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
| ||||
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 | 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.
VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.
https://vxlabels.com/lib/vaccines/vax/pfizer-biontech-covid-19-vaccine/page/3/