Enrollment Open For Young Children In Moderna Vaccine Study
DETROIT (AP) — A Detroit-based health system is enrolling children ages 6 months to 11 years old for Moderna's COVID-19 vaccine study.
The KidCOVE study will evaluate the safety and effectiveness of the pharma company's mRNA-1273 vaccine for that age group, Henry Ford Health System said Thursday.
The mRNA-1273 is the same vaccine given emergency use authorization by the FDA for people 18 and older.
While children are far less likely than adults to get seriously ill from COVID-19, they represent about 14% of the nation's coronavirus cases. At least 316 have died in the U.S. alone, according to a tally by the American Academy of Pediatrics.
Moderna said Tuesday that its vaccine strongly protects kids as young as 12. Moderna said it will submit its teen data to the U.S. Food and Drug Administration and other global regulators early next month.
Earlier this month, the U.S. and Canada authorized another vaccine — the shot made by Pfizer and BioNTech — to be used starting at age 12. Pfizer also has started testing in children 6 months to 11 years old. Experts hope to see some results in the fall.
"The more vaccine candidates we have for our young people, the better," said Dr. Adnan Munkarah, Henry Ford's executive vice president and chief clinical officer.
Participation in the KidCOVE study will last about 14 months and require both in-person clinic visits and virtual visits. Participants will receive one injection about 28 days apart. Neither the participants or their parents will know whether they received the study vaccine or a placebo injection, according to Henry Ford.
All participants will be closely monitored by the study team.
Michigan has recorded 886,660 virus cases and 19,090 deaths since the start of the pandemic more than a year ago, state health officials reported Thursday.
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