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FDA grants emergency use authorization to Moderna’s COVID-19 booster in pediatric patients

Moderna has announced that their latest BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, has been granted Emergency Use Authorization by the US Food and Drug Administration.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Moderna’s mRNA-1273.222 (SPIKEVAX) in pediatric patients aged 6 to 17 years.

This vaccine is Moderna’s latest BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine. The EUA will allow the vaccine to be administered as a 25 μg dose for patients aged 6 to 11 years and a 50 μg dose for patients aged 12 to 17 years after completion of primary vaccination series or previous booster.

Messenger RNA (mRNA) is contained within the mRNA-1273.222 booster doses, encoding for the spike protein of BA.4/BA.5 and the initial SARS-CoV-2 variant.

The FDA approved the mRNA-1273.222 booster vaccine for adults aged over 18 years in September 2022. Both the pediatric and adult vaccines are based on data from a clinical trial on the original Moderna vaccine for COVID-19. Data from a phase 2/3 trial on another Omicron-targeting booster vaccine developed by Moderna, mRNA-1273.214, was also submitted.

An EUA application for use of the booster in patients aged 6 months to 5 years is currently being worked on. Moderna hopes for the application to be completed before the end of 2022.

Moderna has cautioned against use of the vaccine in patients with severe allergic reactions to any component of the vaccine. They also listed adverse reactions including pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, erythema at the injection site, and rash.

In the case of certain adverse events, Moderna advised vaccination providers to report to the Vaccine Adverse Event Reporting System. Following allergic reactions, Moderna urged immediate treatment.

Reference

Moderna receives FDA authorization for emergency use of omicron-targeting bivalent COVID-19 booster vaccine for children and adolescents 6 to 17 years of age. Moderna. October 12, 2022. Accessed October 13, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-FDA-Authorization-for-Emergency-Use-of-Omicron-Targeting-Bivalent-COVID-19-Booster-Vaccine-for-Children-and-Adolescents-6-to-17-Years-of-Age/default.aspx