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. 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). This trial was later followed by phase II and III trials, where the Moderna COVID-19 Vaccine demonstrated vaccine efficacy of 94.1%.

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] 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. On December 23, 2020, Health Canada issued an expedited authorization for the Moderna COVID-19 Vaccine.

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. A similar booster dose is also available in the US for patients 18 years of age and older. The Moderna COVID-19 Vaccine was fully approved by the FDA on January 31, 2022 and Health Canada expanded the use of the Moderna COVID-19 Vaccine to include individuals aged six to 11. The Moderna COVID-19 vaccine is also approved for use as a fourth booster shot in adults 50 years of age and older.

The Moderna COVID-19 Vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older in the US and Europe, and in individuals 6 months of age and older in Canada. In the US, under the emergency use authorization, the Moderna COVID-19 Vaccine is used for the prevention of COVID-19 in children 6 months of age and older.[L42770]

It is administered in two doses, one month (28 days) apart. A booster dose of the vaccine, to be given at least 6 months following the initial vaccine series, is approved for use in all patients 18 years of age and older in Canada and the US. The Moderna COVID-19 vaccine is also approved for use as a fourth booster shot in adults 50 years of age and older.

A bivalent formulation of the Moderna vaccine which includes davesomeran - targeting the BA.4 and BA.5 Omicron variants - was approved in August 2022 by the FDA and in November 2022 by Health Canada. In Canada, an additional bivalent formulation which includes imelasomeran - targeting the BA.1 Omicron variant - was approved in September 2022, and may be used as a booster dose in individuals ≥6 years of age.