FDA updates emergency use authorisation for mRNA 1273 in COVID-19 – Moderna

Moderna announced that the FDA has approved an update to the emergency use authorization for the Moderna mRNA 1273 COVID-19 vaccine to include a third dose for immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

A recent double-blind, randomized controlled trial of 120 individuals who had undergone solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) demonstrated that a third dose of the Moderna COVID-19 vaccine improved immune response compared to placebo. In the study, the third dose of mRNA-1273 was generally well tolerated.