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Keywords = potential pandemic vaccine

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19 pages, 8275 KiB  
Article
Adenoviral Vector-Based Vaccine Expressing Hemagglutinin Stem Region with Autophagy-Inducing Peptide Confers Cross-Protection Against Group 1 and 2 Influenza A Viruses
by Wen-Chien Wang, Ekramy E. Sayedahmed, Marwa Alhashimi, Ahmed Elkashif, Vivek Gairola, Muralimanohara S. T. Murala, Suryaprakash Sambhara and Suresh K. Mittal
Vaccines 2025, 13(1), 95; https://doi.org/10.3390/vaccines13010095 (registering DOI) - 20 Jan 2025
Viewed by 5
Abstract
Background/Objectives: An effective universal influenza vaccine is urgently needed to overcome the limitations of current seasonal influenza vaccines, which are ineffective against mismatched strains and unable to protect against pandemic influenza. Methods: In this study, bovine and human adenoviral vector-based vaccine platforms were [...] Read more.
Background/Objectives: An effective universal influenza vaccine is urgently needed to overcome the limitations of current seasonal influenza vaccines, which are ineffective against mismatched strains and unable to protect against pandemic influenza. Methods: In this study, bovine and human adenoviral vector-based vaccine platforms were utilized to express various combinations of antigens. These included the H5N1 hemagglutinin (HA) stem region or HA2, the extracellular domain of matrix protein 2 of influenza A virus, HA signal peptide (SP), trimerization domain, excretory peptide, and the autophagy-inducing peptide C5 (AIP-C5). The goal was to identify the optimal combination for enhanced immune responses and cross-protection. Mice were immunized using a prime-boost strategy with heterologous adenoviral (Ad) vectors. Results: The heterologous Ad vectors induced robust HA stem-specific humoral and cellular immune responses in the immunized mice. Among the tested combinations, Ad vectors expressing SP + HA stem + AIP-C5 conferred significant protection against group 1 (H1N1 and H5N1) and group 2 (H3N2) influenza A viruses. This protection was demonstrated by lower lung viral titers and reduced morbidity and mortality. Conclusions: The findings support further investigation of heterologous Ad vaccine platforms expressing SP + HA stem + AIP-C5. This combination shows promise as a potential universal influenza vaccine, providing broader protection against influenza A viruses. Full article
(This article belongs to the Special Issue Advances in Vaccines against Infectious Diseases)
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14 pages, 534 KiB  
Article
Impact of the COVID-19 Pandemic on Seizure Control in Pediatric Epilepsy: Risk Factors and Clinical Outcomes
by Jihye Lim and Ja Un Moon
Healthcare 2025, 13(2), 172; https://doi.org/10.3390/healthcare13020172 - 16 Jan 2025
Viewed by 375
Abstract
Background: Epilepsy is a common neurological disorder in children, associated with significant morbidity and socioeconomic burden. The coronavirus disease 2019 (COVID-19) pandemic disrupted healthcare delivery, potentially exacerbating seizure control among pediatric epilepsy patients. This study aimed to evaluate the pandemic’s impact on seizure [...] Read more.
