Updated (2023–2024 Formula) Pfizer-BioNTech COVID-19 Vaccine

109/29/2023 CS321570-AO

6 Months Through 4 Years of Age

Updated (2023–2024 Formula)

Pfizer-BioNTech COVID-19 Vaccine

Standing Orders for Administering Vaccine

2023–24 Formula Vaccine

Presentation

Diluent

Dose/Injection

Amount

Route

Multidose vial with yellow cap and

yellow label

1.1 mL of 0.9% sodium chloride (normal

saline, preservative-free) diluent

0.3 mL/3 µg

Intramuscular

(IM) injection

Purpose

To reduce morbidity and mortality from coronavirus disease

2019 (COVID-19) by vaccinating persons who meet the criteria

established by the Centers for Disease Control and Prevention’s

Advisory Committee on Immunization Practices (ACIP).

Policy

Where authorized under state law, standing orders enable eligible

nurses and other health care professionals (e.g., pharmacists)

to assess and vaccinate persons who meet the criteria in the

"Procedure" section below without the need for clinician

examination or direct order from the attending provider at the

time of the interaction.

Procedure

Assess children 6 months through 4 years of age for vaccination with the 2023–24 Pﬁzer-BioNTech COVID-19 Vaccine based on the

following criteria:

People who are NOT moderately or severely immunocompromised

* Persons with a recent SARS-CoV-2 infection may consider delaying vaccination by 3 months from symptom onset or positive test (if infection was asymptomatic).

† COVID-19 vaccination history refers to previous receipt of dose(s) of Original monovalent mRNA, bivalent mRNA vaccine, Updated (2023–2024 Formula), or a combination of the

three, unless otherwise speciﬁed.

‡ An 8-week interval between the ﬁrst and second COVID-19 vaccine (Moderna, Novavax, and Pﬁzer-BioNTech) doses might be optimal for some people as it might reduce the small

risk of myocarditis and pericarditis associated with these vaccines.

§ People who are recommended to receive a multidose mRNA series for initial vaccination (i.e., children ages 6 months–4 years and people who are moderately or severely

immunocompromised) should receive all doses from the same manufacturer. However, in the following exceptional situations a diﬀerent age-appropriate COVID-19 vaccine product

may be administered: the same vaccine is not available, the person would otherwise not complete the vaccination series, or the person starts but is unable to complete a vaccination

series with the same vaccine due to a contraindication.

¶ For children who have received 1 Moderna and 1 Pﬁzer-BioNTech vaccines of any formulation, follow a 3-dose schedule. A third dose of either Moderna vaccine or Pﬁzer-BioNTech

vaccine should be administered at least 8 weeks after the second dose.

COVID-19 vaccination history

†

(regardless of COVID-19

vaccine formula)

Schedule for administration of 2023-24 Pﬁzer-

BioNTech COVID-19 Vaccine

Unvaccinated Give a 3-dose initial series. Administer:

 Dose 1 now

 Dose 2 at least 3–8 weeks after Dose 1

‡

 Dose 3 at least 8 weeks after Dose 2

1 previous dose of any Pﬁzer-BioNTech COVID-19 Vaccine (Dose 1)

Complete series. Administer:

 Dose 2 at least 3–8 weeks after Dose 1

‡

 Dose 3 at least 8 weeks after Dose 2

2 doses of any Pﬁzer-BioNTech COVID-19 Vaccine (Doses 1 and 2)

§¶

Complete series. Administer:

 Dose 3 at least 8 weeks after Dose 2

3 or more doses Pﬁzer-BioNTech COVID-19 Vaccine, NOT including

at least 1 dose of 2023–24 COVID-19 vaccine

Give 1 dose at least 8 weeks (2 months) after the previous

dose.

3 or more doses Pﬁzer-BioNTech COVID-19 Vaccine, INCLUDING at

least 1 dose of 2023–24 COVID-19 vaccine

No further doses are indicated.

