Prevnar 13 (pneumococcal 13-valent conjugate vaccine (Diphtheria crm)/PF)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Pneumococcal vaccine is an inactivated (polysaccharide) vaccine that is commercially available in the US as 2 different vaccine types: pneumococcal conjugate vaccine (pneumococcal 15-valent conjugate vaccine, pneumococcal 20-valent conjugate vaccine, and pneumococcal 21-valent vaccine) and pneumococcal vaccine polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax(R) 23). All of the vaccines contain capsular antigens extracted from Streptococcus pneumoniae and are used to stimulate active immunity to pneumococcal infection.
Pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13(R)), pneumococcal 15-valent conjugate vaccine (PCV15; Vaxneuvance(R)), pneumococcal 20-valent conjugate vaccine (PCV20; Prevnar 20(R)), pneumococcal 21-valent conjugate vaccine (PCV21; Capvaxive(R)) and pneumococcal vaccine, polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax(R) 23) are used to stimulate active immunity to infection caused by the serotypes of Streptococcus pneumoniae (S. pneumoniae) contained in the vaccines.
The capsular saccharides present in PCV13 (Prevnar 13 (R)), PCV15 (Vaxneuvance(R)), PCV20 (Prevnar 20(R)), and PCV21 (Capvaxive(R)) promote production of antibody specific for each pneumococcal capsular type in the vaccine. PCV13 (Prevnar 13(R)) elicits a T-cell dependent immune response. Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response.
Antibodies produced in response to pneumococcal conjugate vaccines enhance opsonization, phagocytosis, and killing of S. pneumoniae by leukocytes and other phagocytic cells.
Nonclinical and clinical data support opsonophagocytic activity (OPA), as measured by OPA antibody assay, as a contributor to protection against pneumococcal disease. The OPA antibody assay provides an in vitro measurement of the ability of serum antibodies to eliminate pneumococci by promoting complement-mediated phagocytosis and is believed to reflect relevant in vivo mechanisms of protection against pneumococcal disease. In infants who receive PCV13 (Prevnar 13(R)), OPA correlates well with serotype specific anticapsular polysaccharide immunoglobulin G (IgG ) levels as measured by enzyme-linked immunosorbent assay (ELISA).
A serum anticapsular polysaccharide antibody concentration of at least 0.35 mcg/mL as measured by ELISA 1 month after the third dose of a single antibody reference concentration has been used to estimate the effectiveness of PCV13 (Prevnar 13(R)) against invasive pneumococcal disease in infants and children. An antipolysaccharide binding antibody IgG level to predict protection against invasive pneumococcal disease or nonbacteremic pneumonia has not been defined in adults.
The extent and duration of immunologic response may vary depending on age and immunocompetence of the vaccinee. Antigens in PCV13 (Prevnar 13(R)), PCV15 (Vaxneuvance(R)), and PCV20 (Prevnar(R)) are conjugated to a carrier protein and are more immunogenic in infants and young children than the unconjugated antigens in PPSV23 (Pneumovax(R) 23).
The capsular polysaccharides present in PPSV23 (Pneumovax(R) 23) promote production of antibody specific for each pneumococcal capsular type in the vaccine. These antibodies enhance opsonization, phagocytosis, and killing of S. pneumoniae by leukocytes and other phagocytic cells. Although the immune response to PPSV23 (Pneumovax(R) 23) generally has been evaluated using quantitative measurements of antibodies, antibody levels that correlate with protections against pneumococcal disease have not been clearly defined.
Following administration of a single dose of PPSV23 (Pneumovax(R) 23) in healthy adults, more than 80% develop antibodies specific for the pneumococcal capsular types present in the vaccine, usually within 2-3 weeks. The antibody response to the pneumococcal capsular polysaccharides contained in PPSV23 (Pneumovax(R) 23) generally is poor or inconsistent in infants younger than 2 years of age.
