Vaccines

Research

33 pages, 11518 KB

Open AccessArticle

The Silent Vehicle: Validating the Biological Signals and Noises of Baculovirus Vectors in Macrophage-Targeted Vaccines

by Beginda Ridwan, Farrah Putri Salmanida, Rika Wahyuningtyas, Yin-Siew Lai, Mei-Li Wu, Wen-Bin Chung, Chia-Tsai Chang and Ko-Tung Chang

Vaccines 2026, 14(9), 816; https://doi.org/10.3390/vaccines14090816 - 16 Sep 2026

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Abstract

Objective: The Baculovirus Expression Vector System (BEVS) is an established eukaryotic platform for high-yield recombinant protein production and is widely utilized for generating vaccine antigens, including recombinant classical swine fever virus E2 glycoprotein, African swine fever virus structural proteins (p72, p30, and p54), [...] Read more.

Objective: The Baculovirus Expression Vector System (BEVS) is an established eukaryotic platform for high-yield recombinant protein production and is widely utilized for generating vaccine antigens, including recombinant classical swine fever virus E2 glycoprotein, African swine fever virus structural proteins (p72, p30, and p54), and porcine reproductive and respiratory syndrome virus envelope proteins GP5 and M. These antigens interact with macrophage-associated receptors, including CD163 and CD206, to modulate immune responses through macrophage polarization. However, whether baculovirus vector-derived components intrinsically influence macrophage polarization remains unclear, raising concerns regarding potential impacts on biological activity, vaccine efficacy, and downstream purification strategies. Methods: In this study, an M2-like tumor-associated macrophage (TAM) model capable of repolarizing toward an M1-like phenotype was established to distinguish the transcriptomic effects of the baculovirus vector control (VC) from those of the recombinant antigen (A1). Comparative RNA sequencing, Gene Set Enrichment Analysis (GSEA), functional enrichment analyses, and linear regression analysis were performed to evaluate vector- and antigen-associated transcriptional responses. Results: Comprehensive transcriptomic analysis showed that VC treatment induced only minimal transcriptomic alterations, with limited immune-related pathway enrichment and expression profiles that remained highly similar to those of untreated M2-like TAMs. Furthermore, linear regression analysis demonstrated negligible correlations between VC-induced and A1-induced transcriptional responses indicating that the limited changes associated with the vector backbone did not correspond to the receptor-mediated immune responses elicited by the recombinant antigen. In contrast, A1 stimulation induced distinct transcriptional reprogramming characterized by enrichment of pro-inflammatory and immune-activation pathways and a shift toward an M1-like macrophage phenotype. Conclusions: These findings suggest the negligible correspondence between VC- and A1-induced transcriptional profiles further supports the transcriptomic noises and signals of the baculovirus vector and inserted proteins, reinforcing its suitability as a platform for macrophage-targeted vaccine development while providing a basis for future optimization of downstream purification strategies. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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20 pages, 5358 KB

Open AccessArticle

Preclinical Evaluation of Novel Conserved Neisseria gonorrhoeae Vaccine Candidates Identified Through Infection-Informed Antigen Discovery

by Shea K. Roe, Bo Zheng, Sunita Gulati, Sanjay Ram and Paola Massari

Vaccines 2026, 14(9), 798; https://doi.org/10.3390/vaccines14090798 - 10 Sep 2026

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Abstract

Background: The continued emergence of antimicrobial-resistant Neisseria gonorrhoeae highlights the urgent need for an effective vaccine. We evaluated the immunogenicity and vaccine potential of six new gonococcal conserved hypothetical proteins identified through our immunobioinformatics-based pipeline (Candidate Antigen Selection Strategy, CASS). Methods: NGO0588, NGO0694, [...] Read more.

