Pfizer and partner BioNTech SE said their Covid-19 vaccine was safe and produced strong antibody responses in children ages 5 to 11 in a large-scale trial, findings that could pave the way to begin vaccinating grade-school kids within months.
The long-awaited results offer one of the first looks at how well a Covid vaccine could work for younger children.
Pressure to immunise kids has been on the climb in the US, where a new school year has started just as the delta variant is fueling a surge in cases.
In a trial with 2,268 participants, two shots of a 10 microgram dose — one-third the adult shot — produced antibody levels comparable to those seen in a trial of 16-to-25-year-olds who got the adult dose, the companies said, with similar side effects.
Pfizer and BioNTech said they plan to submit the data as part of a near-term request for an emergency-use authorisation from the US Food and Drug Administration, and to share it with regulators in Europe as well.
A clearance would mark an important new phase of the immunisation campaign in the US, where the Pfizer vaccine already has full approval for people 16 and up and is authorised on an emergency basis for ages 12 to 15. And a pediatric clearance could arrive as millions of older Americans are receiving additional doses to bolster their initial shots.
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