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Messenger RNA (mRNA) vaccines have emerged as a transformative platform in modern vaccinology. mRNA vaccine is a powerful alternative to traditional vaccines due to their high potency, safety, and efficacy, coupled with the ability for rapid clinical development, scalability and cost-effectiveness in manufacturing. Initially conceptualized in the 1970s, the first study about the effectiveness of a mRNA vaccine against influenza was conducted in 1993. Since then, the development of mRNA vaccines has rapidly gained significance, especially in combating the COVID-19 pandemic. Their unprecedented success during the COVID-19 pandemic, as demonstrated by the Pfizer-BioNTech and Moderna vaccines, highlighted their transformative potential. This review provides a comprehensive analysis of the mRNA vaccine technology, detailing the structure of the mRNA vaccine and its mechanism of action in inducing immunity. Advancements in nanotechnology, particularly lipid nanoparticles (LNPs) as delivery vehicles, have revolutionized the field. The manufacturing processes, including upstream production, downstream purification, and formulation are also reviewed. The clinical progress of mRNA vaccines targeting viruses causing infectious diseases is discussed, emphasizing their versatility and therapeutic potential. Despite their success, the mRNA vaccine platform faces several challenges, including improved stability to reduce dependence on cold chain logistics in transport, enhanced delivery mechanisms to target specific tissues or cells, and addressing the risk of rare adverse events. High costs associated with encapsulation in LNPs and the potential for unequal global access further complicate their widespread adoption. As the world continues to confront emerging viral threats, overcoming these challenges will be essential to fully harness the potential of mRNA vaccines. It is anticipated that mRNA vaccines will play a major role in defining and shaping the future of global health.

Influenza A virus is one of the most important zoonotic pathogens that can cause severe symptoms and has the potential to cause high number of deaths and great economic loss. Vaccination is still the best option to prevent influenza virus infection. Different types of influenza vaccines, including live attenuated virus vaccines, inactivated whole virus vaccines, virosome vaccines, split-virion vaccines and subunit vaccines have been developed. However, they have several limitations, such as the relatively high manufacturing cost and long production time, moderate efficacy of some of the vaccines in certain populations, and lack of cross-reactivity. These are some of the problems that need to be solved. Here, we summarized recent advances in the development and application of different types of influenza vaccines, including the recent development of viral vectored influenza vaccines. We also described the construction of other vaccines that are based on recombinant influenza viruses as viral vectors. Information provided in this review article might lead to the development of safe and highly effective novel influenza vaccines.

Unless urgently needed to prevent a pandemic, the development of a viral vaccine should follow a rigorous scientific approach. Each vaccine candidate should be designed considering the in-depth knowledge of protective immunity, followed by preclinical studies to assess immunogenicity and safety, and lastly, the evaluation of selected vaccines in human clinical trials. The recently concluded first phase II clinical trial of a human hepatitis C virus (HCV) vaccine followed this approach. Still, despite promising preclinical results, it failed to protect against chronic infection, raising grave concerns about our understanding of protective immunity. This setback, combined with the lack of HCV animal models and availability of new highly effective antivirals, has fueled ongoing discussions of using a controlled human infection model (CHIM) to test new HCV vaccine candidates. Before taking on such an approach, however, we must carefully weigh all the ethical and health consequences of human infection in the absence of a complete understanding of HCV immunity and pathogenesis. We know that there are significant gaps in our knowledge of adaptive immunity necessary to prevent chronic HCV infection. This review discusses our current understanding of HCV immunity and the critical gaps that should be filled before embarking upon new HCV vaccine trials. We discuss the importance of T cells, neutralizing antibodies, and HCV genetic diversity. We address if and how the animal HCV-like viruses can be used for conceptualizing effective HCV vaccines and what we have learned so far from these HCV surrogates. Finally, we propose a logical but narrow path forward for HCV vaccine development.

