Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 3 of 14)

2.2 Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vaccine will be a white to off-white suspension. Do not administer if vaccine is discolored or contains particulate matter.

Administer Pfizer-BioNTech COVID-19 Vaccine, Bivalent intramuscularly.

2.3 Dose and Schedule

Individuals 6 months of age and older not previously vaccinated with a COVID-19 vaccine

* Notwithstanding the age limitations for use of the vaccine, individuals turning from 4 to 5 years of age during the vaccination series should receive all doses with Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in vials with maroon caps and labels with maroon borders.
Age	Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial Cap and Label Border Color	Dosing Regimen, Dose and Schedule
6m-4y *	Maroon	3 doses, 0.2 mL each Dose 1: Week 0 Dose 2: Week 3 Dose 3: ≥8 weeks after Dose 2
5-11y	Orange	Single dose, 0.2 mL
12-64y	Gray	Single dose, 0.3 mL
≥65y	Gray	Single dose, 0.3 mL One additional dose, 0.3 mL, may be administered ≥4 months after first dose of an authorized bivalent COVID-19 vaccine

Individuals 6 months through 4 years of age previously vaccinated with the monovalent Pfizer-BioNTech COVID-19 Vaccine 3

* Notwithstanding the age limitations for use of the vaccine, individuals turning from 4 to 5 years of age during the vaccination series should receive 2 doses with Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in vials with maroon caps and labels with maroon borders. † For individuals with certain kinds of immunocompromise (as defined in footnote 8) previously vaccinated with three doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine, see text below tables for dosing interval.
Age	Number of Previous Doses of Pfizer‑BioNTech COVID-19 Vaccine	Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial Cap and Label Border Color	Dosing Regimen, Dose and Schedule
6m-4y	1 previous dose	Maroon	2 doses *, 0.2 mL each Dose 1: 3 weeks after receipt of Pfizer‑BioNTech COVID‑19 Vaccine Dose 2: ≥8 weeks after Dose 1
6m-4y	2 previous doses	Maroon	Single dose, 0.2 mL ≥8 weeks after receipt of second dose of Pfizer-BioNTech COVID-19 Vaccine
6m-4y	3 previous doses	Maroon	Single dose, 0.2 mL ≥2 months † after receipt of third dose of Pfizer‑BioNTech COVID-19 Vaccine

Individuals 5 years of age and older previously vaccinated with 1 or more doses of a monovalent COVID-19 vaccine 4

Age	Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial Cap and Label Border Color	Dosing Regimen, Dose and Schedule
5-11y	Orange	Single dose, 0.2 mL ≥2 months after monovalent COVID‑19 vaccine
12-64y	Gray	Single dose, 0.3 mL ≥2 months after monovalent COVID‑19 vaccine
≥65y	Gray	Single dose, 0.3 mL ≥2 months after monovalent COVID‑19 vaccine One additional dose, 0.3 mL, may be administered ≥4 months after first dose of an authorized bivalent COVID-19 vaccine

Individuals with Certain Kinds of Immunocompromise 5

For individuals with certain kinds of immunocompromise 6 months through 4 years of age who have received three 0.2 mL doses (Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent), a fourth dose (0.2 mL) with Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 1 month following the most recent dose; additional doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.

For individuals with certain kinds of immunocompromise 5 years of age and older, a single additional age-appropriate dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine; additional age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.

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3

The monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use in the United States.

4

Monovalent refers to a COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.

5

Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

3 DOSAGE FORMS AND STRENGTHS

Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a suspension for injection.

Individuals 6 months through 4 years of age: vials with maroon caps and labels with maroon borders, a single dose is 0.2 mL.

Individuals 5 through 11 years of age: vials with orange caps and labels with orange borders, a single dose is 0.2 mL.

Individuals 12 years of age and older: vials with gray caps and labels with gray borders, a single dose is 0.3 mL.

4 CONTRAINDICATIONS

Do not administer Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Monitor Pfizer-BioNTech COVID-19 Vaccine, Bivalent recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

5.2 Myocarditis and Pericarditis

Postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For the Pfizer-BioNTech COVID-19 Vaccine, the observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae.

The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).