Moderna begins testing COVID-19 vaccine in younger children

Vaccine study underway in children 6 months to less than 12 years

FILE - In this file photo dated Wednesday, Feb. 17, 2021, three vials of the Moderna COVID-19 Vaccine are pictured in a new coronavirus vaccination center at the 'Velodrom' (velodrome-stadium) in Berlin, Germany. Slow off the blocks in the race to immunize its citizens against COVID-19, Germany faces the problem of having a glut of vaccines and not enough arms to inject. (AP Photo/Michael Sohn, FILE)
FILE - In this file photo dated Wednesday, Feb. 17, 2021, three vials of the Moderna COVID-19 Vaccine are pictured in a new coronavirus vaccination center at the 'Velodrom' (velodrome-stadium) in Berlin, Germany. Slow off the blocks in the race to immunize its citizens against COVID-19, Germany faces the problem of having a glut of vaccines and not enough arms to inject. (AP Photo/Michael Sohn, FILE) (Copyright 2021 The Associated Press. All rights reserved)

Moderna Inc. announced Tuesday it has started testing its mRNA-1273 vaccine candidate against COVID-19 in children ages 6 months to less than 12 years old.

This is part of Moderna’s Phase 2/3 vaccine study called “KidCOVE” in which is intends to enroll about 6,750 pediatric participants in theU.S. and Canada ages 6 months to less than 12 years old.

“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada and we thank NIAID and BARDA for their collaboration,” said Stéphane Bancel, Chief Executive Officer of Moderna. “It is humbling to know that 53 million doses have been administered to people in the U.S. We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population.”

Here’s how Moderna describes the study:

This Phase 2/3 two-part, open label, dose-escalation, age de-escalation (Part 1) and randomized, observer-blind, placebo-controlled expansion study (Part 2) will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart. The Company intends to enroll approximately 6,750 pediatric participants in the U.S. and Canada ages 6 months to less than 12 years.

In Part 1, each participant ages two years to less than 12 years may receive one of two dose levels (50 μg or 100 μg). Also in Part 1, each participant ages six months to less than 2 years may receive one of three dose levels (25 μg, 50 μg and 100 μg). An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination. Vaccine effectiveness will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (ages 18-25) population. Evaluation of vaccine safety and reactogenicity is also a primary endpoint of the study. The ClinicalTrials.gov identifier is NCT04796896. For more information about the trial, including the process for enrolling participants, please visit www.kidcovestudy.com.

-- Moderna Inc.

Read more about the KidCOVE study here.

Such trials in children already were underway in children aged 12 to 15. Both Pfizer and Moderna have started these trials and expect to have results from their trials in older children this summer.

A vaccine for younger children has not been expected ready until early next year (2022).


About the Author:

Dave Bartkowiak Jr. is the digital managing editor for ClickOnDetroit.