Moderna declared on Tuesday that the first children participating in its vaccine trial had been administered initial shots. The pharmaceutical company seeks to enroll about 6,750 children aged six months to less than 12 years old.
First Children Receive Moderna COVID-19 Vaccine
According to the biotechnology company's CEO Stéphane Bancel, "It is humbling to know that 53 million doses had been administered to people in the U.S. This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population," reported US News.
Moderna is anticipating that its novel coronavirus vaccine could help children. The company behind one of the two-dose COVID-19 vaccines and are FDA-approved declared that participants had received their first shot in a new trial. The KidCOVE study, which is scheduled to enroll 6,750 healthy children in both the United States and Canada, is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) targeted at children under 12 years old.
Dr. David Wohl, medical director of the vaccine clinic at the University of North Carolina, who is not involved in the study, remarked that there is a great demand to discover vaccinating children and what it serves. In a separate study, Moderna is testing its vaccine in 3,000 children between 12 to 17 years old.
According to the company, also on Tuesday, it has begun dosing patients in a mid-to-late stage study of its vaccine, mRNA-1273. The study will evaluate the safety and effectiveness of two shots of mRNA-1273 administered 28 days apart, reported Pharma Live.
The KidCOVE study has two phases. Part 1 is an open-label, age de-escalation, and dose-escalation. Part 2 is an observer-blind, randomized, placebo-controlled expansion study.
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The declaration comes exactly one year after the first adult was administered a test dose of the shot developed at the National Institutes of Health (NIH). It is now being used throughout the United States and in multiple other nations.
The findings of testing the vaccine in children aged 12 to 17 have yet to be released as the study in younger children will be more complicated. Researchers need to identify whether to use smaller doses compared to adults and adolescents.
According to Bancel, they are pleased to commence this Phase 2/3 study of mRNA-1273 in healthy children in the United States and Canada. She thanked NIAID and BARDA for their cooperation.
She added that it is humbling to be aware that 17.8 million adults in the U.S. have received the Moderna COVID-19 vaccine to date. These are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above. The pediatric study will help them evaluate the potential safety and immunogenicity of their COVID-19 vaccine candidate in this crucial younger age population, reported Fox 59.
The initial part of the trial will test varying dosages in children. An interim evaluation of the data will determine the number of dosages they receive in the second part of the trial.
