PREVNAR20® (Pneumococcal 20-valent Conjugate Vaccine)

INDICATIONS

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
Prevnar 20® is a vaccine indicated for 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
Prevnar 20® is a vaccine indicated for 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

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

Important Safety Information

Do not administer Prevnar 20® to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or to diphtheria toxoid
Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups, and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20®
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and risks
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, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever
In individuals 15 months through 17 years of age vaccinated with a single dose, the most commonly reported solicited adverse reactions (>10%) were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling, injection site redness, headache, and fever
In individuals 18 years of age and older, the most commonly reported solicited adverse reactions (>10%) were pain at the injection site, muscle pain, fatigue, headache, and arthralgia. Additionally, injection site swelling was also reported (>10%) in individuals 18 through 59 years of age

Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.

Please click for Prevnar 20® full Prescribing Information.

Indications

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
Prevnar 20® is a vaccine indicated for 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
Prevnar 20® is a vaccine indicated for 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