Background: The continued emergence of antimicrobial-resistant Neisseria gonorrhoeae highlights the urgent need for an effective vaccine. We evaluated the immunogenicity and vaccine potential of six new gonococcal conserved hypothetical proteins identified through our immunobioinformatics-based pipeline (Candidate Antigen Selection Strategy, CASS). Methods: NGO0588, NGO0694, NGO0757, NGO0861, NGO1438 and NGO1802 proteins were expressed in E. coli, purified, and used to immunize mice, adjuvanted with Alum and MPLA. Immunological analyses included quantitative and qualitative evaluation of antigen-specific antibody responses, cytokines, serum bactericidal activity (SBA), and protective efficacy in the mouse gonococcal vaginal colonization model. Results: The six antigens elicited robust antigen-specific IgG and IgM antibody responses against N. gonorrhoeae. Antisera to NGO0588, NGO0861, NGO1430 and NGO1802 were bactericidal against different gonococcal strains. IgG antibodies recognizing the antigens were detected in sera obtained from women with disseminated gonococcal infection, particularly against NGO1802, supporting immunogenicity in humans. Taking immunological and biochemical properties into consideration, NGO0861, NGO1438 and NGO1802 were combined in a trivalent vaccine formulation. The trivalent vaccine elicited robust antigen-specific and N. gonorrhoeae-reactive serum IgG and IgM, mucosal IgG, and higher SBA titers than each individual antigen. However, in the mouse gonococcal vaginal colonization model, vaccinated mice and adjuvant control mice did not show statistically significant differences in time to infection clearance or bacterial burdens. Conclusions: A multiantigen vaccine composed of NGO0861, NGO1438 and NGO1802 elicited antibodies that were functional in vitro but did not lead to protection in vivo. Immunological analyses in vitro and in vivo emphasize the importance of evaluating antigen and antibody quality and functional activity for vaccine target prioritization of next-generation gonococcal multicomponent vaccines. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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24 pages, 51034 KB

Open AccessArticle

Exploring the Vaccine Adjuvant Effect and Mechanism of Epimedium Using Network Pharmacology, Molecular Docking, and Molecular Dynamics Simulations

by Meng Tang, Anni Zhao, Yun Yang, Zhen Song, Sheng Wang, Xianghao Ye, Haozheng Luo, Liqun Zhao, Jiale Pan, Quanming Zou, Hongwu Sun and Hao Zeng

Vaccines 2026, 14(5), 385; https://doi.org/10.3390/vaccines14050385 - 26 Apr 2026

Viewed by 755

Abstract

Background: Epimedium is a natural herb with immunomodulatory potential, but its vaccine adjuvant properties remain poorly understood. Objective: The aim of this study was to elucidate the adjuvant effects of Epimedium and the underlying molecular mechanisms. Methods: Network pharmacology was used to [...] Read more.

Background: Epimedium is a natural herb with immunomodulatory potential, but its vaccine adjuvant properties remain poorly understood. Objective: The aim of this study was to elucidate the adjuvant effects of Epimedium and the underlying molecular mechanisms. Methods: Network pharmacology was used to identify bioactive compounds and targets of Epimedium from the TCMSP database, and immunomodulation-related targets from GeneCards and OMIM. PPI networks, KEGG/GO enrichment, molecular docking, and molecular dynamics (MD) simulations were performed. In vivo, female BALB/c mice were immunized with the Staphylococcus aureus (S. aureus) vaccine subunit HI antigen, either alone or with low- or high-dose icariin (ICA). Serum antibody responses (IgG, IgG1, IgG2a, IgG2b) were measured by ELISA. Survival against lethal S. aureus USA300 challenge was monitored. Results: Network pharmacology predicted 488 targets and 13 pathways. Core targets included IL6, TP53, EGFR, CTNNB1, HIF1A, HSP90AA1, JUN, MTOR, SRC, and AKT1. KEGG/GO analysis indicated involvement of T cell receptor and NOD-like receptor signaling pathways in inflammatory responses. Molecular docking and MD simulations confirmed stable ligand-target binding. Experimental validation showed that ICA significantly enhanced HI-specific antibody responses and induced a Th2-biased humoral immune response (IgG1/IgG2a ratio > 1), which is particularly relevant for vaccines targeting extracellular pathogens such as S. aureus. ICA also improved survival after lethal bacterial challenge. Conclusions: This study identifies potential bioactive compounds, core targets, and key pathways of Epimedium as a vaccine adjuvant. Experimentally, ICA, as a representative component, enhanced HI-specific antibody responses and conferred protection against lethal S. aureus challenge. Together, these findings offer a computational–experimental basis that may guide further mechanistic investigation. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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17 pages, 1961 KB

