PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

How Supplied/Storage and Handling for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)

How Supplied

PNEUMOVAX 23 is supplied as follows:

NDC 0006-4943-00 — a box of 10-single-dose vials, color coded with a purple cap and stripe on the vial labels and cartons.

NDC 0006-4837-03 — a box of 10-single-dose, pre-filled Luer-Lok™ syringes with tip caps, color coded with a violet plunger rod and purple stripe on the syringe labels and cartons.

NDC 0006-4837-02 — a box of 1 single-dose, pre-filled Luer-Lok™ syringe with tip cap, color coded with a violet plunger rod and purple stripe on the syringe label and carton.

Brands mentioned are the trademarks of their respective owners.

Storage and Handling

  • Store at 2°C–8°C (36°F–46°F).
  • All vaccine must be discarded after the expiration date.

The vial stoppers, syringe plunger stopper, and syringe tip cap are not made with natural rubber latex.

For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Help Line at 1 -800-MERCK-90 (1-800-637-2590), Monday through Friday, 8:00 AM – 7:00 PM ET.

General Tips

  • If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage and call the Merck Vaccine Customer Center at 1-877-VAX-MERCK (1-877-829-6372), or call the CDC at 1-800-CDC-INFO (1-800-232-4636).
  • Rotate stock so that the earliest-dated vaccine is used first.2
  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.2
  • Record refrigerator and freezer temperatures twice a day in a temperature log.2
  • It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.
  • Needles should be disposed of properly.2
  • All vaccines must be discarded after the expiration date; expired or damaged Vaccines for Children (VFC) vaccines must be returned to your State Immunization Program.2
  • For vaccines that are used as supplied, no reconstitution is necessary.
  • For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Help Line at 1 -800-MERCK-90 (1-800-637-2590), Monday through Friday, 8:00 AM to 7:00 PM ET.
Merck
ref2

Reference

  1. Centers for Disease Control and Prevention (CDC). Storage and handling. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:63–78.

Indication for PNEUMOVAX 23

PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.
Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

Do not administer PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.

Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.

The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Before administering PNEUMOVAX 23, please read the accompanying Prescribing Information. The Patient Information also is available.

PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.


US-PNX-00807 02/20