209/29/2023 CS321570-AO

6 Months Through 4 Years of Age

Updated (2023–2024 Formula)

Pfizer-BioNTech COVID-19 Vaccine

Standing Orders for Administering Vaccine

People who ARE moderately or severely immunocompromised

COVID-19 vaccination history

(regardless of COVID-19

vaccine formula)

Schedule for administration of 2023-24 Pﬁzer-

BioNTech COVID-19 Vaccine

Unvaccinated Give a 3-dose initial series. Administer:

 Dose 1 now

 Dose 2 at least 3 weeks after Dose 1

 Dose 3 at least 8 weeks after Dose 2

1 previous dose of any Pﬁzer-BioNTech COVID-19 Vaccine (Dose 1)

†

Complete series. Administer:

 Dose 2 at least 3 weeks after Dose 1

 Dose 3 at least 8 weeks after Dose 2

2 doses of any Pﬁzer-BioNTech COVID-19 Vaccine

(Doses 1 and 2)

†‡

Complete series. Administer:

 Dose 3 at least 8 weeks after Dose 2

3 or more doses of Pﬁzer-BioNTech COVID-19 Vaccine, NOT

including at least 1 dose of 2023–24 COVID-19 vaccine

†

Give 1 dose at least 8 weeks (2 months) after the previous

dose.

3 or more doses of Pﬁzer-BioNTech COVID-19 Vaccine, INCLUDING

at least 1 dose of 2023–24 COVID-19 vaccine

†

 People who are moderately or severely

immunocompromised have the option to receive 1

additional dose at least 8 weeks (2 months) following

the last recommended dose.

 Further additional dose(s) may be administered,

informed by the clinical judgement of a health care

provider and personal preference and circumstances.

 Any further additional doses should be administered

at least 8 weeks (2 months) after the last COVID-19

vaccine dose.

* COVID-19 vaccination history refers to previous receipt of dose(s) of Original monovalent mRNA, bivalent mRNA vaccine, Updated (2023–2024 Formula), or a combination of the

three, unless otherwise speciﬁed.

† People who are recommended to receive a multidose mRNA series for initial vaccination (i.e., children ages 6 months–4 years and people who are moderately or severely

immunocompromised) should receive all doses from the same manufacturer. However, in the following exceptional situations a diﬀerent age-appropriate COVID-19 vaccine product

may be administered: the same vaccine is not available, the person would otherwise not complete the vaccination series, or the person starts but is unable to complete a vaccination

series with the same vaccine due to a contraindication.

‡ For children who have received 1 Moderna and 1 Pﬁzer-BioNTech vaccines of any formulation, follow a 3-dose schedule. A third dose of either Moderna vaccine or Pﬁzer-BioNTech

vaccine should be administered at least 8 weeks after the second dose.

309/29/2023 CS321570-AO

6 Months Through 4 Years of Age

Updated (2023–2024 Formula)

Pfizer-BioNTech COVID-19 Vaccine

Standing Orders for Administering Vaccine

Additional Clinical Considerations

 2023–24 Pfizer-BioNTech COVID-19 Vaccine may be

simultaneously administered with other routinely

recommended vaccines. There are additional

considerations for simultaneous administration of an

orthopoxvirus vaccine and COVID-19 vaccine.

 Persons who have received HCT or CAR-T-cell therapy

○ Revaccinate persons who received doses of COVID-19

vaccine prior to or during HCT or CAR-T-cell therapy,

following the current COVID-19 vaccination schedule.

Revaccination should start at least 3 months (12 weeks) after

transplant or CAR-T-cell therapy.

 For additional details and all clinical considerations, see

Interim Clinical Considerations for Use of COVID-19 Vaccines.

Contraindications:

History of a severe allergic reaction (e.g., anaphylaxis) after a

previous dose or to a component of the COVID-19 vaccine

Precautions:

History of:

 A diagnosed non-severe allergy to a component of the

COVID-19 vaccine

 Non-severe, immediate (onset less than 4 hours) allergic

reaction after administration of a previous dose of one

COVID-19 vaccine type, if receiving the same vaccine type

 Moderate to severe acute illness, with or without fever

 Multisystem inﬂammatory syndrome in children (MIS-C) or

adults (MIS-A)

 Myocarditis or pericarditis within 3 weeks after a dose of any

COVID-19 vaccine

Administration

 Provide all recipients and/or parents/legal guardians with a

copy of the current Fact Sheet for Recipients and Caregivers.

