Xiang Sun, Tingting Zhang, Jinning Sun, Juan Zhou, Qiang Chen, Chengmei Jia, Yan Xu, Yun Wu, Zhiguo Wang, Wen Wang
{"title":"The seroepidemiology of immunoglobulin G antibodies against pertussis toxin and filamentous hemagglutinin in the east of China during the COVID-19 pandemic.","authors":"Xiang Sun, Tingting Zhang, Jinning Sun, Juan Zhou, Qiang Chen, Chengmei Jia, Yan Xu, Yun Wu, Zhiguo Wang, Wen Wang","doi":"10.1080/21645515.2024.2331438","DOIUrl":"10.1080/21645515.2024.2331438","url":null,"abstract":"<p><p>This study employed sero-epidemiological methods to estimate the incidence of pertussis within a healthy population located in eastern China. The aim was to gain deeper insights into the epidemiological characteristics and burden of pertussis within the country. Blood samples were collected from healthy individuals in Jiangsu Province between June 2019 and December 2022. The levels of IgG antibodies against pertussis toxin (anti-PT) and filamentous hemagglutinin (anti-FHA) in the serum were quantitatively measured using enzyme-linked immunosorbent assay (ELISA). Additionally, pertussis case data reported in Jiangsu Province were collected from the China Information System for Disease Control and Prevention and compared with the results of this study. In 2022, the reported incidence of pertussis stood at 1.0 per 100,000 individuals, marking the highest rate observed in the past two decades. Among 1,909 patients examined, the geometric mean concentration (GMC) of anti-PT IgG antibody was 20.2 (18.5-21.9) IU/ml, while that of anti-FHA IgG antibody was 27.0 (25.4-28.7) IU/ml. The IgG-PT and IgG-FHA seropositivity rate (>20.0 IU/ml) was highest in the 1 ~ 2 y old group and decreased rapidly to the lowest in the 3 ~ 4 y old group and then increased gradually with age. The estimated rate of pertussis infection based on seroprevalence was approximately 25,625-fold higher than the reported notification rate in the ≥15 year age group. Our findings highlight decreased immunity post-vaccination, stressing the importance of additional booster shots for adolescents and adults to maintain immunity and reduce severe illness. Additionally, they offer vital guidance for policymakers to enhance immunization strategies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2331438"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962620/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186151","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}
Olufeyisayo O Odebunmi, Lisa P Spees, Caitlin B Biddell, Tatenda Yemeke, Juan Yanguela, Colleen Higgins, Melissa B Gilkey, Sachiko Ozawa, Stephanie B Wheeler
{"title":"Benefits, challenges, and strategies related to using presumptive recommendations for HPV vaccination: A qualitative study with rural and non-rural-serving primary care professionals.","authors":"Olufeyisayo O Odebunmi, Lisa P Spees, Caitlin B Biddell, Tatenda Yemeke, Juan Yanguela, Colleen Higgins, Melissa B Gilkey, Sachiko Ozawa, Stephanie B Wheeler","doi":"10.1080/21645515.2024.2347018","DOIUrl":"10.1080/21645515.2024.2347018","url":null,"abstract":"<p><p>HPV vaccination coverage remains far below the national target of 80% among US adolescents, particularly in rural areas, which have vaccine uptake rates that are 10% points lower than non-rural areas on average. Primary care professionals (PCPs) can increase coverage by using presumptive recommendations to introduce HPV vaccination in a way that assumes parents want to vaccinate. Through semi-structured interviews, we explored PCPs' experiences and perceptions of using presumptive recommendations in rural- and non-rural-serving primary care clinics in North Carolina. Thematic analysis revealed that most PCPs in rural and non-rural contexts used presumptive recommendations and felt the strategy was an effective and concise way to introduce the topic of HPV vaccination to parents. At the same time, some PCPs raised concerns about presumptive recommendations potentially straining relationships with certain parents, including those who had previously declined HPV vaccine or who distrust medical authority due to their past experiences with the healthcare system. PCPs dealt with these challenges by using a more open-ended approach when introducing HPV vaccination to parents. In conclusion, our findings suggest that PCPs in both rural and non-rural settings see value in using presumptive recommendations to introduce HPV vaccination, but to adequately address concerns and ensure increased HPV vaccine uptake, PCPs can use simple and culturally sensitive language to ensure fully informed consent and to maintain parental trust. And to further strengthen HPV vaccine discussions, PCPs can utilize other effective HPV communication techniques, like the Announcement Approach, in discussing HPV vaccinations with hesitant parents.