EMA Evaluates Data on Booster Dose of Moderna’s COVID-19 Vaccine

September 28, 2021

The European Medicines Agency (EMA) has begun reviewing Moderna’s application for a booster dose of its COVID-19 vaccine for people 12 years and older six months after they receive the two-dose inoculation.

The EMA’s Committee for Medicinal Products for Human Use is conducting an accelerated assessment of the data, although the EMA and the European Centre for Disease Prevention and Control previously said they don’t consider a COVID-19 booster to be urgently needed among the general population.

In the U.S., the FDA is reviewing data from Moderna intended to support authorization of a third shot, either at a 50-microgram (mcg) level or at the current 100-mcg dose of the two initial shots.

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