Ema committee for medicinal products for human use (chmp) recommends the use of moderna's ba.1 targeting bivalent covid-19 booster in children (6-11 years) in the european union
The recommendation is based on clinical data for moderna's bivalent omicron-targeting covid-19 vaccine, mrna.1273.214 moderna's bivalent omicron-targeting covid-19 vaccines (mrna.1273.214 (ba.1) & mrna.1273.222 (ba.4-5)) are approved for use in individuals 12 years of age and older in the european union both bivalents have been shown to trigger a superior antibody response compared to a booster dose of mrna-1273, the company's prototype vaccine, against omicron (ba.4-5) in phase 2/3 clinical trials cambridge, ma / accesswire / december 16, 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 adopted a positive opinion recommending a variation to the marketing authorization (ma) to include a booster dose of spikevax bivalent original/omicron ba.1 (mrna-1273.214), at the dose level for children (6-11 years) of 12.5mcg/12.5mcg (0.25 ml) at least three months after the last prior dose of a covid-19 vaccine. "the recommendation to authorize the use of a booster dose of mrna-1273.214 in children ages 6-11 is crucial to providing protection against omicron and the emergence of new variants of concern, which is especially important during the winter period in europe when respiratory diseases are on the rise," said stÉphane bancel, chief executive officer of moderna.
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