The staff of the Food and Drug Administration said the benefits of Pfizer Inc. and BioNTech SE’s COVID-19 vaccine for young children likely outweigh its risks, ahead of a meeting next week where experts will weigh whether the shot should be cleared for use.
According to the staff report, which was posted on the FDA website late Friday, the vaccine’s capacity to prevent hospitalizations and deaths likely exceeds the risk of adverse outcomes such as the heart condition myocarditis, which has been reported in some younger males who have received messenger RNA shots for COVID-19.
Pfizer and BioNTech earlier this month asked the FDA to grant an emergency authorization for children age 5 to 11 to receive its vaccine. The formulation for young kids is one-third the dose of the adult shot.