Michigan Hospital Takes Part In Moderna Study On Young Children

DETROIT — A southeast Michigan health system is enrolling children as young as six months in a Moderna COVID-19 vaccination study.

Henry Ford Health System announced Thursday it is the only site in Michigan to be participating in the Moderna vaccine study, which involves children ranging from six months to 11 years old.

“The more vaccine candidates we have for our young people, the better,” said Adnan Munkarah, Henry Ford's Executive Vice President and Chief Clinical Officer. “We encourage parents to consider enrolling their children who may qualify for this vaccine study.”

According to the health system, the KidCOVE study will evaluate the safety and efficacy of Moderna’s mRNA-1273 vaccine for children in this age group. The mRNA-1273 vaccine is the same vaccine that was given Emergency Use Authorization by the FDA for people 18 and older.

Moderna said this week that it would apply for authorization in June to use the vaccine for 12- to 17-year-olds.

To date, more than 122 million doses of the Moderna vaccine have been administered in the United States and more than 53 million people are fully vaccinated with it. Nearly 3.4 million doses of the Moderna vaccine have been administered in Michigan, according to Michigan Department of Health and Human Services data.

KidCOVE is the fourth COVID-19 vaccine trial for which Henry Ford has been selected as a study site. The health system was a Phase 3 study site and the only Michigan site for Moderna’s two-dose adult vaccine and for Johnson & Johnson’s ENSEMBLE 1 one-dose and ENSEMBLE 2 two-dose adult vaccine, hospital officials said in a release.

That the health system was chosen a fourth time for a COVID-19 vaccine trial is a reflection of its research expertise, Munkarah said.

“We’re very proud to have an integral role in these important vaccine trials and our study teams have done a phenomenal job leading our efforts,” he said.

KidCOVE is a randomized, placebo-controlled study that will help determine which is the safest and most effective dose for children in this age group.

Officials said that in a Phase 2 study, the study vaccine, drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

In a Phase 3 study, the study vaccine, drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the vaccine, drug or treatment to be used safely, officials said.