However, this is costly and difficult to implement at a large scale. To deliver effective, precise, and consistent vaccines it is imperative to use good manufacturing practice (GMP) compliant equipment, facilities, and procedures. The manufacturing of new vaccines is typically a lengthy (6 to 36 months), challenging and expensive process, as no standard process is available. In the case of toxoid and subunit vaccines, and despite their safety and stability profile, the use of adjuvants is required for a strong immune response and the protection lifetime is limited ( Table 1 However, they present safety concerns due to the use of whole pathogens and in many cases, they dońt have a defined composition. Traditional attenuated and inactivated vaccines are still widely used today (e.g., Bacillus Calmette–Guérin vaccine, BCG and Inactivated Polio vaccine, IPV) owing to their robustness and stability. ĭespite the proven effectiveness of current vaccines, there is still room for improvement in the vaccine technology field. Technology advances coupled with progress in target selection and understanding of the immunosuppressive mechanisms have led to the development of therapeutic cancer vaccines. The use of vaccines goes beyond prevention of infectious diseases. Additionally, by preventing bacterial infection and, subsequently, reducing the need for antibiotic treatment, vaccines can have an impact on antimicrobial resistance. Their impact on the economic viability of the healthcare system is also very large, since vaccines lower the treatment costs of diseases, and reduce the impact and risk of outbreaks. Vaccines save 6 million lives every year and are one of the major responsible for the increase of human longevity. Vaccination targets and milestones adapted from. In this review we describe the current state-of-art of mRNA vaccines, focusing on the challenges and bottlenecks of manufacturing that need to be addressed to turn this new vaccination technology into an effective, fast and cost-effective response to emerging health crises. Large scale production of mRNA vaccines consists in a 1 or 2-step in vitro reaction followed by a purification platform with multiple steps that can include Dnase digestion, precipitation, chromatography or tangential flow filtration. The increased demand for mRNA vaccines requires a technology platform and cost-effective manufacturing process with a well-defined product characterisation. Additionally, mRNA vaccines are being studied in the clinic to treat a number of diseases including cancer, HIV, influenza and even genetic disorders. In fact, mRNA vaccines were the technology of choice for many companies to combat the Covid-19 pandemic, and it was the first technology to be approved in both United States and in Europe Union as a prophylactic treatment. Owing to its precision, safe profile and flexible manufacturing, mRNA vaccines are reaching the stoplight as a new alternative to conventional vaccines. Vaccines are one of the most important tools in public health and play an important role in infectious diseases control.
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