The licensure is based on the existing evidence surrounding the application of a 10 μg booster dose after completion of the primary vaccination schedule with the original (monovalent) Moderna vaccine. The booster dose of the mRNA-1273.222 vaccine contains mRNA that encodes for the production of spicule protein of the BA.4/BA.5 variants, as well as spicule protein the original SARS-CoV-2 virus strain (wuhan ancestral strain) thus generating immunological memory for these variants.

"With the FDA's decision, children and adolescents of all age groups in the U.S. will now be eligible for our updated bivalent booster against Covid-19, providing families with an important protective tool as we move through the winter months", said Stéphane Bancel, chief executive officer of Moderna.

"We appreciate the FDA's timely review"

The mRNA-1273.222 vaccine, which targets the BA.4/BA.5 omicron subvariants and the Wuhan ancestral strain, also received FDA clearance for use by children and adolescents aged 6 to 17 years, as well as adults 18 years and older.

The pediatric AUE application is based on booster data from clinical trials with Moderna's original vaccine, mRNA-1273. In addition, the AUE application included preclinical data for the mRNA-1273.222 vaccine, as well as data from Phase 2/3 clinical trials studying the mRNA-1273.214 vaccine, another bivalent booster vaccine targeting omicron variants developed by Moderna.

Last month, Moderna announced the results of a Phase 2/3 trial in more than 500 adults, which showed that the mRNA-1273.222 vaccine induced significantly higher neutralizing antibody titers against the BA.4/BA.5 omicron variants compared to a booster dose of Moderna's original vaccine.

A Phase 2/3 trial evaluating the omicron-targeted bivalent vaccines as a booster and primary schedule in children aged 6 months to 5 years is currently underway, with initial results expected in early 2023.

Translated by: A.M