Bivalent COVID-19 Vaccines Now Authorized for Individuals 6 months of Age and Older
On Dec. 8, 2022, the U.S. Food and Drug Administration (FDA) issued amended Emergency Use Authorizations (EUAs) to both Moderna and Pfizer-BioNTech to authorize bivalent COVID-19 vaccines for children down to 6 months of age. The bivalent vaccines contain two messenger RNA (mRNA) components of SARS-CoV-2 virus; one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. The Moderna COVID-19 Vaccine, Bivalent has received authorization as a booster dose for individuals 6 months to 5 years and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent has received authorization as the third dose of the three-dose primary series for children 6 months to 4 years.
Also, as of Dec. 8, 2022, monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use as the third dose of the three-dose primary series in children 6 months through 4 years of age. The monovalent Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration as the first two doses of the three-dose primary series in individuals 6 months through 4 years of age, as a two-dose primary series for individuals 5 years of age and older, and as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromising health conditions. Administration of monovalent Pfizer-BioNTech COVID-19 Vaccine used as the third dose of the three-dose primary series in children 6 months through 4 years of age is now considered a vaccine administration error and must be reported to the Vaccine Adverse Event Reporting System (VAERS).
This technical bulletin summarizes the recent Pfizer-BioNTech and Moderna Bivalent COVID-19 Vaccine eligibility. Vaccine products made by the same manufacturer should be used for all doses of the primary series.
Those eligible to receive the recommended Pfizer-BioNTech COVID-19 Vaccine, Bivalent include:
- Any child 6 months to 4 years of age who has not yet begun their three-dose Pfizer-BioNTech COVID-19 Vaccine primary series or has not yet received the third dose of their (monovalent) Pfizer-BioNTech COVID-19 Vaccine primary series
- Dose interval: A single bivalent dose administered as the third dose in the three-dose Pfizer COVID-19 vaccine primary series (two doses of the Pfizer COVID-19 vaccine monovalent, followed by one dose of Pfizer COVID-19 vaccine bivalent to complete the primary series).
- Dose amount: 0.2mL each dose (3 mcg/dose), to be administered intramuscularly (note that this product requires diluent).
NOTE: Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated.bivalent vaccine at this time. Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant.
Those eligible to receive the recommended Moderna COVID-19 Vaccine, Bivalent Booster include:
- Any child 6 months to 5 years of age who has completed Moderna’s monovalent COVID-19 vaccine primary series
- Dose interval: a single booster dose administered at least two months following completion of Moderna’s age appropriate, monovalent vaccine primary series
- Dose amount: 0.2mL each dose (10 mcg/dose), to be administered intramuscularly
For more information and/or additional resources, the Centers for Disease Control and Prevention (CDC) has published updated interim clinical considerations and COVID-19 vaccine schedules for non-immunocompromised individuals and immunocompromised individuals. In addition, the CDC has also published a guide for “Special Situations for COVID-19 Vaccination of Children and Adolescents,” which includes information on age transitions and COVID-19 vaccine interchangeability.
Both Pfizer-BioNTech and Moderna’s COVID-19 Bivalent Vaccines, for this age group, are new COVID-19 products with some different storage and handling parameters than other COVID-19 products. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (6 months-4 years) is packaged in 10-dose vials in cartons of 10 vials each (100 doses total) and will require diluent. Moderna’s COVID-19 Vaccine, Bivalent Booster (ages 6 months-5 years) be packaged in 2-dose vials in cartons of 10 vials each (20 doses total). Additional storage and handling parameters include:
|Pfizer-BioNTech COVID-19 Vaccine Storage and|
|Moderna COVID-19 Vaccine Storage and|
(2.2mL diluent/per vial)
|Does NOT require diluent|
|Ultra-cold freezer storage (-90°C to -60°C) until expiry||NO ULTRA-COLD FREEZER STORAGE|
|NO FREEZER STORAGE||Freezer storage (-25°C to -15°C) until expiry|
|Refrigerate (2°C to 8°C) up to 10 weeks without|
|Refrigerate (2°C to 8°C) up to 30 days without|
|Once punctured, vial must be used|
within 12 hours
|Once punctured, vial must be used|
within 8 hours
|Vial/Label Color: Maroon Cap with Maroon border|
(Please note that the cap & vial border colors are
IDENTICAL for both Pfizer’s monovalent and bivalent formulations for 6 months – 4 years. Vial label will specifically say “Bivalent” on it to differentiate
between the two)
|Vial/Label Color: Dark Pink Cap with Yellow Box Label|
|Under 5 Bivalent Vaccine Vial|
(6 months – 4 years):
Under 5 Bivalent Vaccine Label (6 months – 4 years):
|Under 5 Bivalent Booster Vial|
(6 months – 5 years):
Under 5 Bivalent Booster Label (6 months – 5 years):
It is important to note the primary goal of the COVID-19 vaccine response should continue to be COVID-19 vaccine administration to the unvaccinated. The Nevada Department of Health and Human Services is encouraging individuals to speak with a health care provider about vaccination and COVID-19 vaccines. Individuals may be referred to NVCOVIDFighter.org or 1-800-401-0946 for more information on vaccine access and other COVID-19 resources.