Background: Epilepsy is a common neurological disorder in children, associated with significant morbidity and socioeconomic burden. The coronavirus disease 2019 (COVID-19) pandemic disrupted healthcare delivery, potentially exacerbating seizure control among pediatric epilepsy patients. This study aimed to evaluate the pandemic’s impact on seizure characteristics and identify risk factors contributing to seizure exacerbation in children with epilepsy. Methods: A retrospective cohort study was conducted using medical records of 84 pediatric epilepsy patients at The Catholic University of Korea Yeouido St. Mary’s Hospital from July 2019 to July 2022. Data were collected on demographics, epilepsy characteristics, and healthcare accessibility. Changes in seizure outcomes were analyzed alongside potential risk factors, including infections and socioeconomic variables. Statistical analyses assessed correlations between these factors and seizure exacerbations. Results: Among the 84 pediatric epilepsy patients, 25% experienced significant seizure exacerbations during the COVID-19 pandemic. These included increased seizure frequency (18%), prolonged duration (13%), emergence of new seizure types (4%), and status epilepticus requiring hospitalization (5%). Multivariate analysis identified recent epilepsy diagnosis (<1 year) and low socioeconomic status as independent predictors of seizure worsening (p < 0.05). Infections with non-COVID-19 respiratory viruses, such as RSV and influenza, were strongly associated with exacerbated seizure activity (p < 0.001). Dissatisfaction with access to epilepsy care further increased the risk of poor seizure control, reflecting the challenges posed by disrupted healthcare systems. Notably, no significant relationship was observed between SARS-CoV-2 infection and seizure outcomes, suggesting that indirect factors, rather than direct viral effects, were primary contributors to seizure exacerbation. Conclusions: This study highlights the compounded impact of disrupted healthcare access, socioeconomic challenges, and respiratory viral infections on seizure control during the COVID-19 pandemic. Strategies such as telehealth expansion, regular monitoring, and vaccination against respiratory pathogens are essential to optimize seizure management in future health crises. Full article
(This article belongs to the Collection The Impact of COVID-19 on Healthcare Services)
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12 pages, 1908 KiB  
Article
Enhanced Immunogenicity and Affinity with A35R-Fc-Based Chimeric Protein Compared to MPXV A35R Protein
by Shimeng Bai, Yanxin Cui, Qibin Liao, Hongyang Yi, Zhonghui Liao, Gengwei Zhang, Fenfang Wu and Hongzhou Lu
Viruses 2025, 17(1), 116; https://doi.org/10.3390/v17010116 - 16 Jan 2025
Viewed by 273
Abstract
The re-emergence of the mpox pandemic poses considerable challenges to human health and societal development. There is an urgent need for effective prevention and treatment strategies against the mpox virus (MPXV). In this study, we focused on the A35R protein and created a [...] Read more.
The re-emergence of the mpox pandemic poses considerable challenges to human health and societal development. There is an urgent need for effective prevention and treatment strategies against the mpox virus (MPXV). In this study, we focused on the A35R protein and created a chimeric A35R-Fc protein by fusing the Fc region of IgG to its C-terminal. We then assessed its reactivity with A35R-specific antibodies and human convalescent plasma, as well as its immunogenicity. Our findings indicate that the A35R-Fc protein significantly enhances affinity to A35R antibodies compared to the commercially available A35R protein and exhibits considerable reactivity to human plasma. Additionally, mice immunized with A35R-Fc exhibited increased neutralizing antibody titers against the live MPXV. These results support the potential of Fc domain chimeric antigens as a strategy to enhance the efficacy of subunit vaccines targeting the MPXV. Full article
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22 pages, 7210 KiB  
Article
Single Dose of Attenuated Vaccinia Viruses Expressing H5 Hemagglutinin Affords Rapid and Long-Term Protection Against Lethal Infection with Highly Pathogenic Avian Influenza A H5N1 Virus in Mice and Monkeys
by Fumihiko Yasui, Keisuke Munekata, Tomoko Fujiyuki, Takeshi Kuraishi, Kenzaburo Yamaji, Tomoko Honda, Sumiko Gomi, Misako Yoneda, Takahiro Sanada, Koji Ishii, Yoshihiro Sakoda, Hiroshi Kida, Shosaku Hattori, Chieko Kai and Michinori Kohara
Vaccines 2025, 13(1), 74; https://doi.org/10.3390/vaccines13010074 - 15 Jan 2025
Viewed by 605
Abstract
Background/Objectives: In preparation for a potential pandemic caused by the H5N1 highly pathogenic avian influenza (HPAI) virus, pre-pandemic vaccines against several viral clades have been developed and stocked worldwide. Although these vaccines are well tolerated, their immunogenicity and cross-reactivity with viruses of different [...] Read more.
