FDA Authorizes and CDC Recommends use of COVID-19 Bivalent Booster Vaccine in Ages 5 yrs and Oldr

FDA authorized and CDC recommended administration of bivalent mRNA booster to individuals 5 years and older after completion of a monovalent primary series or previously received monovalent booster dose(s).  These recommendations replace all prior booster recommendations for these age groups.  The timing of these actions is different than previous ones, as they were on the same day of each other.

Note:  recommendation is for use of a bivalent Moderna booster dose in people ages 6-17 years  (previous authorization was for 18 years and older)

Note:  recommendation is for use of a bivalent Pfizer-BioNTech booster dose in people ages 5- 11 years  (previous authorization was for 12 years and older)

Moderna COVID-19 Vaccine, Bivalent Booster (Moderna COVID-19 Vaccine, Bivalent)

Age:  6 years of age and older

Administration:  Single booster dose administered at least 2 months after either:

·       Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or

·       Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

For individuals 6 years through 11 years of age, a single booster dose is 0.25mL

For individuals 12 years of age and older, a single booster dose is 0.5 mL

How supplied:  Multiple-dose vial with a dark blue cap and a label with a gray border.  The vaccine is a suspension for intramuscular injection.

Number of doses per vial:
 0.5mL doses yields 5 booster doses
 0.25mL doses yields 10 booster doses
Both 0.5mL doses and 0.25mL doses may be withdrawn from the same multiple-dose vial
(DO NOT pool vaccines from multiple vials)

Pfizer BioNTech COVID-19 Vaccine, Bivalent Booster (Pfizer BioNTech COVID-19 Vaccine, Bivalent)

Age:  5 through 11 years of age
Administration:  Single booster dose administered at least 2 months after either:

·       Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or

·       Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

For individuals 6 years through 11 years of age, a single booster dose is 0.25mL

For individuals 12 years of age and older, a single booster dose is 0.5 mL

How supplied:  Pfizer-BioNTech COVID-19 Vaccine for individuals 5 through 11 years of age, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for individuals 5 through 11 years of age are both supplied in multiple dose vials with orange caps and labels with orange borders.  Dilute before using.  The vaccine is a suspension for intramuscular injection.

It is important to carefully read the labels to differentiate between the vaccines: The Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 5 through 11years of age to provide a primary series. ThePfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 5 through 11 years of age to provide a single booster dose.

Number of doses per vial: 10 from a single vial
(DO NOT pool vaccines from multiple vials)

Note:  the Pfizer BioNTech COVID-19 Vaccine, Bivalent supplied in vials with gray caps and labels with gray borders, SHOULD NOT be used in individuals 5 through 11 years of age.  Boosters of these vaccines for individuals 12 years and older are 0.3mL.  Do Not Dilute the vaccine in a gray cap vial.

Resources / References
Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC
Moderna DHCP Letter Bivalent 10122022 (fda.gov)
Moderna HCP FS for bivalent booster for 6 years and older (Gray Label) 10122022 (fda.gov)
Moderna COVID-19 Vaccines | FDA
Pfizer DHCP Letter Bivalent 10122022 (fda.gov)
Pfizer New HCP FS for bivalent booster doses for 5 through 11 year olds (orange) 10122022 (fda.gov)
Pfizer HCP FS Bivalent Booster Grey 10122022 (fda.gov)
Pfizer DHCP Letter Bivalent 10122022 (fda.gov)

Mitchel Rothholz, RPh, MBA
Three-C Consulting Group
202-497-5350
mrothholz@three-cconsulting.com
https://three-cconsulting.com/
101 Harvest Glenn Dr
Harleysville, PA 19438