Pneumococcal Vaccine

Name: Pneumococcal Vaccine

Cautions for Pneumococcal Vaccine

Contraindications

  • PCV13 (Prevnar 13): Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the formulation or any vaccine containing diphtheria toxoid.181

  • PPSV23 (Pneumovax 23): Anaphylactic/anaphylactoid or severe allergic reaction to any ingredient in the formulation.129

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Allergic reactions, including anaphylactic/anaphylactoid reactions,129 181 rash,129 181 urticaria,129 181 bronchospasm,181 serum sickness,129 facial edema,181 erythema multiforme,129 181 and angioedema,129 181 reported with pneumococcal vaccines.

Take all known precautions to prevent adverse reactions, including review of the patient’s history with respect to health status and possible sensitivity to the vaccine or similar vaccines.184

Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs.181

General Precautions

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.129 134 181 Consider possibility that immune response to vaccines may be diminished or suboptimal in these individuals.129 134 181

If possible, administer pneumococcal vaccine at least 2 weeks prior to initiation of immunosuppressive therapy or defer until at least 3 months after immunosuppressive therapy is discontinued.134 (See Specific Drugs under Interactions.)

Since antibody response may be impaired after splenectomy, ACIP and AAP recommend that vaccination with PCV13 (Prevnar 13) and/or PPSV23 (Pneumovax 23) be completed at least 2 weeks prior to elective splenectomy, if possible.105 134 184

Concomitant Illness

A decision to administer or delay administration of vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness.129 134

ACIP, AAP, and others state that minor acute illness, such as mild diarrhea or mild upper respiratory infection (with or without fever), usually does not preclude vaccination.105 134 However, vaccination of individuals with moderate or severe acute illness (with or without fever) generally should be deferred until they have recovered from the acute phase of the illness.105 134

Manufacturer of PPSV23 (Pneumovax 23) states defer vaccination in individuals with moderate or severe illness.129

Manufacturer of PPSV23 (Pneumovax 23) states administer with caution in individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction could pose a substantial risk.129

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against pneumococcal disease.129 181

Will not prevent pneumococcal infection caused by S. pneumoniae serotypes not represented in the vaccines.129 181

Primary immunization with the usually recommended age-appropriate vaccination regimen before an expected exposure to pneumococcal infection ensures the highest level of protection.100 105 184

May not prevent infection in individuals who do not achieve protective antibody titers;129 181 minimum titer of serum anticapsular antibody needed to confer immunity against S. pneumoniae serotypes not established.129 181

Manufacturer of PCV13 (Prevnar 13) states effectiveness of the vaccine administered <5 years after PPSV23 (Pneumovax 23) not known.181

Vaccination with PCV13 (Prevnar 13) and/or PPSV23 (Pneumovax 23) does not replace prophylaxis with penicillin (or other appropriate anti-infectives) for prevention of pneumococcal disease in patients with functional or anatomic asplenia (e.g., sickle cell disease).105 129 If such prophylaxis indicated, continue regardless of vaccination status.105 129

Although ACIP and AAP recommend use of PPSV23 (Pneumovax 23) in individuals with CSF leaks,202 203 the manufacturer states the vaccine may not be effective in preventing pneumococcal meningitis in patients with chronic CSF leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.129

Antigens in PCV13 (Prevnar 13) are conjugated to a carrier protein;181 conjugated antigens are more immunogenic in infants and young children than the unconjugated antigens in PPSV23 (Pneumovax 23).100 134 184 (See Actions.)

