By: Helen Li, PharmD Candidate c/o 2023

              On June 18, 2022, Centers for Disease Control and Prevention (CDC) Director, Rochelle P. Walensky, M.D., M.P.H., endorsed the Advisory Committee on Immunization Practices’ recommendation to expand eligibility of Coronavirus Disease 2019 (COVID-19) vaccinations to children 6 months through 5 years of age.¹ On August 31, 2022, the United States (US) Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 vaccines to authorize bivalent formulations for use as booster doses at least two months following primary series or booster vaccination.² As of December 2022, pharmacists are able to administer the Pfizer-BioNTech and Moderna vaccines to children as young as 6 months of age.³ Primary series doses utilize monovalent vaccines, designed to protect against the original strain of the virus that causes COVID-19. Booster doses utilize updated, bivalent vaccines, designed to protect against both the original strain and the Omicron variant BA.4 and BA.5.³

Pfizer-BioNTech: Immunization Schedule for Children 6 Months to 4 Years of Age

Pfizer-BioNTech permits primary vaccination in children 6 months to 4 years of age using two doses of the monovalent vaccine followed by one dose of the bivalent vaccine. Both the monovalent and bivalent vaccines are packaged as maroon-capped vials with maroon-bordered labels. Each vaccine must first be reconstituted using 2.2 mL of 0.9% sodium chloride. Each dose for administration is 3 μg/0.2 mL.⁴ The first two doses of the vaccination series utilize the monovalent vaccine. The second dose is administered 3 to 8 weeks after the first dose. The third dose given is the bivalent vaccine, which can be administered at least 8 weeks after the second dose. Children 6 months to 4 years of age are considered up to date with the COVID-19 vaccination 2 weeks after the third dose. As of December 2022, an additional booster dose is not recommended for this age group.³ The injection site for children 6 months to 2 years of age is the vastus lateralis muscle, located in the anterolateral thigh. The injection site for children 3 years of age and older is the deltoid muscle, located in the upper arm.⁴

Pfizer-BioNTech: Immunization Schedule for Children 5 to 11 Years of Age

Children ages 5 to 11 can complete the vaccination series with the administration of two doses of the monovalent vaccine and one booster dose of the bivalent vaccine.³ Both the monovalent and bivalent vaccines are packaged as orange-capped vials with orange-bordered labels. Each vaccine must first be reconstituted using 1.3 mL of 0.9% sodium chloride. Each vaccine is administered as a dose of 10 μg/0.2 mL.⁴ The second dose of the primary series is administered 3 to 8 weeks after the first dose. The booster dose is administered at least 8 weeks after the second dose or last booster. Children ages 5 to 11 are considered up to date immediately after receiving the most recent bivalent booster.³

Pfizer-BioNTech: Immunization Schedule for Children 12 to 17 Years of Age

A three-dose vaccination series, consisting of two monovalent vaccine doses and one bivalent booster dose, is available for children 12 to 17 years of age.³ Both the monovalent and bivalent vaccines are packaged as gray-capped vials with gray-bordered labels. Reconstitution is not needed for either vaccine vial. Both vaccines are administered as a dose of 30 μg/0.3 mL.⁴ The second dose of the primary series is administered 3 to 8 weeks after the first dose. The booster dose is administered at least 8 weeks after the second dose or last booster. Children ages 12 to 17 are considered up to date immediately after receiving the most recent bivalent booster.³

Moderna: Immunization Schedule for Children 6 Months to 5 Years of Age

The Moderna vaccination series in children 6 months to 5 years of age consists of two doses of the monovalent vaccine and one dose of the bivalent booster. The monovalent vaccine is packaged as a blue-capped vial with a magenta-bordered label. Each dose for administration is 25 μg/0.25 mL.⁵ The bivalent vaccine is packaged as a dark pink-capped vial with a yellow-bordered label. Each dose for administration is 10 μg/0.2 mL. Reconstitution is not required for either vaccine vial. Children 6 months to 5 years of age will receive two doses of the monovalent vaccine. The second dose is administered 4 to 8 weeks after the first dose. The booster dose is administered at least 8 weeks after the second primary series dose. Children 6 months to 5 years of age are considered up to date immediately after they have received the most recent bivalent vaccine.³ Similar to the Pfizer-BioNTech vaccine, the injection site for children 6 months to 2 years of age is the vastus lateralis muscle, located in the anterolateral thigh. The injection site for children 3 years of age and older is the deltoid muscle, located in the upper arm.⁵

Moderna: Immunization Schedule for Children 6 to 11 Years of Age

Children ages 6 to 11 can complete the vaccination series with the administration of two doses of the monovalent vaccine and one booster dose of the bivalent vaccine.³ The monovalent vaccine is packaged as a blue-capped vial with a purple-bordered label. It is administered at a dose of 50 μg/0.5 mL. The bivalent vaccine is packaged as a blue-capped vial with a gray-bordered label. It is administered at a dose of 25 μg/0.25 mL. Neither of the vaccines have to be reconstituted.⁵ The second dose of the primary series is administered 4 to 8 weeks after the first dose. The booster dose is administered at least 8 weeks after the second primary series dose. Children ages 6 to 11 are considered up to date immediately after receiving the most recent bivalent booster.³

Moderna: Immunization Schedule for Children 12 to 17 Years of Age

A three-dose vaccination series, consisting of two monovalent vaccine doses and one bivalent booster dose, is available for children 12 to 17 years of age.³ The monovalent vaccine is packaged as a red-capped vial with a blue-bordered label. It is administered at a dose of 100 μg/ 0.5 mL. The bivalent vaccine is packaged as a blue-capped vial with a gray-bordered label. It is administered at a dose of 50 μg/0.5 mL. Neither of the vaccines have to be reconstituted.⁵ The second dose of the primary series is administered 4 to 8 weeks after the first dose. The booster dose is administered at least 8 weeks after the second primary series dose. Children ages 12 to 17 are considered up to date immediately after receiving the most recent bivalent booster.³

Conclusion

As of November 30, 2022, the US has seen approximately 1,610,000 children under the age of 5 receive at least one COVID-19 vaccine dose since June 18, 2022.⁶ Regarding those 5 years of age and older, about 265,553,660 (85%) Americans have received at least one COVID-19 vaccine dose. Within this age group, about 39,719,443 (12.7%) Americans have received an updated, bivalent booster dose.⁶ The increased eligibility criteria and expanded availability of bivalent booster vaccines enable pharmacists to maximize immunization efforts. Pharmacists play a vital role in the community to help ensure that patients are receiving the appropriate vaccines in a timely manner. As vaccination eligibility and recommendations evolve, healthcare providers must stay informed and remain vigilant to ensure adherence to vaccine schedules and improve public health efforts.

References

1. CDC Recommends COVID-19 Vaccines for Young Children. Centers for Disease Control and Prevention. https://www.cdc.gov/media/releases/2022/s0618-children-vaccine.html. Published 06/18/2022.
2. Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use. Published 08/31/2022.
3. Stay Up to Date with COVID-19 Vaccines Including Boosters. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html#pfizer-17-and-under. Last Updated 12/09/2022.
4. Administration of Pfizer-BioNTechCOVID-19 Vaccines. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/administration.html. Published 10/14/2022.
5. Administration of Moderna COVID-19 Vaccines. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/administration.html. Published 10/14/2022.
6. COVID Data Tracker: COVID-19 Vaccinations in the United States. Centers for Disease Control and Prevention. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-pop5. Last Updated 11/30/2022.

Published by Rho Chi Post