The Food and Drug Administration said the Covid-19 vaccine from Pfizer Inc. and BioNTech SE met the agency’s criteria for immune responses in a study in children ages 5 to 11 years.
In a report released Friday, the agency flagged the risk of heart-inflammation conditions including myocarditis associated with the vaccine but said the overall benefits, in preventing Covid-19 disease and hospitalizations, would outweigh the risk of the heart conditions.