Vaccine Safety Potpourri

Moderator(s)

• 

  Wilhelmine Meeraus, PhD

  Epidemiology Director
  Medical Evidence, Vaccines & Immune Therapies, AstraZeneca, Cambridge, UK
  Cambridge, United Kingdom
• 

  Deborah Layton, PhD, FISPE

  Director
  PEPI Consultancy Limited
  Southampton, United Kingdom

Presentations:

• 1:30 PM – 1:45 PM CEST

  Risk of Neurologic or Immune-Mediated Adverse Events After COVID-19 Diagnosis in the United States
  

  Presenting Author: J. Bradley Layton, PhD, FISPE (he/him/his) – RTI Health Solutions

  Co-Author: Stella G. Muthuri, PhD – IBM Consulting

  Co-Author: Arnstein Lindaas, MA – Acumen, LLC

  Co-Author: Patricia C. Lloyd, ScM, PhD – U.S Food and Drug Administration

  Co-Author: Morgan M. Richey, Ph.D, MPH – RTI International

  Co-Author: Joann F. Gruber, PhD, MSPH – US FDA

  Co-Author: Tainya C. Clarke, PhD, MPH, MSc (she/her/hers) – US FDA

  Co-Author: Lisa Kowarski, MPH – IBM Consulting

  Co-Author: Mollie McKillop – IBM Consulting

  Co-Author: Shelby Fisher – RTI International

  Co-Author: Hai Lyu – Acumen., LLC

  Co-Author: Angela Cheng, MPH – Acumen LLC

  Co-Author: Christine L. Bui, MPH – RTI-HS

  Co-Author: Pablo Freyria Duenas, MA – Acumen LLC

  Co-Author: Yangping Chen, MPH – Acumen, LLC

  Co-Author: Richard A. Forshee, PhD – Office of Biostatistics and Pharmacovigilance, CBER, US FDA

  Co-Author: Steven A. Anderson, PhD, MPP – Food and Drug Administration

  Co-Author: Jeffrey B. Beers, MD – IBM Consulting

  Co-Author: Timothy Burrell, MD, MBA – IBM Consulting

  Co-Author: Yoganand Chillarige, MPA – Acumen LLC

  Co-Author: Mary S. Anthony, PhD – RTI International Health Solutions

  Co-Author: Azadeh Shoaibi, PhD, MHS – FDA
• 1:45 PM – 2:00 PM CEST

  Case Series Analysis of Thromboembolic Events (Arterial and Venous) in Vaccinees Following AZD1222 (ChAdOx1 nCoV-19): Results from a UK Post-authorisation Active Surveillance Study
  

  Co-Author: Miranda Davies – Drug Safety Research Unit, Southampton, UK

  Co-Author: Sandeep Dhanda – Drug Safety Research Unit

  Co-Author: Alison Evans, PhD – Drug Safety Research Unit

  Presenting Author: Debabrata Roy, PhD (he/him/his) – Drug Safety Research Unit

  Co-Author: Saad Shakir, MB ChB LRCP&S – Drug Safety Research Unit, Southampton, UK
• 2:00 PM – 2:15 PM CEST

  Assessing the impact of data diversity on background incidence rates of adverse events of special interest: the component strategy from the COVID-19 Vaccine Monitoring project
  

  Co-Author: Giuseppe Roberto, PhD, PharmD – ARS Toscana, Florence

  Co-Author: Davide Messina – ARS Toscana, Florence, Italy

  Co-Author: Carlos E. Durán, MD, PhD – Department of Data Science and Biostatistics, University Medical Center Utrecht

  Co-Author: Judit Riera-Arnau, MD – Department of Data Science and Biostatistics, Julius Global Health, University Medical Center Utrecht (UMCU), Utrecht, Netherlands

  Co-Author: Patricia Garcia – Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain

  Co-Author: Mar Martín-Pérez, PharmD, PhD – Spanish Agency of Medicines and Medical Devices (AEMPS)

  Co-Author: Olga Paoletti – ARS Toscana

  Co-Author: Carlo Alberto Bissacco – Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)

  Co-Author: Felipe Villalobos, MD, PhD – Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)

  Co-Author: Juan José Carreras, PhD, PharmD – Vaccine Research Department, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO - Public Health), Avenida Cataluña, 21, 46020 Valencia, Spain.

  Co-Author: Ainara Mira, PhD – Vaccine Research Department, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO - Public Health), Avenida Cataluña, 21, 46020 Valencia, Spain.

  Co-Author: Patrick C. Souverein, PhD (he/him/his) – Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

  Co-Author: Fabio Riefolo, PhD – Teamit Institute, Partnership, Barcelona Health Hub, Barcelona, Spain.

  Co-Author: Olaf H. Klungel, PharmD, PhD – Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

  Co-Author: Miriam C.J.M. Sturkenboom, PhD – Department of Data Science & Biostatistics, Julius Global Health, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands

  Presenting Author: Rosa Gini, PhD (she/her/hers) – ARS Toscana, Florence, Italy
• 2:15 PM – 2:30 PM CEST

  The Masking Phenomenon: Evaluating COVID-19 Vaccine Reports and Their Impact on AE Reporting in KAERS
  

  Presenting Author: Suvin Park – Ewha Womans University

  Co-Author: Na-Young Jeong, PhD – Ewha Womans University

  Co-Author: Hui-Eon Lee – Ewha Womans University

  Co-Author: Hee-Jin Kim, MA – Ewha Womans University

  Co-Author: Eunsun Lim, MS – Ewha Womans University

  Co-Author: Nam-Kyong Choi – Ewha Womans University
• 2:30 PM – 2:45 PM CEST

  Estimating the risk of transient ischemic attacks and non-hemorrhagic stroke following Spikevax bivalent compared to influenza vaccination in the US
  

  Presenting Author: Christopher Bush, MPH (he/him/his) – Aetion, Inc.

  Co-Author: Neloufar Rahai, PhD, MPH (she/her/hers) – Aetion, Inc.

  Co-Author: John Kroner – Aetion, Inc.

  Co-Author: Brian Conroy – Aetion, Inc.

  Co-Author: Katherine E. Mues, PhD, MPH – Aetion, Inc.

  Co-Author: Priyadarshani Dharia, PhD, MD, MPH (she/her/hers) – Moderna, Inc.

  Co-Author: Lei Zhu – Moderna, Inc.

  Co-Author: Daina B. Esposito, MPH, PhD (she/her/hers) – Moderna, Inc.
• 2:45 PM – 3:00 PM CEST

  Intussusception Risk after Rotavirus Vaccination in Korean Infants
  

  Presenting Author: Haerin Cho, MA – Ewha Womans University

  Co-Author: Na-Young Jeong, PhD – Ewha Womans University

  Co-Author: Hee-Jin Kim, MA – Ewha Womans University

  Co-Author: Nam-Kyong Choi – Ewha Womans University