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Moderna’s phase 2/3 pediatric trial showed a lesser dose of the company’s 2-dose COVID-19 vaccine mRNA-1273 is associated with a significant neutralizing antibody response in children aged 6 to <12 years old.
Moderna plans to have what the company considers pretty convincing data when it seeks approval for its COVID-19 vaccine for children. Unpublished, interim data from Moderna’s phase 2/3 pediatric trial showed a lesser dose of the company’s 2-dose COVID-19 vaccine mRNA-1273 is associated with a significant neutralizing antibody response in children aged 6 to <12 years old.
The shared data from the ongoing KidCOVE trial, which includes a cohort of 4753 pediatric participants, will be used in Moderna’s application to the US Food and Drug Administration (FDA) for regulated use of the mRNA vaccine in preventing COVID-19 among the pediatric age group.
The randomized, blinded, placebo-controlled KidCOVE is an expansion assessment of 2-dose 50 mcg mRNA-1273 in health children aged 6 months to <12 years old. Though the trial is continuing to enroll children aged 6 months to <6 years old in North America, Moderna has reached its endpoint for assessment of the cohort aged 6 to <12 years old.
Investigators assessed a comparison of SARS-CoV-2 neutralizing antibody response in vaccinated children versus that observed in young adults included in Moderna’s phase 3 COVE trial, using a geometric mean ratio (GMR). At 1 month following the second dose of 50 mcg mRNA-1273, GMR of response from observed children versus young adults was 1.5 greater (95% CI, 1.3 – 1.8), with a seroresponse rate of 99.3% (difference, 0.6%; 95% CI, -2.8 to 2.8).
The vaccine was generally well tolerated in children aged 6 to <12 years old, with a safety and tolerability profile consistent with that observed in adolescents and adults from the phase 3 trial. Adverse events were generally mild or moderate in severity, and the most commonly reported events included fatigue, headache, fever, and injection site pain.
In a statement accompanying the data, which is yet to be peer reviewed, Stephane Bancel, Moderna chief executive officer, expressed optimism brought on by the newest pediatric COVID-19 vaccination metrics.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Bancel said. “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.”
Pediatric immunity from COVID-19 continues to be an under-addressed issue in pandemic response; data from the American Association of Pediatrics (AAP) show children comprise more than 16% of all US cases—a rate has been on the rise in past months. For the week ending October 14, children made up 25.5% of the weekly reported COVID-19 cases, despite only comprising 22.2% of the country’s population.
This article originally appeared inContagion®.