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).

Frequently Asked Questions about PNEUMOVAX 23

What is the indication for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)?

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).

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.

What are the contraindications, warnings and precautions, and most common adverse reactions for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)?

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.

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 for the first time in a clinical trial, 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.

What is the recommended dosing and administration for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)?

PNEUMOVAX 23 is for intramuscular or subcutaneous injection only. The vaccine is used directly as supplied. No dilution or reconstitution is necessary.

Administer PNEUMOVAX 23 intramuscularly or subcutaneously into the deltoid muscle or lateral mid-thigh. Do not inject intravascularly or intradermally.

  • Single-Dose Vial
    Administer a single 0.5 mL dose of PNEUMOVAX 23 using a sterile needle and syringe. Discard vial after use.
  • Single-Dose, Prefilled Syringe
    Administer the entire contents of the single-dose, prefilled syringe per standard protocol using a sterile needle. Discard syringe after use.

How is PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) prepared for administration?

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If either of these two conditions exists, the vaccine should not be administered.

Do not mix PNEUMOVAX 23 with other vaccines in the same syringe or vial.

Use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.

  • Single-Dose Vial
    Withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.
  • Single-Dose, Prefilled Syringe
    The package does not contain a needle. Attach a sterile needle to the prefilled syringe by twisting in a clockwise direction until the needle fits securely on the syringe.

Can PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) be administered concurrently with other vaccines?

Limited safety and immunogenicity data from clinical trials are available on the concurrent administration of PNEUMOVAX 23 and vaccines other than ZOSTAVAX®(Zoster Vaccine Live).

In a randomized clinical study, a reduced immune response to ZOSTAVAX as measured by gpELISA was observed in individuals who received concurrent administration of PNEUMOVAX 23 and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.

Can PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) be administered with vaccines for COVID-19?

There is no information in the Prescribing Information for PNEUMOVAX 23 on concomitant administration of COVID-19 vaccines. Please consult health authorities such as the CDC for more information.

How do I report a suspected adverse event?

To report a suspected adverse reaction, contact Merck at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

How do I report a suspected product quality complaint?

To report a suspected product quality complaint, contact Merck at 1-877-888-4231.

Is revaccination with PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) recommended?

The Advisory Committee on Immunization Practices (ACIP) has recommendations for revaccination against pneumococcal disease for persons at high risk who were previously vaccinated with PNEUMOVAX 23. Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine, is not recommended.

Does the packaging for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) include natural rubber latex?

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

What is the effectiveness of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) against invasive pneumococcal disease?

A retrospective cohort analysis study based on the U.S. Centers for Disease Control and Prevention (CDC) pneumococcal surveillance system, showed 57% (95%CI: 45% to 66%) overall protective effectiveness against invasive infections caused by serotypes included in PNEUMOVAX 23 in persons ≥6 years of age, 65 to 84% effectiveness among specific patient groups (eg, persons with diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia) and 75% (95%CI: 57% to 85%) effectiveness in immunocompetent persons aged ≥65 years of age. Vaccine effectiveness could not be confirmed for certain groups of immunocompromised patients.

What pneumococcal serotypes are contained in PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)?

PNEUMOVAX 23 is a sterile, liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

When was PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) first approved for use by the FDA?

PNEUMOVAX 23 was first approved by the FDA in 1983.

What are the CDC Recommendations for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)?

View CDC recommendations for adults age ≥65 years.

View CDC recommendations for adults under 65 years of age with certain chronic conditions.

What are the storage requirements for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)?

Store at 2-8°C (36-46°F).

All vaccine must be discarded after the expiration date.

What is the CPT Code for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)?

The CPT code for PNEUMOVAX 23 is 90732. This CPT code is effective as of January 2017 as set forth in the Current Procedural Terminology 2017.

The information provided here is compiled from sources believed to be accurate, but Merck makes no representation that it is accurate. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of a particular code and for information on additional codes. This information is subject to change. Merck cautions that payer coding requirements vary and can frequently change, so it’s important to regularly check with each payer as to payer-specific requirements.

You are solely responsible for determining the appropriate codes and for any action you take in billing. The information provided here is not intended to be definitive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Merck makes no warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for your particular use given the frequent changes in public and private payer billing. The use of this information does not guarantee payment or that any payment received will cover your costs. Diagnosis codes should be selected only by a health care professional.

Need CPT codes for other Merck vaccines? Call the Merck Vaccine Reimbursement Support Center™ at 1-800-734-6282.

CPT, Current Procedural Terminology.
Current Procedural Terminology© 2019 American Medical Association. All Rights Reserved.
CPT is a registered trademark of the American Medical Association.

reference12

Reference

  1. Butler JC, Breiman RF, Campbell JF, et al. Pneumococcal polysaccharide vaccine efficacy: An evaluation of current recommendations. JAMA. 1993;270(15):1826–1831.

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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 for the first time in a clinical trial, 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.

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