Duration of Immunity

Duration of protection after age-appropriate vaccination with PCV13 (Prevnar 13) not known.181 Because the capsular antigens contained in PCV13 (Prevnar 13) are conjugated to a T-cell dependent carrier protein (diphtheria CRM197 protein), this may result in improved primary response to the antigens.134 166 Revaccination with PCV13 (Prevnar 13) after age-appropriate vaccination not currently recommended.166 199 200

Duration of protection after administration of PPSV23 (Pneumovax 23) not fully determined.155 169 Because capsular antigens in PPSV23 (Pneumovax 23) are unconjugated, the vaccine antigens do not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens.134 166 Although routine revaccination of immunocompetent individuals who previously received a dose of PPSV23 (Pneumovax 23) not recommended,129 166 169 revaccination indicated in individuals with certain medical conditions that put them at increased risk for pneumococcal disease, provided at least 5 years have elapsed since the last dose.100 129 155 156 166 169 184 199 200 202 203 205 Revaccination with PPSV23 (Pneumovax 23) also recommended in adults ≥65 years of age who received a dose of the vaccine at a younger age, provided at least 5 years have elapsed since the previous dose.169 200 204 (See Dosage under Dosage and Administration.)

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.134

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.134 (See Storage under Stability.)

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.134 If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.134

Specific Populations

Pregnancy

PCV13 (Prevnar 13): Category B.181 No evidence of fetal harm or impaired fertility in animal studies using the vaccine at doses 20 times the human dose;181 no adequate and well-controlled studies in pregnant women.181 Use during pregnancy only when clearly needed.181

PPSV23 (Pneumovax 23): Category C.129 No animal reproduction studies; not known whether the vaccine can cause fetal harm or affect reproductive capacity.129 Use during pregnancy only when clearly needed.129

ACIP, AAP, and others state PPSV23 (Pneumovax 23) may be used when indicated in pregnant women at increased risk for pneumococcal disease.105 200

AAP states that pneumococcal vaccination generally should be deferred during pregnancy, but risk of severe pneumococcal disease in a pregnant woman who has not received PPSV23 (Pneumovax 23) within the previous 5 years and has underlying medical conditions that increase risk of invasive pneumococcal disease should prompt immunization with PPSV23 (Pneumovax) 23.105

Lactation

Not known whether antigens contained in PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23) are distributed into milk.129 181

Use with caution in nursing women.129 181

Because inactivated vaccines do not multiply within the body, ACIP states they should not pose any unusual problems for lactating women or their infants.134

Pediatric Use

PCV13 (Prevnar 13): Safety and efficacy not established in infants <6 weeks of age.181 Manufacturer states immune response to the vaccine in preterm infants not adequately studied to date.181 Because apnea reported following IM vaccination in some infants born prematurely, base decisions regarding use of IM vaccines in such infants on consideration of the individual infant’s medical status and potential benefits and possible risks of vaccination.181

PPSV23 (Pneumovax 23): Safety and efficacy not established in children <2 years of age.129 Children <2 years of age may not have a satisfactory antibody response to PPSV23 (Pneumovax 23).129

Geriatric Use

PCV13 (Prevnar 13): Antibody responses in adults ≥65 years of age are lower compared with those in adults 50 through 59 years of age;181 no overall differences in safety between adults ≥65 years of age compared to adults 50 through 59 years of age.181

PPSV23 (Pneumovax 23): Rate of vaccine-related systemic adverse effects was higher following revaccination than primary vaccination in those ≥65 years of age.129 Possibility that some older adults may exhibit increased frequency and/or greater severity of adverse reactions cannot be ruled out.129

Common Adverse Effects

PCV13 (Prevnar 13): Local reactions at injection site (e.g., pain/tenderness, swelling, erythema, limitation of arm movement), fever, headache, fatigue, muscle or joint pain, chills, rash, decreased appetite, irritability, increased sleep, decreased sleep.181

PPSV23 (Pneumovax 23): Local reactions at injection site (e.g., pain/soreness/tenderness, swelling/induration, erythema), headache, asthenia/fatigue, myalgia.129

