Henry Ford enrolling kids as young as six months in Moderna vaccine study
Henry Ford Health System announced Thursday it's enrolling infants and young children for a Moderna COVID-19 vaccine study.
The health system is the only enrollment site in Michigan and the international trial will be open to children from six months to 11 years old, said Dr. Tisa Johnson-Hooper, the health system's interim chair of pediatrics.
"Until we get more people vaccinated, there's still an opportunity for the virus to continue to spread and mutate," Johnson-Hooper said during a Thursday afternoon news conference. "While young children are believed to spread COVID less often than adults, their ability to transmit it rises with age."
The randomized KidCOVE study will evaluate the safety and efficiency of the mRNA-1273 vaccine and is in the second of three phases. During the second phase, the vaccine is given to a larger group of people and is monitored for side effects.
The KidCOVE study kicked off in March enrolling approximately 6,750 healthy children in the U.S. and Canada. The first age group will start with children between the ages of 6 to 11 years old; the second, which will be recruited later on, will be children ages 2 to 5 years old and last to start will be six months to less than 2 years old.
Participation in KidCOVE will last 14 months and require both in-person clinic visits and virtual visits for updates. It's unclear how many will be taking part in the Michigan trial or when enrollment will be complete.
Participants have to be considered healthy and must not have recently contracted the coronavirus or other illness. They also must not have taken part in another COVID-19 trial in the past month or received an approved vaccine.
Children will be given two doses of the vaccine 28 days apart. Neither the participants nor their parents will know whether they received the study vaccine or a placebo injection. All participants will be closely monitored by the study team.
The most common side effects are fevers, headache, muscle aches or pain, joint aches or tiredness, Johnson-Hooper said.
The Moderna vaccine was given emergency use authorization by the U.S. Food and Drug Administration for adults 18 and older. On Tuesday, Moderna said it would apply for authorization in June to use the vaccine for 12-to 17-year-olds. To date, more than 122 million doses have been administered and 53 million people are fully vaccinated with it.
Dr. Adnan Munkarah, Henry Ford Health executive vice president and chief clinical officer, said Thursday that it's still concerning that more than 40% of the adult population has not received one dose of the vaccine.
"COVID is under control but it's not behind us," Munkarah said. "We encourage parents to consider enrolling their children who may qualify for this vaccine study."
As of Wednesday, 58.1% of Michigan residents over age 16 had received at least one dose of the COVID-19 vaccine.
Children ages 12-15 in Michigan became eligible for the Pfizer vaccine earlier this month. In turn, the increase in the population eligible for vaccination has decreased the percentage of the population vaccinated to about 52.9%.
Overall, Michigan has recorded 886,660 cases of COVID-19 and 19,090 deaths from the virus since the first case was detected here in March 2020, according to the state Department of Health and Human Services.
The COVID-19 vaccine trial announced Thursday is the fourth for Henry Ford Health System, Munkarah said. The health system was selected to participate in the third phase of the initial Moderna vaccine trial in August, the Johnson & Johnson one-dose and two-dose vaccines.
Parents may sign up their children for KidCOVE at this link www.henryford.com/modernakidcove