Chaoying Hu, Yu Bai, Jianyang Liu, Yiping Wang, Qian He, Xuanxuan Zhang, Feiran Cheng, Miao Xu, Qunying Mao, Zhenglun Liang
INTRODUCTION: The mRNA vaccine technologies have progressed rapidly in recent years. The COVID-19 pandemic has accelerated the application of mRNA vaccines, with research and development and clinical trials underway for many vaccines. Application of the quality by design (QbD) framework to mRNA vaccine development and establishing standardized quality control protocols for mRNA vaccines are essential for the continued development of high-quality mRNA vaccines. AREAS COVERED: mRNA vaccines include linear mRNA, self-amplifying mRNA, and circular RNA vaccines...
May 11, 2024: Expert Review of Vaccines
Shigeki Nakamura, Masashi Mikami, Tomoyuki Hayamizu, Naohiro Yonemoto, Camille Moyon, Mark Gouldson, Catriona Crossan, Jeffrey Vietri, Kazumasa Kamei
BACKGROUND: The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is used in the Japanese National Immunization Program for older adults and adults with increased risk for pneumococcal disease, however, disease incidence and associated burden remain high. We evaluated the cost-effectiveness of pneumococcal conjugate vaccines (PCVs) for adults aged 65 years and high-risk adults aged 60-64 years in Japan. RESEARCH DESIGN AND METHODS: Using a Markov model, we evaluated lifetime costs using societal and healthcare payer perspectives and estimated quality-adjusted life-years (QALYs), and number of prevented cases and deaths caused by invasive pneumococcal disease (IPD) and non-IPD...
May 4, 2024: Expert Review of Vaccines
Cynthia Burman, Markus Knuf, Marco Aurelio P Sáfadi, Jamie Findlow
INTRODUCTION: Invasive meningococcal disease (IMD) is potentially fatal and associated with severe sequelae among survivors. It is preventable by several vaccines, including meningococcal vaccines targeting the most common disease-causing serogroups (A, B, C, W, Y). The meningococcal ACWY tetanus toxoid conjugate vaccine (MenACWY-TT [Nimenrix]) is indicated from 6 weeks of age in the European Union and > 50 additional countries. AREAS COVERED: Using PubMed, Google Scholar, ClinicalTrials...
May 2, 2024: Expert Review of Vaccines
Ashraf Madkour, Adel M Elsayed, Hala Sweed, Ibrahim El Ebrashy, Magdy Abdelhamid, Mohamed Zidan
INTRODUCTION: Lower respiratory tract infection is one of the leading causes of morbidity and mortality all over the world, with a substantial impact on healthcare costs. In Egypt, local consensus on its burden, diagnosis, and vaccination is scarce. This expert opinion is the first to address the local recommendations for vaccinating adults against respiratory infection. It sheds light on the growing need to understand the barriers and underpublicized concept of adult vaccination in Egypt...
May 2, 2024: Expert Review of Vaccines
Jia-Ying Yang, Guo-Chun Li, Ying Yuan
BACKGROUND: Traditional vaccine development, often a lengthy and costly process of three separated phases. However, the swift development of Covid-19 vaccines highlighted the critical importance of accelerating the approval of vaccines. This article showcases a seamless phase 2/3 trial design to expedite the development process, particularly for multi-valent vaccines. RESEARCH DESIGN AND METHODS: This study utilizes simulation to compare the performance of seamless phase 2/3 design with that of conventional trial design, specifically by re-envisioning a 9-valent HPV vaccine trial...
April 29, 2024: Expert Review of Vaccines
Masayoshi Shinjoh, Kanae Togo, Tomoyuki Hayamizu, Naohiro Yonemoto, Junko Morii, Johnna Perdrizet, Kazumasa Kamei
BACKGROUND: The Japanese National Immunization Program currently includes the pediatric 13valent pneumococcal conjugate vaccine (PCV13) to prevent pneumococcal infections. We aimed to evaluate the cost-effectiveness of 20-valent PCV (PCV20) as a pediatric vaccine versus PCV13. METHODS: A decision-analytic Markov model was used to estimate expected costs, qualityadjusted life-years (QALYs), and prevented cases and deaths caused by invasive pneumococcal disease, pneumonia, and acute otitis media over a ten-year time horizon from the societal and healthcare payer perspectives...
April 29, 2024: Expert Review of Vaccines
Peter J Hotez, Maria Elena Bottazzi, Nelufa Yesmin Islam, Jungsoon Lee, Jeroen Pollet, Cristina Poveda, Ulrich Strych, Syamala Rani Thimmiraju, Nestor Uzcategui Araujo, Leroy Versteeg, Daniel Gorelick
INTRODUCTION: Zebrafishesrepresent a proven model for human diseases and systems biology, exhibitingphysiological and genetic similarities and having innate and adaptive immunesystems. However, they are underexplored for human vaccinology, vaccinedevelopment, and testing. Here we summarize gaps and challenges. AREAS COVERED: Zebrafish models have fourpotential applications: 1) Vaccine safety: The pastsuccesses in using zebrafishes to test xenobiotics could extend to vaccine andadjuvant formulations for general safety or target organs due to the zebrafish embryos'optical transparency...