Interactions for Pneumococcal Vaccine

Other Vaccines

Although specific studies may not be available evaluating concurrent administration with each antigen, simultaneous administration with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during the same health-care visit generally is not expected to affect immunologic responses or adverse reactions to any of the preparations.105 134 Immunization with pneumococcal vaccines can be integrated with immunization against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), hepatitis A, hepatitis B, human papillomavirus (HPV), influenza, measles, mumps, rubella, meningococcal disease, poliomyelitis, rotavirus, and varicella.105 134 However, each parenteral vaccine should be administered using a different syringe and different injection site.105 134

Specific Drugs

Drug

Interaction

Comments

Acetaminophen

Infants receiving PCV13 (Prevnar 13): Prophylactic acetaminophen (first dose given at time of each vaccine dose and additional doses given at 6- to 8-hour intervals) reduced antibody response to some pneumococcal vaccine serotypes after third vaccine dose compared with antibody responses among infants who received antipyretics only as needed for treatment;181 reduced antibody responses not observed after fourth dose of PCV13 in those receiving prophylactic acetaminophen181

ACIP states evidence does not support use of antipyretics before or at time of vaccination, but antipyretics can be used for treatment of fever and local discomfort occurring following vaccination134

Diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTaP)

PCV13 (Prevnar 13): Has been administered concurrently with fixed-combination vaccine containing DTaP (DTaP-HepB-IPV; Pediarix) in infants at 2, 4, and 6 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with DTaP (using different syringes and different injection sites)105 134

Haemophilus b (Hib) vaccine

PCV13 (Prevnar 13): Has been administered concurrently with Hib vaccine in infants at 2, 4, and 6 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with Hib vaccine (using different syringes and different injection sites)105 134

Fixed-combination vaccine containing Hib vaccine and meningococcal polysaccharide groups C and Y vaccine (Hib-MenCY; MenHibrix): May be administered concurrently with PCV13 (Prevnar 13) in infants 2 through 18 months of age (using different syringes and different injection sites)177

Hepatitis A (HepA) vaccine

PCV13 (Prevnar 13): Has been administered concurrently with HepA vaccine in infants 12–15 months of age181

Concomitant administration of previously available 7-valent vaccine (PCV7; Prevnar) and HepA vaccine (Havrix) in infants 15 months of age did not result in decreased immune response to any pneumococcal serotypes contained in PCV7172

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with HepA vaccine (using different syringes and different injection sites)105 134

Hepatitis B (HepB) vaccine

PCV13 (Prevnar 13): Has been administered concurrently with fixed-combination vaccine containing HepB (DTaP-HepB-IPV; Pediarix) in infants at 2, 4, and 6 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with HepB vaccine (using different syringes and different injection sites)105 134

Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific immune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])

No evidence that immune globulin preparations interfere with immune response to pneumococcal vaccine134

Pneumococcal vaccine may be administered simultaneously with or at any interval before or after immune globulin or specific hyperimmune globulin134

Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)

Potential for suboptimal antibody response to vaccines105 129 134 181

Pneumococcal vaccine may be administered at least 2 weeks before initiation of immunosuppressive therapy or deferred until ≥3 months after therapy discontinued129 134

If administered during chemotherapy, revaccinate after immune competence is regained134

Influenza vaccine

Parenteral inactivated influenza vaccine: Concomitant administration with PCV13 (Prevnar 13) in adults ≥50 years of age did not increase frequency of local adverse effects, but increases in some solicited systemic reactions were reported compared with administration of either vaccine alone;181 concomitant administration with PPSV23 (Pneumovax 23) has resulted in increased incidence of adverse local and systemic effects compared with administration of influenza vaccine alone;145 146 ACIP states concomitant administration of these vaccines results in satisfactory antibody responses without increasing incidence or severity of adverse reactions134

Intranasal live influenza vaccine: Concomitant administration with pneumococcal vaccines not studied179

Parenteral inactivated influenza vaccine: May be administered concomitantly (using different syringes and different injection sites) with PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23)105 134

Intranasal live influenza vaccine: May be administered simultaneously with or at any time before or after PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23) 134 178

Measles, mumps, and rubella vaccine (MMR)

