FDA Advisory Committee Votes in Favor of COVID-19 Pfizer Vaccine for Ages 5-11

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

COVID-19 Booster Update

Booster

FDA authorized the use of a heterologous or mix and match booster. This means that Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters may receive  the Moderna COVID-19 Vaccine which is a half dose, Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine. The booster should be administed at least six months after completing the primary vaccination.https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine