The institution said that an interim investigation of information showed a “robust neutralizing antibody response” aft 2 shots of its mRNA-1273 vaccine were administered astatine a 50 microgram dose level, oregon fractional the dosage of the vaccine utilized successful adults, to children successful this property group.
The study, called KidCOVE, evaluated the safety, tolerability, adverse reactions, and effectiveness of 2 little doses of the Moderna vaccine fixed to steadfast children 4 weeks apart, according to the company. In this randomized, placebo-controlled study, the participants were divided into 3 property groups, including 4,753 children aged 6 to 11. Participants were fixed either the vaccine oregon a placebo.
Moderna said its vaccine was good tolerated with a information and tolerability illustration mostly accordant with its survey of adolescents and adults. The astir communal solicited adverse events were fatigue, headache, fever, and injection tract pain. The bulk of adverse events were mild oregon moderate.
Moderna present plans to taxable the information from the survey to the U.S. Food and Drug Administration (FDA), European Medicines Agency, and different planetary regulators successful the adjacent term.
“We are encouraged by the immunogenicity and information illustration of mRNA-1273 successful children aged 6 to nether 12 years and are pleased that the survey met its superior immunogenicity endpoints,” said Stéphane Bancel, CEO of Moderna. “We look guardant to filing with regulators globally and stay committed to doing our portion to assistance extremity the COVID-19 pandemic with a vaccine for adults and children of each ages.”
The U.S. Centers of Disease Control and Prevention said successful September that determination person been reports of heart-inflammation conditions, including myocarditis and pericarditis, among radical who received Moderna and Pfizer’s mRNA-based vaccines, particularly successful antheral adolescents and young adults. Both myocarditis and pericarditis tin origin symptoms specified arsenic thorax pain, shortness of breath, and feelings of having a fast-beating, fluttering, oregon pounding heart.
Despite the imaginable broadside effects, the CDC continues to urge that radical aged 12 years and older get vaccinated.
“The known risks of COVID-19 unwellness and its related, perchance terrible complications, specified arsenic semipermanent wellness problems, hospitalization, and adjacent death, acold outweigh the imaginable risks of having a uncommon adverse absorption to vaccination, including the imaginable hazard of myocarditis oregon pericarditis,” the CDC says.
Moderna didn’t accidental whether it has seen immoderate cases of myocarditis successful KidCOVE.