Marina Amaral de Avila Machado, Sophie Gallo, Alexander Goldstein, Parth Vachhani, Reddappa Maniganahally Byrareddy, Anu Kantele, Hanna Välimaa, Jörg Schelling
{"title":"Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season.","authors":"Marina Amaral de Avila Machado, Sophie Gallo, Alexander Goldstein, Parth Vachhani, Reddappa Maniganahally Byrareddy, Anu Kantele, Hanna Välimaa, Jörg Schelling","doi":"10.1080/21645515.2025.2475616","DOIUrl":"https://doi.org/10.1080/21645515.2025.2475616","url":null,"abstract":"<p><p>Enhanced Passive Safety Surveillance was used to detect safety signals before the peak period of immunization with quadrivalent inactivated influenza vaccines (IIV4) in Finland (standard dose [SD]) and Germany (high dose [HD]) in the 2023-24 season. The primary objective was to evaluate adverse drug reactions (ADRs) occurring ≤7 days following IIV4 vaccination. Enrolled participants were vaccinated in routine clinical care settings and encouraged to report ADRs. Exposure data and ADR reports were collected in a near real-time manner using an electronic system. Vaccinee reporting rate (RR) with 95% confidence interval (CI) was calculated as the number of vaccinees reporting ≥ 1 ADR divided by total number of vaccinees. In Finland for SD-IIV4, among 1,003 vaccinees aged ≥ 6 months, 81 reported a total of 192 suspected ADRs occurring ≤ 7 days following vaccination (vaccinee RR 8.08%; 95% CI 6.46, 9.94). In Germany for HD-IIV4, among 1,075 vaccinees aged ≥ 60 years, 15 reported 46 ADRs that occurred in ≤ 7 days of vaccination (vaccinee RR 1.40%; 95% CI 0.78, 2.29). No safety signal was detected during this surveillance. The 2023-24 season surveillance did not suggest any clinically significant changes in safety profile compared with previously reported safety data for SD-IIV4 and HD-IIV4.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2475616"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143651628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abby E Rudolph, Nadine Al Akoury, Natalija Bogdanenko, Kristen Markus, Isabelle Whittle, Olivia Wright, Hammam Haridy, Julia R Spinardi, John M McLaughlin, Moe H Kyaw
{"title":"Factors affecting the impact of COVID-19 vaccination on post COVID-19 conditions among adults: A systematic literature review.","authors":"Abby E Rudolph, Nadine Al Akoury, Natalija Bogdanenko, Kristen Markus, Isabelle Whittle, Olivia Wright, Hammam Haridy, Julia R Spinardi, John M McLaughlin, Moe H Kyaw","doi":"10.1080/21645515.2025.2474772","DOIUrl":"10.1080/21645515.2025.2474772","url":null,"abstract":"<p><p>This systematic literature review summarizes the evidence across 56 publications and pre-prints (January 2020-July 2023) with low-risk of bias based on JBI critical appraisal, that report adjusted estimates for the relationship between COVID-19 vaccination and Post-COVID-19 Condition (PCC) by timing of vaccination relative to infection or PCC-onset. Comparisons of adjusted vaccine effectiveness (aVE) against ≥1 PCC (vs. unvaccinated) across study characteristics known to impact PCC burden or VE against other COVID-19 endpoints were possible for 31 studies where vaccination preceded infection. Seventy-seven percent of pre-infection aVE estimates were statistically significant (range: 7%-95%). Statistically significant pre-infection aVE estimates were slightly higher for mRNA (range: 14%-84%) than non-mRNA vaccines (range: 16%-38%) and aVE ranges before and during Omicron overlapped. Our findings suggest that COVID-19 vaccination before SARS-CoV-2 infection reduces the risk of PCC regardless of vaccine type, number of doses received, PCC definition, predominant variant, and severity of acute infections included.