Pharmacoepidemiology in Vaccine Safety and Efficacy

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "Vaccine Efficacy and Safety".

Deadline for manuscript submissions: 31 May 2025 | Viewed by 4122

Special Issue Editors


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Guest Editor
Department of Pediatrics, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 701, Taiwan
Interests: infectious diseases; pediatrics; translational medicine
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Special Issue Information

Dear Colleagues,

The pharmacoepidemiology of vaccines provides near-real-time monitoring and scientific information for evidence-based decision-making. The field involves assessing the risks and benefits associated with vaccination programs, which includes monitoring adverse events following vaccination, evaluating vaccine effectiveness in preventing disease, and studying factors that influence vaccine uptake and effectiveness. This field provides evidence-based information to guide decision-making regarding vaccine development, recommendations, and implementation strategies. We are inviting original articles, review articles, brief communications, and case reports related to "Pharmacoepidemiology in Vaccine Safety and Efficacy" for this Special Issue.

Dr. Chao-Min Cheng
Dr. Ching-Fen Shen
Guest Editors

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Keywords

  • pharmacoepidemiology
  • safety
  • efficacy
  • vaccines

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Published Papers (2 papers)

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Research

14 pages, 274 KiB  
Article
The Effectiveness of Four Quadrivalent, Inactivated Influenza Vaccines Administered Alone or in Combination with Pneumococcal and/or SARS-CoV-2 Vaccines: A Population-Wide Cohort Study
by Cecilia Acuti Martellucci, Annalisa Rosso, Enrico Zauli, Alessandro Bianconi, Matteo Fiore, Graziella Soldato, Patrizia Marani Toro, Marco De Benedictis, Graziano Di Marco, Roberto Carota, Rossano Di Luzio, Maria Elena Flacco and Lamberto Manzoli
Vaccines 2025, 13(3), 309; https://doi.org/10.3390/vaccines13030309 - 13 Mar 2025
Viewed by 930
Abstract
Background: Several influenza vaccine formulations are available, including adjuvanted, high-dose, trivalent, and quadrivalent vaccines, and direct, comparative evidence on the relative effectiveness is limited. Real-life data on the potential impact of the co-administration of pneumococcal and/or SARS-CoV-2 vaccinations are also very scarce. [...] Read more.
Background: Several influenza vaccine formulations are available, including adjuvanted, high-dose, trivalent, and quadrivalent vaccines, and direct, comparative evidence on the relative effectiveness is limited. Real-life data on the potential impact of the co-administration of pneumococcal and/or SARS-CoV-2 vaccinations are also very scarce. During the 2023–2024 influenza season, we carried out a retrospective cohort study on the entire elderly population of the Pescara province, Italy, in order to evaluate the effectiveness of the quadrivalent influenza vaccine, offered alone or in combination with other recommended vaccinations. Methods: All the immunization, demographic, co-payment, and hospitalization data were extracted from the official National Healthcare System, and the follow-up lasted from October 2023 to September 2024. The outcomes were all-cause mortality and hospital admissions for influenza and/or pneumonia. All the Cox models were adjusted (or stratified) for gender, age, hypertension, diabetes, COPD, CVD, renal disorders, cancer, and previous SARS-CoV-2 infection. Results: Overall, 43.9% of the population aged ≥60 years received an influenza vaccine (n = 46,355/105,527). A total of 3188 (3.0%) and 1047 (1.0%) individuals died of any cause or were hospitalized for influenza and/or pneumonia, respectively. During the follow-up, compared with the unvaccinated, those who received an influenza vaccine showed almost half the likelihood of death (adjusted HR: 0.52; 95%CI: 0.49–0.56) and hospitalization (aHR: 0.55; 95%CI: 0.48–0.62), regardless of the gender and age group. As compared with sole influenza immunization, the co-administration of a pneumococcal or COVID-19 vaccine was associated with a significantly lower risk of both outcomes. No substantial differences were observed by influenza vaccine formulation (MF59 adjuvanted; non-adjuvanted, standard dose; non-adjuvanted, high dose), with the exception of a greater mortality reduction for the MF59-adjuvanted vaccine as compared with the high-dose formulation. Conclusions: During the influenza season 2023–2024, all the influenza vaccines were largely effective among the elderly, with no substantial differences by formulation, age, or gender. However, the co-administration of a pneumococcal and/or SARS-CoV-2 vaccine further reduced the risk of both death and hospitalization. Specific, head-to-head randomized trials are required to confirm both findings. Full article
(This article belongs to the Special Issue Pharmacoepidemiology in Vaccine Safety and Efficacy)
24 pages, 9238 KiB  
Article
COVID-19 Vaccination in Pregnancy: Pilot Study of Plasma MicroRNAs Associated with Inflammatory Cytokines after COVID-19 mRNA Vaccination
by Ching-Ju Shen, Yen-Pin Lin, Wei-Chun Chen, Mei-Hsiu Cheng, Jun-Jie Hong, Shu-Yu Hu, Ching-Fen Shen and Chao-Min Cheng
Vaccines 2024, 12(6), 658; https://doi.org/10.3390/vaccines12060658 - 14 Jun 2024
Viewed by 2612
Abstract
Background: The impact of mRNA COVID-19 vaccines on the immunological profiles of pregnant women remains a crucial area of study. This research aims to explore the specific immunological changes triggered by these vaccines in this demographic. Methods: In a focused investigation, we examined [...] Read more.
Background: The impact of mRNA COVID-19 vaccines on the immunological profiles of pregnant women remains a crucial area of study. This research aims to explore the specific immunological changes triggered by these vaccines in this demographic. Methods: In a focused investigation, we examined the effects of mRNA COVID-19 vaccination on microRNA expression in pregnant women. Key microRNAs, including miR-451a, miR-23a-3p, and miR-21-5p, were analyzed for expression changes post-vaccination. Additionally, we assessed variations in S1RBD IgG levels and specific cytokines to gauge the broader immunological response. Results: Post-vaccination, significant expression shifts in the targeted microRNAs were observed. Alongside these changes, we noted alterations in S1RBD IgG and various cytokines, indicating an adapted inflammatory response. Notably, these immunological markers displayed no direct correlation with S1RBD IgG concentrations, suggesting a complex interaction between the vaccine and the immune system in pregnant women. Conclusions: Our pilot study provides valuable insights into the nuanced effects of the mRNA COVID-19 vaccine on immune dynamics in pregnant women, particularly emphasizing the role of microRNAs. The findings illuminate the intricate interplay between vaccines, microRNAs, and immune responses, enhancing our understanding of these relationships in the context of pregnancy. This research contributes significantly to the growing body of knowledge regarding mRNA COVID-19 vaccines and their specific impact on maternal immunology, offering a foundation for further studies in this vital area. Full article
(This article belongs to the Special Issue Pharmacoepidemiology in Vaccine Safety and Efficacy)
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