Background/Objectives: In preparation for a potential pandemic caused by the H5N1 highly pathogenic avian influenza (HPAI) virus, pre-pandemic vaccines against several viral clades have been developed and stocked worldwide. Although these vaccines are well tolerated, their immunogenicity and cross-reactivity with viruses of different clades can be improved. Methods: To address this aspect, we generated recombinant influenza vaccines against H5-subtype viruses using two different strains of highly attenuated vaccinia virus (VACV) vectors. Results: rLC16m8-mcl2.2 hemagglutinin (HA) and rLC16m8-mcl2.3.4 HA consisted of a recombinant LC16m8 vector encoding the HA protein from clade 2.2 or clade 2.3.4 viruses (respectively); rDIs-mcl2.2 HA consisted of a recombinant DIs vector encoding the HA protein from clade 2.2. A single dose of rLC16m8-mcl2.2 HA showed rapid (1 week after vaccination) and long-term protection (20 months post-vaccination) in mice against the HPAI H5N1 virus. Moreover, cynomolgus macaques immunized with rLC16m8-mcl2.2 HA exhibited long-term protection when challenged with a heterologous clade of the HPAI H5N1 virus. Although the DIs strain is unable to grow in most mammalian cells, rDIs-mcl2.2 HA also showed rapid and long-lasting effects against HPAI H5N1 virus infection. Notably, the protective efficacy of rDIs-mcl2.2 HA was comparable to that of rLC16m8-mcl2.2 HA. Furthermore, these vaccines protected animals previously immunized with VACVs from a lethal challenge with the HPAI H5N1 virus. Conclusions: These results suggest that both rLC16m8-mcl2.2 HA and rDIs-mcl2.2 HA are effective in preventing HPAI H5N1 virus infection, and rDIs-mcl2.2 HA is a promising vaccine candidate against H5 HA-subtype viruses. Full article
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18 pages, 3272 KiB  
Article
Plant-Based Antigen Production Strategy for SARS-CoV-2 Nucleoprotein and RBD and Its Application for Detection of Antibody Responses in COVID-19 Patients
by Katerina Takova, Valeria Tonova, Ivan Minkov, Eugenia S. Mardanova, Nikolai V. Ravin, Stanislav Kotsev, Maria Pishmisheva and Gergana Zahmanova
Appl. Sci. 2025, 15(2), 786; https://doi.org/10.3390/app15020786 - 15 Jan 2025
Viewed by 1141
Abstract
During the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, the development of efficient serological tests for monitoring the dynamics of the disease as well as the immune response after illness or vaccination was critical. In this regard, low-cost and fast production of [...] Read more.
During the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, the development of efficient serological tests for monitoring the dynamics of the disease as well as the immune response after illness or vaccination was critical. In this regard, low-cost and fast production of immunogenic antigens is essential for the rapid development of diagnostic serological kits. This study assessed the plant-based production of nucleoprotein (N) of SARS-CoV-2 and chimeric receptor-binding domain (RBD) of SARS-CoV-2 presented by hepatitis E virus capsid (HEV/RBD) and validation of the plant-derived proteins as diagnostic antigens for serological tests. The target proteins were expressed in and purified from Nicotiana benthamiana plants. The resulting yield of chimeric HEV/RBD protein reached 100 mg/kg fresh weight and 30 mg/kg fresh weight for N protein. The purified N protein and HEV/RBD protein were used to develop an indirect enzyme-linked immunosorbent assay (iELISA) for the detection of antibodies to SARS-CoV-2 in human sera. To validate the iELISA tests, a panel of 84 sera from patients diagnosed with COVID-19 was used, and the results were compared to those obtained by another commercially available ELISA kit (Dia.Pro D. B., Sesto San Giovanni, Italy). The performance of an HEV/RBD in-house ELISA showed a sensitivity of 89.58% (95% Cl: 75.23–95.37) and a specificity of 94.44% (95% Cl: 76.94–98.2). Double Recognition iELISA based on HEV/RBD and N protein is characterized by a lower sensitivity of 85.42% (95% Cl: 72.24–93.93) and specificity of 94.44% (95% Cl: 81.34–99.32) at cut-off = 0.154, compared with iELISA based on HEV/RBD. Our study confirms that N and fusion HEV/RBD proteins, which are transiently expressed in plants, can be used to detect responses to SARS-CoV-2 in human sera reliably. Our research validates the commercial potential of using plants as an expression system for recombinant protein production and their application as diagnostic reagents for serological detection of infectious diseases, hence lowering the cost of diagnostic kits. Full article
(This article belongs to the Section Chemical and Molecular Sciences)
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24 pages, 2957 KiB  
Review
Nipah Virus: A Zoonotic Threat Re-Emerging in the Wake of Global Public Health Challenges
by Francesco Branda, Giancarlo Ceccarelli, Marta Giovanetti, Mattia Albanese, Erica Binetti, Massimo Ciccozzi and Fabio Scarpa
Microorganisms 2025, 13(1), 124; https://doi.org/10.3390/microorganisms13010124 - 9 Jan 2025
Viewed by 680
Abstract
The re-emergence of the Nipah virus (NiV) in Kerala, India, following the tragic death of a 14-year-old boy, underscores the persistent threat posed by zoonotic pathogens and highlights the growing global public health challenge. With no vaccine or curative treatment available, and fatality [...] Read more.
