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 Unpublished, interim data from Moderna’s phase 2/3 pediatric trial showed a lesser dose of the company’s 2-dose COVID-19 vaccine mRNA-1273 is associated with a significant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®.
Stay prepared and protected with Infection Control Today's newsletter, delivering essential updates, best practices, and expert insights for infection preventionists.
US Withdrawal From UNESCO Signals a Dangerous Step Back for Global Science
July 22nd 2025In a decision heavy with consequence and light on foresight, the US has once again chosen to walk away from UNESCO, leaving behind not just a seat at the table, but a legacy of global scientific leadership that now lies in question.
Breaking the Cycle of Silence: Why Sharps Injuries Go Unreported and What Can Be Done
Published: July 24th 2025 | Updated: July 23rd 2025Despite decades of progress in health care safety, a quiet but dangerous culture still lingers: many health care workers remain afraid to report sharps injuries, fearing blame more than the wound itself.
Telemedicine's Transformative Role in PPE Distribution and Sterile Equipment Management
July 22nd 2025In an era defined by digital transformation and post-pandemic urgency, telemedicine has evolved beyond virtual visits to become a vital infrastructure for delivering personal protective equipment (PPE) and managing sterile supplies. By enabling real-time forecasting, remote quality control, and equitable distribution, telemedicine is revolutionizing how health care systems protect both patients and providers.
Reducing Hidden Risks: Why Sharps Injuries Still Go Unreported
July 18th 2025Despite being a well-known occupational hazard, sharps injuries continue to occur in health care facilities and are often underreported, underestimated, and inadequately addressed. A recent interview with sharps safety advocate Amanda Heitman, BSN, RN, CNOR, a perioperative educational consultant, reveals why change is overdue and what new tools and guidance can help.