Abstract
In December 2019, a new and highly pathogenic coronavirus emerged—coronavirus disease 2019 (COVID-19), a disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), quickly spread throughout the world. In response to this global pandemic, a few vaccines were allowed for emergency use, beginning in November 2020, of which the mRNA-based vaccines by Moderna (Moderna, Cambridge, MA, USA) and BioNTech (BioTech, Mainz, Germany)/Pfizer (Pfizer, New York, NY, USA) have been identified as the most effective ones. The mRNA platform allowed rapid development of vaccines, but their global use is limited by ultracold storage requirements. Most resource-poor countries do not have cold chain storage to execute mass vaccination. Therefore, determining strategies to increase stability of mRNA-based vaccines in relatively higher temperatures can be a game changer to address the current global pandemic and upcoming new waves. In this review, we summarized the current research strategies to enhance stability of the RNA vaccine delivery system.
Highlights
Coronavirus disease 2019 (COVID-19) was first identified in December 2019 in Wuhan, China
Another lipid nanoparticles (LNP)-based messenger RNA (mRNA) vaccine CVnCoV was developed by CureVac (CureVac, Tübingen, Germany) which can be stored at much warmer temperatures (5 ◦C) for at least three months (Table 1) [13], indicating better thermostability compared to vaccines from Moderna or BioNTech/Pfizer
Due to lack of published data on thermostability of LNP formulations with mRNA, we looked at stability data of LNP formulations that were prepared to deliver small interfering RNA [12,52]
Summary
Coronavirus disease 2019 (COVID-19) was first identified in December 2019 in Wuhan, China. Clinical trials are currently underway for mRNA vaccines which could provide protection against emerging variants of SARS-CoV-2 (ClinicalTrials.gov (accessed 15 September 2021) Identifier: NCT04785144) Despite these merits of efficacy and safety, instability and ultracold storage requirement of mRNA vaccines remain major limitations. ARCoV China mRNA encoding viral receptor binding domain of spike glycoprotein LNP Ionizable lipid (unknown) Helper lipids (DSPC, Cholesterol) PEG lipid (PEG-DMG) Another LNP-based mRNA vaccine CVnCoV was developed by CureVac (CureVac, Tübingen, Germany) which can be stored at much warmer temperatures (5 ◦C) for at least three months (Table 1) [13], indicating better thermostability compared to vaccines from Moderna or BioNTech/Pfizer. A new mRNA LNP vaccine developed by Walvax (Walvax, Kunming, China) (ARCoV), undergoing a phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT04847102), showed promising thermostability This vaccine employed nucleoside modified the mRNA encoding viral receptor binding domain (RBD) [7,18]. We highlight the findings in the current literature that explore potential strategies of developing thermostable RNA vaccine delivery systems
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