The re-emergence of the Nipah virus (NiV) in Kerala, India, following the tragic death of a 14-year-old boy, underscores the persistent threat posed by zoonotic pathogens and highlights the growing global public health challenge. With no vaccine or curative treatment available, and fatality rates as high as 94% in past outbreaks, the Nipah virus is a critical concern for health authorities worldwide. Transmitted primarily through contact with fruit bats or consumption of contaminated food, as well as direct human-to-human transmission, NiV remains a highly lethal and unpredictable pathogen. The World Health Organization has classified Nipah as a priority pathogen due to its alarming potential to cause widespread outbreaks and even trigger the next pandemic. Recent outbreaks in India and Bangladesh, occurring with seasonal regularity, have once again exposed the vulnerability of public health systems in containing this virus. This study explores the epidemiology, ecological factors driving transmission, and the public health response to NiV, emphasizing the role of zoonotic spillovers in pandemic preparedness. As the global community grapples with an increasing number of emerging infectious diseases, the Nipah virus stands as a stark reminder of the importance of coordinated surveillance, rapid containment measures, and the urgent development of novel strategies to mitigate the impact of this re-emerging threat. Full article
(This article belongs to the Special Issue Advances in Human Infections and Public Health)
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28 pages, 1043 KiB  
Review
How Broadly Neutralising Antibodies Are Redefining Immunity to Influenza
by Rebecca Steventon, Lucas Stolle and Craig Peter Thompson
Antibodies 2025, 14(1), 4; https://doi.org/10.3390/antib14010004 - 7 Jan 2025
Viewed by 424
Abstract
Recent avian influenza outbreaks have heightened global concern over viral threats with the potential to significantly impact human health. Influenza is particularly alarming due to its history of causing pandemics and zoonotic reservoirs. In response, significant progress has been made toward the development [...] Read more.
Recent avian influenza outbreaks have heightened global concern over viral threats with the potential to significantly impact human health. Influenza is particularly alarming due to its history of causing pandemics and zoonotic reservoirs. In response, significant progress has been made toward the development of universal influenza vaccines, largely driven by the discovery of broadly neutralising antibodies (bnAbs), which have the potential to neutralise a broad range of influenza viruses, extending beyond the traditional strain-specific response. This could lead to longer-lasting immunity, reducing the need for seasonal vaccinations, and improve preparedness for future pandemics. This review offers a comprehensive analysis of these antibodies, their application in clinical studies, and both their potential and possible shortcomings in managing future influenza outbreaks. Full article
(This article belongs to the Section Antibody Discovery and Engineering)
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29 pages, 1162 KiB  
Review
Antigen Delivery Platforms for Next-Generation Coronavirus Vaccines
by Aziz A. Chentoufi, Jeffrey B. Ulmer and Lbachir BenMohamed
Vaccines 2025, 13(1), 30; https://doi.org/10.3390/vaccines13010030 - 31 Dec 2024
Viewed by 735
Abstract
The COVID-19 pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), is in its sixth year and is being maintained by the inability of current spike-alone-based COVID-19 vaccines to prevent transmission leading to the continuous emergence of variants and sub-variants of [...] Read more.
