Wednesday, October 5, 2022
HomeLatest NewsCovid-19FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5...

FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

The U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.
On Jan. 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 12 through 15 years of age after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. Today’s action expands the use of a single booster dose of the vaccine for administration to individuals 5 through 11 years age at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 years of age and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in individuals 16 years of age and older.

FDA Evaluation of Safety

The safety of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine in this age group was assessed in approximately 400 children who received a booster dose at least five months (range 5 to 9 months) after completing a two-dose primary series. The most commonly reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills and fever.

The FDA did not hold a meeting of its Vaccines and Related Biological Products Advisory Committee on today’s action, as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of Pfizer’s EUA request, the FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members. The FDA will make available on its website relevant documents regarding today’s authorization.

The amendment to the EUA was granted to Pfizer Inc.

Stay Connected

Unified Voice Newsletter

Events This Month

october

05oct11:00 am12:00 pmNo Surprises Act: Are you Ready for 2023?SDAHO Webinar11:00 am - 12:00 pm Event Type :Education Events,Webinar

06oct9:00 am3:00 pmFocus on the Medication AideAvera Education & Staffing Solutions9:00 am - 3:00 pm

06oct11:00 am12:00 pmKey Strategies in Developing Policies and ProceduresSDAHO Webinar11:00 am - 12:00 pm Event Type :Education Events,Webinar

06oct12:00 pm1:00 pmLeverage Data to Hold Payers AccountableAHA Webinar12:00 pm - 1:00 pm Event Type :Education Events,Webinar

10oct9:30 am3:30 pmAHA/IFDHE Region 6 Health Equity Innovation SummitAHA Event9:30 am - 3:30 pm Event Type :Community Events,Education Events

X


By submitting this form, you are consenting to receive marketing emails from: SDAHO, 3708 W Brooks Place, Sioux Falls, SD, 57106, http://sdaho.org. You can revoke your consent to receive emails at any time by using the SafeUnsubscribe® link, found at the bottom of every email. Emails are serviced by Constant Contact