Moderna COVID-19 Vaccine

The Moderna COVID-19 Vaccine (mRNA-1273) is a novel mRNA-based vaccine encapsulated in a lipid nanoparticle that encodes for a full-length pre-fusion stabilized spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by the novel coronavirus, SARS-CoV-2, leading to a respiratory illness alongside other complications. COVID-19 has high interpatient variability in symptoms, ranging from mild symptoms to severe illness.^L28026 A phase I, open-label, dose-ranging clinical trial (NCT04283461) was initiated in March 2020 in which 45 subjects received two intramuscular doses (on days 1 and 29).^L12660 This trial was later followed by phase II and III trials, where the Moderna COVID-19 Vaccine demonstrated vaccine efficacy of 94.1%.^L28026

On December 18, 2020, the FDA first issued an emergency use authorization (EUA) for the Moderna COVID-19 Vaccine as the second vaccine for the prevention of COVID-19 caused by SARS-CoV-2 in patients aged 18 years and older, after the EUA issued for the Pfizer-BioNTech Covid-19 Vaccine (Tozinameran) on December 11, 2020. The Moderna COVID-19 Vaccine is administered as a series of two intramuscular injections, one month (28 days) apart. In clinical trials, there were no differences in the safety profiles between younger and older (65 years of age and older) study participants.^L28026 On December 23, 2020, Health Canada issued an expedited authorization for the Moderna COVID-19 Vaccine.^L28143

In November 2021, Health Canada and the EMA authorized the use of the Moderna COVID-19 vaccine as a booster shot to be given at least six months following the primary vaccination series and at half (50 mcg) of its regular strength.L39160, L39277 A similar booster dose is also available in the US for patients 18 years of age and older.^L39217 The Moderna COVID-19 Vaccine was fully approved by the FDA on January 31, 2022 ^L40079 and Health Canada expanded the use of the Moderna COVID-19 Vaccine to include individuals aged six to 11.^L39307 The Moderna COVID-19 vaccine is also approved for use as a fourth booster shot in adults 50 years of age and older.^L41350

Updated formulations of Spikevax have been produced to target developing variants of concern. For the 2024-2025 season, an updated formulation was approved for use in Canada and the US to target the Omicron KP.2 subvariant.L51404,L40074