Pfizer and its 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 elementary school children. in a few months.
The long-awaited results offer one of the first looks at how well a Covid vaccine might work for younger children.
Pressure to immunize children has been mounting in the US, where a new school year has started just as the delta variant is driving an increase in cases.
In a trial of 2,268 participants, two injections of a 10-microgram dose (one-third of the adult vaccine) produced antibody levels comparable to those seen in a trial of 16 to 25-year-olds who received the adult dose, the companies. he said, with similar side effects.
Pfizer and BioNTech said they plan to submit the data as part of a short-term request for an emergency use authorization from the US Food and Drug Administration, and share it with regulators in Europe as well.
An authorization would mark an important new phase of the immunization campaign in the US, where the Pfizer vaccine already has full approval for people 16 years and older and is emergency authorized for ages 12-15. And a pediatric clearance could reach millions of older Americans are receiving additional doses to reinforce their initial injections.