U.S. biotechnology giant Moderna announced that they had begun a study that tests the company's COVID-19 vaccine in children aged six months to less than 12 years old.
According to a statement from the company, the study is a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), the National Institute of Allergy and Infectious Diseases (NIAID), as well as the National Institutes of Health (NIH).
"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," Chief Executive Officer of Moderna Stéphane Bancel said.
The KidCOVE study
The two-part study, called the KidCOVE, is all about evaluating the safety of the mRNA-1273 vaccine against the COVID-19 virus.
Moderna intends to have approximately 6,750 children participants, who will all receive two doses of the vaccine administered 28 days apart.
Children aged less than two years old will be given 25, 50, or 100 micrograms of vaccine per dose, while children older than two years old will be given 50 or 100 micrograms of vaccine per dose.
According to ClinicalTrials.gov, trial organizers will administer the lowest dose of vaccine to the first children vaccinated in each group so that they can watch for side effects before giving higher doses to other children.
They will then perform an interim analysis to pinpoint the appropriate dose level for each age group and use it in the second stage of the study.
Afterward, children enrolled in the second stage of the trial will be administered with either the selected dose or placebo shots of saline.
All the participants will be monitored for a year after receiving the shots so that the trial organizers can track possible side effects, antibody levels, and cases of COVID-19 infection.
Moderna will also be testing the mRNA-1273 vaccine in adolescents between 12 and 18 years old by December 2021.
Is The Study Safe For Children?
Moderna President Dr. Stephen Hoge said there is no evidence supporting that the COVID-19 vaccine is unsafe for children.
However, he mentioned that, unlike the other studies, the ones involving babies and younger children would take a bit longer, NBC News reported.
According to Dr. Hoge, the trial needs to be a little more cautious in progressing and working down dose levels to pinpoint the accurate dose.
The Centers for Disease Control and Prevention (CDC) reminded everyone of the possible side effects of getting the Moderna vaccine.
The announcement comes after a small number of patients reported a painful reaction in the arm up to 11 days after inoculation dubbed as "COVID arm."
The CDC assured that the said side effect is a normal sign that the body is building protection as expected and will go away in a few days.
This article is owned by Tech Times
Written by Lee Mercado