Open AccessEditor’s ChoiceArticle

Nanoparticle Vaccines Based on the Truncated VZV gE Elicit a Robust Immune Response in Mice

by Tianxin Shi, Hai Li, Jiehui Wu, Hongqiao Hu, Jie Jiang, Ruichen Wang, Ziyi Li, Qianqian Cui, Shihong Fu, Kai Nie, Fan Li, Qikai Yin, Huanyu Wang and Songtao Xu

Vaccines 2026, 14(1), 69; https://doi.org/10.3390/vaccines14010069 - 7 Jan 2026

Cited by 1 | Viewed by 1606

Abstract

Background: Herpes zoster (HZ), caused by the reactivation of varicella-zoster virus (VZV), primarily affects elderly populations worldwide. Although current recombinant HZ vaccines show strong immunogenicity, their high cost and potential side effects may limit their widespread use. Therefore, developing a cost-effective HZ vaccine [...] Read more.

Background: Herpes zoster (HZ), caused by the reactivation of varicella-zoster virus (VZV), primarily affects elderly populations worldwide. Although current recombinant HZ vaccines show strong immunogenicity, their high cost and potential side effects may limit their widespread use. Therefore, developing a cost-effective HZ vaccine with improved safety profiles would have significant clinical and public health implications. Methods: Building upon our previously optimized truncated gE (tgE350) from VZV, we developed the tgE350 + Fe nanoparticle vaccine using SpyTag/SpyCatcher covalent conjugation. The tgE350 protein (with a SpyTag tag) and the Fe protein (with a SpyCatcher tag) were expressed in HEK293F and E. coli BL21, respectively, enabling spontaneous nanoparticle assembly. Protein expression and nanoparticle formation were confirmed through SDS-PAGE and negative-stain electron microscopy. BALB/c mice were inoculated with either tgE350 + Fe or tgE350 combined with Al and CpG adjuvants. Immune responses were evaluated using ELISpot and flow cytometry for cellular immunity, along with ELISA, VZV microneutralization, and fluorescent antibody membrane antigen (FAMA) assays for antibody titers. Histopathological examination of major organs ensured vaccine safety. Results: Compared with the truncated vaccine tgE350, the nanoparticle vaccine tgE350 + Fe significantly enhanced VZV neutralizing antibodies and specific antibody responses in mice without causing significant changes in lymphocyte populations (no difference from the control group). Moreover, the tgE350 + Fe group had significantly more lymphocytes secreting IFN-γ, IL-2, and IL-4 than the tgE350 group. No apparent pathological damage was observed in the heart, liver, spleen, or lungs of mice in any experimental group. Conclusions: This experiment successfully developed the HZ nanoparticle vaccine tgE350 + Fe. It enhanced VZV-specific neutralizing antibodies, generated better cellular and humoral immune responses, and demonstrated good safety. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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22 pages, 2697 KB

Open AccessArticle

A Cyclic-di-AMP Adjuvanted CPAF Protein Vaccine Is Immunogenic in Swine, but It Fails to Reduce Genital Chlamydia trachomatis Burden

by Leonie Bettin, Maria Stadler, Christine Unterweger, Maximiliane Dippel, Jonathan M. Harris, Andrea Buzanich-Ladinig, Taylor B. Poston, Toni Darville and Tobias Käser

Vaccines 2025, 13(5), 468; https://doi.org/10.3390/vaccines13050468 - 27 Apr 2025

Cited by 3 | Viewed by 2651

Abstract

Background/Objectives: Chlamydia trachomatis (Ct) is the leading bacterial cause of sexually transmitted infection globally. If undiagnosed or left untreated, these infections can lead to serious complications such as infertility, ectopic pregnancies, and chronic pelvic pain. Despite the high prevalence and [...] Read more.

