Pediatric COVID-19 Vaccine Guidance

February 8, 2022

To all health care providers who care for pediatric patients,

As the CDC prepares for the possible recommendation of COVID-19 vaccinations for children aged 6 months through 4 years, expected as early as the end of February, we would like to provide you with important information to prepare for vaccinating your pediatric patients. You are a trusted source of medical advice and care for your patients and their families, and your participation in the vaccination process is imperative to keeping our youngest children healthy and safe.

This is what we currently know about COVID-19 vaccines for children aged 6 months through 4 years:

Pfizer has submitted a rolling submission request to the FDA for Emergency Use Authorization (EUA) for COVID-19 vaccine for children 6 months through 4 years of age.
Initial data suggests that a two-dose series has a good safety profile and provides good protection to children between 6 months and 2 years old.
Clinical trials are currently testing a third dose, but data on a third shot will not be available until at least late March.
By starting with a review of two-doses it is possible that children could start their primary series months earlier than waiting until the third-dose data comes in - possibly by end of February or mid-March. A third dose could be recommended/added later.
FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting February 15 to discuss the Pfizer EUA application for children: Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age | FDA
It is anticipated that the Advisory Committee on Immunization Practices (ACIP) will meet soon after any FDA authorization is granted. ACIP will evaluate the evidence of safety and effectiveness prior to making a recommendation to CDC for the use of the vaccine in this population.

The CDC is sharing the following planning assumptions (see chart below for additional details):

The current products for adults, adolescents, and children ages 5–11 years old should NOT be used in children under 5 years old. There will be a new formulation for this age group.
The Pfizer-BioNTech vaccine for children aged 6 months through 4 years has a similar product configuration to the 5–11-year-old pediatric vaccine, but with a different color cap, different dose, a new national drug code (NDC), and potentially a different schedule. The packaging configuration for vaccine product for children aged 6 months through 4 years is expected to be 10-dose vials in cartons of 10 vials each (100 doses total) with a minimum order quantity of 100 doses.
The Pfizer-BioNTech COVID-19 vaccine for children ages 6 months through 4 years will require diluent. The diluent will be provided with ancillary supplies to support 100 doses per kit.
Once open, doses in vials should be used within 12 hours.

Ordering Information: Effective immediately, Massachusetts COVID-19 Vaccine Program (MCVP)-enrolled provider sites are able to place pre-orders for the new under 5 formulation of vaccine through the Massachusetts Immunization Information System (MIIS). Assuming FDA and CDC approvals occur next week, orders for this formulation placed before 9AM Thursday February 10^th will be delivered on Monday February 21^st. Please note that February 21^st is a holiday, therefore you must ensure your office is open on February 21^st if you are placing vaccine orders in the MIIS on 2/7-2/10. Any orders placed on or after Friday February 11^th will begin being delivered on Tuesday February 22^nd and throughout the rest of that week.

We recommend that pediatric practices incorporate COVID vaccinations into your routine immunization protocols, including:

vaccination at all well child visits,
co-administration with flu vaccine, and
establishment of COVID specific or combined COVID/flu vaccine dedicated clinics at convenient hours for working families (weekend hours)

We also strongly recommend the scheduling of dedicated vaccination clinics as soon as vaccine becomes available as there will likely be demand as soon as the recommendations are announced. Keep in mind that many public settings where older children and adults are currently receiving COVID-19 vaccines (i.e., pharmacies, mass vaccination sites, local health department clinics) may not provide vaccines to this younger age group.

For pediatric practices that are not yet enrolled in the Massachusetts COVID-19 Vaccine Program (MCVP), we encourage you to enroll as soon as possible so you are able to order and receive pediatric COVID vaccine once it is available. Over the last several months, your practice was sent a unique MCVP enrollment link. If you are unable to locate the MCVP enrollment link, please contact the Vaccine Unit at 617-983-6828 or [email protected] to have another enrollment link sent to you.

Other helpful information may be found in these resource materials:

Mini Guide - How to order COVID-19 vaccines in the MIIS
Mini Guide - How to transfer COVID-19 vaccines in the MIIS
Mini Guide - How to process storage and handling issues in the MIIS
Massachusetts COVID-19 Vaccine Program – main MCVP page to assist providers in preparing to receive and administer COVID-19 vaccine: who can administer the vaccine, who is eligible to receive vaccine supply, EUA fact sheets and more
MDPH COVID-19 Vaccine Storage, Handling, Administration and Safety Training – free accredited training for providers administering COVID-19 including: vaccine storage, handling, administration and safety
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States – Overview of all the clinical guidelines
U.S. COVID-19 Vaccine Product Information – Screening forms, standing orders, FAQs for HCPs, EUAs/Factsheets, Preparation & Administration summaries, and more
American Academy of Pediatrics COVID-19 Vaccine Campaign Toolkit
MDPH Provider Bulletin – a weekly bulletin of up to date information and clinical guidelines for MCVP-enrolled providers with vaccine inventory

This is a promising and long-awaited opportunity. We hope you will take the necessary steps to be ready to vaccinate your younger pediatric population as soon as it is authorized by CDC. Thank you.

Margret R. Cooke

Commissioner

Massachusetts Department of Public Health

Lloyd Fisher, MD, FAAP

President

Massachusetts Chapter of the American Academy of Pediatrics

MDPH - Immunization Division

305 South Street

Jamaica Plain, MA 02130