(Bloomberg) -- Moderna Inc. filed for U.S. emergency-use authorization of its Covid-19 vaccine in adolescents, a move that would further expand access to the pandemic preventive.
Authorization by the U.S. Food and Drug Administration would make it the second vaccine approved for this age group. Pfizer Inc. and partner BioNTech SE received authorization for use of their shot in teens in May. Both vaccines are now being studied in younger children.
Medtronic has already filed for authorization in Canada and Europe and will file with regulators around the world for clearance in the adolescent age group, Chief Executive Officer Stephane Bancel said in a statement.
The submission to the FDA is based on data from adolescents 12 through 17 years old, Moderna said. In nearly 2,500 adolescents who received the vaccine, its efficacy was observed to be 100% and immune responses met the primary goal of a study, according to Moderna.
The shares fell 0.4% in trading before U.S. markets opened.
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