Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 3 of 12)


3
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.
4
Dosing schedule for individuals 6 months through 4 years of age for Pfizer-BioNTech COVID-19 vaccines: Dose 1: Week 0; Dose 2: Week 3; Dose 3: ≥8 Weeks after Dose 2. For individuals turning from 4 to 5 years of age during the vaccination series, complete the series with doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with yellow caps and labels with yellow borders.
5
Dosing schedule for individuals 5 through 11 years of age for Pfizer-BioNTech COVID-19 vaccines: Dose 1: Week 0; Dose 2: Week 3; Dose 3: ≥4 weeks after Dose 2. Individuals turning from 11 to 12 years of age during the vaccination series may complete the series with doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with blue caps and labels with blue borders.
6
For immunocompromised individuals 6 months through 4 years of age, the last previous dose refers to the last dose of Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) or Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which are no longer authorized for use in the U.S.
7
For immunocompromised individuals 5 through 11 years of age, the last previous dose refers to the last dose of a COVID-19 vaccine (Original monovalent) or bivalent COVID-19 vaccine, which are no longer authorized for use in the U.S.
8
For immunocompromised individuals 6 months through 4 years of age, the last dose of a COVID-19 vaccine (2023-2024 Formula) refers to a dose with Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).
9
For immunocompromised individuals 5 through 11 years of age, the last dose of a COVID-19 vaccine (2023-2024 Formula) refers to a dose with Moderna COVID-19 Vaccine (2023-2024 Formula) or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).

3 DOSAGE FORMS AND STRENGTHS

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

A single dose is 0.3 mL.

4 CONTRAINDICATIONS

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (11)] or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.

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.

Monitor Pfizer-BioNTech COVID-19 Vaccine 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 data with authorized or approved 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).

5.3 Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

5.4 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to Pfizer-BioNTech COVID-19 Vaccine.

5.5 Limitations of Vaccine Effectiveness

Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

6 ADVERSE REACTIONS

An overview of clinical studies contributing to the safety assessment of Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months through 11 years of age is provided in Table 1. Participants in these clinical studies received a 2- or 3-dose initial series depending on age, with 3 weeks between Dose 1 and Dose 2 and 8 weeks between Dose 2 and Dose 3 (referred to as a primary series) and subsequent doses (referred to as booster dose(s)).

Table 1: Clinical Studies

*
Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
Received the vaccine during placebo-control period.
Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5), previously authorized as Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
§
Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu1 strain (Original) and Omicron variant lineage BA.1 (not authorized or approved in the U.S.).

Study

Age Group

Vaccine

Strain Composition

Dosing

Number of Participants

Primary Series

Study 1

(NCT04380701)

18 through 55 years

Original *

Primary series

60

Study 2

(NCT04368728)

12 through 15 years

Original *

Primary series

1131

≥16 years

Original *

Primary series

21720

Study 3

(NCT04816643)

5 through 11 years

Original *

Primary series

3109

2 through 4 years

Original *

Primary series

606

6 through 23 months

Original *

Primary series

386

Booster Dose

Study 2

(NCT04368728)

18 through 55 years

Original *

1st booster

306

Study 3

(NCT04816643)

5 through 11 years

Original *

1st booster

401

Study 5

(NCT05472038)

≥12 years of age

Original and Omicron BA.4/BA.5

2nd booster

316

Study 6

(NCT05543616)

5 through 11 years

Original and Omicron BA.4/BA.5

2nd booster

113

2 through 4 years

Original and Omicron BA.4/BA.5

1st booster

(4th dose)

36

6 through 23 months

Original and Omicron BA.4/BA.5

1st booster

(4th dose)

24

Study 4

(NCT04955626)

>55 years

Original * and Original and Omicron BA.1§

2nd booster

610

The safety data accrued with the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent, no longer authorized for use in the U.S.), Pfizer-BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1) [not authorized or approved in the U.S., hereafter referred to as bivalent vaccine (Original and Omicron BA.1)] and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron, BA.4/BA.5) [no longer authorized for use in the U.S.] are relevant to Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) because these vaccines are manufactured using the same process.

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