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2474772"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11913386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Immune checkpoint inhibitors in cancer patients with autoimmune disease: Safety and efficacy.","authors":"Jiayuan Le, Yuming Sun, Guangtong Deng, Yating Dian, Yanli Xie, Furong Zeng","doi":"10.1080/21645515.2025.2458948","DOIUrl":"10.1080/21645515.2025.2458948","url":null,"abstract":"<p><p>The utilization of immune-checkpoint inhibitors (ICIs) in cancer immunotherapy frequently leads to the occurrence of immune-related adverse events (irAEs), making it generally not recommended for patients with preexisting autoimmune diseases. Hence, we conducted a meta-analysis on safety and efficacy of ICIs in cancer patients with preexisting autoimmune diseases to provide further insights. PubMed, EMBASE, and Cochrane Library were systematically searched until December 20, 2024. The main summary measures used were pooled rate and risk ratio (RR) with 95% confidential interval (CI), which were analyzed using R statistic software. A total of 52 articles were included in the study. When cancer patients with preexisting autoimmune diseases received ICIs treatment, the overall incidence was 0.610 (95% CI: 0.531-0.686) for any grade irAEs, 0.295 (95% CI: 0.248-0.343) for flares, 0.325 (95% CI: 0.258-0.396) for de novo irAEs, 0.238 (95% CI: 0.174-0.309) for grade ≥3 irAEs, and 0.143 (95% CI: 0.109-0.180) for discontinuation due to immunotoxicity. Compared with those without autoimmune diseases, cancer patients with autoimmune diseases experienced a higher risk of any-grade irAEs (RR: 1.23, 95% CI: 1.12-1.35) and discontinuation due to immunotoxicity (1.40, 95% CI: 1.11-1.78). However, no statistically significant differences were observed in the incidence of grade ≥3 irAEs, objective response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) between the two groups. During ICIs treatment, irAEs are common among cancer patients with autoimmune diseases, but severe irAEs is relatively low. ICIs are effective in this population, but should be strictly monitored when used to avoid immunotoxicity.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2458948"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shiyuan Wang, Yang Zhang, Guifan Li, Jinhui Shi, Xianyun Chang, Hao Zhang, Fengcai Zhu, Jingxin Li, Kai Chu, Jinfang Sun
{"title":"Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China.","authors":"Shiyuan Wang, Yang Zhang, Guifan Li, Jinhui Shi, Xianyun Chang, Hao Zhang, Fengcai Zhu, Jingxin Li, Kai Chu, Jinfang Sun","doi":"10.1080/21645515.2025.2452681","DOIUrl":"10.1080/21645515.2025.2452681","url":null,"abstract":"<p><p>Chickenpox outbreaks frequently occur in collective settings such as kindergartens and schools, posing a significant threat to children's physical and mental health. This study aimed to evaluate the immunogenicity and safety of the freeze-dried live attenuated varicella vaccine (VarV) developed by Beijing Minhai Biotechnology Co. LTD. in healthy participants aged 1-12 years. In this phase III, single-center, randomized, double-blind, active-controlled trial,1,200 healthy participants randomly assigned in a 1:1 ratio to receive one dose of either the test vaccine or the active control vaccine. Venous blood samples were collected before vaccination and 42 days after vaccination, and the fluorescent antibody to membrane antigen (FAMA) assay was used to detect VZV antibody. Adverse events (AEs) observed within 42 days after vaccination and serious adverse events (SAEs) within six months after vaccination were recorded. The seroconversion rates in the test and control groups were 96.79% and 96.43%, respectively, with a difference of 0.36% (95% CI, -1.76%-2.48%). The geometric mean titers (GMTs) were 61.74 and 58.04, respectively, with a difference of 1.06 (95% CI, 0.92-1.23). The lower limits of the 95% CI for the differences in seroconversion rates and GMT ratios between the two groups were greater than their respective pre-set non-inferiority margins. The overall incidence of AEs (<i>p</i> = .0112) in the test group was significantly lower than that in the control group. The freeze-dried live attenuated VarV developed by Beijing Minhai Biotechnology Co. LTD. demonstrated good immunogenicity and higher safety compared to the active control vaccine in healthy participants aged 1-12 years.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2452681"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792797/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dhriti Jagadish, Nathaniel Mamo, Felicia Pasadyn, Arthur Caplan