The COVID-19 pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), is in its sixth year and is being maintained by the inability of current spike-alone-based COVID-19 vaccines to prevent transmission leading to the continuous emergence of variants and sub-variants of concern (VOCs). This underscores the critical need for next-generation broad-spectrum pan-Coronavirus vaccines (pan-CoV vaccine) to break this cycle and end the pandemic. The development of a pan-CoV vaccine offering protection against a wide array of VOCs requires two key elements: (1) identifying protective antigens that are highly conserved between passed, current, and future VOCs; and (2) developing a safe and efficient antigen delivery system for induction of broad-based and long-lasting B- and T-cell immunity. This review will (1) present the current state of antigen delivery platforms involving a multifaceted approach, including bioinformatics, molecular and structural biology, immunology, and advanced computational methods; (2) discuss the challenges facing the development of safe and effective antigen delivery platforms; and (3) highlight the potential of nucleoside-modified mRNA encapsulated in lipid nanoparticles (LNP) as the platform that is well suited to the needs of a next-generation pan-CoV vaccine, such as the ability to induce broad-based immunity and amenable to large-scale manufacturing to safely provide durable protective immunity against current and future Coronavirus threats. Full article
(This article belongs to the Special Issue Role of Next Generation Vaccines in Immunotherapeutics)
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18 pages, 1527 KiB  
Article
Intranasal Immunization with DNA Vaccine HA-CCL19/Polyethylenimine/Chitosan Composite Provides Immune Protection Against H7N9 Infection
by Yuqing Xiang, Hongbo Zhang, Youcai An and Ze Chen
Vaccines 2025, 13(1), 10; https://doi.org/10.3390/vaccines13010010 - 26 Dec 2024
Viewed by 430
Abstract
Background/Objectives: The H7N9 avian influenza virus (AIV) constitutes a novel subtype of influenza virus that has emerged within the past decade. Empirical studies have demonstrated that H7N9 AIV holds the potential to trigger a human pandemic. Vaccines constitute the sole armament available to [...] Read more.
Background/Objectives: The H7N9 avian influenza virus (AIV) constitutes a novel subtype of influenza virus that has emerged within the past decade. Empirical studies have demonstrated that H7N9 AIV holds the potential to trigger a human pandemic. Vaccines constitute the sole armament available to humanity in combating influenza epidemics. DNA vaccines present numerous merits; however, substantial conundrums persist regarding how to augment their immunogenicity and implement their delivery through mucosal immunization. Methods: In this study; BALB/c mice were utilized as a model to investigate the effect of CCL19 as a molecular adjuvant and to determine the immune response elicited by polyethylene imine (PEI) and chitosan (CS) as adjuvants during the delivery of a DNA vaccine through the nasal mucosal route. Results: Our results revealed that the CCL19 molecular adjuvant exerts a substantial immunomodulatory enhancement effect on the H7N9-HA DNA vaccine, inducing more pronounced cellular and humoral immunity. Additionally, our results indicated that the composite formed by the HA-CCL19 DNA in combination with PEI and CS effectively activates local mucosal immunity as well as systemic humoral and cellular immunity, offering 100% protection against lethal doses of homologous virus challenges. Conclusions: CCL19 conspicuously augments the immunogenicity of the influenza virus HA DNA and conserves the integrity of the vaccine antigen. Simultaneously, CS and PEI proficiently facilitate the mucosal delivery of DNA, thereby eliciting mucosal immunity related to DNA vaccines. This study investigated the feasibility of utilizing nasal mucosa for DNA vaccine immunization, which holds significant implications for the advancement and application of DNA vaccines in public health Full article
(This article belongs to the Special Issue Novel Viral Vaccine and Molecular Immunology)
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20 pages, 8670 KiB  
Article
Cell Membrane- and Extracellular Vesicle-Coated Chitosan Methacrylate-Tripolyphosphate Nanoparticles for RNA Delivery
by Wen Jie Melvin Liew, Syed Abdullah Alkaff, Sheng Yuan Leong, Marin Zhen Lin Yee, Han Wei Hou and Bertrand Czarny
Int. J. Mol. Sci. 2024, 25(24), 13724; https://doi.org/10.3390/ijms252413724 - 23 Dec 2024
Viewed by 1126
Abstract
mRNA-based vaccines against the COVID-19 pandemic have propelled the use of nucleic acids for drug delivery. Conventional lipid-based carriers, such as liposomes and nanolipogels, effectively encapsulate and deliver RNA but are hindered by issues such as premature burst release and immunogenicity. To address [...] Read more.
