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|Articles|October 26, 2021
Moderna Announces Positive Results in Study On COVID-19 Vaccine in Children
Author(s)BioPharm International Editors
Moderna’s KidCOVE study showed a robust neutralizing antibody response in children aged six to under 12.
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Moderna announced positive results from its KidCOVE study on the effects of its COVID-19 vaccine (mRNA-1273) in children aged six to under 12 on Oct. 2, 2021. According to a company press release, the interim analysis demonstrated a robust neutralizing antibody response following two 50-µg doses of the company’s mRNA-1273 vaccine.
KidCOVE was a Phase II/III, randomized, observer-blind, placebo-controlled expansion study that measured the effectivity of the mRNA-1273 vaccine in 4753 children. The study found that the neutralizing antibody geometric mean ratio (GMR) between children and young adults from the Phase III COVE study was 1.5, with a seroresponse rate of 99.3%—a difference of 0.6%.
According to the press release, these results meet the co-primary immunogenicity endpoints for one month after the second dose. The vaccine was deemed to be well-tolerated with a safety and tolerability profile comparable to the COVE study.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged [six] to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Stéphane Bancel, CEO, Moderna, in the press release. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
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