Infectious Disease

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.

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.

O'Brien P, Campbell K, Anderson SJ, Cornic L, Davis A, Schroeder M. Cost-effectiveness of every two month Cabotegravir Long-Acting (CAB-LA) for Pre-exposure Prophylaxis (PrEP) compared with daily oral Tenofovir Disoproxil Fumarate (TDF)/ emtricitabine (FTC) as PrEP to prevent HIV-1 UK. Poster presented at the ISPOR 2024; May 7, 2024. Atlanta, GA. [abstract] Value Health. 2024 Jun; 27(6 Supplement):S109. doi: 10.1016/j.jval.2024.03.580


Rousculp MD, Hollis K, Ziemiecki R, Odom D, Marchese AM, Montazeri M, Odak S, Jackson L, Miller A, Toback S. Burden and impact of reactogenicity among adults receiving COVID-19 vaccines in the United States and Canada: results from a prospective observational study. Vaccines (Basel). 2024 Jan 13;12(1):83. doi: 10.3390/vaccines12010083


Shah HA, Herrera-Restrepo O, Jutlla G, Grace M, Graham J, Khan SA, Begum S, Kocaata K. Market and non-market productivity losses associated with invasive meningococcal disease (IMD) in the United States (US). Poster presented at the 42nd Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) 2024; May 20, 2024. Copenhagen, Denmark.


Paret K, Beyhaghi H, Herring WL, Mauskopf J, Shane LG, Rousculp WD. Going forward: potential impact of protein-based COVID-19 vaccination coverage on population outcomes and costs in the United States. Vaccines (Basel). 2024 Jan 12;12(1):74. doi: 10.3390/vaccines12010074


Fernandez MM, Bektas M, Colosia A, Kuper K, Al-Taie A, Kotb R. Evidence gaps in the burden of complicated urinary tract infection (cUTI). Poster presented at the 34th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID); April 27, 2024. Barcelona, Spain.


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