A retrospective cohort analysis study based on US Centers for Disease Control and Prevention (CDC) pneumococcal surveillance data indicated that the overall protective effectiveness of PPSV23 (Pneumovax(R) 23) against invasive pneumococcal infection caused by serotypes included in the vaccine was 57% in individuals 6 years of age or older, 65-84% among specific patient groups (e.g., those with diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia), and 75% in immunocompetent adults 65 years of age or older.
Individuals with immunodeficiency diseases (e.g., hypogammaglobulinemia, leukemia, lymphoma, multiple myeloma), individuals receiving immunosuppressive therapy, and individuals with Hodgkin's disease who have received extensive chemotherapy, radiation therapy, and splenectomy may have diminished or suboptimal antibody responses to PPSV23 (Pneumovax(R) 23).
Following administration of PPSV23 (Pneumovax(R) 23) in healthy adults, antibodies formed in response to the vaccine remain elevated for at least 5 years, but antibody levels decline after 5-10 years. Antibody levels decline more rapidly in individuals with certain underlying illnesses, including those who have undergone splenectomy following trauma and those with sickle cell disease or nephrotic syndrome.
Antigens contained in PPSV23 (Pneumovax(R) 23) cannot induce long-lasting immunity, since they do not induce T-cell-dependent responses associated with immunologic memory.
Pneumococcal vaccine is commercially available in the US as 2 different vaccine types: pneumococcal conjugate vaccines: pneumococcal conjugate vaccine (pneumococcal 13-valent conjugate vaccine, pneumococcal 15-valent conjugate vaccine, pneumococcal 20-valent conjugate vaccine and pneumococcal 21-valent conjugate vaccine), and pneumococcal vaccine polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax(R) 23). Although both vaccine types contain capsular antigens extracted from S. pneumoniae, the vaccines contain different numbers and forms of these antigens.
PCV13 (Prevnar 13(R)) is a sterile suspension containing purified capsular saccharide antigens extracted from 13 serotypes of S. pneumoniae and individually conjugated to diphtheria CRM197. PCV13 (Prevnar 13(R)) contains the following 13 capsular saccharide serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Each serotype of S. pneumoniae is cultured in soy peptone broth and the individual polysaccharides are purified using centrifugation, precipitation, ultrafiltration, and column chromatography.
The polysaccharides are chemically inactivated to make saccharides and these are directly conjugated by reductive amination to the protein carrier (diphtheria CRM197) to form the glycoconjugate. Potency of the vaccine is determined by quantification of each of the saccharide antigens and by the saccharide to protein ratios in the individual glycoconjugates. After shaking, PCV13 (Prevnar 13(R)) occurs as a homogeneous white suspension.
PCV15 (Vaxneuvance(R)) is a sterile suspension of purified capsular polysaccharides extracted from 15 serotypes of S. pneumoniae and individually conjugated to diphtheria CRM197. PCV15 (Vaxneuvance(R)) contains the following 15 capsular saccharide serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F. Each S. pneumoniae serotype is grown in media containing yeast extract, dextrose, salts and soy peptone and purified by a series of chemical and physical methods.
Then each polysaccharide is chemically activated and conjugated to the carrier protein CRM197 to form each glycoconjugate. The final vaccine is prepared by blending the fifteen glycoconjugates with aluminum phosphate adjuvant in a final buffer containing histidine, polysorbate 20, and sodium chloride. After shaking, PCV15 (Vaxneuvance(R)) occurs as an opalescent suspension.
PCV20 (Prevnar 20(R)) is a sterile suspension of purified capsular polysaccharides extracted from 20 serotypes of S. pneumoniae and individually conjugated to diphtheria CRM197. PCV20 (Prevnar 20(R)) contains the following 20 capsular saccharide serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Each serotype of S. pneumoniae is grown in soy peptone broth and the individual polysaccharides are purified by a series of chemical and physical methods.
