Vaccines
Weibel D, de Luise C, Cid Royo A, Ryan O, Vaz T, Aguado J, Marsal J, Garcia de Albeniz Martinez X, Weinrib R, Yefimenko N, Pala E, Poblador-Plou B, Gimeno-Miguel A, Santos-Mejias A, Marconi E, Barbieri E, Stona L, Lysen T, Roy D, Hyeraci G, Girardi A, Lupattelli A, Desalegn AA, Villalobos F, Bissacco CA, Kendrick K, Garg R, Rubino H, Sturkenboom MCJM, Arana A. Interim results from the VAC4EU Post-Authorization Safety Study (PASS) among recipients of the Pfizer-BioNTech COVID-19 (Comirnaty®) vaccine in Europe. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Ahmadizar F, Fortuny J, Royo AC, Plana E, Weinrib R, Garcia Esteban R, Boric K, Yefimenko N, Haugh M, Carreras JJ, Urchueguia-Fornes A, Correcher E, van den Berg JM, Lysen T, Villalobos F, Bissacco CA, Newbern EC, Willame C, Praet N, Sturkenboom MCJM. Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data sources: methods and results of the second study feasibility assessment. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
BACKGROUND: As part of the lifecycle benefit-risk assessment of vaccines, we are conducting a post-authorisation safety study (PASS) utilizing real-world data to characterize and assess the safety profile of JCOVDEN.
Cook C, Carrico J, Talbird S, Gountas I, Skroumpelos A, Boutselakou E, Trimis G, Sabale U, Bencina G. Public health and economic impact of pediatric immunization program in Greece. Presented at the 42nd Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) 2024; May 24, 2024. Copenhagen, Denmark.
BACKGROUND: Greece has one of the most extensive pediatric vaccination programs in Europe preventing against 14 pathogens. The aim of the study was to assess the public health and economic impact of the pediatric immunization program (PIP) in Greece.
Layton JB, Richey M, Lindaas A, Muthuri S, Lloyd PC, Gruber JF, Bui C, McKillop M, Kowarski L, Lyu H, Cheng A, Wan Z, Clarke TC, Kawai AT, Beers J, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Events on day zero of follow-up: considerations for cohort studies of adverse events after COVID-19 diagnosis. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
BACKGROUND: Observing numerous events on day 0 of follow-up is common in studies of the association between diagnosed coronavirus disease 2019 (COVID-19) and adverse events (AE). Starting follow-up on day 0 may induce bias when evaluating some diseases or time periods, such as the COVID-19 pandemic.
Layton JB, Lindaas A, Muthuri S, Lloyd PC, Richey MM, Gruber JF, Clarke TC, Kowarski L, McKillop M, Fisher S, Lyu H, Cheng A, Bui C, Duenas PF, Chen Y, Beers JB, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Risk of cardiovascular adverse events after COVID-19 diagnosis in the United States. Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
BACKGROUND: More United States (US) data are needed that quantify the risk of serious cardiovascular adverse events (AEs) associated with COVID-19 diagnoses to provide context for COVID-19 vaccine safety surveillance.
Layton JB, Muthuri S, Lindaas A, Lloyd PC, Richey MM, Gruber JF, Clarke TC, Kowarski LS, McKillop M, Fisher S, Lyu H, Cheng A, Bui CL, Duenas PF, Chen Y, Forshee RA, Anderson SA, Beers JB, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States. Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
BACKGROUND: Many neurological or immune-mediated conditions have been evaluated as potential adverse events (AEs) in coronavirus 2019 (COVID-19) vaccine surveillance activities. To contextualize United States (US) surveillance findings, data are needed to quantify the risk of AEs associated with COVID-19 diagnoses.
Layton JB, Peetluk LS, Lloyd PC, Jiao Y, Djibo DA, Deng J, Gruber JF, Ogilvie RP, Parambi R, Miller M, Song J, Weatherby LB, Bell EJ, Lo AC, Hervol JR, Wernecke M, Cho S, Wong H-L, Clarke TC, Bui CL, Stone A, Tarazi W, Deshazo J, Forshee RA, Anderson SA, Seeger JD, Amend KL, MaMahill-Walraven CN, Chillarige Y, Yang GW, Anthony MS, Shoaibi A. Effectiveness over time of a complete primary series of the original, monovalent COVID-19 vaccines among adults aged 18-64 years in the United States. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
BACKGROUND: Although several COVID-19 vaccines are approved or authorized in the United States (US), early real-world studies have shown waning vaccine effectiveness (VE) against SARS-CoV-2 infection over time. Changes in circulating variants may also complicate assessments of waning VE over time.
Singer D, La E, Graham J, Grace M, Poston S, Molnar D. Cost effectiveness of adjuvanted RSVPreF3 vaccination in adults aged 50-59 years with diabetes in the United States. Poster presented at the American Diabetes Association's 84th Scientific Sessions; June 21, 2024. Orlando, FL. [abstract] Diabetes. 2024 Jun; 73(Suppl 1):1045.
INTRODUCTION & OBJECTIVE: Older adults and adults with comorbidities, such as metabolic diseases, are at increased risk of severe respiratory syncytial virus (RSV) disease. This study assessed the cost-effectiveness of adjuvanted RSVPreF3 vaccination in adults 50-59 years of age (YOA) with diabetes in the US.
Singer D, La E, Graham J, Grace M, Poston S, Molnar D. Cost-effectiveness of adjuvanted RSVPreF3 vaccination in adults aged 50-59 years with cardiopulmonary diseases in the United States. Poster presented at the ISPOR 2024; May 8, 2024. Atlanta, GA. [abstract] Value Health. 2024 Jun; 27(6 Supplement):S137. doi: 10.1016/j.jval.2024.03.735
OBJECTIVES: Older adults and adults with chronic cardiopulmonary diseases are at increased risk of severe respiratory syncytial virus (RSV) disease. This study examined the cost-effectiveness of adjuvanted RSVPreF3 vaccination in adults 50-59 years of age (YOA) with select cardiopulmonary diseases.