The Food and Drug Administration (FDA) said in a report on Friday that Pfizer-BioNTech’s COVID-19 vaccine meets the agency’s criteria for the immune response it generated in children aged 5 to 11; the agency also said that the vaccine would likely provide more benefits than risks in most scenarios.
The FDA briefing document (pdf) was published ahead of a scheduled meeting of a panel of outside experts on Oct. 26. Members of the Vaccines and Related Biological Products Advisory Committee are to vote on that day on whether they would recommend the FDA to authorize the shots.