The polysaccharides are chemically activated and then directly conjugated to the carrier protein CRM197, to form the glycoconjugate. Potency of the formulated vaccine is determined by quantification of each of the saccharide antigens and by the saccharide to protein ratios in the individual glycoconjugates. After shaking, PCV20 (Prevnar 20(R)) occurs as a homogeneous white suspension.
Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 mcg of each of S. pneumoniae serotypes.
PCV21 (Capvaxive(R)) is a sterile solution of purified capsular polysaccharides extracted from 21 serotypes of S. pneumoniae and individually conjugated to diphtheria CRM197to form the conjugate. PCV21 (Capvaxive(R)) contains the following 21 capsular saccharide serotypes: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B (de-O-acetylated prior to conjugation), 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B. Each serotype of S. pneumoniae is grown separately in media containing yeast extract, dextrose, salts, and soy peptone and the bacteria are inactivated after growth by addition of phenol to the culture media.
The polysaccharides are chemically activated and then directly conjugated to the carrier protein CRM197, to form the glycoconjugate. Subsequently, each polysaccharide is purified to produce a powder using a series of chemical and physical methods. Serotype 15B polysaccharide is de-O-acetylated (deOAc 15B).
Each 0.5 mL dose of the vaccine is formulated to contain 4 mcg of each S. pneumoniae for a total of 84 mcg of pneumococcal polysaccharide antigen.
PPSV23 (Pneumovax(R) 23) is a sterile solution containing purified capsular polysaccharide antigens extracted from 23 different serotypes of S. pneumoniae. PPSV23 (Pneumovax(R) 23) contains the following 23 capsular polysaccharide serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F. PPSV23 (Pneumovax(R) 23) occurs as a clear, colorless solution.
Each 0.5-mL dose of PPSV23 (Pneumovax(R) 23) contains 25 mcg of each type of capsular polysaccharide antigen in 0.9% sodium chloride injection. The vaccine does not contain thimerosal, but does contain phenol as a preservative.
USES: This vaccine is used to help prevent pneumococcal disease, an infection caused by a certain bacteria (Streptococcus pneumoniae). This bacteria can cause ear infections or other more serious infections (such as pneumonia, meningitis, blood infection). Vaccination is the best way to protect against this disease.
This vaccine works by increasing the body's natural defense (immunity) against the bacteria. Vaccines may not fully protect everyone who receives them.
Generic name: pneumococcal 13-valent conjugate vaccine (Diphtheria crm)/PF
Pronunciation: (NEU-mo-KOK-al KON-jih-gut)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Prevnar 13
Indications
The following indications are listed for Prevnar 13:
- Streptococcus Pneumoniae Vaccination
- Vaccination To Prevent Otitis Media Due To Streptococcus Pneumoniae
Also known as: Active Immunization Against Streptococcus Pneumoniae, Active Immunization To Prevent S. Pneumoniae Otitis Media, Active Immunization To Prevent Streptococcus Pneumoniae Infection, Prevention Of Otitis Media Due To S. Pneumococcus, Streptococcus Pneumoniae Otitis Media Prophylaxis, Vaccination To Prevent Streptococcus Pneumoniae, Vaccination To Prevent Streptococcus Pneumoniae Infection.
Dosing
The dosage schedule (i.e., number of doses) and specific pneumococcal vaccine administered vary depending on age, immunization status, and presence of medical conditions that increase the risk of pneumococcal disease. The age-appropriate recommendations for the specific preparation used should be followed.
Medically stable preterm infants (i.e., gestational age less than 37 weeks), regardless of birthweight, should be vaccinated at the usual chronologic age using the usual dosage and dosage schedules.
Interruptions resulting in an interval between doses longer than recommended should not interfere with the final immunity achieved; there is no need to administer additional doses or start the vaccination series over.
Each IM dose of PCV13 (Prevnar 13(R)) in infants and children 6 weeks of age or older, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.
Each IM dose of PCV15 (Vaxneuvance(R)) in infants and children 6 weeks of age or older, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.
Each IM dose of PCV20 (Prevnar 20(R)) in infants and children >=6 weeks of age, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.
