Pneumococcal Conjugate Vaccine

Pronunciation: (nu-ma-KA-kal)
Class: Vaccine, bacterial

Trade Names

Prevnar
- Injection, suspension 2 mcg each of 6 polysaccharide isolates, and 4 mcg of serotype 6B per 0.5 mL dose

Prevnar 13
- Injection, suspension 2.2 mcg each of 12 polysaccharide isolates, and 4.4 mcg of serotype 6B per 0.5 mL dose

Pharmacology

Induces antibodies against serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F for Prevnar or 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, and 23F for Prevnar 13 ) of Streptococcus pneumoniae , which are directly conjugated to the protein carrier CRM ₁₉₇ to form glycoconjugate.

Indications and Usage

Active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine; active immunization of infants and toddlers against invasive disease caused by S. pneumoniae because of capsular serotypes included in the vaccine.

Contraindications

Hypersensitivity to any component of the vaccine, including diphtheria toxoid.

Dosage and Administration

Vaccination Schedule
Prevnar / Prevnar 13 Children 15 mo of age and younger

IM 3 doses of 0.5 mL each at approximately 2-mo intervals, followed by a fourth dose of 0.5 mL at 12 to 15 mo of age. Usually the first dose is at 2 mo of age; however, it can be given as young as 6 wk of age. The recommended dosing interval is 4 to 8 wk. Administer the fourth dose at least 2 mo after the third dose.

Previously Unvaccinated Older Infants and Children Beyond Age of Routine Infant Schedule
Children at least 24 mo through 9 y of age ( Prevnar )

IM 1 dose of 0.5 mL.

Children at least 24 mo through 5 y of age ( Prevnar 13 )

IM 1 dose of 0.5 mL.

Children 12 to 23 mo of age

IM 2 doses of 0.5 mL at least 2 mo apart.

Children 7 to 11 mo of age

IM 3 doses of 0.5 mL; administer 2 doses at least 4 wk apart and the third dose after the 1-y birthday. Administer the third dose at least 2 mo after the second dose.

Prevnar 13 Schedule for Children Previously Vaccinated With Prevnar
Children who previously received 1 or more doses

IM May complete the 4-dose immunization series with Prevnar 13 .

Children 15 mo through 5 y of age who previously received 4 doses

IM May receive 1 dose of Prevnar 13 to elicit immune responses to the 6 additional serotypes.

General Advice

• Preferred sites of IM injection are the anterolateral aspect of the thigh in infants or deltoid muscle of the upper arm in toddlers and young children. Avoid injection into gluteal area or areas where there may be a major nerve trunk or blood vessel.
• For IM injection only. Not for IV, subcutaneous, or intradermal administration.
• Can be administered simultaneously with diphtheria, tetanus toxoids, and acellular pertussis (DTap)–hepatitis B oligosaccharide-CRM197 vaccine (HbOC) or inactivated polio vaccine (IPV); hepatitis B; measles, mumps, rubella (MMR); and varicella vaccine.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• Shake vial vigorously immediately prior to use to obtain a uniform suspension.
• Examine vial after shaking. Suspension should be homogeneous and white. Do not use if particulate matter or discoloration is noted or if vaccine cannot be resuspended.
• Always record manufacturer's name and vaccine lot number in patient's permanent medical record file along with date of administration and name and title of person administering vaccine.
• Take precautions to avoid injection into or near a blood vessel or nerve.

Storage/Stability

Store in refrigerator (36° to 46°F). Do not freeze.

Drug Interactions

Anticoagulants

Because bleeding may occur following IM injection, use with caution.

Haemophilus b conjugate vaccine

After 3 doses of Haemophilus b conjugate vaccine, antibody levels to Haemophilus influenza type b were higher when pneumococcal 7-valent conjugated vaccine was administered than when Haemophilus b conjugate vaccine was given alone. After 4 doses, antibody levels were lower when Haemophilus b conjugate vaccine was given with pneumococcal 7-valent conjugated vaccine. However, more than 97% of children receiving Haemophilus b conjugate vaccine with pneumococcal 7-valent conjugated vaccine achieved serum antibody levels of 1 mcg/mL or more.

Immunosuppressive agents (alkylating agents, antimetabolites, cytotoxic agents, large amounts of corticosteroids)

Children may not respond optimally to active immunization.

Pertussis

Some inconsistent differences in response to pertussis antigen were observed; however, the clinical relevance is unknown.

Adverse Reactions

CNS

Irritability (86%); increased sleep (72%); fussiness (54%); decreased sleep (48%); drowsiness (41%); decreased appetite (57%); restless sleep (25%).

Dermatologic

Erythema (48%); urticarial rash (1%); erythema multiforme (postmarketing).

GI

Vomiting (17%); diarrhea (13%).

Hematologic-Lymphatic

Lymphadenopathy localized to injection site (postmarketing).

Hypersensitivity

Anaphylactic/anaphylactoid reactions (including shock), hypersensitivity reaction (including bronchospasm, dyspnea, and face edema) (postmarketing).

Local

Tenderness (83%); redness (70%); induration (48%); swelling (45%); injection-site dermatitis, pruritus, urticaria (postmarketing).

Miscellaneous

Interference with limb movement (39%); fever (37%); angioneurotic edema, apnea, crying (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 6 wk of age or after the tenth birthday ( Prevnar ) or after the sixth birthday ( Prevnar 13 ).

Elderly

Not recommended for use in adult population.

Special Risk Patients

Pneumococcal 7-valent conjugate vaccine does not replace the 23-valent pneumococcal polysaccharide vaccination in children 24 mo of age and older with sickle cell disease, asplenia, HIV infection, or chronic illness, or those who are immunocompromised.

Bleeding disorders

Do not give to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate IM injection unless the benefits clearly outweigh the risk of administration.

Efficacy

Will not protect against S. pneumoniae disease other than that caused by the 7 serotypes included in the vaccine.

Febrile illness

Postpone administration in patients suffering from acute severe febrile illness. Minor illnesses, such as mild respiratory infection with or without low-grade fever, are generally not contraindications to vaccination.

Fever/Seizures

Fever and, rarely, febrile seizures have been reported in children. For children at higher risk of seizures than the general population, appropriate antipyretics may be given around the time of vaccination to reduce the possibility of postvaccination fever.

Immunocompromised patients

May have reduced response to immunization.

Premature infants

Apnea following IM vaccination has been observed in some infants born prematurely.

Overdosage

Symptoms

Most individuals experiencing overdosage were asymptomatic.

Patient Information

• Advise parent or guardian that vaccine provides protection against the 7 most common ( Prevnar ) or 13 most common ( Prevnar 13 ) serious pneumococcal infections in infants and toddlers but does not provide protection from other causes of bacterial infection.
• Review immunization schedule and advise parent or guardian that entire series must be completed to provide maximum benefit.
• Provide parent or guardian with vaccine information and immunization history record.
• Advise parent or guardian to use OTC analgesics (eg, acetaminophen, ibuprofen) for fever, pain, or discomfort at injection site.
• Advise parent or guardian to notify health care provider if bothersome adverse effects last more than 24 h.

Copyright © 2009 Wolters Kluwer Health.