PCV13 (Prevnar 13): Has been administered concurrently with MMR or fixed-combination vaccine containing MMR and varicella vaccine (MMRV; ProQuad) in infants 12–15 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with MMR or MMRV (using different syringes and different injection sites)105 134

Meningococcal vaccine

PCV13 (Prevnar 13): Manufacturer states data insufficient to assess concurrent administration with meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV4-D, MenACWY-D; Menactra) or meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (MCV4-CRM, MenACWY-CRM; Menveo) in children and adolescents181

MCV4-D (Menactra): Concurrent administration with PCV7 (Prevnar) in infants 12 months of age resulted in decreased immune response to some of the pneumococcal vaccine serotypes compared with administration of PCV7 without MCV4-D108 177

MCV4-CRM (Menveo): Concurrent administration with PCV7 (Prevnar) in infants at 2, 4, 6, and 12 months of age resulted in possible interference with antibody response to 2 of the pneumococcal vaccine serotypes at 1 month after third dose, but no evidence of immune interference to any pneumococcal vaccine serotypes after fourth dose176

PCV13 (Prevnar 13): Do not administer MCV4-D (Menactra) concurrently or within 4 weeks after PCV13;105 177 to avoid possible interference with immune response in infants and children with anatomic or functional asplenia, complete PCV13 (Prevnar 13) vaccination series first and then administer MCV4-D (Menactra) at least 4 weeks later177

PPSV23 (Pneumovax 23): May be administered concurrently with MCV4-D (Menactra) or meningococcal polysaccharide vaccine (MPSV4; Menomune) using different syringes and different injection sites105

Fixed-combination vaccine containing Hib vaccine and meningococcal polysaccharide groups C and Y vaccine (Hib-MenCY; MenHibrix): May be administered concurrently with PCV13 (Prevnar 13) in infants 2 through 18 months of age (using different syringes and different injection sites)177

Poliovirus vaccine inactivated (IPV)

PCV13 (Prevnar 13): Has been administered concurrently with fixed-combination vaccine containing IPV (DTaP-HepB-IPV; Pediarix) in infants at 2, 4, and 6 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with IPV (using different syringes and different injection sites)105 134

Rotavirus vaccine

Concomitant administration of rotavirus vaccine live (Rotarix, RotaTeq) with previously available 7-valent vaccine (PCV7; Prevnar) did not result in reduced immune responses to either vaccine170 174 175

PCV13 (Prevnar 13): May be administered concurrently with rotavirus vaccine105 134

Varicella vaccine

PCV13 (Prevnar 13): Has been administered concurrently with varicella vaccine (Varivax) or fixed-combination vaccine containing MMR and varicella vaccine (MMRV; ProQuad) in infants 12–15 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with varicella vaccine or MMRV (using different syringes and different injection sites)105 134

Zoster vaccine

PPSV23 (Pneumovax 23): Concurrent administration with zoster vaccine in adults ≥60 years of age resulted in substantially reduced antibody responses to zoster vaccine compared with that reported when the vaccines were administered 4 weeks apart129 180 186

Manufacturer of zoster vaccine and PPSV23 (Pneumovax 23) states consider giving the 2 vaccines at least 4 weeks apart129 186

Stability

Storage

Parenteral

Injection, for IM Use (PCV13; Prevnar 13)

2–8°C;181 after shipping, may arrive at temperatures ranging from 2–25°C.181

Do not freeze.134 181 Since it contains an aluminum adjuvant,134 181 exposure to freezing temperatures causes irreversible loss of vaccine potency.134

Does not contain thimerosal or any other preservatives.100 184

Injection, for Sub-Q or IM Use (PPSV23; Pneumovax 23)

2–8°C.129

Does not contain thimerosal, but does contain phenol 0.25% as a preservative.105 129

Actions

  • PCV13 (Prevnar 13): Sterile suspension containing purified capsular polysaccharide antigens extracted from 13 serotypes of S. pneumoniae (i.e., 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and individually conjugated to diphtheria CRM197 protein.181 184

