FDA Authorizes Use of COVID Bivalent Vaccine for Pediatric Population

Dear COVID-19 Vaccination Provider,

Yesterday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines.  CDC’s Director Dr. Rochelle Walensky released a statement and signed a decision memo recommending updated (bivalent) COVID-19 boosters for children five years and older. This expands on CDC’s recommendation issued September 1, 2022, for updated COVID-19 boosters of people ages 12 and older.

1. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age.
2. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.
3. With today’s authorization, the Monovalent Pfizer-BioNTech COVID-19 vaccines is no longer authorized as a booster dose for individuals five years of age and older. Scheduled forthcoming appointments to administer monovalent Pfizer-BioNTech or Moderna boosters in people 5 years of age and older must be rescheduled for when locations have the Bivalent COVID-19 vaccines available.
4. Monovalent Moderna COVID-19 Vaccines and Pfizer-BioNTech COVID-19 Vaccines continue to be authorized for primary series administration in individuals six months of age and older.
5. The Pfizer Pediatric (ages 5-11) Bivalent booster only vaccine vials and Pfizer Pediatric (ages 5-11) Monovalent primary only vaccine vials have a similar appearance – orange cap and orange vial label border.  The vial labels of the Bivalent says “Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).”  It is critical for stock of these two products be kept separate and to verify the vials (including labels) prior to preparation and administration to help avoid administration errors.

Pfizer Pediatric (ages 5-11) Bivalent vaccine pre-orders placed through October 4, 2022 will begin to ship to providers, but are not expected to begin delivering until Monday, October 17, 2022 and may take several days for all pre-orders to deliver.  Your primary vaccine coordinator will receive a shipping notification email with tracking number from Pfizer once the vaccine ships.  Since the CDC Director has already made the recommendation for use of these vaccines, bivalent boosters to children five and older may begin once vaccine is received.

NYSDOH COVID-19 vaccination program providers are able to request Bivalent booster doses through routine ordering in NYSIIS.  When placing a Moderna Bivalent order it is important to choose the correct ordering intention based upon your ancillary kit needs:

1. The same Moderna Bivalent vials that are current authorized for ages 18+ will be used for ages 6-11 and ages 12-17.  However, one vial yields double the number of doses when used for 6–11-year-olds (0.25 mL dose) as when used for people aged 12 years and older (0.5 mL dose).
2. If you will be administering Moderna Bivalent to ages 6-11 and need enough ancillary supplies to support administration of 200 doses, you must enter your order under the Pediatric Intention. This will result in two ancillary kits (all 1” needles for up to 200 vaccine doses) being sent.
3. If you will NOT be administering Moderna Bivalent to ages 6-11 or do not need additional ancillary supplies you must order under the Adult Intention. This will result in one ancillary kit (80% 1” needles and 20% 1.5” needles).
4. The Moderna Bivalent vaccine received for both intentions is the SAME and may be administered for booster doses to anyone age 6 and older (once approved). The only difference is the ancillary kit(s) sent!

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

NYSDOH COVID-19 Vaccine Team