General: If the vaccine is used in persons receiving immunosuppressive therapy, the expected serum antibody response may not be obtained and potential impairment of future immune responses to pneumococcal antigens may occur. (See Timing of Vaccination under INDICATIONS/USES.)
Intradermal administration may cause severe local reactions.
Caution and appropriate care should be exercised in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.
Any febrile respiratory illness or other active infection is reason for delaying use of PNEUMOVAX 23, except when, in the opinion of the physician, withholding the agent entails even greater risk.
In patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with PNEUMOVAX 23.
As with any vaccine, vaccination with PNEUMOVAX 23 may not result in complete protection in all recipients.
Use in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with PNEUMOVAX 23.
It is not known whether PNEUMOVAX 23 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PNEUMOVAX 23 should be given to pregnant women only if clearly needed.
Use in Lactation: It is not known whether this vaccine is excreted in human milk. Caution should be exercised when PNEUMOVAX 23 is administered to a nursing mother.
Use in Children: PNEUMOVAX 23 is not recommended for use in children less than 2 years of age. Safety and effectiveness in children below the age of 2 years have not been established. Children in this age group respond poorly to the capsular types contained in this vaccine.
Use in Elderly: Persons 65 years of age or older were enrolled in several clinical studies of PNEUMOVAX 23 that were conducted pre- and post-licensure. In the largest of these studies, the safety of PNEUMOVAX 23 in adults 65 years of age and older (n=629) was compared to the safety of PNEUMOVAX 23 in adults 50 to 64 years of age (n=379). The subjects in this study were ambulatory and had an expected prevalence of age associated chronic diseases. The clinical data did not suggest an increased rate or severity of adverse reactions among subjects ≥ 65 years of age compared to those 50 to 64 years of age. However, 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. Post-marketing reports have been received in which some frail elderly individuals with multiple co-morbid conditions had severe adverse experiences and a complicated clinical course following vaccination.