 Prepare to administer the vaccine following the manufacturer's

guidance.

 Prepare to administer vaccine by IM injection.

○ Needle gauge and length: Use a 22–25 gauge, 1-inch

○ For children:

» 6 months through 2 years: Vastus lateralis muscle in the

anterolateral thigh

†

» 2 through 4 years: Deltoid muscle in the upper arm

‡

* A 5/8 inch needle may be used if administering the vaccine in the deltoid muscle AND the skin is stretched tightly and the subcutaneous tissue is not bunched for children ages 1–4

years.

† The deltoid muscle in the upper arm may be used if the muscle mass is adequate for ages 1 through 2 years

‡ The vastus lateralis muscle in the anterolateral thigh may be used as an alternate site.

○ Administer Pfizer-BioNTech COVID-19 Vaccine by

intramuscular (IM) injection using the vial with yellow cap

and yellow label. Administer 0.3 mL/3 μg

Document Vaccination

Document each recipient's vaccine administration information:

 Medical record: The vaccine and the date it was administered,

manufacturer, lot number, vaccination site and route, name

and title of the person administering the vaccine.

 Vaccination record for recipient: Date of vaccination,

product name/manufacturer, lot number, and name/location

of the administering clinic or health care professional.

 Immunization information system (IIS): Report the

vaccination to the appropriate state/local IIS.

Be Prepared to Manage Medical Emergencies

Consider observing persons after vaccination to monitor for

allergic reactions and syncope:

 30 minutes for persons with:

○ A history of a non-severe, immediate (onset within 4 hours)

allergic reaction after a previous dose of one COVID-19

vaccine type, if receiving the same vaccine type

○ A history of a diagnosed non-severe allergy to a component

of the COVID-19 vaccine, if receiving the same vaccine type

 15 minutes: All other persons

Syncope may occur in association with injectable vaccines.

Procedures should be in place to avoid falling injuries and

manage syncopal reactions.

Have a written protocol to manage medical emergencies

following vaccination.

Health care personnel who are trained and qualiﬁed to recognize

the signs and symptoms of anaphylaxis as well as administer

intramuscular epinephrine should be available at the vaccination

location at all times.

Report Adverse Events to the Vaccine Adverse Event

Reporting System (VAERS)

Adverse events that occur in a recipient following administration

of any licensed or authorized COVID-19 vaccine should be

reported to VAERS, including:

 Vaccine administration errors, whether or not associated with

an adverse event

 Serious adverse events, irrespective of attribution to

vaccination

409/29/2023 CS321570-AO

6 Months Through 4 Years of Age

Updated (2023–2024 Formula)

Pfizer-BioNTech COVID-19 Vaccine

Standing Orders for Administering Vaccine

 Cases of Multisystem Inﬂammatory Syndrome (MIS) in adults

and children

 Cases of myocarditis

 Cases of pericarditis

 Cases of COVID-19 that result in hospitalization or death

Reporting is also encouraged for any other clinically signiﬁcant

adverse event, even if it is uncertain whether the vaccine caused

the event. Information on how to submit a report to VAERS is

available at https://vaers.hhs.gov or by calling 1-800-822-7967.

For More Information, Please See:

 Interim Considerations: Preparing for the Potential

Management of Anaphylaxis after COVID-19 Vaccination

 CDC’s General Best Practice Guidelines for Immunization,

“Preventing and Managing Adverse Reactions,”

 Medical Management of Vaccine Reactions in Children and

Teens in a Community Setting

Note: For more information/guidance, please contact the immunization program at your state or local health department or the

appropriate state body (e.g., state board of medical/nursing/pharmacy practice).

Standing Orders Authorization

This policy and procedure shall remain in eﬀect for all patients of the

eﬀective until rescinded or until .

Medical director (or other authorized practitioner)

/ / .

Adapted with appreciation from the immunize.org standing orders.