Each IM dose of PCV21 (Capvaxive(R)) in adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.
Each IM or subcutaneous dose of PPSV23 (Pneumovax(R) 23) in children 2 years of age or older, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe or 0.5 mL from a single-dose vial.
Pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13(R)), pneumococcal 15-valent conjugate vaccine (PCV15; Vaxneuvance(R)), pneumococcal 20-valent conjugate vaccine (PCV20; Prevnar 20(R)), and pneumococcal 21-valent conjugate vaccine (PCV-21; Capvaxive(R)) are administered only by intramuscular (IM) injection.
Pneumococcal vaccine, polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax(R) 23) is administered only by IM or subcutaneous injection.
PCV13 (Prevnar 13(R)), PCV15 (Vaxneuvance(R)), PCV20 (Prevnar 20(R)), PCV-21 (Capvaxive(R)), and PPSV23 (Pneumovax(R) 23) should not be diluted or mixed with any other vaccine or solution.
PCV13 (Prevnar 13(R)) or PCV15 (Vaxneuvance(R)) should not be administered concomitantly with PPSV23 (Pneumovax(R) 23). When these vaccines are indicated, PPSV23 (Pneumovax(R) 23) should be administered sequentially after the recommended age-appropriate regimen of PCV13 (Prevnar 13(R)) or PCV15 (Vaxneuvance(R)), if possible. However, PCV13 (Prevnar 13(R)), PCV15 (Vaxneuvance(R)), PCV20 (Prevnar 20(R)), PCV21 (Capvaxive(R)), or PPSV23 (Pneumovax(R) 23) may be given simultaneously with other age-appropriate vaccines during the same healthcare visit. When multiple vaccines are administered during a single healthcare visit, each parenteral vaccine should be given with a different syringe and at different injection sites, and injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.
PCV13 (Prevnar 13(R)) should be stored at 2-8degreesC; after shipping, the vaccine may arrive at temperatures ranging from 2-25degreesC. PCV13 (Prevnar 13(R)) should not be frozen. Since the vaccine contains an aluminum adjuvant, exposure to freezing temperatures causes irreversible loss of vaccine potency.
PCV15 (Vaxneuvance(R)) should be stored at 2-8degreesC and should not be frozen.
PCV20 (Prevnar 20(R)) should be stored at 2-8degreesC; after shipping, the vaccine may arrive at temperatures ranging from 2-25degreesC. PCV20 (Prevnar 20(R)) should not be frozen. Store syringes horizontally in the refrigerator to minimize the resuspension time.
PCV21 (Capvaxive(R)) should be stored at 2-8degreesC and should not be frozen. Protect from light.
PPSV23 (Pneumovax(R) 23) should be stored at 2-8degreesC.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*PCV13 (Prevnar 13(R)), PCV15 (Vaxneuvance(R)), PCV20 (Prevnar 20(R)), and PCV21 (Capvaxive(R)) are contraindicated in individuals who have had a severe allergic reaction (e.g., anaphylaxis) to any ingredient in the formulation or to any vaccine containing diphtheria toxoid.
