US pharmaceutical company Moderna said on Wednesday that interim studies it conducted indicated that its COVID-19 vaccine is safe and effective for very young children, and which is submitting an application for approval to US and international drug regulators.
In a statement posted on its website, Moderna said interim data from its phase 2/3 study showed “a robust neutralizing antibody response” to a series of two 25-microgram doses of its vaccine among children 6 months to just under 2 years, and children from 2 years to just under 6.
Based on these results, the company said it will submit an approval application for the two-dose series for children 6 months to just under 6 years of age to the US Food and Drug Administration, the European Medicines Agency. and other global regulators in the coming weeks.
If approved, it would be the first vaccine available in the United States for children under 5 years of age. The Pfizer-BioNTech vaccine it is currently available in smaller doses for children ages 5 to 12 and in full doses for children ages 12 and older.
An initial trial of Pfizer’s vaccine for children 2 to 4 years old showed a weaker immune response than in adults, forcing the trial to be extended to try a third dose. Results are expected in April.
* With information from AP, Reuters and AFP.
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