From Bench to the Clinic: The Path to Translation of Nanotechnology-Enabled mRNA SARS-CoV-2 Vaccines

Abstract

During the last decades, the use of nanotechnology in medicine has effectively been translated to the design of drug delivery systems, nanostructured tissues, diagnostic platforms, and novel nanomaterials against several human diseases and infectious pathogens. Nanotechnology-enabled vaccines have been positioned as solutions to mitigate the pandemic outbreak caused by the novel pathogen severe acute respiratory syndrome coronavirus 2. To fast-track the development of vaccines, unprecedented industrial and academic collaborations emerged around the world, resulting in the clinical translation of effective vaccines in less than one year. In this article, we provide an overview of the path to translation from the bench to the clinic of nanotechnology-enabled messenger ribonucleic acid vaccines and examine in detail the types of delivery systems used, their mechanisms of action, obtained results during each phase of their clinical development and their regulatory approval process. We also analyze how nanotechnology is impacting global health and economy during the COVID-19 pandemic and beyond.

Current advancements and future prospects of COVID-19 vaccines and therapeutics: a narrative review

“…Nanotechnology-enabled vaccines have been positioned as potential solutions to the pandemic outbreak caused by the novel pathogen SARS-CoV-2. 56 RNAs are exceptional bioactive macromolecules that have been identified as key players in regulating a wide range of biochemical pathways. 57 The ability to control cell fate and tissue activities intimately makes RNA-based drugs the most intriguing family of bioactive agents.…”

“… 57 Unprecedented industrial and academic collaborations emerged around the world to accelerate vaccine development, resulting in the clinical translation of effective vaccines in less than a year. 56 Today, new requests for the development of RNA-based vaccines have emerged as a result of the COVID-19 pandemic, bringing this technology to the forefront. 57 During the next few decades, the area of RNA therapies is predicted to explode, despite its current limitations, there is space for advancement and improvement.…”

Immune Response in Regard to Hypersensitivity Reactions after COVID-19 Vaccination

“…The clinical manifestations of this disease range from an asymptomatic flu-like syndrome to anosmia, atypical pneumonia, coagulopathy problems, and cytokine storms inducing multiple organ failure, and even death. In addition to the respiratory tract, patients frequently manifest symptoms in their gastrointestinal system, liver, heart, skin, and/or central nervous system [ 2 , 3 ]. In addition, there have been reports of hypersensitivity reactions following COVID-19 infection, including urticaria, morbilliform rash, pernio-like acral lesions, vasculitis, pemphigus vulgaris, and Stevens–Johnson syndrome [ 4 , 5 , 6 ].…”

“…Coronaviruses are positive-sense single-stranded RNA viruses (+ssRNA), named after their crown-like appearance due to spike glycoproteins on the spherical or pleomorphic envelope ( Figure 1 a) [ 2 , 3 ]. COVID-19 belongs to the beta genera of the Orthocoronavirinae subfamily of the Coronaviridae family, similar to the severe acute respiratory syndrome coronavirus (SARS-CoV) and the Middle East respiratory syndrome coronavirus [ 2 , 3 ]. Its origins have been traced to bats, and the virus was newly transmitted to humans without a clear underlying reason.…”

“…The WHO has defined a successful vaccine as one with >30% vaccine efficacy and at least 50% disease reduction [ 3 ]. Traditionally, vaccine development (from the exploratory and pre-clinical stage to approval and surveillance) requires approximately 10–15 years and a budget of approximately USD 1 billion [ 10 , 11 ].…”