Ema committee for medicinal products for human use adopts positive opinion recommending authorization of moderna's updated covid-19 vaccine in the european union

The positive opinion follows the recommendation from regulators and global public health bodies to develop monovalent xbb.1.5 covid-19 vaccines for autumn/winter 2023 vaccination campaigns clinical trial data from research assay confirmed moderna's updated covid-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including ba.2.86, eg.5, and fl.1.5.1 variants cambridge, ma / accesswire / september 14, 2023 / moderna, inc. (nasdaq:mrna) today announced that the european medicines agency's (ema) committee for medicinal products for human use (chmp) has adopted a positive opinion recommending marketing authorization for spikevax, its updated covid-19 vaccine containing spike proteins for the xbb.1.5 sublineage of sars-cov-2 for active immunization to prevent covid-19 caused by sars-cov-2 in individuals six months of age and older. following the chmp's positive opinion, the european commission will make an authorization decision on the use of moderna's updated covid-19 vaccine for autumn/winter 2023.
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