On September 1, 2022, the Centers for Disease Control and Prevention (CDC) endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendations for use of the COVID-19 Omicron updated boosters (i.e., bivalent boosters) from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.
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.
The Omicron boosters (bivalent) are for those ages 12 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.
Moderna COVID-19 Omicron (Bivalent) Boosters:
The Moderna COVID-19 Omicron (bivalent) booster is authorized for use in individuals 18 years of age and older as a 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.
Moderna COVID-19 Omicron (bivalent) booster is supplied as a multidose vial with a dark blue cap and gray border label and administered as a 0.5 mL dose. 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 for use in individuals 12 years of age and older as a 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.
The Pfizer COVID-19 Omicron (bivalent) booster is currently supplied in a multidose vial with a gray cap and label with gray border administered as a 0.3 mL dose. This product is not diluted prior to use.
Other Considerations:
❖ Storage/Handling
Storage/handling and more can be found in the emergency use authorizations (EUAs).
Pfizer EUA: https://bit.ly/PfizerOmicronEUA
Moderna EUA: https://bit.ly/ModernaOmicronEUA
❖ Original Boosters – No Longer Authorized for Ages 12+
As a reminder, if your entity offers the original (monovalent) COVID-19 boosters for ages 12 years and older, halt immediately. However, those original mRNA vaccines (Pfizer and Moderna, monovalent) remain authorized and recommended for use as the primary series.
❖ Important Naming Note
There are several terms being used across the national, state, and local networks to refer to the new boosters. While the clinical considerations provided so far from CDC, 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. Consider using more common language (i.e., Omicron, updated) when discussing options with patients.
❖ Clinical Considerations and Updates
The CDC’s Interim Clinical Considerations for the Use of COVID-19 Vaccines is expected to be updated in the next few days. As the official clinical guidance becomes available, state resources such as the COVID-19 Vaccination Due Date Calculator, FAQs on vaccinate.wv.gov, and Just-in-Time Trainings will be updated/provided.