FDA reviewers said Pfizer-Biontech’s COVID-19 vaccine is safe and effective in children aged six months to four years.
In summary papers released Sunday evening, administration reviewers said their evaluation did not reveal any new safety concerns regarding the use of the vaccine in young children.
The FDA’s analysis of data from the Pfizer trials was released ahead of the June 15 external consultants’ meeting. The recommendations of external consultants will determine the FDA’s decision on vaccines.
In most parts of the world, COVID-19 vaccines are not approved for children under the age of six.
On Friday, the U.S. Food and Drug Administration released a review saying Moderna’s COVID-19 vaccine appears safe and effective for use in children aged six months to 17 years.
