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 Unpublished, interim data from Moderna’s phase 2/3 pediatric trial showed a lesser dose of the company’s 2-dose COVID-19 vaccine mRNA-1273 is associated with a significant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®.
Show, Tell, Teach: Elevating EVS Training Through Cognitive Science and Performance Coaching
April 25th 2025Training EVS workers for hygiene excellence demands more than manuals—it requires active engagement, motor skills coaching, and teach-back techniques to reduce HAIs and improve patient outcomes.
The Rise of Disposable Products in Health Care Cleaning and Linens
April 25th 2025Health care-associated infections are driving a shift toward disposable microfiber cloths, mop pads, and curtains—offering infection prevention, regulatory compliance, and operational efficiency in one-time-use solutions.
Phage Therapy’s Future: Tackling Antimicrobial Resistance With Precision Viruses
April 24th 2025Bacteriophage therapy presents a promising alternative to antibiotics, especially as antimicrobial resistance continues to increase. Dr. Ran Nir-Paz discusses its potential, challenges, and future applications in this technology.