Background/Objectives: Chlamydia trachomatis (Ct) is the leading bacterial cause of sexually transmitted infection globally. If undiagnosed or left untreated, these infections can lead to serious complications such as infertility, ectopic pregnancies, and chronic pelvic pain. Despite the high prevalence and potential for serious health complications, no vaccine has been licensed. Pigs offer a valuable biomedical model for chlamydia research: they have an overall high degree of similarity to humans and serve as natural hosts for Chlamydia suis (Cs), a close relative of Ct. Thus, in this study, the pig model was used to evaluate a vaccine candidate against Ct. Methods: The vaccine candidate consists of chlamydial-protease-like activity factor (CPAF) protein adjuvanted with STING (Stimulator of Interferon Genes) pathway agonist cyclic-di-AMP (c-di-AMP). Pigs received two doses intramuscularly followed by two intranasal doses. Each week, the systemic T cell response was assessed via IFN-γ and IL-17 ELISpots, as well as multi-parameter flow cytometry on 0, 14, and 28 days post vaccination (dpv). The humoral immune response was analyzed by measuring CPAF-specific antibody levels and avidity via ELISAs. Results: Vaccination with c-di-AMP adjuvanted CPAF triggered low-level systemic IFN-γ and multifunctional IFN-γ⁺TNF-α⁺ CD4 T cell responses. Despite the rather low systemic effector cytokine production, robust anti-CPAF IgG responses were detected in serum, vaginal swab eluates, and oviduct flushes. Genital Ct challenge 42 dpv resulted in only transient infection, precluding a confident assessment of vaccine efficacy of the tested CPAF/c-di-AMP vaccine candidate. However, after challenge, vaccinated pigs exhibited boosted systemic anti-CPAF IFN-γ and mucosal IgG responses compared to unvaccinated pigs. Conclusions: Thus, while vaccine efficacy remains elusive, the CPAF/c-di-AMP vaccine candidate was immunogenic: it elicited a low-level systemic cell-mediated response and robust humoral immune responses. Future studies will incorporate a STING agonist directly conjugated to CPAF as well as addition of other Th1-inducing adjuvants to enhance cellular immunity. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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Review

Jump to: Research, Other

29 pages, 696 KB

Open AccessReview

The State-of-the Art of Personalized Vaccines for Non-Communicable Diseases: A Narrative Review

by Mario Caldarelli, Pierluigi Rio, Carlotta Renna, Andrea Marrone, Giulia Guazzarotti, Antonio Gasbarrini, Giovanni Gambassi and Rossella Cianci

Vaccines 2026, 14(8), 693; https://doi.org/10.3390/vaccines14080693 - 12 Aug 2026

Viewed by 776

Abstract

Non-communicable diseases (NCDs), including cancer, cardiovascular, neurodegenerative, autoimmune, and allergic diseases, account for a significant amount of global morbidity and mortality. Chronic viral infections have not been recognized as NCDs, despite the availability of several therapeutic vaccination strategies against oncogenic viruses, such as [...] Read more.

Non-communicable diseases (NCDs), including cancer, cardiovascular, neurodegenerative, autoimmune, and allergic diseases, account for a significant amount of global morbidity and mortality. Chronic viral infections have not been recognized as NCDs, despite the availability of several therapeutic vaccination strategies against oncogenic viruses, such as the hepatitis B virus (HBV) and the human papillomavirus (HPV). Indeed, chronic viral infection leads to the development and progression of malignancies directly linked to the viruses. These considerations support a connection between NCDs, infectious diseases, and therapeutic vaccination. Recent advances in technology have paved the way to the use of vaccines beyond the prevention of infectious diseases, heralding innovative therapeutic and preventative strategies for a variety of chronic NCDs. Here we will review the state of the art of personalized vaccine strategies for NCDs, with an emphasis on the diverse technological platforms used to develop them, including mRNA and DNA vaccines, viral vectors, dendritic cell-based vaccines, nanoparticle delivery systems, and next-generation adjuvants. The review intends to make the case for personalized and antigen-specific vaccination strategies as a compelling option for precision immunotherapy primarily in oncology, where neoantigen-based vaccines are being developed. In addition, we will also review tolerogenic vaccination strategies, vaccination strategies targeting pathological proteins and pathways in neurodegenerative and cardiovascular diseases, and vaccine-based treatment of chronic viral infections. Current evidence about vaccines suggests that several ways are available to induce an immune response or create tolerance to a disease, and possibly altering its course instead of simply controlling the symptoms. However, many challenges are still to be overcome, including disease variability, how to identify appropriate target antigens, the complexity of manufacturing process, long-term safety, and integration with already established treatments. By virtue of the convergence of multiple fields—immunology, genomics, bioinformatics, and new delivery systems—precision vaccinology is gaining momentum. Thus, it is envisaged that personalized vaccines will be an increasingly essential component of future preventive and therapeutic approaches for non-communicable diseases. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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19 pages, 681 KB

