Challenges:

In light of the global impact of the COVID-19 pandemic, numerous nations, including Saudi Arabia, have acknowledged the significance of establishing domestic capacities for manufacturing human vaccines. As an integral part of its Vision 2030 strategy, the Kingdom aims to increase the localization of drug production from the existing 35% to 40%. The focus will be on prioritizing the production of routine vaccines for children and other highly sought-after medications.

ُ The vaccine manufacturing industry poses significant challenges, as even the most rudimentary steps involved in producing vaccines that are safe, effective, and consistent throughout their lifespan can be immensely difficult to execute. The effectiveness of a vaccine can vary greatly due to a multitude of factors, including the inherent biological variations in the starting materials, the characteristics of the microorganism itself, the environmental conditions during microbial cultivation, the expertise of the manufacturing technician, and the intricacies of the purification processes. Furthermore, regulatory bodies not only approve specific vaccines but also examine and authorize the entire manufacturing, testing, and release procedures associated with those vaccines. Even a minor alteration in the production process can have profound implications on the final product, impacting its purity, safety, or effectiveness. The compounded complexity arising from biological and physical variability sets vaccine manufacturing apart from the production of conventional small molecule pharmaceuticals. Consequently, the number of successful and thriving vaccine manufacturers remains low despite the global demand for various vaccines remaining unmet.

Establishing a vaccine production facility presents several challenges on the commercial, technological, and regulatory fronts. Firstly, specialized equipment, clean rooms, and containment rooms are essential requirements for such facilities. However, there is a global shortage of personnel possessing the precise combination of skills, expertise, knowledge, competence, and suitable personalities to effectively operate vaccine production lines. While countries like Brazil, China, and India have made notable progress in this regard, many developing nations face limitations in their educational systems, resulting in a scarcity of qualified candidates. Consequently, vaccine manufacturers in these countries often rely on expatriate staff to ensure uninterrupted production. To successfully build a vaccine manufacturing plant, it becomes imperative to address these challenges through appropriate means.

• »Vaccine R&D and manufacturing requires a large initial investment and is considered a risky investment as only a small fraction of developed vaccines receive regulatory approval.
• »Vaccine development, research and registration can take several years and therefore realization of costs requires time.
• »Vaccine pricing must strike a balance between accessibility and profitability. There must be a willingness from government and non-government organizations to subsidize vaccine costs to ensure successful commercialization.
• »Stringent regulatory requirements, including World Health Organization (WHO) prequalification and local regulations combined with quality assurance (QA)/quality control(QC) requirements, are significant drivers of cost and require well-trained staff that can adapt to any regulatory changes.
• »Certain vaccines require precise temperature control throughout the supply chain which introduces logistical challenges especially in remote or resource limited areas.
• »Vaccine supply chain is vulnerable to disruption as various stages of the supply chain are carried out in different geographical regions.
• »Public perception, misinformation and hesitancy can affect vaccine demand and acceptance.

َ Two potential solutions have been proposed to address these challenges. The first option is to establish local vaccine production plants in collaboration with international vaccine companies through strategies such as in-licensing or joint venture partnerships. This approach would help overcome barriers related to expensive vaccine discovery, research, and development. An alternative approach involves initially setting up local plants as downstream manufacturing facilities, specifically for the filling and finishing stages of the vaccine production process. The aim of this approach is to foster collaboration between local plants and reputable pharmaceutical companies. It also encourages local facilities to gain expertise in running a factory that meets the requirements of both upstream and downstream supply chains for vaccines. To ensure the success of these strategies, new investors in the vaccine industry should adopt a broader vision for the future and actively support research and development efforts. The potential rewards of developing a new molecule or formulation in the vaccine field can be significant, but it requires patience, substantial investments, and comprehensive research to achieve the desired goals