Moderna has begun administering its coronavirus vaccine in children ages 6 months to 12 years as part of a Phase 2/3 study dubbed KidCOVE. The vaccine, which has already received emergency use authorization in the U.S., is currently only approved for adults ages 18 and older.
"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," Stéphane Bancel, Moderna CEO, said in a news release. "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."
The current study will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of the mRNA-1273 vaccine given 28 days apart. Dr. Anthony Fauci, director of the National Institutes of Health, which is helping to collaborate on the study, previously cautioned that results regarding the safety of COVID-19 vaccines in children will likely not come until later this year.
On Monday, Moderna announced that it had begun testing its next generation COVID-19 vaccine, mRNA-1283, in a separate clinical trial. The new vaccine candidate could potentially pave the way for easier distribution as it was developed as a refrigerator-stable vaccine. The new vaccine candidate is thus far only being tested in healthy individuals.
Several other companies have begun exploring the safety of COVID-19 vaccines in children, with Pfizer and BioNTech’s currently being the only one approved for use in teens as young as 16. The American Academy of Pediatrics (AAP) recommends that "anyone 16 years of age and older" who meets the criteria for eligibility should get the vaccine.
"It is critical that pediatric patients of all ages be included in trials as quickly as possible, including those 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," the AAP said in a statement released earlier this month. "Evidence of safety and efficacy, or immune responses indicating efficacy, in children is necessary in order to expand the age indication for COVID-19 vaccines. Once approved, vaccine distribution and access should be supported for all children and adolescents, with particular attention to those disproportionately affected by the pandemic."