{"title":"Is informed consent correctly obtained for vaccinations?","authors":"Dhriti Jagadish, Nathaniel Mamo, Felicia Pasadyn, Arthur Caplan","doi":"10.1080/21645515.2025.2465116","DOIUrl":"10.1080/21645515.2025.2465116","url":null,"abstract":"<p><p>Informed consent is an integral tenet of medical ethics. However, the United States lacks a standardized consent process for immunizations, with states and private companies instead reliant on Vaccine Information Statements (VISs) introduced by the 1986 National Childhood Vaccine Injury Act. VISs, rather than being developed with patient autonomy in mind, were a response to excessive vaccine injury litigation and resulting vaccine supply shortages. VISs do not provide meaningful information disclosures, with its producer - the Centers for Disease Control and Prevention - itself admitting that VISs should not be mistaken for informed consent forms. In its content, the VIS is too complex in its readability, does not situate immunization in a public health context, and does not present all alternatives. VIS delivery is also inadequate, with limited time given for patients to digest vaccine information and no documentation required to ensure that VISs were presented at all. Simply put, VISs do little to spark deliberation and increase vaccine confidence. This article recommends minor improvements to VIS content, delivery, and accountability mechanisms to ensure distribution. The authors argue that these patient-provider moments - for patients to better understand their health, the threat of disease, and the weight of their contribution to the public - should not be squandered.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2465116"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Hotspots evolution and frontiers of immunotherapy for the treatment of acute myeloid leukemia: A bibliometric analysis.","authors":"Nana Zhe, Qiang Li, Nanqu Huang, Hang Li, Hongyun Chen, Pinwei Zhu","doi":"10.1080/21645515.2024.2448888","DOIUrl":"https://doi.org/10.1080/21645515.2024.2448888","url":null,"abstract":"<p><p>Given the growing significance of immunotherapy in addressing the limitations of conventional acute myeloid leukemia (AML) treatments, this study aimed to elucidate the hotspot evolution and frontiers of immunotherapy in AML using bibliometric analysis. With a strict retrieval strategy applied in the Web of Science Core Collection, 2411 publications were obtained and exported. The temporal and geographical distributions of these publications and the countries, institutions, journals, and authors who contributed to the field were investigated. An in-depth content analysis was performed. The United States had various research institutions dedicated to AML immunotherapy. <i>Frontiers in Immunology</i> had the highest number of publications, but <i>Blood</i> had the highest H-index. Marion Subklewe was the most productive author. The current research hotspots of AML immunotherapy included chimeric antigen receptor-T-cell therapy, antibody-based immunotherapies, immune checkpoint blockade, and combination therapy, highlighting the key aspects of immunotherapy for AML treatment and providing comprehensive insights into the research status and advances in this field. Novel immunotherapies combined with chemotherapy may become the primary focus of AML treatment.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2448888"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143014658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Simon Fifer, Lili Toh, Daniel Yu, Katherine Young, Jason Menche
{"title":"Australian preferences for influenza vaccine attributes and cost: A discrete choice experiment.","authors":"Simon Fifer, Lili Toh, Daniel Yu, Katherine Young, Jason Menche","doi":"10.1080/21645515.2024.2440164","DOIUrl":"https://doi.org/10.1080/21645515.2024.2440164","url":null,"abstract":"<p><p>People in Australia have access to different influenza vaccines, but may be unaware of their options and features. Preference studies for differentiated influenza vaccines including cell-based vaccines are limited, particularly in Australia. This study investigated which influenza vaccine attributes people in Australia value using a discrete choice experiment (DCE). Adults in Australia ineligible for free influenza vaccines had been vaccinated in the last 5 years and intended to be vaccinated