First COVID-19 Vaccine Trial in Children

The Phase 2/3 study called KidCOVE comprises two parts.

      1. 

Part 1

: open label, dose-escalation, age de-escalation study.

• 2 yo – up to 12 yo: each participant may receive either 50 μg or 100 μg dose of the vaccine.
• 6 mo – up to 2 yo: each participant may receive either 25 μg, 50 μg, or 100 μg dose.

      2. 

Part 2

: randomised, observer-blind, placebo-controlled expansion study based on the preliminary evaluation of the Part 1 results.

The participants will receive two doses of the vaccine 28 days apart. To evaluate the medicine’s safety, tolerability, reactogenicity and effectiveness, the company will observe the participants for 12 months after the second jab. It plans to enrol about 6,750 paediatric participants within the stated age range, in the U.S. and Canada.

According to Stéphane Bancel, Moderna’s Chief Executive Officer, the company is “encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above” and now is looking to “assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population”.