Vaccines

Fisher SS, Lindaas A, Muthuri SG, Lloyd PC, Gruber JF, Richey MM, Lyu H, Cheng AS, Kowarski LS, McKillop MM, Bui C, Clarke TC, Beers J, Burrell T, Duenas PF, Chen Y, Sheng M, Forshee RA, Anderson SA, Chillarige Y, Anthony MS, Shoaibi A, Layton JB. Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States. PLoS One. 2025 Nov 24;20(11):e0333704. doi: 10.1371/journal.pone.0333704


Singer D, La EM, Graham J, Molnar D, Grace M, Poston S, Verelst F. Public health impact and cost-effectiveness of adjuvanted RSVPreF3 vaccination among adults in the USA aged 50–59 years at increased risk of severe RSV disease. Infect Dis Ther. 2025 Dec;14(12):2743-61. doi: 10.1007/s40121-025-01238-8


INTRODUCTION: Adults with certain comorbidities, including metabolic and cardiopulmonary diseases, are at increased risk of severe respiratory syncytial virus (RSV) disease. We evaluated the cost-effectiveness of adjuvanted RSVPreF3 vaccination in adults in the USA aged 50-59 years at increased risk of severe RSV.

Sweeney C, Boyle K, Calhoun S, Davenport E, Wang WJ, Mehta D. Potential operational efficiencies of a combination influenza and COVID-19 vaccine in US pharmacies. Poster presented at the ISPOR Europe 2025; November 9, 2025. Glasgow, Scotland.


OBJECTIVES: To evaluate and quantify potential operational efficiencies associated with the introduction of a combination influenza/COVID-19 vaccine in US community pharmacy settings.

La E, Singer D, De Gennes CD, Graham J, Grace M, Poston S, Verelst F. Public health impact and cost-effectiveness of adjuvanted RSVPReF3 vaccination in U.S. adults aged ≥60 years with diabetes. Poster presented at the 85th Scientific Sessions of the American Diabetes Association; June 18, 2025. Chicago, IL. [abstract] Diabetes. 2025 Jun 20; 74(Suppl 1):1053-P. doi: 10.2337/db25-1053-P


INTRODUCTION AND OBJECTIVE: Adults with diabetes are at increased risk of severe respiratory syncytial virus (RSV) disease. This study modeled the potential public health impact and cost-effectiveness of adjuvanted RSVPreF3 vaccination in US adults ≥60 years of age (YOA) with diabetes.

Yeung MW, Tuite A, Nam A, Ximenes R, Arthurs E, Awan A, Khaliq S, Loukov D, Carrico J, Hicks K. Cost-effectiveness analyses for SHINGRIX (RZV) in 18+ IC populations in Canada. Presented at National Advisory Committee on Immunization Herpes Zoster Working Group; November 1, 2021. Virtual.


Abstract not available at this time.

Ghaswalla P, Joshi K, Hicks KA, Xiao Z, Fust K, Kohli M, Weinstein MC. Cost-effectiveness of Moderna's RSV vaccine, mRNA-1345 (mRESVIA) compared to no vaccination in adults 18-49 years at increased risk of severe RSV disease in the United States. Presented at the US Advisory Committee on Immunization Practices Respiratory Syncytial Virus Vaccines - Adults Work Group; May 2025. Atlanta, GA.


Abstract not available at this time.

Ahmadizar F, Cid Royo A, Ryan O, Plana E, Arnau JR, Tarazjani AD, Mohammadi S, Garcia-Esteban R, Pajouheshnia R, Boric K, Pala E, Brutau A, Haugh M, Martinez JJC, Urchueguia A, Martinez EC, Herrero-Silvestre M, Lysen T, Overbeek J, Gaspersz J, Villalobos F, Bissacco CA, Williams C, Praet N, Sturkenboom MCJ, Fortuny J. Evaluating the safety profile of the Janssen COVID-19 vaccine (JCOVDEN): a VAC4EU post-authorization safety study. Presented at the 2025 International Society for Pharmacoepidemiology (ISPE) Annual Meeting; August 26, 2025. Washington, DC.


BACKGROUND: The European Commission authorized the Ad26.COV2.S vaccine for individuals aged 18 and older on 11 March 2021 and requested a post-authorization safety study to evaluate the vaccine's safety profile in real-world settings.

Pala E, Dehgahn Tarazjani A, Ryan O, Cid Royo A, Plana E, Bissacco CA, Boric K, Brutau A, Carreras Martinez JJ, Correcher Martinez E, Garcia-Esteban R, Gaspersz J, Herrero-Silvestre M, Haugh M, Lysen T, Mohammadi S, Overbeek J, Arnau JR, Urchueguia A, Villalobos F, Praet N, Williams C, Ahmadizar F, Sturkenboom MCJ, Fortuny J. Evaluating the diagnostic accuracy of adverse events of special interest following Janssen COVID-19 vaccine (JCOVDEN) using the VAC4EU validation pipeline. Poster presented at the 2025 International Society for Pharmacoepidemiology (ISPE) Annual Meeting; August 24, 2025. Washington, DC.


BACKGROUND: Adverse events of special interest (AESI) are assessed in post-authorization safety studies (PASS) using real-world data (RWD), but the accuracy of codes and algorithms to identify them require validation according to the regulatory guidance for RWD studies.

Weibel D, Tarazhani AD, Rebordosa C, Fortuny J, Zwiers l, Ahmadizar F, Arana A, Sturkenboom MCJ. The VAC4EU comprehensive framework for case validation applied in real world evidence studies to monitor vaccine safety. Presented at the 2025 International Society for Pharmacoepidemiology (ISPE) Annual Meeting; August 24, 2025. Washington, DC.


Weibel D, De Luise C, Cid Royo A, Ryan O, Vaz T, Aguado J, Marsal J, Garcia de Albeniz X, Weinrib R, Pala E, Haugh M, Poblador B, Gimeno-Miguel A, Santos-Mejias A, Marconi E, Barbieri E, Stona L, Lysen T, Gaspersz J, Overbeek J, Herings R, Roy D, Lane S, Fry C, Morris D, Hyeraci G, Girardi A, Lupattelli A, Desalegn A, Villalobos F, Bissacco CA, Rubino H, Sturkenboom MCJ, Arana A. 2024 interim results from the VAC4EU post-authorisation safety study (PASS) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty®) in Europe. Poster presented at the 2025 International Society for Pharmacoepidemiology (ISPE) Annual Meeting; August 24, 2025. Washington, DC.


BACKGROUND: Comirnaty® received conditional marketing authorisation in the European Union (EU), United Kingdom (UK) and United States (US) in December 2020. We describe interim results from a post-authorisation safety study (PASS); a commitment to EU and US regulatory authorities.