Molecular Pathogens 2024, Vol.15, No.2, 61-71 http://microbescipublisher.com/index.php/mp 64 3.3 Role of biotechnology in vaccine development Biotechnology plays a crucial role in the advancement of veterinary vaccine development. Techniques such as genetic engineering and rational vaccine design have enabled the creation of vaccines that are more effective and safer than traditional methods. For example, live attenuated vaccines that lack specific viral proteins, such as the NS1 protein in H5N1 influenza vaccines, have demonstrated significant immunogenicity and safety in clinical trials (Nicolodi et al., 2019). Furthermore, the use of viral-like particles and nanoparticle-based platforms has revolutionized the field, offering innovative solutions to address the challenges of vaccine development for both viral and bacterial pathogens (Brisse et al., 2020; Files et al., 2022). These biotechnological advancements not only enhance our understanding of vaccine immunology but also pave the way for the development of vaccines against rapidly emerging infectious diseases and other health threats. In summary, the field of veterinary vaccine development is witnessing significant progress through the integration of traditional approaches with cutting-edge technologies and biotechnological innovations. These advancements hold promise for more effective and safer vaccines, capable of addressing the evolving landscape of emerging pathogens. 4 Challenges in Developing Vaccines for Emerging Pathogens 4.1 Scientific and technical challenges Developing vaccines for emerging pathogens presents numerous scientific and technical challenges. One significant issue is the high variability and rapid evolution of pathogens, which can lead to persistent infections and reduce vaccine efficacy (Celis-Giraldo et al., 2021; Gebre et al., 2021). Traditional vaccine technologies, such as inactivated and live-attenuated vaccines, often fall short in addressing these challenges due to their inherent limitations, including variable efficacy and safety concerns (Aida et al., 2021). Moreover, the development of vaccines for Risk Group 3 (RG-3) and Risk Group 4 (RG-4) pathogens, which include many zoonotic diseases, requires high and maximum biocontainment facilities. These facilities are essential for safely handling and studying highly infectious agents, but they also add complexity and cost to the vaccine development process (Brake et al., 2021). Emerging technologies, such as nanovaccines and viral vector vaccines, offer promising solutions by providing more effective antigen delivery and immunostimulatory properties. These technologies can potentially overcome some of the limitations of traditional vaccines, but they also require significant research and development to ensure their safety and efficacy (Brisse et al., 2020; Celis-Giraldo et al., 2021; Gebre et al., 2021). 4.2 Regulatory and approval processes The regulatory and approval processes for veterinary vaccines are stringent and complex, often requiring extensive data to meet the licencing requirements of global regulatory bodies (Francis, 2022). This process can be particularly challenging for novel vaccine platforms, which may not fit neatly into existing regulatory frameworks. The rapid development and approval of COVID-19 vaccines have highlighted the potential for accelerated regulatory pathways, but these are not yet standard practice for veterinary vaccines (Excler et al., 2021; Francis, 2022). Additionally, the development of vaccines for emerging pathogens often involves navigating different regulatory environments across countries, which can further complicate the approval process. Harmonizing these regulations and creating more flexible frameworks could facilitate the faster development and deployment of vaccines for emerging threats (Excler et al., 2021; Francis, 2022). 4.3 Economic and market considerations Economic and market considerations play a crucial role in the development of veterinary vaccines. The cost of developing and manufacturing vaccines, particularly for emerging pathogens, can be prohibitively high. This is
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