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Pharmaceutics
Special Issues
Trends in mRNA Vaccine Development and Applications
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Trends in mRNA Vaccine Development and Applications

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Gene and Cell Therapy".

Deadline for manuscript submissions: closed (30 April 2025) | Viewed by 14083

Special Issue Editor

Prof. Dr. Janos Szebeni

E-Mail Website
Guest Editor
Nanomedicine Research and Education Center, Institute of Translational Medicine, Semmelweis University, 1089 Budapest, Hungary
Interests: anti-PEG antibodies; complement system/activation/inhibition; pharmacokinetics; immunotoxicity; adverse immunological side effects; hypersensitivity/allergic reactions; gene therapy; LNP-mRNA vaccines; immune activation by nano-biopharmaceuticals; complement-activation-related pseudoallergy (CARPA); cytokine release/storm syndrome; in vitro/in vivo models of innate immune activation; infusion reactions/anaphylaxis; allergic/anaphylactic reactions to COVID vaccines
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Since the roll-out of mRNA-lipid nanoparticle (LNP)-based COVID-19 vaccines in 2020, billions of people have been immunized with this type of vaccine, representing a novel technology platform to fight infectious diseases. Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, the lead mRNA-LNP formulations, trigger immune responses that effectively reduce the pathogenicity of SARS-CoV-2, saving millions from severe illness or death. The mechanism of this benefit, details of these vaccines’ structure and function, as well as their side effects have been the subjects of unprecedented scientific and public attention, yet novelties in these fields emerge each day. Many believe that technology will surpass all other approaches of gene and pharmacotherapy, but there is also a lot of scientific and public discussion of presently ill-understood adverse effects, of which clarification is necessary to secure safe beside efficacy.

The goal of this Special Issue of Pharmaceutics is to provide a 2024 update on the most recent developments and prospects in this field, good or unfavorable, that may guide the development of next-generation mRNA-LNP vaccines and other pharmaceuticals. Original research data and comprehensive reviews are all welcome to be submitted to this Special Issue in order to make it a source of state-of-the-art information in the field.

Prof. Dr. Janos Szebeni
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • vaccines
  • vaccination
  • modified mRNA
  • lipid nanoparticles (LNPs)
  • mRNA-LNP
  • COVID-19 pandemic
  • SARS-CoV-2
  • spike protein
  • immunogenicity
  • adverse reactions

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Published Papers (2 papers)

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Research

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38 pages, 28895 KiB  
Article
Bioinformatics-Driven mRNA-Based Vaccine Design for Controlling Tinea Cruris Induced by Trichophyton rubrum
by Amir Elalouf, Hanan Maoz and Amit Yaniv Rosenfeld
Pharmaceutics 2024, 16(8), 983; https://doi.org/10.3390/pharmaceutics16080983 - 25 Jul 2024
Cited by 2 | Viewed by 2248 | Correction
Abstract
Tinea cruris, a dermatophyte fungal infection predominantly caused by Trichophyton rubrum and Epidermophyton floccosum, primarily affects the groin, pubic region, and adjacent thigh. Its recurrence is frequent, attributable to repeated fungal infections in susceptible individuals, especially those with onychomycosis or tinea pedis, [...] Read more.
Tinea cruris, a dermatophyte fungal infection predominantly caused by Trichophyton rubrum and Epidermophyton floccosum, primarily affects the groin, pubic region, and adjacent thigh. Its recurrence is frequent, attributable to repeated fungal infections in susceptible individuals, especially those with onychomycosis or tinea pedis, which act as reservoirs for dermatophytes. Given the persistent nature of tinea cruris, vaccination emerges as a promising strategy for fungal infection management, offering targeted, durable protection against various fungal species. Vaccines stimulate both humoral and cell-mediated immunity and are administered prophylactically to prevent infections while minimizing the risk of antifungal resistance development. Developing fungal vaccines is challenging due to the thick fungal cell wall, similarities between fungal and human cells, antigenic variation, and evolutionary resemblance to animals, complicating non-toxic target identification and T-cell response variability. No prior research has shown an mRNA vaccine for T. rubrum. Hence, this study proposes a novel mRNA-based vaccine for tinea cruris, potentially offering long-term immunity and reducing reliance on antifungal medications. This study explores the complete proteome of T. rubrum, identifying potential protein candidates for vaccine development through reverse vaccinology. Immunogenic epitopes from these candidates were mapped and integrated into multitope vaccines and reverse translated to construct mRNA vaccines. Then, the mRNA was translated and computationally assessed for physicochemical, chemical, and immunological attributes. Notably, 1,3-beta-glucanosyltransferase, CFEM domain-containing protein, cell wall galactomannoprotein, and LysM domain-containing protein emerged as promising vaccine targets. Antigenic, immunogenic, non-toxic, and non-allergenic cytotoxic T lymphocyte, helper T lymphocyte, and B lymphocyte epitopes were selected and linked with appropriate linkers and Toll-like receptor (TLR) agonist adjuvants to formulate vaccine candidates targeting T. rubrum. The protein-based vaccines underwent reverse translation to construct the mRNA vaccines, which, after inoculation, were translated again by host ribosomes to work as potential components for triggering the immune response. After that, molecular docking, normal mode analysis, and molecular dynamic simulation confirmed strong binding affinities and stable complexes between vaccines and TLR receptors. Furthermore, immune simulations of vaccines with and without adjuvant demonstrated activation of immune responses, evidenced by elevated levels of IgG1, IgG2, IgM antibodies, cytokines, and interleukins. There was no significant change in antibody production between vaccines with and without adjuvants, but adjuvants are crucial for activating the innate immune response via TLRs. Although mRNA vaccines hold promise against fungal infections, further research is essential to assess their safety and efficacy. Experimental validation is crucial for evaluating their immunogenicity, effectiveness, and safety. Full article
(This article belongs to the Special Issue Trends in mRNA Vaccine Development and Applications)
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Review