Messenger RNA (mRNA) vaccines offer an adaptable and scalable platform for cancer immunotherapy, requiring optimal design to elicit a robust and targeted immune response. Recent advancements in bioinformatics and artificial intelligence (AI) have significantly enhanced the design, prediction, and optimization of mRNA vaccines. This paper reviews technologies that streamline mRNA vaccine development, from genomic sequencing to lipid nanoparticle (LNP) formulation. We discuss how accurate predictions of neoantigen structures guide the design of mRNA sequences that effectively target immune and cancer cells. Furthermore, we examine AI-driven approaches that optimize mRNA-LNP formulations, enhancing delivery and stability. These technological innovations not only improve vaccine design but also enhance pharmacokinetics and pharmacodynamics, offering promising avenues for personalized cancer immunotherapy.

The development of effective vaccines is crucial for combating current and emerging pathogens. Despite significant advances in the field of vaccine development there remain numerous challenges including the lack of standardized data reporting and curation practices, making it difficult to determine correlates of protection from experimental and clinical studies. Significant gaps in data and knowledge integration can hinder vaccine development which relies on a comprehensive understanding of the interplay between pathogens and the host immune system. In this review, we explore the current landscape of vaccine development, highlighting the computational challenges, limitations, and opportunities associated with integrating diverse data types for leveraging artificial intelligence (AI) and machine learning (ML) techniques in vaccine design. We discuss the role of natural language processing, semantic integration, and causal inference in extracting valuable insights from published literature and unstructured data sources, as well as the computational modeling of immune responses. Furthermore, we highlight specific challenges associated with uncertainty quantification in vaccine development and emphasize the importance of establishing standardized data formats and ontologies to facilitate the integration and analysis of heterogeneous data. Through data harmonization and integration, the development of safe and effective vaccines can be accelerated to improve public health outcomes. Looking to the future, we highlight the need for collaborative efforts among researchers, data scientists, and public health experts to realize the full potential of AI-assisted vaccine design and streamline the vaccine development process.

Influenza remains a significant public health concern, particularly among high-risk populations, due to its capacity to cause annual epidemics and potentially trigger global pandemics. Despite the availability of countermeasures such as vaccines and antiviral treatments, their effectiveness is hindered by factors such as resistance development with manufacturing of the influenza vaccine still heavily relying on decades-old technologies. This review therefore examines the mechanisms by which influenza viruses evade host immunity and evaluates current and emerging approaches to enhance vaccine-mediated protection. Advances targeting the conserved hemagglutinin (HA) stem, incorporating multiple HA subtypes, and the use of adjuvants are discussed, alongside increased attention to neuraminidase (NA) and other viral components as immunogenic targets. Strategic epitope prediction, through glycan masking, evolutionary forecasting, and consensus sequence design, offer promising frameworks for rational vaccine design. Furthermore, delivery platforms, including recombinant protein, mRNA, and conjugate vaccines are explored for their potential to elicit broad and durable immunity. Collectively, these developments highlight a multifaceted approach towards the design of effective interventions against this persistent healthcare challenge.

The COVID-19 pandemic altered the vaccine development paradigm with accelerated timelines from concept through clinical safety and efficacy. Characterization and release assays for vaccine programs were developed under similar time constraints to support bioprocess development, scaleup and formulation. During the development of these vaccines, SARS-CoV-2 variants of concern (VOCs) emerged requiring integration of additional antigens into the target product profile. Biochemical testing to support the addition of new antigen variants (identity, quantity, antigenicity/potency) needed substantial re-development. Here we present a reversed-phase high-performance liquid-chromatography method for antigen purity with orthogonal identification characterization comprising of Simple Wes and liquid-chromatography tandem mass spectrometry (LC/MS/MS) to support accelerated process development for recombinant protein vaccines. This suite of assays was deployed to support rapid, scientific decision-making enabling the transition from completion of a placebo-controlled dose-ranging Phase 2 study to the start of the global Phase 3 safety and efficacy trial in less than 2 weeks.