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2347018"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11085946/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872327","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}
Yao Zhu, Wanting Zhang, Jie Hu, Shuying Luo, Yang Zhou, Xuewen Tang, Rui Yan, Xuan Deng, Hanqing He
{"title":"Seroprevalence of IgG antibodies against pertussis toxin in the Chinese population: A systematic review and meta-analysis.","authors":"Yao Zhu, Wanting Zhang, Jie Hu, Shuying Luo, Yang Zhou, Xuewen Tang, Rui Yan, Xuan Deng, Hanqing He","doi":"10.1080/21645515.2024.2341454","DOIUrl":"10.1080/21645515.2024.2341454","url":null,"abstract":"<p><p>Pertussis is a vaccine-preventable infectious disease; however, data on pertussis antibody levels in a nationwide population are still limited in China. We aimed to pool the seropositivity rates of IgG antibodies against pertussis toxin (PT-IgG) across the country. We systematically searched PubMed, Web of Science, Embase, and the China National Knowledge Infrastructure Database for studies published between January 1, 2010, and June 30, 2023. Studies reporting the seroprevalence of PT-IgG among a healthy Chinese population were included. Pooled estimates were obtained using random-effects meta-analyzes. The meta-analysis included 39 studies (47,778 participants) reporting anti-PT IgG seropositivity rates. The pooled rate for all ages was 7.06% (95% CI, 5.50%-9.07%). Subgroup analyzes showed rates ranging from 6.36% to 12.50% across different age groups. This meta-analysis indicated a low anti-PT IgG seropositivity rate in the Chinese population, particularly among school-aged children and young adults. This finding underscores the urgent need to refine immunization strategies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2341454"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11067989/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872882","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}
Zelan Dai, Ruiru Cai, Hong Zeng, Hailian Zhu, Youwei Dou, Shibo Sun
{"title":"Exosome may be the next generation of promising cell-free vaccines.","authors":"Zelan Dai, Ruiru Cai, Hong Zeng, Hailian Zhu, Youwei Dou, Shibo Sun","doi":"10.1080/21645515.2024.2345940","DOIUrl":"10.1080/21645515.2024.2345940","url":null,"abstract":"<p><p>Traditional vaccines have limits against some persistent infections and pathogens. The development of novel vaccine technologies is particularly critical for the future. Exosomes play an important role in physiological and pathological processes. Exosomes present many advantages, such as inherent capacity being biocompatible, non-toxic, which make them a more desirable candidate for vaccines. However, research on exosomes are in their infancy and the barriers of low yield, low purity, and weak targeting of exosomes limit their applications in vaccines. Accordingly, further exploration is necessary to improve these problems and subsequently facilitate the functional studies of exosomes. In this study, we reviewed the origin, classification, functions, modifications, separation and purification, and characterization methods of exosomes. Meanwhile, we focused on the role and mechanism of exosomes for cancer and COVID-19 vaccines.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2345940"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140877748","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}
Vladimír Dvořák, Marek Petráš, Vladimír Dvořák, Danuše Lomozová, Pavel Dlouhý, Ivana Králová Lesná, Radovan Pilka
