Pfizer-BioNTech Covid-19 Vaccine for Young Kids Satisfied FDA Criteria, Agency Says

The Food and Drug Administration said the Covid-19 vaccine from Pfizer Inc. PFE 0.70% and BioNTech 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. The FDA assessment could support the agency’s authorization of the vaccine in children in the coming days or weeks, but the myocarditis risk is likely to be a topic of debate among advisers to the FDA who are scheduled to first review the application.