The company said that an interim analysis of data showed a “robust neutralizing antibody response” after two shots of its mRNA-1273 vaccine were administered at a 50 microgram dose level, or half the dosage of the vaccine used in adults, to children in this age group.
The study, called KidCOVE, evaluated the safety, tolerability, adverse reactions, and effectiveness of two lower doses of the Moderna vaccine given to healthy children four weeks apart, according to the company. In this randomized, placebo-controlled study, the participants were divided into three age groups, including 4,753 children aged 6 to 11. Participants were given either the vaccine or a placebo.
Moderna said its vaccine was well tolerated with a safety and tolerability profile generally consistent with its study of adolescents and adults. The most common solicited adverse events were fatigue, headache, fever, and injection site pain. The majority of adverse events were mild or moderate.
Moderna now plans to submit the data from the study to the U.S. Food and Drug Administration (FDA), European Medicines Agency, and other global regulators in the near term.
“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,” said Stéphane Bancel, CEO of Moderna. “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.”
The U.S. Centers of Disease Control and Prevention said in September that there have been reports of heart-inflammation conditions, including myocarditis and pericarditis, among people who received Moderna and Pfizer’s mRNA-based vaccines, especially in male adolescents and young adults. Both myocarditis and pericarditis can cause symptoms such as chest pain, shortness of breath, and feelings of having a fast-beating, fluttering, or pounding heart.
Despite the potential side effects, the CDC continues to recommend that people aged 12 years and older get vaccinated.
“The known risks of COVID-19 illness and its related, possibly severe complications, such as long-term health problems, hospitalization, and even death, far outweigh the potential risks of having a rare adverse reaction to vaccination, including the possible risk of myocarditis or pericarditis,” the CDC says.
Moderna didn’t say whether it has seen any cases of myocarditis in KidCOVE.