Officials with Moderna said Monday that they plan to soon submit data to regulators in countries including the U.S. after a late-stage clinical trial found its COVID-19 vaccine generated a “strong immune response” in children aged 6 to 11.
In the study, the results of which were announced in a statement Monday, about 4,750 children between the ages of 6 and 11 were given two 50 mg doses of the company’s vaccine, spaced 28 days apart. The dose is half that given to adults, according to Bloomberg News.
Officials said the company’s vaccine “was generally well tolerated,” with results consistent for younger children as they were in studies of the vaccine in older children and adults. Most side effects were described as “mild or moderate,” with fatigue, headache, fever and injection site pain the most common complaints.
“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,” Moderna CEO Stephane Bancel said in a statement. “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 results are part of the KidCOVE study, in which Moderna is studying the effect of giving two 50 microgram doses of its vaccine to children in three age groups: those aged 6 to 11, 2 to 5 and 5 months to 1 year.
The data reported Monday has not been peer reviewed. Moderna officials said they plan to later submit data from the KidCOVE study to a peer-reviewed publication.
An influential Food and Drug Administration committee is set to debate whether to endorse the COVID-19 vaccine developed by Pfizer and BioNTech for children aged 5 to 11 years old on Tuesday after the companies reported their vaccine to be more than 90% effective at preventing symptomatic infection.
Vaccines against COVID-19 are currently available in the U.S. for people aged 12 years and older. As of Sunday, about 66% of the population, or 220.3 million people, had gotten at least one vaccine dose, according to data from the Centers for Disease Control and Prevention. About 57% of Americans, or 190.5 million people, have so far been fully vaccinated, according to the CDC.
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