On October 12, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) and the Centers for Disease Control and Prevention (CDC) recommended use of the COVID-19 Omicron updated boosters (i.e., bivalent boosters) from Pfizer-BioNTech for people ages 5-11 years and from Moderna for people ages 6-11 years and 12-17 years.
Updated COVID-19 boosters add Omicron BA.4 and BA.5 spike protein components to the original COVID-19 vaccine composition. This helps the immune system restore protection that may have waned since previous vaccination by targeting variants that are prevalent and highly transmissible in our communities at this time.
Omicron boosters (bivalent) are now for those ages 5 years and older who have completed the primary series with any authorized/approved COVID-19 vaccine, and their most recent original (monovalent) COVID-19 vaccine of any kind was at least 2 months ago.
Original (monovalent) COVID-19 vaccines are no longer authorized for use as booster shots. Only Omicron (bivalent) COVID-19 vaccines can be used as booster shots.
The original (monovalent) COVID-19 vaccines remain the only authorized and recommended COVID-19 vaccines for primary series vaccination in ages 6 months and older.
Moderna COVID-19 Omicron (Bivalent) Boosters
The Moderna COVID-19 Omicron (bivalent) booster is authorized as a single booster dose administered at least 2 months after completion of primary series vaccination or receipt of the most recent booster dose with any authorized or approved original (monovalent) COVID-19 vaccine.
• For individuals 12 years of age and older, a single Moderna Omicron (bivalent) booster dose is 0.5 mL.
• For individuals 6 years through 11 years of age, a single Moderna Omicron (bivalent) booster dose is 0.25 mL.
The Moderna COVID-19 Omicron (bivalent) booster is supplied in a multiple-dose vial with a dark blue cap and a label with a gray border. This is the same product as is authorized for use in ages 18 years and older.
This product is not diluted prior to use (as with other Moderna COVID-19 vaccine products).
Pfizer-BioNTech COVID-19 Omicron (Bivalent) Boosters
The Pfizer-BioNTech COVID-19 Omicron (bivalent) booster is authorized as a single booster dose administered at least 2 months after completion of primary series vaccination or receipt of the most recent booster dose with any authorized or approved original (monovalent) COVID-19 vaccine.
• For individuals 5 years through 11 years of age and older, a single Pfizer Omicron (bivalent) booster dose is 0.2 mL.
The Pfizer COVID-19 Omicron (bivalent) booster for ages 5 through 11 is currently supplied in a multidose vial with an orange cap and label with an orange border.
This product MUST BE DILUTED with 1.3 mL sterile 0.9% Sodium Chloride Injection, USP prior to use.
Other Considerations
❖ Storage/Handling
Storage/handling and more can be found in the EUAs.
Pfizer EUA: https://www.fda.gov/media/162250/download
Moderna EUA: https://www.fda.gov/media/161318/download
❖ Original (Monovalent) COVID-19 Vaccines No Longer Authorized as Boosters
As a reminder, if your entity has been offering original (monovalent) COVID-19 shots for any
individuals/groups ages 5 years and older, stop immediately. However, the original mRNA vaccines
(Pfizer and Moderna, monovalent) remain authorized and are the only mRNA products recommended for
use at this time as the primary series in individuals ages 6 months and older.
❖ Important Naming Note
There are several terms being used across national, state, and local networks to refer to the updated
boosters. While the clinical considerations from CDC, portions of the vial labels, and portions of the EUA
refer to them as “Bivalent,” this is a term not easily understood or recognized by the general public. Instead,
“Omicron Booster” and “Updated Booster” are commonly used and better understood by the
public. It is essential for providers to note that “bivalent”, “Omicron”, and “updated” boosters are referring
to the same products.
❖ Clinical Considerations & Updates
The CDC’s Interim Clinical Considerations for the Use of COVID-19 Vaccines and related resources have
been partially updated. As the official clinical guidance resources become more fully updated/available,
state resources such as the COVID-19 Vaccination Due Date Calculator, FAQs on vaccinate.wv.gov, and
Just-in-Time Trainings will also be updated/provided.
For questions about this advisory, contact the Office of Epidemiology and Prevention Services (OEPS) at
1-800-423-1271, ext. 1 and/or 304-558-5358, ext. 1.