again completed an online survey. Participants (<i>N</i> = 1203) were presented three influenza vaccine profiles described by eight attributes. Half the DCE scenarios described influenza season severity to be the same as last year, and the other half as more severe. DCE data were analyzed using a mixed multinomial logit (MMNL) model. All eight attributes significantly predicted vaccine choice (<i>p</i> < .05). Regardless of influenza season severity, participants preferred a vaccine: with greater protection, designed to be an exact match to circulating strains (match), using modern technology, manufactured by an Australian company, available at pharmacies, preferred by health care professionals (HCP), government funded for high-risk individuals and having lower cost. The top three attributes by importance were protection, match and cost. Participants were willing to pay more for match and higher protection. The Marginal Willingness to Pay (MWTP) for the most important attributes, excluding cost, were AUD $1.61/$2.18 for each additional percent in protection (same/more severe season), AUD $25.37/$32.37 for match and AUD $4.06/$15.97 for HCP preference. Findings indicate that match, protection, cost and HCP preference are key to vaccine choice, highlighting the importance of shared decision-making.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2440164"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
John C Lang, Colleen Burgess, Salome Samant, Jazmin Figueroa, Luciana Hirata, Manjiri Pawaskar
{"title":"Modeling the effects of improving varicella vaccination coverage on clinical and economic outcomes in Peru.","authors":"John C Lang, Colleen Burgess, Salome Samant, Jazmin Figueroa, Luciana Hirata, Manjiri Pawaskar","doi":"10.1080/21645515.2025.2485838","DOIUrl":"10.1080/21645515.2025.2485838","url":null,"abstract":"<p><p>Despite the implementation of a single-dose universal varicella vaccination program in Peru since 2018, vaccination coverage rates (VCRs) remain low, with a VCR of 66% as of 2022. We employed a dynamic transmission model (DTM) to evaluate the impact of increasing varicella VCRs in Peru. We parameterized a previously published DTM with publicly available demographic, healthcare resource use, cost, and epidemiological data inputs specific to Peru (or suitable regional proxy), including Peruvian varicella VCRs up to 2022. We modeled six single-dose UVV strategies over 10 years (2023-2032) that increased VCRs to 80-90% over 1-, 2- or 5-year periods, compared with the reference strategy assuming the continuation of the current VCR of 65.6%. Clinical and economic outcomes were reported; economic outcomes were reported in 2023 USD with 5% annual discounting. Parameter uncertainty was evaluated through probabilistic and deterministic sensitivity analyses. All six strategies with increased VCR resulted in 13%-25% fewer varicella cases, and 13%-24% fewer outpatient and inpatient cases, over 10 years, compared to continuing the current varicella VCR, with shorter VCR ramp-up periods resulting in more clinical outcomes averted. However, this led to a 12%-21% ($0.05-0.08 per person per year) increase in costs from the payer perspective. The PSA indicated that model results were robust to parameter uncertainty. Increasing varicella VCR led to improved clinical outcomes, with small increase in costs. Improving VCR at faster rates leads to better clinical outcomes relative to the reference strategy at a small per-capita cost increase.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2485838"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
José Luis Huerta, An Ta, Elizabeth Vinand, Gustavo Ivan Torres, Warisa Wannaadisai, Liping Huang
