Moderna to Seek FDA Authorization of COVID-19 Vaccine for Children Under 6 After Positive Data

Moderna is hoping to get the green light to administer a pediatric, low-dose COVID-19 vaccine for children ages 6 months to under 6 years of age, it said in a statement.

via: Complex

Wednesday, the Massachusetts-headquartered company shared an extended public statement on the positive interim data from its Phase 2/3 KidCOVE study of the vaccine in children as young as six months to under two years, as well as in children between the ages of two and six.

Per the findings, a 25-microgram two-dose series of shots showed a “robust neutralizing antibody response” and a “favorable safety profile” in each age group. An estimated 6,700 total participants from these two age groups were included in the reporting, with Moderna highlighting that the larger “tolerability profile” of both groups was aligned with what was previously seen among older ages. Neither age group included in the latest reported data saw any severe instances of COVID-19.

Moving forward, Moderna said it is submitting an FDA request for authorization of this two-dose vaccine regimen for kids between the ages of six months and six years. In a statement, Moderna CEO Stéphane Bancel pointed to the additional positive impact the company is aiming for with the latest data.

“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,” Bancel said. “Additionally, after consultation with the U.S. FDA we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data. We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages”

Per the Associated Press, Moderna’s COVID-19 vaccine could now be an option for the youngest children by this summer. Pfizer, meanwhile, is said to be releasing results of a similarly focused study next month.

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