mRNA-based vaccines against the COVID-19 pandemic have propelled the use of nucleic acids for drug delivery. Conventional lipid-based carriers, such as liposomes and nanolipogels, effectively encapsulate and deliver RNA but are hindered by issues such as premature burst release and immunogenicity. To address these challenges, cell membrane-coated nanoparticles offer a promising alternative. We developed a novel nanoparticle system using chitosan methacrylate-tripolyphosphate (CMATPP), which capitalizes on interactions involving membrane proteins at biointerfaces. Ionic crosslinking between chitosan methacrylate and tripolyphosphate facilitates the formation of nanoparticles amenable to coating with red blood cell (RBC) membranes, extracellular vesicles (EVs), and cell-derived nanovesicles (CDNs). Coating CMATPP nanoparticles with RBC membranes effectively mitigated the initial burst release of encapsulated small interfering RNA (siRNA), sustaining controlled release while preserving membrane proteins. This concept was extended to EVs, where CMATPP nanoparticles and CDNs were incorporated into a microfluidic device and subjected to electroporation to create hybrid CDN-CMATPP nanoparticles. Our findings demonstrate that CMATPP nanoparticles are a robust siRNA delivery system with suppressed burst release and enhanced membrane properties conferred by cell or vesicle membranes. Furthermore, the adaptation of the CDN-CMATPP nanoparticle formation in a microfluidic device suggests its potential for personalized therapies using diverse cell sources and increased throughput via automation. This study underscores the versatility and efficacy of CMATPP nanoparticles in RNA delivery, offering a pathway towards advanced therapeutic strategies that utilize biomimetic principles and microfluidic technologies. Full article
(This article belongs to the Special Issue Biomaterials for Drug Delivery and Advanced Therapies)
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17 pages, 818 KiB  
Perspective
Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China
by Xiaojing Li, Su Jin, Shuyang Guo, Dan Yang, Wenbo Sai, Xiao Qiu, Xin Zhao, Lan Wang, Tao Wang and Min Li
Vaccines 2024, 12(12), 1436; https://doi.org/10.3390/vaccines12121436 - 20 Dec 2024
Viewed by 816
Abstract
The concept of “platform technology” gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during the COVID-19 pandemic, where platform technology enabled the rapid development [...] Read more.
The concept of “platform technology” gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during the COVID-19 pandemic, where platform technology enabled the rapid development and approval of vaccines, optimizing regulatory processes, and enhancing global public health responses. As a transformative tool, platform technology streamlines product development, allowing for the reduction in the number of clinical trials or exemption from certain clinical trials and facilitating cross-referencing in regulatory submissions. Despite significant efforts to establish standardized regulatory procedures, challenges remain, particularly in achieving a unified definition and application of platform technology across regions. This paper explores the evolution, applications, and regulatory strategies of platform technology, with a focus on China’s experience in this field. China’s approach, encompassing risk assessment, and the expedited approval of emergency vaccines, offers valuable insights into global regulatory coordination. By analyzing China’s regulatory contributions and international practices, this paper highlights the potential of platform technology to address future pandemics, including “Pathogen X”, and underscores the importance of harmonizing global regulatory efforts to strengthen public health preparedness and response. Full article
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10 pages, 948 KiB  
Article
Anti-COVID-19 Vaccination in the Italian General Population: Proactive Clinical Risk Analysis Using Failure Mode, Effects, and Criticality Analysis Technique
by Beatrice Balestracci, Giuseppe Candido, Lorenzo Federici, Chiara Parretti, Riccardo Tartaglia, Peter Lachman, Alessandra Bianco and Micaela La Regina
Healthcare 2024, 12(24), 2541; https://doi.org/10.3390/healthcare12242541 - 16 Dec 2024
Viewed by 664
Abstract
Background: Large-scale vaccination was crucial to address the global COVID-19 pandemic and its associated health risks, including fatal and disabling diseases. However, there were significant challenges to be overcome to ensure the safe and effective implementation of the vaccination program. The aim [...] Read more.
