WHO recommendation Moderna COVID-19 mRNA Vaccine (nucleoside modified)
Moderna used its mRNA-based platform to develop mRNA-1273, a novel, lipid nanoparticle (LNP)-encapsulated, mRNA-based vaccine against SARS-CoV-2 (2019 novel coronavirus). The proprietary LNPs encapsulating the mRNA increase its delivery efficiency and improve vaccine tolerability. The vaccine is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2. The mRNA-1273 vaccine is administered by intramuscular (IM) injection, and mRNA is subsequently delivered into cells, primarily to antigen presenting cells at the injection site and draining lymph nodes. After delivery, the mRNA utilizes the cell’s translational machinery to produce the spike protein, which after proper assembly and processing is trafficked to the cell membrane for display to the immune system.
The clinical data presented were generated from three trials. The vaccine was shown to be safe and immunogenic. In the phase III trial that enrolled 28,207 participants, the data cut on 25 November 2020, showed that 185 cases of COVID-19 occurred in the placebo group and 11 cases occurred in the group that received mRNA-1273, giving a vaccine efficacy of 94.1% (95% confidence interval, 89.3% – 96.8%) against symptomatic COVID-19.
COVID-19 Vaccine Moderna is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
The European Medicines Agency (EMA) is the regulatory authority of reference and has granted conditional Marketing Authorization for the use of COVID-19 Vaccine Moderna. The vaccine is endorsed by other regulatory authorities (e.g., the Food and Drug Administration of the United States of America and Health Canada).
This report was prepared by the product evaluation group (PEG) to be discussed by the technical advisory group for emergency use listing (TAG-EUL).