{"title":"Reduced risk of CIN2+ recurrence in women immunized with a 9-valent HPV vaccine post-excision: Retrospective cohort study.","authors":"Vladimír Dvořák, Marek Petráš, Vladimír Dvořák, Danuše Lomozová, Pavel Dlouhý, Ivana Králová Lesná, Radovan Pilka","doi":"10.1080/21645515.2024.2343552","DOIUrl":"10.1080/21645515.2024.2343552","url":null,"abstract":"<p><p>The main aim of our study was to investigate the specific contribution of a 9-valent human papillomavirus vaccine (9vHPV) to the recurrence risk of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women vaccinated post-excision. Therefore, we conducted a retrospective monocentric cohort study in women aged 22-49 years undergoing conization between 2014 and 2023. The 9vHPV-vaccinated women were matched to unvaccinated women for age and follow-up duration in a 1:2 ratio to eliminate allocation bias. The risk of CIN2+ recurrence was estimated by the incidence rate ratio using Poisson regression with adjustment for comorbidities, smoking status, nulliparity, CIN grade, positive cone margin, and HPV genotypes. The CIN2+ recurrence rates in 147 women enrolled in the analysis were 18 and 2 cases per 100,000 person-days for unvaccinated and vaccinated women, respectively, during a mean follow-up period of 30 months (±22 months). A reduction in CIN2+ recurrences by 90% (95% confidence interval: 12-99%) was documented in 9vHPV-vaccinated participants compared to women undergoing only surgical excision. Moreover, vaccinated women with a positive cone margin showed a 42% (though non-significant) reduction in relapse (<i>p</i> = .661). Full post-conization vaccination with the 9vHPV contributed to an additional reduction in the risk of CIN2+ recurrence. This finding is consistent with current knowledge and suggests a high adjuvant effect of the 9vHPV vaccine.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2343552"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899702","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":"Association between combination COVID-19-influenza vaccination and long COVID in middle-aged and older Europeans: A cross-sectional study.","authors":"Wenyan Wu, Xiaowei Zheng, Huan Ding, Tongtong Miao, Yuhan Zang, Suwen Shen, Yumeng Gao","doi":"10.1080/21645515.2024.2345505","DOIUrl":"10.1080/21645515.2024.2345505","url":null,"abstract":"<p><p>The potential impact of combined COVID-19 and influenza vaccination on long COVID remains uncertain. In the present cross-sectional study, we aimed to investigate the plausible association between them in middle-aged and older Europeans based on the Survey of Health, Ageing, and Retirement in Europe (SHARE). A total of 1910 participants were recruited in the analyses. The study outcome was long COVID. Participants were divided into 4 groups through the self-reported status of COVID-19 and influenza vaccination. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. 1397 participants experienced long COVID. After multivariable adjustment, those vaccinated with neither COVID-19 nor influenza vaccine had higher risk of long COVID (OR, 1.72; 95% CI, 1.26-2.35) compared to those vaccinated with both vaccines. Furthermore, adding the 4 statuses of COVID-19 vaccination/influenza vaccination to conventional risk model improved risk reclassification for long COVID (continuous net reclassification improvement was 16.26% [<i>p</i> = .003], and integrated discrimination improvement was 0.51% [<i>p</i> = .005]). No heterogeneity was found in the subgroup analyses (all <i>p</i>-interaction ≥0.05). Our study might provide a strategy for people aged 50 and over to reduce the occurrence of long COVID, that is, to combine the use of the COVID-19 vaccine and influenza vaccines.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2345505"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11085989/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899740","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}
Bowen Liu, Min Li, Xian Li, Jingyi Yang, Huimin Yan
