Monday, 17 October 2022 03:27

Moderna receives FDA clearance for emergency use of booster vaccine

Written by Evelyn Alas

Moderna, Inc, a biotechnology company pioneering messenger ARN (ARNm), therapeutics and vaccines, announced today that it received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its bivalent COVID-19 booster vaccine targeting omicron BA.4/BA, 5, mRNA-1273.222, for children and adolescents 6 to 17 years of age.

The licenses are based on a 25 μg booster dose for children 6 to 11 years of age and a 50 μg booster dose for adolescents 12 to 17 years of age, each following a full primary schedule of either of the licensed COVID-19 vaccines or a previous booster.

"We are proud to have received clearance for our updated bivalent booster for COVID-19 for children and teens ages 6 to 17", said Stéphane Bancel, Moderna's chief executive officer. "With bivalent boosters available for most age groups, families have access to updated tools as the winter months and holiday gatherings approach. We thank the FDA for their thorough and timely review".

Last month, mRNA-1273.222, which targets the BA.4/BA.5 subvariants of omicron, received FDA approval for adults 18 years and older. The EUA application for children and adolescents is based on booster data from clinical studies for Moderna's original vaccine, mRNA-1273, which was administered to more than 1,000 participants in each cohort.

In addition, the U.S. filing included Phase I trial data for mRNA- 1273.222, as well as Phase 2/3 clinical trial data studying mRNA-1273.214, another bivalent omicron-targeted booster vaccine developed by Moderna.

Moderna is currently working to finalize its U.S. application for children aged 6 months to 5 years. The application is expected to be completed later this year.