In addition, instead of complex mRNAs coding for many viral proteins, the ivt mRNA vaccine contains a single mRNA coding for one (in the case of non-replicating mRNA vaccines) selected protein: a structural protein from an infectious agent, an allergen, or a tumor antigen, for example. However, instead of a viral membrane containing many components (lipids and proteins), the ivt mRNA vaccine envelope that is used in the current anti-COVID-19 vaccines is made of a liposome consisting of a few (usually four) defined lipids. The exact same mechanisms account for the functionality of the ivt mRNA vaccines. The infected cells produce the viral proteins and sense danger, which leads to the triggering of inflammation, allowing for the development of an immune response. It can be considered that the vaccines against yellow fever, measles, mumps, and rubella are early versions of mRNA vaccines: These attenuated viruses are injected subcutaneously and without adjuvants to deliver their RNA genomes into the cells of the host. History of Synthetic Non-Replicating mRNA Vaccines It has been approved for emergency use in the UK (2 December 2020) and in the US (11 December 2020), but also under regular authorization conditions in Switzerland (19 December 2020) and the EU (21 December 2020).Ģ. This very low dose of the mRNA vaccine as well as its safety and efficacy features make it the superlative vaccine that is needed to curb the COVID-19 pandemic. Interestingly, the newcomer in this list of synthetic RNA therapeutics, the vaccine against SARS-CoV-2, requires remarkably low doses: 30 µg of synthetic in vitro transcribed mRNA (ivt mRNA) that is injected twice into the muscle, while Macugen ® (OSI Pharmaceuticals, Melville, NY, USA) is given intravitreal at a dose of 3000 µg every six weeks and Onpattro ® (Alnylam Pharmaceuticals, Inc., Cambridge, MA, USA) is intravenously delivered at a dose up to 30,000 µg every three weeks. RNAs control gene expression, as seen with micro RNAs (miRNAs) that has been turned into a drug (siRNA) that degrades messenger RNA encoding transthyretin and it is used for the treatment of hereditary transthyretin amyloidosis. The distribution of these vaccines throughout the world will bring a halt to the coronavirus pandemic.
The efficacy and safety data are stunning. Remarkably, the 30 µg of mRNA that are contained in the first approved anti-COVID-19 vaccine are sufficient for generating high levels of neutralizing antibodies against the virus in all injected volunteers (including participants over 65 years old). It follows the aptamer Macugen ® (which neutralizes VEGF) and the siRNA Onpattro ® (which destroys the transthyretin-coding mRNA). The anti-COVID-19 mRNA vaccine (coding the SARS-CoV-2 spike protein) is the third synthetic RNA therapeutic being approved. Synthetic mRNA in liposomes can be seen as a modern, more refined, and thereby a safer version of those live attenuated RNA viruses.
The mRNA vaccines are not new: vaccines that are based on attenuated mRNA viruses, such as Mumps, Measles, and Rubella, immunize by delivering their mRNAs into the cells of the vaccinated individual, who produces the viral proteins that then prime the immune response.
In the race for a vaccine against SARS-CoV-2, the synthetic mRNA format has been shown to be the fastest one and proved to be safe and highly efficient, even at the very low dose of a few µg per injection.
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