{"title":"An optimized caries model of <i>Streptococcus mutans</i> in rats and its application for evaluating prophylactic vaccines.","authors":"Bowen Liu, Min Li, Xian Li, Jingyi Yang, Huimin Yan","doi":"10.1080/21645515.2024.2345943","DOIUrl":"10.1080/21645515.2024.2345943","url":null,"abstract":"<p><p>Dental caries is a prevalent oral disease that mainly results from <i>Streptococcus mutans</i>. Susceptibility to <i>S. mutans</i> decreased rapidly after weaning in a well-known rat model. However, owing to the lack of time to establish protective immunity ahead of challenge, the weaning rat model is suboptimal for assessing prophylactic vaccines against <i>S. mutans</i> infection. In this study, we found that, in adult rats, <i>S. mutans</i> cultured under air-restricted conditions showed dramatically increased colonization efficacy and accelerated development of dental caries compared with those cultured under air-unrestricted conditions. We propose that <i>S. mutans</i> cultured under air-restricted conditions can be used to develop an optimal caries model, especially for the evaluation of prophylactic efficacy against <i>S. mutans</i>. Therefore, we used the anti-caries vaccine, KFD2-rPAc, to reevaluate the protection against the challenge of <i>S. mutans</i>. In immunized rats, rPAc-specific protective antibodies were robustly elicited by KFD2-rPAc before the challenge. In addition to inhibiting the initial and long-term colonization of <i>S. mutans in vivo</i>, KFD2-rPAc immunization showed an 83% inhibitory efficacy against the development of caries, similar to that previously evaluated in a weaning rat model. These results demonstrate that culturing under air-restricted conditions can promote <i>S. mutans</i> infection in adult rats, thereby helping establish a rat infection model to evaluate the prophylactic efficacy of vaccines and anti-caries drugs.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2345943"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11110711/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140960468","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}
Bertin Mindje Kolomba, Francois Kalenga Luhembwe, Deca Blood Banza Ndala, Pacifique Kanku Wa Ilunga, Paul Ciamala Mukendi, Amide Ngongo Kitenge, John Ngoy Lumbule, Elie Kilolo Ngoy, Antoine Umba Ilunga, Judith Mbidi Miema, Christelle Kalikat Mwavita, Guillaume Ngoy Mwamba, Aime Cikomola Wa Bene, Audry Mulumba Wakamba, Alain Ngashi Ngongo, Michel Kabamba Nzaji
{"title":"Healthcare workers' willingness to receive COVID-19 booster dose and associated factors in the Democratic Republic of the Congo.","authors":"Bertin Mindje Kolomba, Francois Kalenga Luhembwe, Deca Blood Banza Ndala, Pacifique Kanku Wa Ilunga, Paul Ciamala Mukendi, Amide Ngongo Kitenge, John Ngoy Lumbule, Elie Kilolo Ngoy, Antoine Umba Ilunga, Judith Mbidi Miema, Christelle Kalikat Mwavita, Guillaume Ngoy Mwamba, Aime Cikomola Wa Bene, Audry Mulumba Wakamba, Alain Ngashi Ngongo, Michel Kabamba Nzaji","doi":"10.1080/21645515.2024.2357214","DOIUrl":"10.1080/21645515.2024.2357214","url":null,"abstract":"<p><p>The COVID-19 booster dose is considered an important adjunct for the control of the COVID-19 pandemic due to reports of reduced immunity in fully vaccinated individuals. The aims of this study were to assess healthcare workers' intention to receive the booster dose of COVID-19 vaccine and to identify predictive factors among healthcare workers. A cross-sectional study was conducted among healthcare workers selected in two provinces, Kasai Oriental, and Haut-Lomami. Data were collected using a questionnaire administered through structured face-to-face interviews, with respondents using a pre-tested questionnaire set up on the Open Data Kit (ODK Collect). All data were analyzed using SPSS v26.0 (IBM Corporation, Armonk, NY, USA). Vaccination coverage for COVID-19, considering declarations by health workers, is around 85.9% for the province of Kasai Oriental and 85.8% for Haut-Lomami. A total of 975 responses were collected, 71.4% of health workers at Kasai Oriental and 66.4% from Haut-Lomami declared a definite willingness to receive a COVID-19 vaccine booster. The duration of protection was the main reason for accepting a booster COVID-19 dose for 64.6% of the respondents. Logistic regression analysis showed that having chronic diseases (aOR = 2.95 [1.65-5.28]), having already received one of the COVID-19 vaccines (aOR = 2.72 [1.43-5. 19]); the belief that only high-risk individuals, such as healthcare professionals and elderly people suffering from other illnesses, needed a booster dose (aOR = 1.75 [1.10-2.81]). Considering the burden of COVID-19, a high acceptance rate for booster doses could be essential to control the pandemic. Our results are novel and could help policymakers design and implement specific COVID-19 vaccination programs to reduce reluctance to seek booster vaccination.