Background: Large-scale vaccination was crucial to address the global COVID-19 pandemic and its associated health risks, including fatal and disabling diseases. However, there were significant challenges to be overcome to ensure the safe and effective implementation of the vaccination program. The aim of the present study was to assess patient safety threats related to the anti-COVID-19 large-scale vaccination process. Methods: Between February and May 2021, we conducted a proper analysis to proactively identify risks and potential Failure Modes (FMs) in the COVID-19 vaccination process using the Failure Mode, Effects, and Criticality Analysis (FMECA) technique at an Italian Public Health Authority. A standardized risk scoring system was used to assess the severity, frequency, and detectability of events associated with potential failures. Criticalities were identified in both the preparatory and operational areas of the vaccination process, and several potential FMs were listed in descending order of risk score (Risk Priority Number, RPN) to ensure prioritization of interventions. Results: The most critical steps were found to be in the operational area rather than in the preparatory one. The highest RPNs were associated with failure or inadequate management of severe allergic reactions that can lead to serious harm and even death of the vaccinated person (RPN 60) and failure to keep updated vaccination teams’ knowledge (RPN 36). Conclusions: Ensuring patient safety and effective clinical risk management are crucial in mass vaccination campaigns. By prioritizing these aspects through collaboration with various stakeholders and implementing preventive measures, patient trust—on which vaccination campaign success relies—can be built and maintained. Full article
(This article belongs to the Special Issue Improving Healthcare Quality)
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14 pages, 441 KiB  
Review
Pemphigus and Bullous Pemphigoid Following COVID-19 Vaccination: A Systematic Review
by Fabrizio Martora, Teresa Battista, Luca Potestio, Maddalena Napolitano, Cataldo Patruno, Matteo Megna and Michela D’Agostino
Viruses 2024, 16(12), 1896; https://doi.org/10.3390/v16121896 - 9 Dec 2024
Viewed by 1680
Abstract
The COVID-19 pandemic has encouraged the rapid development and licensing of vaccines against SARS-CoV-2. Currently, numerous vaccines are available on a global scale and are based on different mechanisms of action, including mRNA technology, viral vectors, inactive viruses, and subunit particles. Mass vaccination [...] Read more.
The COVID-19 pandemic has encouraged the rapid development and licensing of vaccines against SARS-CoV-2. Currently, numerous vaccines are available on a global scale and are based on different mechanisms of action, including mRNA technology, viral vectors, inactive viruses, and subunit particles. Mass vaccination conducted worldwide has highlighted the potential development of side effects, including ones with skin involvement. This review synthesizes data from 62 manuscripts, reporting a total of 142 cases of autoimmune blistering skin diseases (AIBDs) following COVID-19 vaccination, comprising 59 cases of pemphigus and 83 cases of bullous pemphigoid. Among the 83 bullous pemphigoid cases, 78 were BP, with additional cases including 2 oral mucous membrane pemphigoid, 1 pemphigoid gestationis, 1 anti-p200 BP, and 1 dyshidrosiform BP. The mean age of affected individuals was 72 ± 12.7 years, with an average symptom onset of 11 ± 10.8 days post-vaccination. Notably, 59% of cases followed vaccination with BNT162b2 (Pfizer-BioNTech), 51.8% were new diagnoses, and 45.8% occurred after the second dose. The purpose of our review is to analyze the cases of pemphigus and bullous pemphigoid associated with COVID-19 vaccination and to investigate the pathogenetic mechanisms underlying the new development or flare-up of these diseases in association with vaccination. Our results show that the association between COVID-19 vaccines and AIBDs is a possible event. Full article
(This article belongs to the Special Issue Cutaneous Reactions Following Virus Infections and Antiviral Vaccines)
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20 pages, 4402 KiB  
Article
Seasonal Shifts in Influenza, Respiratory Syncytial Virus, and Other Respiratory Viruses After the COVID-19 Pandemic: An Eight-Year Retrospective Study in Jalisco, Mexico
by Ernestina Quintero-Salgado, Jaime Briseno-Ramírez, Gabriel Vega-Cornejo, Roberto Damian-Negrete, Gustavo Rosales-Chavez and Judith Carolina De Arcos-Jiménez
Viruses 2024, 16(12), 1892; https://doi.org/10.3390/v16121892 - 8 Dec 2024
Viewed by 1711
Abstract
The coronavirus disease 2019 (COVID-19) pandemic profoundly disrupted the epidemiology of respiratory viruses, driven primarily by widespread non-pharmaceutical interventions (NPIs) such as social distancing and masking. This eight-year retrospective study examines the seasonal patterns and incidence of influenza virus, respiratory syncytial virus (RSV), [...] Read more.
