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Moderna Has Started Testing Its COVID-19 Vaccine On Kids & Babies

Older children will get the vaccine first, followed by progressively younger age groups should preliminary data show it to be safe.

by Morgan Brinlee

The first participants in Moderna’s pediatric COVID-19 vaccine trial have been vaccinated, the biotechnology company announced Tuesday. Moderna’s trial will study the COVID vaccine in kids between the ages of six months to 11 years old and is expected to include more than 6,700 children from the United States and Canada.

Moderna CEO Stéphane Bancel said the biotechnology company was “pleased” to have begun its Phase 2/3 study, which it has named the KidCOVE study. “We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above,” Bancel said in a statement issued by Moderna. “This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population.”

Moderna likely isn’t the only one pleased to see a study geared at examining the COVID-19 vaccine in younger children kick-off. Many parents are eager to see their children protected against the COVID-19 vaccine ahead of the 2021-2022 school year while the American Academy of Pediatrics (AAP) has called for vaccine trials to include pediatric patients “of all ages.”

“It is critical that pediatric patients of all ages be included in trials as quickly as possible,” AAP President Dr. Lee Savio Beers said in February. “We are especially concerned about children who belong to racial, ethnic, and cultural groups that have been disproportionately affected by the pandemic or who have underlying conditions that place them at increased risk for developing severe COVID-19 infection.”

Conducted in collaboration with the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), the KidCOVE study aims to evaluate the safety and effectiveness of Moderna’s COVID-19 vaccine in young children via a blind randomized and placebo-controlled expansion study.

According to Moderna, the KidCOVE study has been structured to be an “age de-escalation” study, meaning older children will receive the vaccine first followed by progressively younger age groups when and if preliminary data has shown it to be safe. Additionally, the study will also be conducted as a “dose escalation,” meaning participants will first receive smaller doses of Moderna’s COVID-19 vaccine and gradually work their way up to the normal dosage when and if smaller doses have been proven safe. Each of the trial’s approximate 6,750 child participants will be followed for a full 12 months beginning after the administration of the second vaccine dose to give researchers a large window within which to monitor potential side effects and antibody levels.

While the KidCOVE study is Moderna’s first trial to include infants, toddlers, and young children, the biotechnology company is already examining the safety and effectiveness of its COVID-19 vaccine in children aged 12 to 17 in a separate study. And Moderna isn’t the only COVID vaccine manufacturer testing its vaccine on children.

According to CNBC, Pfizer enrolled more than 2,000 kids between the ages of 12 and 15 in its pediatric vaccine trial in January. Additionally, the New York Times reported last month that Johnson & Johnson has plans to test its COVID vaccine in infants and pregnant women.

If you think you’re showing symptoms of coronavirus, which include fever, shortness of breath, and cough, call your doctor before going to get tested. If you’re anxious about the virus’s spread in your community, visit the CDC for up-to-date information and resources, or seek out mental health support. You can find all of Romper’s parents + coronavirus coverage here.