By Sabela Ojea


Moderna Inc. on Wednesday said that its Covid-19 vaccine has been recommended for marketing authorization in the European Union to include children under 6 years old.

The biotechnology company said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for a double dose of Moderna's Spikevax vaccine in children aged six months to 5 years old.

Preliminary efficacy analysis on PCR-confirmed Covid-19 cases during the Omicron wave showed a two-dose series of Spikevax has similar levels of efficacy in adults and children under five years old, Moderna said.

Earlier Wednesday, Pfizer Inc. and BioNTech SE said they received EU marketing authorization for a Covid-19 vaccine as a three-dose series for children under 5 years old.

Moderna Chief Executive Officer Stephane Bancel said this new EU recommendation reaffirms the effectiveness and safety of Spikevax.

"This recommendation provides parents across Europe with another option to protect their young children against Covid-19, a group at high risk of infection and where additional health prevention measures may not always be feasible," Mr. Bancel said.


Write to Sabela Ojea at


(END) Dow Jones Newswires

October 19, 2022 13:22 ET (17:22 GMT)

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