Bivalent Booster Dose FDA Authorization and CDC Recommendations

This week, the FDA authorized and the CDC recommended the use of Moderna and Pfizer Bivalent Vaccines for a single booster dose given at least 2 months after completion of the primary series or the most recent booster dose of an approved or authorized monovalent (original) COVID-19 vaccine. The Western States Scientific Safety Review Workgroup statement is pending.

Resources:

• CDPH Communication on FDA Authorization of Bivalent Booster Doses
• FDA Statement on Bivalent Booster Doses
• Interim Clinical Considerations for COVID-19 Vaccines: Bivalent Booster Doses (CDC ACIP Slides)

Fact Sheets:

• Pfizer-BioNTech COVID-19 Vaccine, Bivalent Provider Fact Sheet

• Pfizer-BioNTech COVID-19 Vaccine, Bivalent Recipient/Caregiver Factsheet

• Moderna COVID-19 Vaccine, Bivalent Provider Factsheet

• Moderna COVID-19 Vaccine, Bivalent Recipient/Caregiver Factsheet

myCAvax Updates

Bivalent COVID-19 Boosters in myCAvax 

Given the FDA’s authorization of Bivalent COVID-19 Boosters, some Wave 1 pre-orders may arrive as early as this week. Please be prepared to receive shipments of Bivalent Boosters earlier than expected. 

Note: To distinguish between the new Bivalent Booster and Primary series vaccines, the Vaccine Order Request page has two new product groupings: Booster Adolescent/Adult and Primary Adolescent/Adult. 

myCAvax Release 30 Delayed 

The myCAvax Release 30 has been rescheduled to Thursday, September 15th to accommodate the new Monkeypox (MPX) functionality. 

Support Desk Hours During Labor Day 

The My Turn and myCAvax Help Desk (1-833-502-1245) and the COVID-19 Provider Call Center (covidcallcenter@cdph.ca.gov) will be closed on Monday, September 5th in observation of Labor Day.  

VaccineFinder Update: Bivalent Booster Doses

VaccineFinder has been updated with the new bivalent booster doses. Before receiving the initial vaccine shipment, add bivalent boosters using the COVID Locating Health portal to enable inventory reporting to VaccineFinder. Refer to Reporting Inventory to VaccineFinder for details.

Report New Product Inventory Upon Receipt

Reminder: Report new bivalent booster inventory upon receipt. Further reporting for all COVID-19 vaccine should be completed, at least, weekly by Fridays, close of business. Note: Weekly reporting is not required when inventory is depleted and zeroed out in VaccineFinder.

Public Display on Vaccines.gov

Locations may turn on public display once beginning bivalent booster vaccine administration. Public display allows the public to search for locations on Vaccines.gov to find where vaccines are available, and how they can make an appointment. To enter your location, please follow, instructions to enter location information manually or use file upload.

Upcoming Webinar: Talking with Patients about Bivalent Booster Doses

Updated CDC COVID-19 Vaccine Product Guide

The CDC COVID-19 Vaccine Product Guide has been updated for all vaccines and ancillary kits, including Novavax. The guide will be updated with bivalent booster doses soon.