Ema committee for medicinal products for human use issues positive opinion recommending authorization for the use of spikevax (mrna-1273) in children 6 months - 5 years in the european union
Announcement follows chmp's previous decision to issue a positive opinion recommending marketing authorization for moderna's covid-19 vaccine to include children 6 years of age and older two-dose series takes one month to complete, with similar vaccine efficacy estimates against omicron to those seen in adults cambridge, ma / accesswire / october 19, 2022 / moderna, inc. (nasdaq:mrna), a biotechnology company pioneering messenger rna (mrna) therapeutics and vaccines, today announced that the european medicines agency's (ema) committee for medicinal products for human use (chmp) has issued a positive opinion recommending a variation to the conditional marketing authorization (cma) to include a 25 Μg two-dose series of spikevax (mrna-1273) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in children 6 months to 5 years. following the chmp's positive opinion, the european commission will make an authorization decision on the use of spikevax in children ages 6 months to 5 years.
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