The FDA’s Vaccines and Related Biological Products Advisory Committee (FDA Vaccine Advisory Committee ) voted 17-0 (one abstention) to approve the use of the COVID-19 Pfizer Vaccine for Ages 5-11 using a risk/benefit approach. If authorized, the dosage would be a lower dose than for adults.
Next Steps- FDA would have to agree with the FDA Vaccine Advisory Committee recommendation. Next the Centers for Disease Control and Prevention’s (CDC) independent advisory committee (Advisory Committee) will meet in early November and vote on whether to recommend the vaccine for this age group. Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or perhaps amend the Advisory Committee’s recommendation.
Here are Direct Links for Review:
FDA Briefing Document and Meeting
EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age Vaccines and Related Biological Products Advisory Committee Meeting October 26, 2021 https://www.fda.gov/media/153447/download and https://www.youtube.com/watch?v=laaL0_xKmmA