{"title":"PCV20 for the prevention of invasive pneumococcal disease in the Mexican pediatric population: A cost-effectiveness analysis.","authors":"José Luis Huerta, An Ta, Elizabeth Vinand, Gustavo Ivan Torres, Warisa Wannaadisai, Liping Huang","doi":"10.1080/21645515.2025.2475594","DOIUrl":"10.1080/21645515.2025.2475594","url":null,"abstract":"<p><p>The introduction of a pneumococcal conjugate vaccine (PCV) covering 13 serotypes (PCV13) into the Mexican pediatric national immunization program (NIP) has substantially reduced the burden of pneumococcal disease (PD) since 2010. This study aimed to estimate the impact of replacing either PCV13 or 15valent PCV (PCV15) with 20-valent PCV (PCV20) in the Mexican pediatric NIP. A decision-analytic Markov model was developed to compare the cost-effectiveness of PCV20 versus lower-valent vaccines from a Mexican public health sector (payer) perspective over 10 years. Epidemiological and cost inputs were sourced from Mexican data. Direct and indirect vaccine effects were estimated using PCV13 clinical effectiveness, 7-valent PCV efficacy studies, and PCV13 impact data in Mexico. The estimated disease and cost impact of PCV20 was compared with PCV13 and PCV15, all under a 2 + 1 dosing schedule. A discount rate of 5% per annum was applied to costs and health outcomes. Model robustness was evaluated through sensitivity analyses, including deterministic sensitivity analysis (DSA), probabilistic sensitivity analysis (PSA), and additional scenario assessments. PCV20 was estimated to provide considerably more health benefits than both comparators by averting more cases of PD compared with both PCV13 and PCV15, as well as a total cost saving of over 10 billion Mexican pesos. The DSA, PSA, and scenario assessments confirmed minimal deviation from the base case. Therefore, the introduction of PCV20 (2 + 1) into the Mexican pediatric NIP is expected to reduce the burden of PD and medical costs compared with lower-valent alternatives.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2475594"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Suraya Bondy, Elisabeth McClymont, Gal Av-Gay, Arianne Albert, Janice Andrade, Sandra Blitz, Ianna Folkes, Lucia Forward, Erin Fraser, Sela Grays, Jon Barrett, Julie Bettinger, Tali Bogler, Isabelle Boucoiran, Eliana Castillo, Rohan D'Souza, Darine El-Chaâr, Shaza Fadel, Verena Kuret, Gina S Ogilvie, Vanessa Poliquin, Manish Sadarangani, Heather Scott, John W Snelgrove, Modupe Tunde-Byass, Deborah Money
{"title":"Acceptance and attitudes towards COVID-19 vaccination during pregnancy in Canada.","authors":"Suraya Bondy, Elisabeth McClymont, Gal Av-Gay, Arianne Albert, Janice Andrade, Sandra Blitz, Ianna Folkes, Lucia Forward, Erin Fraser, Sela Grays, Jon Barrett, Julie Bettinger, Tali Bogler, Isabelle Boucoiran, Eliana Castillo, Rohan D'Souza, Darine El-Chaâr, Shaza Fadel, Verena Kuret, Gina S Ogilvie, Vanessa Poliquin, Manish Sadarangani, Heather Scott, John W Snelgrove, Modupe Tunde-Byass, Deborah Money","doi":"10.1080/21645515.2025.2458353","DOIUrl":"10.1080/21645515.2025.2458353","url":null,"abstract":"<p><p>The COVID-19 pandemic posed a unique set of risks to pregnant women and pregnant people. SARS-CoV-2 infection in pregnancy is associated with increased risk of severe illness and adverse perinatal outcomes. However, evidence regarding the use of COVID-19 vaccines in pregnancy shows safety and efficacy. Despite eligibility and recommendations for COVID-19 vaccination among pregnant women and pregnant people in Canada, uptake remains lower compared to the general population, warranting exploration of influencing factors. The COVERED study, a national prospective cohort, utilized web-based surveys to collect data from pregnant women and pregnant people across Canada on COVID-19 vaccine attitudes, uptake, and hesitancy factors from July 2021 to December 2023. Survey questions were informed by validated tools including the WHO Vaccine Hesitancy Scale (VHS) and the Theory of Planned Behavior (TPB). Of 1093 respondents who were pregnant at the time of the survey, 87.7% received or intended to receive a COVID-19 vaccine during pregnancy. TPB variables such as positive attitudes toward COVID-19 vaccines (OR = 1.11, 95% CI = 1.08-1.14), direct social norms, and indirect social norms were significantly associated with vaccine acceptance. Perceived vaccine risks, assessed by the WHO VHS, were greater in those not accepting of the vaccine. Our study identified several key factors that play a role in vaccine uptake: perceived vaccine risks and safety and social norms. These findings may guide public health recommendations and prenatal vaccine counseling strategies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2458353"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}