*PPSV23 (Pneumovax(R) 23) is contraindicated in individuals with a history of anaphylactic/anaphylactoid reactions or severe allergic reaction to any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Local Effects with Pneumococcal 13-valent Conjugate Vaccine (PCV13; Prevnar 13(R)): The most common adverse effects reported with PCV13 (Prevnar 13(R)) are local reactions at the injection site, including pain/tenderness, redness, and swelling. In infants who received a 4-dose immunization series of PCV13 (Prevnar 13(R)) at 2, 4, 6, and 12-15 months of age in 3 US safety studies, tenderness at the injection site was reported in 59-65% of infants after each of the first 3 vaccine doses and in 58% after the fourth dose; tenderness interfered with limb movement in 8-10% and 7% of these infants, respectively. Redness was reported in 24-37% of infants after the first 3 vaccine doses and in 42% after the fourth dose. Swelling at the injection site was reported in 20-27% of infants after the first 3 vaccine doses and in 32% after the fourth dose. When a dose of PCV13 (Prevnar 13(R)) was administered to adults 50-64 years of age who were previously unvaccinated (had not received PPSV23 (Pneumovax(R) 23)), local reactions at the injection site, including pain (69-89%), redness (12-20%), and swelling (10-22%), were commonly reported and limitation of arm movement was reported in 24-41%. When a dose of PCV13 (Prevnar 13(R)) was administered to previously vaccinated adults 68 years of age or older (had received PPSV23 (Pneumovax(R) 23) at least 3-5 years prior to study enrollment), pain, redness, swelling, and limitation of arm movement were reported in 51-52%, 11-14%, 10-13%, and 11-16%, respectively. Dermatitis, urticaria, and pruritus at the injection site were reported during postmarketing experience with PCV13 (Prevnar 13(R)).
Systemic Effects with Pneumococcal 13-valent Conjugate Vaccine (PCV13; Prevnar 13(R)): In infants who received a 4-dose immunization series of PCV13 (Prevnar 13(R)) at 2, 4, 6, and 12-15 months of age in 3 US safety studies, fever (38degreesC or greater) occurred in 24-37% of infants after each of the first 3 doses; fever was reported in 32% after the fourth dose. Irritability was reported in 80-86%, increased sleep in 58-72%, and decreased sleep in 43-47% of infants after each of the first 3 doses; after the fourth dose, these effects were reported in 80, 49, and 45%, respectively. Decreased appetite was reported in 48% of infants after each of the first 3 doses of PCV13 (Prevnar 13(R)) and in 51% after the fourth dose. Diarrhea, vomiting, and rash have been reported in greater than 1% of infants and children receiving PCV13 (Prevnar 13(R)) in clinical studies. Adverse reactions occurring in less than 1% of infants and children receiving the vaccine included crying, hypersensitivity reaction (e.g., facial edema, dyspnea, bronchospasm), seizures (e.g., febrile seizures), and urticaria or urticaria-like rash. When a dose of PCV13 (Prevnar 13(R)) was administered to adults 50-64 years of age who were previously unvaccinated (had not received PPSV23 (Pneumovax(R) 23)), fatigue occurred in 51-63%, headache in 50-66%, chills in 20-24%, muscle pain in 22-62%, joint pain in 14-32%, rash in 9-17%, decreased appetite in 15-25%, vomiting in 3-7%, and fever in 2-4%. When a dose of PCV13 (Prevnar 13(R)) was administered to previously vaccinated adults 68 years of age and older (had received PPSV23 (Pneumovax(R) 23) at least 3-5 years prior to study enrollment), fatigue occurred in 34%, headache in 24-26%, chills in 8%, muscle pain in 12-37%, joint pain in 10-13%, rash in 7-8%, decreased appetite in 10-11%, vomiting in 1-2%, and fever in 1%. Lymphadenopathy in the region of the injection site, cyanosis, pallor, hypotonia, anaphylactic/anaphylactoid reactions (including shock), angioedema, erythema multiforme, and apnea were reported during postmarketing experience with PCV13 (Prevnar 13(R)).
Local Effects with PCV15 (Vaxneuvance(R)): The most commonly reported local adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were injection-site pain (25.9-40.3%), injection-site induration (13.2-15.4%), injection-site erythema (13.7-21.4%), and injection-site swelling (11.3-13.4%). Reported local adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were injection-site pain (54.8%), injection-site swelling (20.9%), injection-site erythema (19.2%), and injection-site induration (6.8%). The most commonly reported adverse reactions in adults 18-49 years of age were injection-site pain (75.8%), injection-site swelling (21.7%), and injection-site erythema (15.1%). The most commonly reported adverse reactions in adults >=50 years of age were injection-site pain (66.8%), injection-site swelling (15.4%), and injection-site erythema (10.9%).
