WARNINGS
THIS VACCINE WILL NOT PROTECT AGAINST S. PNEUMONIAE DISEASE CAUSED BY SEROTYPES UNRELATED TO THOSE IN THE VACCINE, NOR WILL IT PROTECT AGAINST OTHER MICROORGANISMS THAT CAUSE INVASIVE INFECTIONS SUCH AS BACTEREMIA AND MENINGITIS OR NON-INVASIVE INFECTIONS SUCH AS OTITIS MEDIA.
This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration. If the decision is made to administer this vaccine to children with coagulation disorders, it should be given with caution. (See DRUG INTERACTIONS .)
Immunization with Prevnar® does not substitute for routine diphtheria immunization.
PRECAUTIONS
Prevnar® is for intramuscular use only. Prevnar® SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY. The safety and immunogenicity for other routes of administration (eg, subcutaneous) have not been evaluated.
Fever, and rarely febrile seizure, have been reported in children receiving Prevnar®. For children at higher risk of seizures than the general population, appropriate antipyretics (dosed according to respective prescribing information) may be administered around the time of vaccination, to reduce the possibility of post-vaccination fever.
Minor illnesses, such as a mild respiratory infection with or without low-grade fever, are not generally contraindications to vaccination. The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. The administration of Prevnar should be postponed in subjects suffering from acute severe febrile illness. 32,33
General
CARE IS TO BE TAKEN BY THE HEALTHCARE PROFESSIONAL FOR THE SAFE AND EFFECTIVE USE OF THIS PRODUCT.
- PRIOR TO ADMINISTRATION OF ANY DOSE OF THIS VACCINE, THE PARENT OR GUARDIAN SHOULD BE ASKED ABOUT THE PERSONAL HISTORY, FAMILY HISTORY, AND RECENT HEALTH STATUS OF THE VACCINE RECIPIENT. THE HEALTHCARE PROFESSIONAL SHOULD ASCERTAIN PREVIOUS IMMUNIZATION HISTORY, CURRENT HEALTH STATUS, AND OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE EVENT AFTER PREVIOUS IMMUNIZATIONS IN THE CHILD TO BE IMMUNIZED, IN ORDER TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH THIS VACCINE AND TO ALLOW AN ASSESSMENT OF RISKS AND BENEFITS.
- BEFORE THE ADMINISTRATION OF ANY BIOLOGICAL, THE HEALTHCARE PROFESSIONAL SHOULD TAKE ALL PRECAUTIONS KNOWN FOR THE PREVENTION OF ALLERGIC OR ANY OTHER ADVERSE REACTIONS. This should include a review of the patient's history regarding possible sensitivity; the ready availability of epinephrine 1:1000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.
- Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunization. 32,33,34 (See DRUG INTERACTIONS .)
- The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccine in children ≥ 24 months of age with sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised. Data on sequential vaccination with Prevnar® followed by 23-valent pneumococcal polysaccharide vaccine are limited. (See PRECAUTIONS, Special Populations )
- Since this product is a suspension containing an aluminum adjuvant, shake vigorously immediately prior to use to obtain a uniform suspension.
- A separate sterile syringe and needle or a sterile disposable unit should be used for each individual to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
- Special care should be taken to prevent injection into or near a blood vessel or nerve.
Information for Parents or Guardians
Prior to administration of this vaccine, the healthcare professional should inform the parent, guardian, or other responsible adult of the potential benefits and risks to the patient (see ADVERSE REACTIONS and WARNINGS sections), and the importance of completing the immunization series unless contraindicated. Parents or guardians should be instructed to report any suspected adverse reactions to their healthcare professional. The healthcare professional should provide vaccine information statements prior to each vaccination.
DRUG INTERACTIONS
Children receiving therapy with immunosuppressive agents (large amounts of corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may not respond optimally to active immunization. 33,34 (See PRECAUTIONS, General .)
As with other intramuscular injections, Prevnar® should be given with caution to children on anticoagulant therapy.