Open AccessReview

Cultures Through Time: Forging a Xeno-Free Future for Cell Culture-Based Virology

by Arvind Singh Kaulsay, Nurshariza Abdullah and Nur Amelia Azreen Adnan

Vaccines 2026, 14(6), 476; https://doi.org/10.3390/vaccines14060476 - 28 May 2026

Viewed by 880

Abstract

As a cornerstone of modern science, cell lines are the foundational platforms for key medical advances. They enable vaccinology (through viral propagation and attenuation), gene therapy (via vector development), and biopharmaceutical production (via recombinant protein expression). Designer mammalian, avian, and insect expression systems, [...] Read more.

As a cornerstone of modern science, cell lines are the foundational platforms for key medical advances. They enable vaccinology (through viral propagation and attenuation), gene therapy (via vector development), and biopharmaceutical production (via recombinant protein expression). Designer mammalian, avian, and insect expression systems, including Vero, MDCK, HEK293, BHK21, CHO, PER.C6, EB66, and Sf21/Sf9, have become indispensable cellular platforms, delivering enhanced biologic yields, superior genetic stability, and validated end-product biosafety. Simultaneous advances in cell culture media optimization have enabled a critical shift from serum-dependent media to serum-free, chemically defined, and xeno-free alternatives, which aim to restore compositional traceability of culture media components, reduce potential residual xenogeneic proteins in serum-supplemented media, and promote reproducibility even at the molecular level. This review emphasizes the far-reaching influence of cell culture systems as the expression powerhouse that sustains modern virology, whilst focusing on recent cell-engineering methods and optimization strategies in culture media that have facilitated this shift. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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18 pages, 686 KB

Open AccessReview

Clinical Evaluation of Allergen Immunotherapy for Allergic Rhinitis

by Francesco Catamerò, Maria Chiara Bragato, Montserrat Alvaro Lozano, Giorgio Walter Canonica, Domingo Barber Hernández, Maria M. Escribese, Enrico Heffler, Oliver Pfaar, Umit Sahiner, Giovanni Paoletti and Mattia Giovannini

Vaccines 2026, 14(4), 326; https://doi.org/10.3390/vaccines14040326 - 7 Apr 2026

Cited by 2 | Viewed by 4011

Abstract

Background/Objectives: Allergen immunotherapy (AIT), involving subcutaneous (SCIT) or sublingual (SLIT) administration of the culprit allergen, is the only treatment capable of modifying the natural course of allergic diseases, and provides lasting benefits in terms of symptom reduction and medication use. AIT for [...] Read more.

Background/Objectives: Allergen immunotherapy (AIT), involving subcutaneous (SCIT) or sublingual (SLIT) administration of the culprit allergen, is the only treatment capable of modifying the natural course of allergic diseases, and provides lasting benefits in terms of symptom reduction and medication use. AIT for allergic rhinitis is acknowledged as safe and effective in both adults and children; however, no studies have comprehensively evaluated the safety and efficacy of AIT in these populations, integrating results from randomized controlled trials (RCTs) and real-world evidence (RWE). Methods: We evaluated data in the literature including studies from RCTs and RWE in which the safety and efficacy of AIT in both children and adults have been analyzed. A narrative literature search was conducted in PubMed up to January 2026 using the following keywords for the search string: “allergen immunotherapy,” “AIT,” “safety,” “efficacy,” “clinical outcome,” and “clinical evaluation.” Results: RCTs and meta-analyses showed that both SCIT and SLIT significantly reduced allergic symptoms and medication use and improved quality of life (QoL). Large SLIT tablet trials have confirmed its efficacy in adults and children, whereas RWE supports its effectiveness in broader populations. Safety data indicated that SCIT carries a small but higher risk of systemic reactions than SLIT, which mainly causes mild local effects. Conclusions: AIT was effective and safe for treating allergic rhinitis across RCT and RWE studies. Integrating RWE with RCT findings is essential for guideline development, particularly for capturing long-term outcomes and real-world applications. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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18 pages, 691 KB