April 25, 2024: Expert Review of Vaccines
Xiaojian Zhang, Ted M Ross
INTRODUCTION: Anti-neuraminidase (NA) immunity correlates with the protection against influenza virus infection in both human and animal models. The aim of this review is to better understand the mechanism of anti-NA immunity, and also to evaluate the approaches on developing NA-based influenza vaccines or enhancing immune responses against NA for current influenza vaccines. AREAS COVERED: In this review, the structure of influenza neuraminidase, the contribution of anti-NA immunity to protection, as well as the efforts and challenges of targeting the immune responses to NA were discussed...
April 17, 2024: Expert Review of Vaccines
Josiah Ryman, Jeffrey R Sachs, Natalie Banniettis, Thomas Weiss, Maurice Ahsman, Ka Lai Yee, Jessica Weaver
BACKGROUND: Next generation, higher valency pneumococcal conjugate vaccines (PCVs) are assessed and licensed by comparing the immune response across serotypes shared with the PCVs that are standard of care for prevention of pneumococcal disease. METHODS: Using a previously qualified method we predicted the serotype-specific vaccine effectiveness (VE) against invasive pneumococcal disease of V114 and PCV20 for the serotypes shared with PCV13 in an EU, Russian, and Australian pediatric population that is recommended to receive a 2 + 1 dosing regimen...
March 28, 2024: Expert Review of Vaccines
Abundio Balgos, Suad Ai Hannawi, Wen-Li Chen, Alaa Abuquta, Linda Safeldin, Aala Hassan, Ahmad Alamadi, Louie Tirador, Anjuli May Jaen, Ralph Elvi Villalobos, Chen Mo, Zi-Jing Yue, Ying Ma, Qing-Shuang Wang, Ren-Du Wen, Zheng Yao, Jia-Ping Yu, Wen-Rong Yao, Jian-Hui Zhang, Kun-Xue Hong, Yong Liu, Jing-Xin Li
BACKGROUND: Recombinant protein vaccines play a crucial role in providing broad immuno-protection against SARS-CoV-2 variants. This study evaluates the safety and immunogenicity of ReCOV as a booster dose in two randomized, observer-blinded, active-controlled Phase 2 clinical trials. RESEARCH DESIGN AND METHODS: In Study-1, adults who had received two or three doses of inactivated COVID-19 vaccine were randomized (1:1:1) to receive 20 μg ReCOV, 40 μg ReCOV, or an inactivated vaccine (COVILO®) in the United Arab Emirates...
March 26, 2024: Expert Review of Vaccines
Ray Borrow, Jamie Findlow
INTRODUCTION: The epidemiology of invasive meningococcal disease (IMD), a rare but potentially fatal illness, is typically described as unpredictable and subject to sporadic outbreaks. AREAS COVERED: Meningococcal epidemiology and vaccine use during the last ~200 years are examined within the context of meningococcal characterization and classification to guide future IMD prevention efforts. EXPERT OPINION: Historical and contemporary data highlight the dynamic nature of meningococcal epidemiology, with continued emergence of hyperinvasive clones and affected regions...
March 22, 2024: Expert Review of Vaccines
Gabiria Pastore, Jacopo Polvere, Fabio Fiorino, Simone Lucchesi, Giorgio Montesi, Ilaria Rancan, Sara Zirpoli, Arianna Lippi, Miriam Durante, Massimiliano Fabbiani, Mario Tumbarello, Francesca Montagnani, Donata Medaglini, Annalisa Ciabattini
BACKGROUND: Heterologous prime-boost SARS-CoV-2 vaccine schedules could enhance immunogenicity and improve mass immunization during vaccine shortages. RESEARCH DESIGN AND METHODS: Here, we measured the immunogenicity and effectiveness in the real-world setting of the mRNA booster dose in 181 subjects who had completed primary vaccination with ChAdOx1, BNT162b2 or mRNA1273 vaccines (IMMUNO_COV study; protocol code 18,869). The spike-specific antibody and B cell responses were analyzed up to 6 months after boosting...
March 22, 2024: Expert Review of Vaccines
Hua Shi, Ted M Ross
INTRODUCTION: Vaccination is the most effective method to control the prevalence of seasonal influenza and the most widely used influenza vaccine is the inactivated influenza vaccine (IIV). Each season, the influenza vaccine must be updated to be most effective against current circulating variants. Therefore, developing a universal influenza vaccine (UIV) that can elicit both broad and durable protection is of the utmost importance. AREA COVERED: This review summarizes and compares the available influenza vaccines in the market and inactivation methods used for manufacturing IIVs...
