March 23, 2022
Moderna's COVID-19 vaccine generates a strong immune response and is well-tolerated in children ages 5 and under, according to interim results from the company's clinical trial.
In the study, the young children received two 25-microgram doses 28 days apart. It generated an immune response similar to those seen among young adults, who received two 100-microgram doses, Moderna said.
Moderna plans to request the U.S. Food and Drug Administration authorize the vaccine for children ages 6 months to 5 years based on data from its KidCOVE study. The interim data released Wednesday was based on 6,900 participants.
"We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age," Moderna CEO Stéphane Bancel said. "We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults.
"Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible."
The majority of adverse reactions reported during the study were mild or moderate, Moderna reported. They were more frequent after the second shot. There were no deaths or cases of myocarditis – inflammation of the heart muscle – or pericarditis – inflammation of the lining of the heart.
The vaccine was less effective against the omicron variant, which was dominant in the U.S. at the time of the study, but Moderna said its efficacy remained statistically significant. Its efficacy was 43.7% among children age 1 or younger and 37.5% among children ages 2 to 5.
This is similar to the protection the vaccine provided adults against omicron, Moderna said.
The company is planning to investigate the potential need for a booster shot for all children. The additional shot would target the omicron variant as well as the original coronavirus.
Moderna previously requested the FDA authorize its vaccine in adolescents ages 12-17, who would receive two 100-microgram doses, but that process has been delayed. The company said Wednesday that it has provided the FDA with additional follow-up data.