The coronavirus disease 2019 (COVID-19) pandemic profoundly disrupted the epidemiology of respiratory viruses, driven primarily by widespread non-pharmaceutical interventions (NPIs) such as social distancing and masking. This eight-year retrospective study examines the seasonal patterns and incidence of influenza virus, respiratory syncytial virus (RSV), and other respiratory viruses across pre-pandemic, pandemic, and post-pandemic phases in Jalisco, Mexico. Weekly case counts were analyzed using an interrupted time series (ITS) model, segmenting the timeline into these three distinct phases. Significant reductions in respiratory virus circulation were observed during the pandemic, followed by atypical resurgences as NPIs were relaxed. Influenza displayed alternating subtype dominance, with influenza A H3 prevailing in 2022, influenza B surging in 2023, and influenza A H1N1 increasing thereafter, reflecting potential immunity gaps. RSV activity was marked by earlier onset and higher intensity post-pandemic. Other viruses, including human rhinovirus/enterovirus (HRV/HEV) and parainfluenza virus (HPIV), showed altered dynamics, with some failing to return to pre-pandemic seasonality. These findings underscore the need for adaptive surveillance systems and vaccination strategies to address evolving viral patterns. Future research should investigate the long-term public health implications, focusing on vaccination, clinical outcomes, and healthcare preparedness. Full article
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20 pages, 15671 KiB  
Article
Expression of an Efficient Selection Marker Out of a Duplicated Site in the ITRs of a Modified Vaccinia Virus Ankara (MVA)
by Sirine Abidi, Aurora Elhazaz Fernandez, Nicole Seehase, Lina Hanisch, Alexander Karlas, Volker Sandig and Ingo Jordan
Vaccines 2024, 12(12), 1377; https://doi.org/10.3390/vaccines12121377 - 6 Dec 2024
Viewed by 747
Abstract
Background/Objectives: Poxviruses are large DNA viruses that replicate in the host cytoplasm without a nuclear phase. As vaccine vectors, they can package and express large recombinant cassettes from different positions of their genomic core region. We present a comparison between wildtype modified [...] Read more.
Background/Objectives: Poxviruses are large DNA viruses that replicate in the host cytoplasm without a nuclear phase. As vaccine vectors, they can package and express large recombinant cassettes from different positions of their genomic core region. We present a comparison between wildtype modified vaccinia Ankara (MVA) and isolate CR19, which has significantly expanded inverted terminal repeats (ITRs). With this expansion, a site in wildtype MVA, called deletion site (DS) IV, has been duplicated at both ends of the genome and now occupies an almost central position in the newly formed ITRs. Methods: We inserted various reporter genes into this site and found that the ITRs can be used for transgene expression. However, ITRs are genomic structures that can rapidly adapt to selective pressure through transient duplication and contraction. To test the potential utility of insertions into viral telomers, we inserted a factor from the cellular innate immune system that interferes with viral replication as an example of a difficult transgene. Results: A site almost in the centre of the ITRs can be used for transgene expression, and both sides are mirrored into identical copies. The example of a challenging transgene, tetherin, proved to be surprisingly efficient in selecting candidate vectors against the large background of parental viruses. Conclusions: Insertion of transgenes into ITRs automatically doubles the gene doses. The functionalisation of viruses with tetherin may accelerate the identification and generation of recombinant vectors for personalised medicine and pandemic preparedness. Full article
(This article belongs to the Section Attenuated/Inactivated/Live and Vectored Vaccines)
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