March 20, 2024: Expert Review of Vaccines
Vipin M Vashishtha, Puneet Kumar
INTRODUCTION: Current vaccines vary widely in both their efficacy against infection and disease, and the durability of the efficacy. Some vaccines provide practically lifelong protection with a single dose, while others provide only limited protection following annual boosters. What variables make vaccine-induced immune responses last? Can breakthroughs in these factors and technologies help us produce vaccines with better protection and fewer doses? The durability of vaccine-induced protection is now a hot area in vaccinology research, especially after COVID-19 vaccines lost their luster...
March 15, 2024: Expert Review of Vaccines
Xuanxuan Zhang, Jialu Zhang, Si Chen, Qian He, Yu Bai, Jianyang Liu, Zhongfang Wang, Zhenglun Liang, Ling Chen, Qunying Mao, Miao Xu
INTRODUCTION: Following the coronavirus disease pandemic, respiratory mucosal vaccines that elicit both mucosal and systemic immune responses have garnered increasing attention. However, human physiological characteristics pose significant challenges in the evaluation of mucosal immunity, which directly impedes the development and application of respiratory mucosal vaccines. AREAS COVERED: This study summarizes the characteristics of immune responses in the respiratory mucosa and reviews the current status and challenges in evaluating immune response to respiratory mucosal vaccines...
March 6, 2024: Expert Review of Vaccines
Cody Palmer, Christiaan Dolk, Ugne Sabale, Wei Wang, Kunal Saxena
BACKGROUND: A bivalent human papillomavirus vaccine (2vHPV) is currently used in the Netherlands; a nonavalent vaccine (9vHPV) is also licensed. RESEARCH DESIGN AND METHODS: We compared the public health and economic benefits of 2vHPV- and 9vHPV-based vaccination strategies in the Netherlands over 100 years using a validated deterministic dynamic transmission metapopulation model. RESULTS: Compared to 2vHPV, the 9vHPV strategy averted an additional 3,245 cases of and 825 deaths from 9vHPV-strain-attributable cancers, 4,247 cases of and 190 deaths from recurrent respiratory papillomatosis (RRP), and 1,009,637 cases of anogenital warts (AGWs), with an incremental cost-effectiveness ratio (ICER) of €4,975 per quality-adjusted life year (QALY) gained...
February 28, 2024: Expert Review of Vaccines
Mitsuhiro Nagano, Kazumasa Kamei, Hiroyuki Matsuda, Chihiro Takahashi, Jingyan Yang, Koji Wada, Naohiro Yonemoto
BACKGROUND: The aim of this study was to evaluate the public health and economic impact of the COVID-19 booster vaccination with BNT162b2 in Japan during an Omicron-dominant period from early 2022. RESEARCH DESIGN AND METHODS: A combined cohort Markov decision tree model estimated the cost-effectiveness of annual or biannual booster vaccination strategies compared to no booster vaccination for those aged 65 years and above, and those aged 60-64 years at high risk as the base case...
February 27, 2024: Expert Review of Vaccines
Alberto San Francisco Ramos, Carolina Liu Sanchez, Tatiana Bovill Rose, David Smith, Natasha Thorn, Eva Galiza, Thahmena Miah, Jennifer Pearce, Cecilia Hultin, Catherine Cosgrove, Yingfen Hsia, Paul T Heath
INTRODUCTION: Different COVID-19 vaccines are being utilized as boosters. This systematic review and meta-analysis aims to evaluate the reactogenicity of COVID-19 vaccines given as booster doses, according to vaccine type, dose, timing, participant characteristics and primary immunization regimen received. METHODS: Four databases (MEDLINE, Embase, Web of Science and CENTRAL) were searched for randomized controlled trials between 1 January 2020 and 1 January 2023 according to predetermined criteria...
February 20, 2024: Expert Review of Vaccines
Shanti Pather, Alexander Muik, Ruben Rizzi, Federico Mensa
Summary What are variant-adapted COVID-19 vaccines? The COVID-19 vaccine developed by BioNTech and Pfizer is known as BNT162b2 (Comirnaty). BNT162b2 contains messenger RNA, or mRNA, from SARS-CoV-2. SARS-CoV-2 is the virus responsible for COVID-19. mRNA is a type of genetic material that contains the instructions that tell cells in the body how to make a protein. The mRNA in BNT162b2 tells the body to make one of the proteins from SARS-CoV-2 known as the spike protein.This teaches the body's defense system, known as the immune system, to recognize and respond to a SARS-CoV-2 infection...
December 31, 2024: Expert Review of Vaccines
James J Bull, Scott L Nuismer, Christopher H Remien, Megan E Griffiths, Rustom Antia
INTRODUCTION: Transmissible vaccines offer a novel approach to suppressing viruses in wildlife populations, with possible applications against viruses that infect humans as zoonoses - Lassa, Ebola, rabies. To ensure safety, current designs propose a recombinant vector platform in which the vector is isolated from the target wildlife population. Because using an endemic vector creates the potential for preexisting immunity to block vaccine transmission, these designs focus on vector viruses capable of superinfection, spreading throughout the host population following vaccination of few individuals...
February 19, 2024: Expert Review of Vaccines
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