Healthcare Advisory: Updated bivalent mRNA COVID-19 boosters available to children 5 years or older; Novavax received FDA authorization

Note: This advisory is for healthcare professionals. To read public health advisories, visit kitsappublichealth.org/news/categories/advisories

October 24, 2022

Actions Requested

• Be aware, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and Western States Scientific Safety Review Workgroup approved an age expansion for updated COVID-19 vaccine bivalent booster dose at least 2 months after their primary series or last booster dose. The expansion allows children:

  • 5–11 years old to get 1 booster dose of Pfizer pediatric updated bivalent COVID-19 vaccine.

  • 6–17 years old to get 1 booster dose of Moderna updated bivalent COVID-19 vaccine.

• Understand that updated bivalent COVID-19 vaccines help restore protection that has waned since prior vaccination. The formulations add Omicron BA.4 and BA.5 spike protein components, targeting recent Omicron variants that are more transmissible and immune evading.

• Be aware, original mRNA COVID-19 vaccine formulations are no longer approved as a booster for anyone at any age. 

• Be aware, Novavax is now authorized for emergency use as a two-dose primary series for individuals 12 years of age and older, given as two doses (0.5 mL each) 3 weeks apart. 

• Be aware, Novavax has also received FDA emergency authorization for use as a first booster for those that have completed a primary COVID-19 vaccine series.  Eligible individuals include those 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.  For these individuals, a booster dose (0.5 mL) of Novavax COVID-19 Vaccine, Adjuvanted may be administered at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. We are waiting for updated standing orders from CDC/DOH to reflect this change.

• Be aware, evidence to date supports the safety of authorized and licensed COVID-19 vaccines, with over 640 million doses administered in the United States.

• Be aware, the Western States Scientific Safety Review Workgroup is concerned about potential errors administering the various COVID-19 vaccines, as formulations for different age groups look alike.

  • To minimize errors, vaccine preparation and administration staff should:

    • Familiarize themselves with Vaccine Administration: Preventing Vaccine Administration Errors (cdc.gov)

    • Report any suspected adverse events following COVID-19 vaccination (primary series or booster dose) to Vaccine Adverse Event Reporting System (VAERS) to continue national safety surveillance efforts.

• Find updated Pfizer and Moderna standing orders for Bivalent boosters on CDC’s website:

  • Pfizer-BioNTech COVID-19 Vaccine: Standing Orders for Administering Vaccine (Monovalent and Bivalent) • 5 through 11 Years of Age (cdc.gov)

  • Pfizer-BioNTech COVID-19 Vaccine: Standing Orders for Administering Vaccine (Monovalent and Bivalent) • 12 Years of Age and Older (cdc.gov)

  • Moderna COVID-19 Vaccine: Standing Orders for Administering Vaccine • Formulation: 6 through 11 Years of Age (cdc.gov)

  • Moderna COVID-19 Vaccine: Standing Orders for Administering Vaccine (Monovalent and Bivalent) • 12 Years of Age and Older (cdc.gov)

• Direct and help individuals to find COVID vaccine appointments and more information on our COVID-19 vaccine page.

• Recommend everyone 5 years or older get an updated COVID booster and it is safe to give a flu shot simultaneous with COVID-19 vaccine (primary series or booster dose). Be aware of people at higher risk for flu-related complications:

  • Young children

  • Pregnant

  • Have an underlying health condition

  • 65 years or older

Contacting the Health District

• Call (360) 728-2235. Use this number to report notifiable conditions 24 hours a day, 7 days a week. After hours, leave a message with the patient’s name, date of birth and disease.

• Fax (360) 813-1168

Additional Information

• Updated bivalent COVID-19 vaccine booster doses for children press release, FDA.

• Updated bivalent COVID-19 vaccine booster doses for children press release, CDC.

• Updated bivalent COVID-19 vaccine booster doses for children statement, Western States Scientific Safety Review Workgroup.

• Updated Novavax EUA, FDA.

• COVID-19 vaccine page, Kitsap Public Health District.

• COVID-19 isolation and precaution guidelines, CDC.

• COVID-19 guidance for schools and childcare, DOH.

• Interim clinical considerations for use of COVID-19 vaccines, CDC.

• Flu Season (kitsappublichealth.org)