Updated 6/2/22 from the CDC is the following changes. Availability may come as soon as this month. Read up on the findings and follow us at www.cycsaco.org/covid.
Updated CDC Pediatric COVID-19 Vaccination Operational Planning Guide — Information for the COVID-19 Vaccine for Children 6 Months through 4 Years Old and COVID-19 Vaccine for Children 6 Months through 5 Years Old
Overview
Pfizer-BioNTech and Moderna are conducting clinical trials and data collection for COVID-19 vaccines for children ages six months through 4 years and six months through 5 years (hereafter referred to as ages 6m–to 4 years and 6m–5 years), respectively. Pfizer-BioNTech has begun submitting data on a three-dose primary series to FDA for an Emergency Use Authorization (EUA) application for a vaccine for children aged 6m–to 4 years. Moderna has also begun submitting data on a two-dose primary series for children aged 6m–5 years. This operational planning guide includes details about the anticipated Pfizer-BioNTech and Moderna products. This guide is intended to inform planning for all current COVID-19 vaccine programs and channels for vaccine distribution for children aged 6m–4 years and vaccine for children aged 6m–5 years, should either or both vaccines receive FDA EUA and CDC recommendations. Additional information will be released as it becomes available here — https://www.cdc.gov/vaccines/covid-19/planning/children.html.
Please note that new information and updates have been bolded throughout the document.
FACTS
There are approximately 20 million children aged <5 years in the United States; an additional approximately 4 million children aged five years have been eligible for the Pfizer-BioNTech vaccine for children aged 5–11 years since November 2021.
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is tentatively scheduled to meet on June 15, 2022, to discuss the Pfizer-BioNTech vaccine for children aged 6m–4 years and the Moderna vaccine for children aged 6m– 5 years. CDC’s Advisory Committee on Immunization Practices (ACIP) is anticipated to meet within several days of VRBPAC, assuming FDA authorization; the meeting(s) will be posted here once scheduled: https://www.cdc.gov/vaccines/acip/index.html. (Note: For the remainder of this document, when used in reference to vaccines for children aged 6m–4 years or 6m–5 years, authorization refers to vaccines granted an emergency use authorization.)
The current products authorized for use in adults, adolescents, and children aged 5–11 years should NOT be used in children aged <5 years.
The Pfizer-BioNTech vaccine for children aged 6m–4 years ships at -80°C, like all current Pfizer COVID-19 vaccines, and has a similar product configuration to the 5–11-year-old vaccine. Still, with a different color cap (maroon), different concentrations (3 micrograms/0.2mL), different amounts of diluent added (2.2mL), and a new national drug code (NDC). Please see the CDC document “Pfizer-BioNTech COVID-19 Vaccine Products” at https://www.cdc.gov/vaccines/covid-19/downloads/Pfizer-Pediatric-.
Updated 6/2/22 Reference-Planning.pdf for more details. The new NDC will require additional coding and information technology accommodations, which are underway.
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