Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children

Moderna received emergency use authorization (EUA) from FDA for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222 in children six months to five years of age.

The authorization is based on a 10 μg booster dose following a completed primary series of Moderna’s original vaccine. Additionally, the booster dose of mRNA-1273.222 contains messenger RNA (mRNA) encoding for the spike protein of BA.4/BA.5 and mRNA encoding for the original strain of the SARS-CoV-2 virus.

"With the FDA's decision, children and adolescents of all age groups in the US will now be eligible for our updated bivalent COVID-19 booster, providing families with an important protective tool as we continue through the winter months," said Stéphane Bancel, chief executive officer of Moderna, in a press release. "We appreciate the FDA's timely review."

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

The pediatric EUA application is based on clinical trial booster data for Moderna’s original vaccine, Spikevax. This also included pre-clinical data for mRNA-1273.222 and from a Phase II/III studying mRNA-1273.214, which is another Omicron-targeting bivalent booster vaccine created by Moderna.

Moderna recently announced results from a Phase II/III trial in more than 500 adults, which highlighted that mRNA-1273.222 induced significantly higher neutralizing antibody titers against BA.4/BA.5 versus a booster dose of Moderna’s original vaccine.

Currently, a Phase II/III trial evaluating Omicron-targeting bivalent vaccines as booster and primary series in children between six months and five years of age has begun, with preliminary results expected in early 2023.

Source: Moderna Receives FDA Emergency Use Authorization For Omicron-Targeting Bivalent COVID-19 Booster Vaccine In Children 6 Months Through 5 Years Of Age. https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-FDA-Emergency-Use-Authorization-for-Omicron-Targeting-Bivalent-COVID-19-Booster-Vaccine-in-Children-6-Months-Through-5-Years-of-Age/default.aspx (accessed 2022-12-13).