Influenza vaccines that provide more effective immunity to seasonal influenza as well as protection against a broad range of emerging influenza viruses with pandemic potential are needed to reduce the public-health burden of influenza and enhance pandemic preparedness. The Influenza Vaccines Research and Development (R&D) Roadmap (IVR) was published in 2021 to serve as a strategic planning tool to advance influenza vaccine R&D. Following IVR publication, a 3-year monitoring, evaluation, and adjustment (ME&A) program was implemented to assess progress in meeting the milestones outlined in the IVR. As of mid-May 2025, 16 (17%) of the 93 milestones had been accomplished or partially accomplished, with the majority (67; 72%) in various stages of progress. Of the 35 milestones designated high-priority, five (14%) had been accomplished or partially accomplished, 29 (83%) are in progress, and no progress was identified for one (3%). Key accomplishments include: establishing longitudinal cohort studies to characterize immune responses to influenza virus infection and vaccination by age over time and by vaccine product; creating a comprehensive landscape of innovative influenza vaccine technologies in preclinical and clinical development; advancing next-generation and broadly protective influenza vaccine candidates into clinical trials; identifying relevant lessons learned from accelerated SARS-CoV-2 vaccine development during the COVID-19 pandemic; and initiating development of a full value of improved influenza vaccine assessment (FVIVA) to inform investment and guide the eventual uptake of improved vaccines globally. Persistent challenges include clarifying immune mechanisms for generating durable and broadly protective immunity, enhancing understanding of immune imprinting and the role of mucosal immunity in preventing infection and transmission, identifying correlates of protection, and exploring regulatory options for broadly protective influenza vaccine licensure. The IVR ME&A program provides a basis for ongoing critical review of progress in influenza vaccine R&D to inform decision-making on research priorities and funding. •Improved seasonal influenza vaccines can reduce the global burden of influenza.•Broadly protective flu vaccines will enhance preparedness for pandemic influenza.•Many next-generation influenza vaccine candidates are in the R&D pipeline.•Continued research is critical to resolve key issues in immunology and vaccinology.•Consensus is needed to determine the basis for licensing broadly protective vaccines.

Dengue fever (DF), a leading arboviral disease globally, is caused by the Dengue virus (DENV) and represents a significant public health concern, with an estimated 390 million cases reported annually. Due to the complexity of the various dengue variants and the severity of the disease, vaccination emerges as the essential strategy for combating this widespread infectious disease. The absence of specific antiviral medications underscores the critical need for developing a Dengue vaccine. This review aims to present the current status and future prospects of Dengue vaccine development. Further, this review elaborates on the various strategies employed in vaccine development, including attenuated, inactivated, subunit, and viral vector vaccines. Each approach is evaluated based on its immunogenicity, safety, and efficacy, drawing on data from preclinical and clinical studies to highlight the strengths and limitations of each candidate vaccine. The current study sheds light on future directions and research priorities in developing Dengue vaccines. In conclusion, the development of a Dengue vaccine holds significant potential for reducing the global burden of DF. However, challenges remain in terms of vaccine safety, efficacy, delivery, and availability. Overcoming these challenges, coupled with advancements in vaccine technology, could lead to better control and prevention of Dengue, thereby enhancing public health and quality of life.

In 2015 the UK Vaccine Network through its Working Group 3 began the creation of a website describing the conventional development of human and veterinary vaccines, which routinely takes several years to complete from concept through to licensure, in the form of process development maps. This website has proved to be a valuable resource for those involved in commercial vaccine development and it has also highlighted the potential bottlenecks within the processes. However, during the COVID-19 pandemic, vaccines were created, licenced and administered within 1 year of the SARS-CoV-2 virus sequence being made available to researchers globally, through the use of novel platform technologies, such as viral vectors and mRNA. The paper describes the updating of this vaccine process development website and the inclusion of a rapid development map with 14 Stages based knowledge gained during the development of the University of Oxford/Astra Zeneca ChAdOx-1 vectored COVID-19 vaccine. The map captures the key steps required to expedite human vaccine development in the face of a pandemic threat from pre-clinical discovery, vaccine platform development, regulatory review and approval through to the administration of the first dose in humans. •Info is presented on how to rapidly develop and licence a vaccine against a new disease, using experience from COVID-19.•The importance of background data on the disease agent and platform technologies for the rapid development is emphasised.•Within 14 Stages what is required in order to rapidly move a new vaccine from discovery to human application is described.•The differences between conventional and rapid vaccine development processes are outlined.•How to expedite the vaccine regulatory process to gain a more rapid marketing authorisation within one year is described.