Open AccessReview

Vaccination Against Respiratory Infections in Adults with Cancer: A Concise Guide for Clinicians

by Kay Choong See

Vaccines 2026, 14(1), 105; https://doi.org/10.3390/vaccines14010105 - 21 Jan 2026

Cited by 2 | Viewed by 1422

Abstract

Global cancer incidence reached 20 million new cases across 185 countries in 2022, with approximately 10 million cancer-related deaths annually. Among adults with solid tumors and hematological malignancies, infections are a major contributor to morbidity and mortality, with respiratory infections playing a particularly [...] Read more.

Global cancer incidence reached 20 million new cases across 185 countries in 2022, with approximately 10 million cancer-related deaths annually. Among adults with solid tumors and hematological malignancies, infections are a major contributor to morbidity and mortality, with respiratory infections playing a particularly significant role. These infections not only reduce life expectancy but can also delay cancer therapy, negatively affect treatment outcomes, and increase healthcare costs. In recent years, the burden of respiratory infections in this population has been driven by influenza virus, SARS-CoV-2, respiratory syncytial virus, Streptococcus pneumoniae, and Bordetella pertussis. Effective vaccines are available for all these pathogens and are recommended for adults with cancer, yet vaccination uptake remains suboptimal despite their heightened vulnerability. This review provides practical guidance for healthcare professionals on vaccinating adults with cancer against respiratory infections, summarizing key information to help clinicians address vaccination-related complacency, confidence, and convenience. Evidence from studies in both the general population and cancer patients consistently shows that vaccination benefits outweigh potential risks, with adverse event rates comparable to those seen in individuals without cancer. Early vaccination is encouraged, as there is limited justification for delaying immunization even when immune responses may be reduced. Vaccine dosing aligns with recommendations for the general population, with important exceptions. Live attenuated vaccines should be avoided because of the risk of replication and disease in immunocompromised patients, and selected groups may require booster doses to achieve adequate protection. Notably, cancer immunotherapy does not appear to impair vaccine-induced immune responses. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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Other

Jump to: Research, Review

7 pages, 158 KB

Open AccessCommentary

Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products

by Alemayehu Duga, Nebiyu Dereje, Mosoka Papa Fallah, Tedi Angasa, Abebe Genetu Bayih, Edinam Agbenu, Ngashi Ngongo, Raji Tajudeen and Jean Kaseya

Vaccines 2025, 13(6), 646; https://doi.org/10.3390/vaccines13060646 - 16 Jun 2025

Cited by 13 | Viewed by 3270

Abstract

The World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations—Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and [...] Read more.

The World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations—Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe—have attained ML3 status, marking a significant milestone in the continent’s regulatory landscape. Achieving ML3 confers critical benefits, including reducing substandard and falsified medicines, which enhances public health safety and fosters trust in healthcare systems. This progress encourages local manufacturing, diminishing reliance on imported medicines and promoting economic development. Furthermore, ML3 NRAs are better equipped to address public health emergencies, enabling swift approvals for vaccines and therapeutics while upholding safety standards. Nonetheless, challenges persist, including fragmented regulatory systems, the prevalence of counterfeit medicines, and limited resources. Overcoming these hurdles necessitates enhanced organizational capacity, investments in training, and the promotion of collaboration among NRAs. There is an urgent call for greater political commitment and resource allocation to strengthen regulatory systems across Africa. Achieving and maintaining ML3 status is essential for enhancing medicine regulation, supporting local manufacturing, and improving public health outcomes across the continent. While progress has been made, sustained efforts are crucial to tackling existing challenges and harnessing the full potential of advanced regulatory frameworks. Full article

(This article belongs to the Special Issue Challenges to Developing New Vaccines and Improving Existing Platforms)

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