Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Resumo

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Members will participate via teleconference. This 2-day virtual meeting will be held to discuss recent requests to amend the Emergency Use Authorization (EUA) of the Moderna COVID-19 mRNA vaccine to include the administration of a primary series to infants, children, and adolescents 6 months through 17 years of age and to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of a primary series to infants and children 6 months through 4 years of age. The meeting will be open to the public on both days. FDA is establishing a docket for public comment on this document.