  • PPSV23 (Pneumovax 23): Sterile solution containing purified capsular polysaccharide antigens extracted from 23 serotypes of S. pneumoniae (i.e., 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F).129

  • Principal mode of transmission of pneumococcal infection is the respiratory route, most commonly through close personal contact with an individual with invasive pneumococcal disease or direct exposure to nasopharyngeal secretions from an infected individual or by autoinoculation in persons carrying the bacteria in their upper respiratory tract.105 166 S. pneumoniae is a common cause of AOM, sinusitis, and pneumonia and can cause invasive disease, including bacteremia and meningitis.105 Infection with S. pneumoniae has been a leading cause of bacterial meningitis in the US among children <5 years of age.166

  • Surveillance data from 2008 indicated that the 13 serotypes contained in PCV13 (Prevnar 13) accounted for approximately 61% of US cases of invasive pneumococcal disease occurring in children <5 years of age; serotype 19A accounted for 43% of cases.184 Surveillance data from 2007–2009 indicated that 49% of cases of invasive pneumococcal disease in immunocompromised children and adolescents 6 through 18 years of age were caused by serotypes contained in PCV13 (Prevnar 13); an additional 23% of cases were caused by serotypes contained in PPSV23 (Pneumovax 23).203 For adults, surveillance data from 2008 indicated that the 13 serotypes contained in PCV13 (Prevnar 13) accounted for 44–53% of invasive pneumococcal disease and the 23 serotypes contained in PPSV23 (Pneumovax 23) accounted for 66–78% of cases.169 Data from 2010 indicated that 50% of cases of invasive pneumococcal disease in immunocompromised adults were caused by serotypes contained in PCV13 (Prevnar 13); an additional 21% of cases were caused by serotypes contained in PPSV23 (Pneumovax 23).202

  • Pneumococcal vaccines stimulate active immunity to pneumococcal infection by inducing production of antibodies specific for each pneumococcal capsular type represented in the vaccines.129 181 Minimum titers of anticapsular antibodies needed to confer protection against S. pneumoniae serotypes contained in the vaccines not established.129 181

  • Conjugated antigens contained in PCV13 (Prevnar 13) are more immunogenic in infants and young children than the unconjugated antigens contained in PPSV23 (Pneumovax 23).100 184 Conjugated antigens elicit a T-cell dependent immune response;181 antibodies produced in response to pneumococcal conjugate vaccines enhance opsonization, phagocytosis, and killing of S. pneumoniae by leukocytes and other phagocytic cells.181 Unconjugated antigens contained in PPSV23 (Pneumovax 23) do not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens.134 166

  • Following primary vaccination with PCV13 (Prevnar 13) in healthy infants (doses given at 2, 4, 6, and 12–15 months of age), 87–98% had anticapsular IgG antibody concentrations ≥0.35 mcg/mL against 12 of the 13 pneumococcal serotypes in the vaccine 1 month after the third dose;181 184 64% achieved an antibody concentration ≥0.35 mcg/mL against serotype 3.181 184 Antibody concentrations 1 month after the fourth dose were higher for all 13 serotypes compared with concentrations 1 month after the third dose.181 184

  • Following a single dose of PPSV23 (Pneumovax 23) in healthy adults, >80% develop antibodies specific for the pneumococcal capsular types in the vaccine, usually within 2–3 weeks.166 There is some evidence that the overall protective effectiveness of PPSV23 (Pneumovax 23) against invasive pneumococcal infection caused by serotypes included in the vaccine is 57% in individuals ≥6 years of age, 65–84% among specific patient groups (e.g., those with diabetes mellitus, coronary vascular disease, congestive heart failure, COPD, anatomic asplenia), and 75% in immunocompetent adults ≥65 years of age.129 Antibody response to the unconjugated antigens in PPSV23 (Pneumovax 23) generally is poor or inconsistent in infants <2 years of age.129 166

(web3)