Vaccine Information: Prevnar 20

PREVNAR 20- streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 4 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 5 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6b capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 7f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 8 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 9v capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 10a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 11a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 12f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 14 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 15b capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 18c capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 19a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 19f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 22f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 23f capsular polysaccharide diphtheria crm197 protein conjugate antigen and streptococcus pneumoniae type 33f capsular polysaccharide diphtheria crm197 protein conjugate antigen injection, suspension
Wyeth Pharmaceutical Division of Wyeth Holdings LLC

1 INDICATIONS AND USAGE

Prevnar 20^® is a vaccine indicated for

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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.

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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.

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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 [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

2 DOSAGE AND ADMINISTRATION

For intramuscular administration only.

2.1 Preparation

Do not mix Prevnar 20 with other vaccines/products in the same syringe.

Step 1. Resuspend drug product Hold the pre-filled syringe horizontally between the thumb and the forefinger and shake vigorously until the vaccine is a homogeneous white suspension. Do not use the vaccine if it cannot be re-suspended.	(click image for full-size original)
Step 2. Visual inspection Visually inspect the vaccine for large particulate matter and discoloration prior to administration. Do not use if large particulate matter or discoloration is found. If the vaccine is not a homogeneous suspension, repeat Steps 1 and 2.	(click image for full-size original)
Step 3. Remove syringe cap Remove the syringe cap by slowly turning the cap counterclockwise while holding the Luer lock adapter.Avoid pressing the syringe plunger rod while removing the syringe cap.
Step 4. Attach a sterile needle Hold the Luer lock adapter and attach a needle appropriate for intramuscular administration to the pre-filled syringe by turning clockwise.

2.2 Administration

For intramuscular injection only.

Each 0.5-mL dose is to be injected intramuscularly using a sterile needle attached to the supplied pre-filled syringe.

​ 2.3 Vaccination Schedule for Individuals 6 Weeks Through 15 Months of Age

​ Administer Prevnar 20 as a 4-dose series at 2, 4, 6, and 12 through 15 months of age (and at least 2 months after the third dose). The first dose may be given as early as 6 weeks of age.

​ 2.4 Catch-Up Vaccination Schedule for Unvaccinated Individuals 7 Months Through 17 Years of Age

​ Individuals 7 months through 17 years of age who have never received a pneumococcal conjugate vaccine may receive Prevnar 20 according to the schedule in Table 1:

Table 1. Catch-Up Vaccination Schedule for Individuals Initiating Vaccination at 7 Months Through 17 Years of Age *

* ​ The vaccination schedule is based on the catch-up schedule for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). † ​ The first 2 doses at least 4 weeks apart; third dose after the one-year birthday, separated from the second dose by at least 2 months. ‡ ​ Two doses at least 2 months apart.
​ Age at First Dose	​ Total Number of 0.5-mL Doses
​ 7 through 11 months of age	​ 3†
​ 12 through 23 months of age	​ 2‡
​ 24 months of age and above	​ 1

​ 2.5 Catch-Up Vaccination Schedule for Individuals Previously Vaccinated With One or More Doses of a Lower Valency Pneumococcal Conjugate Vaccine

​ Administer a single dose of Prevnar 20 to individuals 15 months through 17 years of age previously vaccinated with one or more doses of a lower valency pneumococcal conjugate vaccine. The dose of Prevnar 20 should be administered at least 8 weeks after the last dose of the lower valency pneumococcal conjugate vaccine.

2.6 Vaccination Schedule ​for Individuals 18 Years of Age and Older

Prevnar 20 is administered as a single dose.

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

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 [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment and supervision used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Prevnar 20.

5.2 Altered Immunocompetence

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.

​ 5.3 Apnea in Premature Infants

​ 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.