■ 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. ■ 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. ■ 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.

Protection against pneumococcal disease is conferred mainly by antibodies (immunoglobulin G [IgG] directed against capsular polysaccharides) and OPA(opsonophagocytic activity) killing of S. pneumoniae. Prevnar 20 induces IgG antibodies and OPA against the 20 vaccine serotypes.

Not applicable (N/A)

Do not administer Prevnar 20 to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20 or to diphtheria toxoid.

There are no adequate and well-controlled studies of Prevnar 20 in pregnant women.

Data are not available to assess the effects of Prevnar 20 on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Prevnar 20 and any potential adverse effects on the breastfed child from Prevnar 20 or from the underlying maternal condition.

Irritability,injection-site pain and redness, drowsiness, decreased appetite, swelling, fever, muscle pain and fatigue, headache, arthralgia ??SAEs occurred in ~4.5% of infants/children and ~1.5% of adults within 6 months after vaccination. Rare events include febrile seizures in pediatric subjects, apnea in premature infants (?28 weeks gestation), and possible anaphylaxis. Vaccination is contraindicated in individuals with a history of severe allergic reaction to vaccine components or diphtheria toxoid.

Prevnar 20 is a suspension for intramuscular injection available in a 0.5 mL single-dose pre-filled syringe.

No dosage adjustment is necessary.

No dosage adjustment is necessary.

No dosage adjustment is necessary.

?? Storage and Handling Summary (Prevnar 20)1. During shipping, the vaccine may reach 2–25 °C.2. After receipt, store refrigerated at 2–8 °C.3. Store syringes horizontally to reduce resuspension time.4. Do not freeze; discard if frozen.5. Administer as soon as possible after removal from refrigeration.?? Temperature Excursions (allowed but not recommended for storage):1. 8–25 °C: total cumulative time ? 96 hours.2. 0–2 °C: total cumulative time ? 72 hours.?? Additional information:The tip cap and plunger stopper of the pre-filled syringe do not contain natural rubber latex.