FDA authorisation for Emergency Use of Omicron-targeting bivalent COVID 19 booster vaccine for adults 18 years and older
Moderna announced that it has received emergency use authorization (EUA) from the (FDA for its BA.4/.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222. Authorization has been given for a 50 µg booster dose for adults over 18 years of age who have received either a primary series or an initial booster of any of the authorized or approved COVID-19 vaccines
The 50 µg booster dose of mRNA-1273.222 includes 25 µg of mRNA encoding for the spike protein of BA.4/.5 and 25 µg encoding for the original strain of the SARS-CoV-2 virus.
mRNA-1273.222, which targets the BA.4/.5 subvariants of Omicron, was developed under guidance from the FDA, which based it's authorization on 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. In addition, a vast and growing body of real-world evidence provides strong evidence for the effectiveness and safety of mRNA-1273, the original Moderna COVID-19 vaccine which is the basis for the company's updated, bivalent vaccines. A Phase II/III clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year.
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