Moderna says recent trial proves its COVID vaccine is safe, effective in children ages 6 to 11
Moderna announced Monday that interim results of a Phase 2/3 trial prove that its vaccine is well-tolerated and effective in generating a robust immune response in children ages 6 to 11.
According to CNN, over 4,700 participants between the ages of 6 and 11 participated in the trial.
The participants were given two 50-microgram doses of Moderna's vaccine 28 days apart, a dose that's significantly smaller than the 100-microgram given to adults.
Moderna compared the antibody response in younger children to the response in young adults in the company's Phase 3 trial, and observed a "strong immune response in this cohort of children one month after the second dose."
While this news is promising, the data has yet to be peer-reviewed or published.
In a news release regarding the findings, Moderna said, "The majority of adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever, and injection site pain."
The company confirmed plans to submit its data to the US Food and Drug Administration (FDA), European Medicines Agency and other global regulators "in the near term."
At this time, Moderna's COVID vaccine is authorized for individuals age 18 and older.
In June, the biotechnology company requested emergency use authorization for its vaccine for a younger age group, 12 to 17. But the FDA has not granted authorization to that age group yet.
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