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2357214"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11135840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141089161","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":"Parental knowledge on the respiratory syncytial virus before the nirsevimab immunization program: Attitudes toward immunization in an autonomous community of Spain.","authors":"Matilde Zornoza Moreno, Jaime Jesús Pérez Martín, Mª Cruz Gómez Moreno, Mª Pilar Ros Abellán","doi":"10.1080/21645515.2024.2357439","DOIUrl":"10.1080/21645515.2024.2357439","url":null,"abstract":"<p><p>Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in young children and associated with most bronchiolitis- and pneumonia-related hospitalizations. A new preventive monoclonal antibody (MAb), nirsevimab, has been launched in the United States, Luxembourg, and France, and was recently approved to be given in a population-based manner throughout Spain. This study aimed to have a first pre-immunization insight into the Spanish parental knowledge about bronchiolitis, RSV, and nirsevimab immunization. Parents in Murcia with children <2 years of age up to the date of September 1, 2023, were selected to complete a questionnaire. The primary endpoint was the parental knowledge about bronchiolitis, RSV, and nirsevimab. A total of 3,217 responses were analyzed. The majority (95.8%) were aware of bronchiolitis. Meanwhile, 46.6% of the respondents knew about RSV, most of them only after the first child's birth. Information about RSV or bronchiolitis was mainly obtained from family members, with only 4.8% reporting having been informed by Health care Professionals (HCPs). Only 11.2% of respondents were aware of nirsevimab. Nonetheless, these were not entirely satisfied with the information received (score of 3.3 out of 5) and shared that HCPs should be the primary source of information. The present survey then highlights the need for better and more efficient educational strategies directed to all parents/legal guardians. It also sheds some light on the different factors that should be considered to improve awareness of RSV immunization to decrease its burden in Spain and beyond.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2357439"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11168215/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141301904","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}
Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani
{"title":"Bridging the gap: The future of biosimilars regulations.","authors":"Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani","doi":"10.1080/21645515.2024.2362450","DOIUrl":"10.1080/21645515.2024.2362450","url":null,"abstract":"<p><p>Biosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities in regulations of biosimilar vaccines and immunotherapeutic products across different nations. It also navigates the benefits of global regulatory alignment and challenges that may be encountered. The current discrepancies in regulations across different countries, which pose significant challenges for the development and approval of biosimilar vaccines and immunotherapeutic products. These disparities often lead to delayed market access, increased development costs, and hindered innovation. The commentary stresses that such obstacles could be mitigated through harmonized regulations, resulting in faster approvals, reduced healthcare costs, and improved patient outcomes. Moreover, the commentary explores the specific complexities associated with biosimilar vaccines and immunotherapeutic, such as the intricate evaluation of biosimilarity due to their molecular composition and immunogenic properties. In conclusion, the editorial advocates for collaborative efforts to overcome the challenges in achieving global regulatory harmonization for biosimilars. This includes establishing uniform standards, fostering international cooperation among regulatory agencies, and promoting educational initiatives for healthcare providers and regulators. The ultimate goal is to ensure that patients worldwide have timely access to safe, effective, and affordable biosimilar treatments.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2362450"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11188803/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141421514","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}