Moderna has new data backing the use of its COVID-19 vaccine Spikevax at a low dose in the youngest children under the age of 6, and it’s moving forward with global regulatory submissions.
Moderna will ask the FDA and the European Medicines Agency (EMA) “in the coming weeks” to authorize Spikevax for children 6 months to under 6 years of age, the company said Wednesday. Simultaneously, Moderna has started a delayed FDA filing for emergency use authorization of the mRNA vaccine in children ages 6 to 11, CEO Stéphane Bancel said in a statement.
