Vaccine Information: Prevnar 20 (Page 6 of 6)

14.4 Concomitant Vaccine Administration

Individuals 6 Weeks Through 15 Months of Age

In Study 8, the concomitant administration of Pediarix and Hiberix with each of the 3 infant doses of either Prevnar 20 or Prevnar 13 were evaluated 1 month after the third dose. Concomitant administration of single doses of M-M-R II and VARIVAX with the fourth dose of either Prevnar 20 or Prevnar 13 were evaluated 1 month following vaccination. There was no evidence that Prevnar 20, as compared to Prevnar 13, interfered with the antibody responses to these concomitantly administered vaccines.

Individuals 65 Years of Age and Older

Clinical Trial in Individuals to Assess Prevnar 20 Given With Influenza Vaccine, Adjuvanted (Fluad Quadrivalent)

Study 7 was a double-blind, randomized study conducted in individuals 65 years of age and older who had no history of prior pneumococcal vaccination or who had previously received PPSV23 and/or Prevnar 13 at least 6 months prior to enrollment. Study participants were randomized in a 1:1 ratio to receive Prevnar 20 concomitantly administered with Fluad Quadrivalent followed approximately one month later by placebo (Group 1, N=898) or Fluad Quadrivalent concomitantly administered with placebo followed approximately one month later by Prevnar 20 (Group 2, N=898). Pneumococcal serotype-specific OPA GMTs were evaluated 1 month after Prevnar 20 and influenza vaccine strain hemagglutinin inhibition assay (HAI) GMTs were evaluated 1 month after Fluad Quadrivalent. The noninferiority criteria for the comparisons of OPA GMTs (lower limit of the 2- sided 95% CI of the GMT ratio [Group 1/Group 2] >0.5, 2-fold noninferiority criterion) were met for all 20 pneumococcal serotypes in Prevnar 20. The noninferiority criteria for the comparisons of HAI GMTs (lower limit of the 2- sided 95% CI for the GMT ratio [Group 1/Group 2] >0.67, 1.5-fold noninferiority criterion) were also met for all 4 influenza vaccine strains.

16 HOW SUPPLIED/STORAGE AND HANDLING

Pre-filled Syringe, 1 Dose (10 per package) – NDC 0005-2000-10.

Pre-filled Syringe, 1 Dose (1 per package) – NDC 0005-2000-02.

After shipping, Prevnar 20 may arrive at temperatures between 2 ºC to 25 ºC (36 ºF to 77 ºF).

Upon receipt, store refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF).

Syringes should be stored in the refrigerator horizontally to minimize the resuspension time.

Do not freeze. Discard if the vaccine has been frozen.

Prevnar 20 should be administered as soon as possible after being removed from refrigeration.

Prevnar 20 can be administered provided total (cumulative multiple excursions) time out of refrigeration (at temperatures between 8 °C and 25 °C) does not exceed 96 hours. Cumulative multiple excursions between 0 °C and 2 °C are also permitted as long as the total time between 0 °C and 2 °C does not exceed 72 hours. These are not, however, recommendations for storage.

The tip cap and plunger stopper of the pre-filled syringe are not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine, inform the individual of the following:

•

The potential benefits and risks of immunization with Prevnar 20 [see Warnings and Precautions (5), Adverse Reactions (6)].

•

Any suspected adverse reactions should be reported to their healthcare professional.

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

US Govt. License No. 3

LAB-1436-3.0

CPT Code 90677

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

NDC 0005-2000-01
Rx only

Pneumococcal 20-valent
Conjugate Vaccine
Prevnar 20^®

One Dose (0.5 mL)
FOR IM USE ONLY
REFRIGERATE
DO NOT FREEZE
SHAKE WELL

Wyeth Pharm. LLCUS Govt. License No. 3

PAA201729

LOT: XXXXXX

EXP: XXXXXX

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton — 0005-2000-10

PfizerNDC 0005-2000-10

Pneumococcal 20-valent Conjugate Vaccine

PREVNAR 20^®

FOR INTRAMUSCULAR USE ONLY

10 One-Dose (0.5 mL) Disposable Syringes

Rx only

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton — 0005-2000-02

Pfizer
NDC 0005-2000-02

Pneumococcal 20-valent Conjugate Vaccine

PREVNAR 20^®

FOR INTRAMUSCULAR USE ONLY

One-Dose (0.5 mL) Disposable SyringeRx only

PREVNAR 20 pneumococcal 20-valent conjugate vaccine injection, suspension

Product Information Product Type VACCINE Item Code (Source) NDC:0005-2000 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 4.4 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug in 0.5 mL

Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 100 ug in 0.5 mL ALUMINUM PHOSPHATE 125 ug in 0.5 mL CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN 51 ug in 0.5 mL SUCCINATE DIANION 295 ug in 0.5 mL SODIUM CHLORIDE 4.4 mg in 0.5 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0005-2000-10 10 SYRINGE in 1 CARTON contains a SYRINGE (0005-2000-01) 1 NDC:0005-2000-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0005-2000-10) 2 NDC:0005-2000-02 1 SYRINGE in 1 CARTON contains a SYRINGE (0005-2000-01) 2 NDC:0005-2000-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0005-2000-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125731 08/10/2021

Labeler — Wyeth Pharmaceutical Division of Wyeth Holdings LLC (054065909)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Ireland Pharmaceuticals		985586408	ANALYSIS (0005-2000), MANUFACTURE (0005-2000), API MANUFACTURE (0005-2000)

Establishment
Name	Address	ID/FEI	Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC		174350868	ANALYSIS (0005-2000), API MANUFACTURE (0005-2000)

Establishment
Name	Address	ID/FEI	Operations
Wyeth Pharmaceutical Division of Wyeth Holdings LLC		883534067	ANALYSIS (0005-2000), API MANUFACTURE (0005-2000)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Manufacturing Belgium NV		370156507	PACK (0005-2000), LABEL (0005-2000), ANALYSIS (0005-2000)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Inc		004954111	MANUFACTURE (0005-2000)

Revised: 05/2023 Wyeth Pharmaceutical Division of Wyeth Holdings LLC