What is the dosage of Prevnar 20?

Prevnar 20 is available in 1 dosages, including 1-0.0044-0.0044-0.0044-0.0044-14-0.0044-0.0044-0.0044-0.0044-0.0044-0.0044-0.0044-3-0.0044-0.0044-4-0.0044-5-0.0044-0.0044-0.0088-0.0044-8-0.0044-0.0044 var units Prefilled Syringe 0.5 ml

How is Prevnar 20 administered?

Prevnar 20 is administered as a Injectable

Prevnar 20

(Streptococcus pneumoniae serotype 1 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 10A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 11A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 12F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 14 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 15B capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 18C capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 19F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 22F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 23F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 3 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 33F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 4 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 5 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 6A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 6B capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 7F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 8 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 9V capsular antigen diphtheria CRM197 protein conjugate vaccine)

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Dosage & 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.

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

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Prevnar 20 Prescribing Information

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.
•: 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.

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.

For intramuscular administration only.

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.
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.
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.

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.

Vaccination Schedule for Individuals 18 Years of Age and Older

Prevnar 20 is administered as a single dose.

Pregnancy

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of Prevnar 20 in pregnant women. Available data on Prevnar 20 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

A developmental toxicity study was performed in female rabbits administered Prevnar 20 prior to mating and during gestation. The dose was 0.5 mL at each occasion (a single human dose is 0.5 mL). This study revealed no evidence of harm to the fetus due to Prevnar 20 (see Data).

Data

Animal Data

In a developmental toxicity study, female rabbits were administered Prevnar 20 by intramuscular injection twice prior to mating (17 days and 4 days prior to mating) and twice during gestation (Gestation Days 10 and 24), 0.5 mL/rabbit/occasion (a single human dose). No adverse effects on pre-weaning development were observed. There were no vaccine-related fetal malformations or variations.

Lactation

Risk Summary

It is not known whether Prevnar 20 is excreted in human milk. 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. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

Pediatric Use

The safety of Prevnar 20 has been established in individuals 6 weeks through 17 years of age [see Adverse Reactions (6.1)].

The effectiveness of Prevnar 20 for the prevention of invasive disease 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 has been established in individuals 6 weeks through 17 years of age [see Clinical Studies (14.2)].

The effectiveness of Prevnar 20 for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F has been established in individuals 6 weeks through 5 years of age [see Clinical Studies (14.1)].

The effectiveness of Prevnar 20 in infants and children initiating vaccination at 7 months through 17 years of age and in children 15 months through 17 years of age previously vaccinated or incompletely vaccinated with a pneumococcal conjugate vaccine is supported by evidence from clinical studies in younger children who received a 4-dose series of Prevnar 20 and by evidence from clinical studies of catch-up vaccination with Prevnar 13 and Prevnar.

The effectiveness of Prevnar 20 for the prevention of pneumonia has not been established in individuals younger than 18 years of age.

The safety and effectiveness of Prevnar 20 in individuals younger than 6 weeks of age have not been established.

Geriatric Use

Of the total number of Prevnar 20 recipients 18 years of age and older evaluated for safety in the 3 main clinical trials (N=4263), 26.7% (n=1138) were 65 years of age and older and 1.7% (n=72) were 80 years of age and older [see Clinical Studies (14.2)].

Prevnar 20 recipients 70 through 79 years of age and ≥80 years of age had lower OPA GMTs for all pneumococcal serotypes compared to Prevnar 20 recipients 18 through 49 years, 50 through 59, and 60 through 64 years of age [see Clinical Studies (14.1)].

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.

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.