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Moderna has begun testing its COVID-19 vaccine in children, the company announced Tuesday.
Children have started receiving doses of mRNA vaccine as part of a phase 2/3 study called KidCOVE. The company plans to enroll 6,750 children ages 6 months through 11 years.
The two-part study will begin by testing different dose levels, then move into a randomized, placebo-controlled expansion study to evaluate safety and effectiveness. Moderna plans to use a correlate of protection or immunobridging to determine effectiveness.
“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,” Moderna CEO Stéphane Bancel said in a news release.
The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority. Moderna and Pfizer-BioNTech also have trials underway in adolescents. Those trials are fully enrolled, but Moderna's news release did not provide any additional update on the status of the study in 12- to 17-year-olds, which is called TeenCOVE.
The AAP has continued to push for pediatric vaccine trials as more than 3.2 million children have been infected with SARS-CoV-2 and at least 266 have died, according to data from the AAP and the Children’s Hospital Association. The pandemic also has taken a toll on children’s mental and emotional health, social well-being and their educational experience.
AAP President Lee Savio Beers, M.D., FAAP, said in a recent statement that children cannot be an afterthought in vaccine development.
“Having a COVID-19 vaccine available for children is essential for our nation to end the pandemic,” she said. “And we must make sure that vaccine trials in children are equitable and include those at increased risk who could most benefit from a vaccine, particularly Black and Latinx children. We need to apply the same urgency to vaccinate children as we have for adults. Pediatricians stand ready to partner with the federal government to make this happen.”