PREVNAR® 20 Highlights

(pneumococcal 20-valent conjugate vaccine)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PREVNAR 20 safely and effectively. See full prescribing information for PREVNAR 20.

PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine), suspension for intramuscular injection
Initial U.S. Approval: 2021

RECENT MAJOR CHANGES

Indications and Usage

04/2023

Dosage and Administration (2.2, 2.3, 2.4, 2.5, 2.6)

04/2023

Warnings and Precautions, Apnea in Premature Infants (5.3)

04/2023

INDICATIONS AND USAGE

Prevnar 20 is a vaccine indicated for

•
active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older. (1)
•
active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age. (1)
•
active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older. (1)

The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1)

DOSAGE AND ADMINISTRATION

For intramuscular administration only.

Children: Administer Prevnar 20 as a 4-dose immunization series at 2, 4, 6, and 12 through 15 months of age. (2.3)

Adults: Administer Prevnar 20 as a single dose in adults 18 years of age and older. (2.6)

DOSAGE FORMS AND STRENGTHS

0.5 mL suspension for intramuscular injection, supplied in a single-dose pre-filled syringe. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20 or to diphtheria toxoid. (4)

WARNINGS AND PRECAUTIONS

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer Prevnar 20 to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination. (5.3)

ADVERSE REACTIONS

•
In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4‑dose schedule, the most commonly reported solicited adverse reactions >10% were irritability (>60%), pain at the injection site (>30%), drowsiness (>30%), decreased appetite and injection site redness (>20%), injection site swelling (>10%), and fever (>10%). (6.1)
•
In individuals 15 months through 17 years of age vaccinated with a single dose, the most commonly reported solicited adverse reactions >10% were irritability (>60% in individuals less than 2 years of age), pain at the injection site (>50%), drowsiness (>40% in individuals less than 2 years of age), fatigue and muscle pain (>20% in individuals 2 years of age and older), decreased appetite (>20% in individuals less than 2 years of age), injection site swelling and injection site redness (>10%) and headache (>10% in individuals 5 years of age and older), and fever (>10% in individuals less than 2 years of age). (6.1)
•
In individuals 18 through 59 years of age, the most commonly reported solicited adverse reactions >10% were pain at the injection site (>70%), muscle pain (>50%), fatigue (>40%), headache (>30%), and arthralgia and injection site swelling (>10%). (6.1)
•
In individuals 60 years of age and older, the most commonly reported solicited adverse reactions >10% were pain at the injection site (>50%), muscle pain and fatigue (>30%), headache (>20%), and arthralgia (>10%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PREVNAR 20 safely and effectively. See full prescribing information for PREVNAR 20.

PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine), suspension for intramuscular injection
Initial U.S. Approval: 2021

RECENT MAJOR CHANGES

Indications and Usage

04/2023

Dosage and Administration (2.2, 2.3, 2.4, 2.5, 2.6)

04/2023

Warnings and Precautions, Apnea in Premature Infants (5.3)

04/2023

INDICATIONS AND USAGE

Prevnar 20 is a vaccine indicated for

•
active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older. (1)
•
active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age. (1)
•
active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older. (1)

The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1)

DOSAGE AND ADMINISTRATION

For intramuscular administration only.

Children: Administer Prevnar 20 as a 4-dose immunization series at 2, 4, 6, and 12 through 15 months of age. (2.3)

Adults: Administer Prevnar 20 as a single dose in adults 18 years of age and older. (2.6)

DOSAGE FORMS AND STRENGTHS

0.5 mL suspension for intramuscular injection, supplied in a single-dose pre-filled syringe. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20 or to diphtheria toxoid. (4)

WARNINGS AND PRECAUTIONS

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer Prevnar 20 to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination. (5.3)

ADVERSE REACTIONS

•
In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4‑dose schedule, the most commonly reported solicited adverse reactions >10% were irritability (>60%), pain at the injection site (>30%), drowsiness (>30%), decreased appetite and injection site redness (>20%), injection site swelling (>10%), and fever (>10%). (6.1)
•
In individuals 15 months through 17 years of age vaccinated with a single dose, the most commonly reported solicited adverse reactions >10% were irritability (>60% in individuals less than 2 years of age), pain at the injection site (>50%), drowsiness (>40% in individuals less than 2 years of age), fatigue and muscle pain (>20% in individuals 2 years of age and older), decreased appetite (>20% in individuals less than 2 years of age), injection site swelling and injection site redness (>10%) and headache (>10% in individuals 5 years of age and older), and fever (>10% in individuals less than 2 years of age). (6.1)
•
In individuals 18 through 59 years of age, the most commonly reported solicited adverse reactions >10% were pain at the injection site (>70%), muscle pain (>50%), fatigue (>40%), headache (>30%), and arthralgia and injection site swelling (>10%). (6.1)
•
In individuals 60 years of age and older, the most commonly reported solicited adverse reactions >10% were pain at the injection site (>50%), muscle pain and fatigue (>30%), headache (>20%), and arthralgia (>10%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2023
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