Moderna is planning a clinical trial of its COVID-19 vaccine candidate, mRNA-1273, with children ages 12 through 17.
The study, posted on ClinicalTrials.gov, will include 3,000 participants, with half receiving the vaccine and half being injected with a saline placebo. Both will be administered in two doses, scheduled 28 days apart — the same dosing and schedule that is being tested in adults.
Last week, Moderna submitted a request for Emergency Use Authorization from the FDA, following the announcement of results from a 30,000-person phase 3 study. The COVE study found that only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says — far above what many scientists were expecting just a few weeks ago.
Pfizer began testing its coronavirus vaccine candidate in children as young as 12 in October. Moderna's recent ClinicalTrials posting lists the adolescent study as “not yet recruiting,” with an intended completion date of June 2022.
See the study posting