FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age

FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age
– December 9, 2022

 

Dear COVID-19 Vaccination Provider:

On December 8, 2022, FDA authorized the bivalent Moderna COVID-19 vaccine for children ages 6 months through 5 years of age and bivalent Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 years of age.  The press release can be found here:  Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age.  Following this authorization, today CDC recommended expanding use of updated (bivalent) COVID-19 vaccines to include children ages 6 months through 5 years.

Some highlights of the emergency use authorization of these two products:

Moderna Bivalent (6 months through 5 years)

• Children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 vaccine two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine.

Pfizer Bivalent (6 months through 4 years)

• Children 6 months through 4 years of age who have not yet completed their three-dose primary series of the Pfizer-BioNTech COVID-19 vaccine will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 vaccine.  The monovalent Pfizer-BioNTech COVID-19 vaccine is no longer authorized for use as the third dose of the three-dose primary series in children 6 months through 4 years of age.
• Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant.

Based on these details, heterologous (mix and match) use of bivalent vaccines for this age group is NOT recommended for children 6 months through 5 years of age.  (Note that heterologous use of bivalent boosters IS still authorized for ages 5 and older.)

Providers that placed pre-orders for these products should start receiving shipments Monday, December 12th.  It may take a few days for all pre-order deliveries to be completed.  Regular orders for these products may now be placed in NYSIIS and do not need to be entered separate from other COVID-19 vaccines product orders.

 

Additional Resources:

Fact Sheet for Healthcare Providers Administering Vaccine:  Moderna COVID-19 Vaccine, Bivalent – Booster dose for 6 months through 5 years of age

Fact Sheet for Healthcare Providers Administering Vaccine:  Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent:  For 6 months through 4 years of age Primary Series

Dear Healthcare Provider Letter:  Pfizer-BioNTech COVID-19 Vaccine, Bivalent – Change in Third Dose of 3-Dose Primary Series for Individuals 6 months through 4 years of age

CDC’s Interim Clinical Considerations for use of COVID-19 Vaccines (updated):  https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

CDC will hold a Clinician Outreach and Communication Activity (COCA) call on bivalent COVID-19 vaccines on Tuesday, December 13, 2022 from 2:00 PM to 3:00 PM EST.  Click this link a few minutes prior to the webinar to join (registration not required):  https://www.zoomgov.com/j/1616717132.

 

Thank you for your participation in the COVID-19 vaccination program.

NYSDOH COVID-19 Vaccine Team