On October 12, 2022, the U.S. Food and Drug Administration (FDA) authorized Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for use as a single booster dose in younger age groups.

On October 12, 2022, Dr. Rochelle Walensky (Director, Centers for Disease Control and Prevention (CDC)) released a statement and signed a decision memo recommending updated (bivalent) COVID-19 boosters for children aged five years and older. The updated COVID-19 boosters add Omicron BA.4 and BA.5 spike protein components to the mRNA COVID-19 vaccine composition, increasing protection against the currently circulating variants.

New updated booster options include:

• Pfizer-BioNTech bivalent COVID-19 booster for children aged 5 through 11 years old (previous authorization was 12 years and older) - Fact Sheet
• Moderna bivalent COVID-19 booster for children ages 6 through 17 years old (previous authorization was 18 years and older) - Fact Sheet
• MONOVALENT vaccines are NO LONGER authorized for booster doses

CDC recommends that everyone aged 6 months and older stay up to date with COVID-19 vaccination. A person is up to date if they have completed a primary vaccine series and received all CDC recommended booster doses. Vaccines are currently the best method  to protect people from serious illness, which might lead to hospitalization or death, due to COVID-19.

Clinical research has demonstrated the safety and effectiveness of updated bivalent COVID-19 vaccines. As for all vaccines—including COVID-19 vaccines—safety monitoring will continue.

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 series with any FDA-authorized or FDA-approved monovalent COVID-19 vaccine, or
  • Receipt of the most recent booster dose with any FDA-authorized or FDA-approved monovalent COVID-19 vaccine.
• Dose:
  • 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  • Both 0.5mL doses and 0.25mL doses may be withdrawn from the same multiple-dose vial  - DO NOT pool vaccines from multiple vials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

• Age:  5 through 11 years of age
• Administration:  Single booster dose administered at least 2 months after either:
  • Completion of primary vaccine series with any FDA-authorized or FDA-approved monovalent COVID-19 vaccine, or
  • Receipt of the most recent booster dose with any FDA-authorized or FDA-approved monovalent COVID-19 vaccine.
• Dose:  0.2mL (after dilution)
• 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.
• 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. 

Familiarize yourself with the importance and considerations involving storage and handling of the different vaccines. You can start preparing today by reviewing the CDC Vaccine Storage and Handling Toolkit.

• National Network of STD Clinical Prevention Training Centers (NNPTC): Monkeypox Clinical Update Webinar - NNPTC faculty will provide a clinical update on monkeypox with time for a facilitated Q&A session.
  • November 7, 2022 12 PM - 1:15 PM ET 

Below is a list of resources and upcoming informational activities related to the recommendations.

• CDC Interim Clinical Considerations
• Vaccines.gov
• CDC COVID-19 booster tool
• Web resources for the public:
  • Stay Up to Date with Your COVID-19 Vaccines | CDC
  • COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised | CDC
  • Overview of COVID-19 Vaccines
  • Frequently Asked Questions about COVID-19 Vaccination | CDC
  • COVID-19 Vaccination for Children and Teens with Disabilities | CDC
  • How Do I Find a COVID-19 Vaccine or Booster?
• Web resources for immunization partners:
  • Vaccinate with Confidence
  • Guidance for Vaccinating Older Adults and People with Disabilities: Ensuring Equitable COVID-19 Vaccine Access 
  • Vaccinating Older Adults and People with Disabilities at Vaccination Clinics
• MMWR: Interim Recommendations from the Advisory Committee on Immunization Practices for use of the bivalent COVID-19 boosters for people aged 5 years and older – United States – November 10, 2022
• Virginia Statewide COVID-19 Standing Order
• Mini-Webinars Regarding Bivalent COVID-19 Boosters
• CDC is offering a series of brief (15-20 minute) webinars addressing topics around COVID-19 vaccination. These interactive, web-based training modules offer a real-world perspective on different issues around COVID-19 vaccines. Topics range from routine clinical and vaccine safety information to guidance for on-site clinic vaccination activities and having conversations with vaccine recipients. Each webinar includes self-test practice questions and lists additional resources related to the topic discussed.
• The October 19 webinar will focus on the bivalent booster recommendations for children ages 5-11 in lieu of a COCA call.  It will be pre-recorded and posted on October 19 at: COVID-19 Vaccine Webinar Series | CDC.
• COVID-19 Bivalent Vaccine Inventory and Wastage Guidance
• When reporting wastage for bivalent boosters in children, always report wastage in full doses based on the volume identified on the label.  Never report wastage in half doses.  The link below is provided to assist with wastage reporting.  Additional information on the identification, disposal and reporting of wastage can be found at Identification, Disposal, and Reporting of COVID-19 Vaccine Wastage | CDC
• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.