RTI Health Solutions
UNC Chapel Hill
Cary, North Carolina, United States

Slides

Author(s)

Miriam C. Sturkenboom, PharmD, PhD, FISPE

prof. dr.
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands

Slides
Cynthia De Luise, MPH, PhD

Pfizer Inc
New York, New York, United States

Slides
Catherine Cohet, PhD

Pharmacoepidemiology/RWE Senior Specialist
European Medicines Agency
Amsterdam, Noord-Holland, Netherlands

Slides
Jeffrey Brown, PhD

Chief Scientific Officer
TriNetX
Cambridge, Massachusetts, United States

Slides
Susana Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP

VP Epidemiology
RTI Health Solutions
BARCELONA, Barcelona, Spain
Patricia C. Lloyd

US Food and Drug Administration
Silver Spring, Maryland, United States

Slides
Joseph Kim, PhD, MPH

Head of Safety Epidemiology
AstraZeneca
Cambridge, Cambridgeshire, United Kingdom

Slides
DE

Daina Esposito, PhD, MPH

Senior Director, Global Safety Epidemiologist
Moderna, United States
Kourtney Davis, PhD, MSPH, FISPE

Janssen Research & Development
Bryn Mawr, Pennsylvania, United States