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16 pages, 2069 KiB  
Review
Expanded Spectrum and Increased Incidence of Adverse Events Linked to COVID-19 Genetic Vaccines: New Concepts on Prophylactic Immuno-Gene Therapy, Iatrogenic Orphan Disease, and Platform-Inherent Challenges
by Janos Szebeni
Pharmaceutics 2025, 17(4), 450; https://doi.org/10.3390/pharmaceutics17040450 - 31 Mar 2025
Viewed by 11035
Abstract
The mRNA- and DNA-based “genetic” COVID-19 vaccines can induce a broad range of adverse events (AEs), with statistics showing significant variation depending on the timing and data analysis methods used. Focusing only on lipid nanoparticle-enclosed mRNA (mRNA-LNP) vaccines, this review traces the evolution [...] Read more.
The mRNA- and DNA-based “genetic” COVID-19 vaccines can induce a broad range of adverse events (AEs), with statistics showing significant variation depending on the timing and data analysis methods used. Focusing only on lipid nanoparticle-enclosed mRNA (mRNA-LNP) vaccines, this review traces the evolution of statistical conclusions on the prevalence of AEs and incidents associated with these vaccines, from initial underestimation of atypical, severe toxicities to recent claims suggesting the possible contribution of COVID-19 vaccinations to the excess deaths observed in many countries over the past few years. Among hundreds of different AEs listed in Pfizer’s pharmacovigilance survey, the present analysis categorizes the main symptoms according to organ systems, with nearly all of them being affected. Using data from the US Vaccine Adverse Event Reporting System and a global vaccination dataset, a comparison of the prevalence and incidence rates of AEs induced by genetic versus flu vaccines revealed an average 26-fold increase in AEs with the use of genetic vaccines. The difference is especially pronounced in the case of severe ‘Brighton-listed’ AEs, which are also observed in COVID-19 and post-COVID conditions. Among these, the increases in incidence rates relative to flu vaccines, given as x-fold rises, were 1152x, 455x, 226x, 218x, 162x, 152x, and 131x for myocarditis, thrombosis, death, myocardial infarction, tachycardia, dyspnea, and hypertension, respectively. The review delineates the concept that genetic vaccines can be regarded as prophylactic immuno-gene therapies and that the observed chronic disabling AEs might be categorized as iatrogenic orphan diseases. It also examines the unique vaccine characteristics that could be causally related to abnormal immune responses which potentially lead to adverse events and complications. These new insights may contribute to improving the safety of this platform technology and assessing the risk/benefit balance of various products. Full article
(This article belongs to the Special Issue Trends in mRNA Vaccine Development and Applications)
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