FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster vaccine in cChildren 6 months through 5 years of age
Moderna, Inc. has announced it has received emergency use authorization (EUA) from the FDA for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, in children 6 months through 5 years of age
The authorization is based on a 10 ?g booster dose following a completed primary series of Moderna's original vaccine. The booster dose of mRNA-1273.222 contains mRNA encoding for the spike protein of BA.4/BA.5 as well as mRNA encoding for the original strain of the SARS-CoV-2 virus.
mRNA-1273.222, which targets the BA.4/BA.5 subvariants of Omicron, has also received FDA EUA for children and adolescents aged 6 through 17 years old, as well as adults over the age of 18. The pediatric EUA application is based upon clinical trial booster data for Moderna's original vaccine, Spikevax.In addition, the EUA application included pre-clinical data for mRNA-1273.222 as well as clinical trial data from a Phase II/III studying mRNA-1273.214, another Omicron-targeting bivalent booster vaccine developed by Moderna.
Last month, Moderna announced results from a Phase II/III trial in over 500 adults, which showed mRNA-1273.222 induced significantly higher neutralizing antibody titers against BA.4/BA.5 compared to a booster dose of Moderna's original vaccine. A Phase II/III trial evaluating Omicron-targeting bivalent vaccines as booster and primary series in children 6 months through 5 years of age is currently underway, with initial results expected in early 2023.
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