Simultaneous Administration with Other Vaccines
During clinical studies, Prevnar® was administered simultaneously with DTaP and HbOC, IPV, Hep B vaccines, MMR, and Varicella vaccine. Thus, the safety experience with Prevnar® reflects the use of this product as part of the routine immunization schedule. 20,21, 25,27, 28,30
The immune response to routine vaccines when administered with Prevnar® (at separate sites) was assessed in 3 clinical studies in which there was a control group for comparison. Higher antibody levels (GMC) to Hib were observed after 3 doses of HbOC given with Prevnar in the infant series, compared to HbOC without Prevnar. After the 4th dose, Hib GMCs were lower when HbOC was given with Prevnar compared to control; however, over 97% of children receiving HbOC with Prevnar achieved a serum antibody concentration of ≥1 μg/mL. Although some inconsistent differences in response to pertussis antigens were observed, the clinical relevance is unknown. The response to 2 doses of IPV given concomitantly with Prevnar®, assessed 3 months after the second dose, was equivalent to controls for poliovirus Types 2 and 3, but lower for Type 1. In another study, over 98% of subjects achieved neutralizing antibody titers ≥1:8 for all polio types, following a third dose of IPV given concomitantly with Prevnar at 12 months of age. 35 Seroresponse rates to measles, mumps and rubella were similar after MMR was given concomitantly with Prevnar at 12 months of age compared to seroresponse rates after MMR was given without Prevnar at 12 months of age. 36 A clinical study demonstrated no interference with the immune response to varicella vaccine when administered concurrently with a 4th dose of Prevnar®. 37
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Prevnar® has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility.
PREGNANCY
Pregnancy Category C
Animal reproductive studies have not been conducted with this product. It is not known whether Prevnar® can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. This vaccine is not recommended for use in pregnant women.
Nursing Mothers
It is not known whether vaccine antigens or antibodies are excreted in human milk. This vaccine is not recommended for use in a nursing mother.
PEDIATRIC USE
Prevnar® has been shown to be usually well-tolerated and immunogenic in infants. The safety and effectiveness of Prevnar® in children below the age of 6 weeks or on or after the 10th birthday have not been established. Immune responses elicited by Prevnar® among infants born prematurely have not been adequately studied. See DOSAGE AND ADMINISTRATION for the recommended pediatric dosage.
GERIATRIC USE
This vaccine is NOT recommended for use in adult populations. It is not to be used as a substitute for the pneumococcal polysaccharide vaccine in geriatric populations.
SPECIAL POPULATIONS
Persons with Sickle Cell Disease
The immunogenicity of Prevnar® has been investigated in an open-label, multicenter study in 49 infants with sickle cell disease. Children in France were vaccinated according to a primary immunization schedule with Prevnar® (2, 3 and 4 months old), and 46 of these children also received a 23-valent pneumococcal polysaccharide vaccine at the age of 15-18 months. After the third dose, the proportion of subjects in the per protocol population (N=26) with an antibody response at the 0.35 ug/mL threshold ranged from 92.3% (95% CI 74.9-99.1) for serotype 6B to 100% (95% CI 86.8-100.0) for serotypes 4, 9V and 14. At the 1.0 ug/mL threshold after the third dose, the response ranged from 92.3% (95% CI 74.9-99.1) for serotypes 6B and 18C to 100% (95% CI 86.8-100.0) for serotype 4. After polysaccharide vaccination, the IgG geometric mean antibody concentration (GMC) to the seven common serotypes ranged from 6.30 µg/mL [95% CI 4.94-8.03] for serotype 18C to 29.71 µg/mL [95% CI 22.67-38.92] for serotype 19F. According to the study protocol, no GMC data were obtained for the remaining 16 pneumococcal serotypes. 38
In an earlier, randomized study, 23 children ≥ 2 years of age with sickle cell disease were administered either 2 doses of Prevnar® followed by a dose of polysaccharide vaccine or a single dose of polysaccharide vaccine alone. In this small study, safety and immune responses with the combined schedule were similar to polysaccharide vaccine alone. However, this study was too small to achieve statistically significant results. 39
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