The FDA is advising healthcare workers who administer Moderna's COVID-19 pediatric vaccine to only administer 0.25 milliliters instead of the entire vial.
Higher doses are not associated with a safety risk, the FDA said Nov. 1, and no serious adverse effects have been reported.
"[The] FDA has become aware that some healthcare providers may not recognize that the single dose vial of Moderna COVID-19 Vaccine (2023-2024 Formula) for use in individuals 6 months through 11 years of age contains notably more than 0.25 mL of the vaccine," the Nov. 1 warning said. "Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual" even though the approved dosage is 0.25 milliliters.
Excess solution from the vial should be discarded, the agency said.