Systemic Effects with PCV15 (Vaxneuvance(R)): The most commonly reported systemic adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were irritability (57.3-63.4%), somnolence (24.2-47.5%), fever >=38.0degreesC (13.3-20.4%), and decreased appetite (14.1-19.0%). Reported systemic reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were myalgia (23.7%), fatigue (15.8%), and headache (11.9%). The most commonly reported systemic reactions in adults 18-49 years of age were fatigue (34.3%), myalgia (28.8%), headache (26.5%), and arthralgia (12.7%). The most commonly reported systemic reactions in adults >=50 years of age were myalgia (26.9%), fatigue (21.5%), headache (18.9%), and arthralgia (7.7%).
Local Effects with PCV20 (Prevnar 20(R)): The most commonly reported local adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were pain at the injection site (>30%) and injection site redness (>20%) and swelling (>10%). Reported local reactions in children and adolescents 15 months through 17 years of age vaccinated with a single dose were pain at the injection site (>50%) and injection site redness and swelling (>10%). In adults 18-59 years of age, the most commonly reported local adverse reactions were pain at the injection site (>70%) and injection site swelling (10%). In adults >=60 years of age, the most commonly reported local adverse reaction was pain at the injection site (>50%).
Systemic Effects with PCV20 (Prevnar 20(R)): The most commonly reported systemic adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were irritability (>60%), drowsiness (>30%), decreased appetite (>20%), and fever (>10%). Reported systemic reactions in children and adolescents 15 months through 17 years of age vaccinated with a single dose were irritability (>60% in individuals <2 years of age), drowsiness (>40% in individuals less than 2 years of age), fatigue and muscle pain (>20% in individuals 2 years of age and older), decreased appetite (>20% in individuals less than 2 years of age), headache (>10% in individuals 5 years of age and older), and fever (>10% in individuals less than 2 years of age). In adults 18-59 years of age, the most commonly reported systemic reactions were muscle pain (>50%), fatigue (>40%), headache (>30%), and arthralgia(>10%). In adults >=60 years of age, the most commonly reported systemic reactions were muscle pain and fatigue (>30%), headache (>20%), and arthralgia (>10%).
Local Effects with PCV21 (Capvaxive(R)): In adults 18-49 years of age, the most commonly reported local adverse reactions were pain at the injection site (73.1%), injection site erythema (13.8%), and injection site swelling (13.3%). In adults >=50 years of age, the most commonly reported local adverse reaction was pain at the injection site (41.2%).
Systemic Effects with PCV21 (Capvaxive(R)): In adults 18-49 years of age, the most commonly reported systemic adverse reactions were fatigue (36.0%), headache (27.5%), and myalgia (16.4%). In adults >=50 years of age, the most commonly reported systemic reactions were fatigue (19.7%) and headache (11.0%).
Local Effects with Pneumococcal 23-valent Vaccine (PPSV23; Pneumovax(R) 23): The most common adverse effects reported after initial vaccination with PPSV23 (Pneumovax(R) 23) are local reactions at the injection site, including pain/soreness/tenderness (60%), swelling/induration (20%), and erythema (16%). Following revaccination with PPSV23 (Pneumovax(R) 23) approximately 3-5 years after the initial vaccine dose, the most common local adverse effects were pain/soreness/tenderness (77%), swelling (40%), and erythema (35%). Injection site reactions generally resolved within 5 days after vaccination. Data from one study in adults indicate that the incidence of adverse effects at the injection site in those 50-64 years of age is similar following initial vaccination (73%) and revaccination (80%). However, the incidence of injection site reactions is higher following revaccination than following initial vaccination in those >=65 years of age. There have been postmarketing reports of cellulitis or cellulitis-like reactions, warmth at the injection site, decreased limb mobility, and peripheral edema in the injected extremity following administration of PPSV23 (Pneumovax(R) 23).
Systemic Effects with Pneumococcal 23-valent Vaccine (PPSV23; Pneumovax(R) 23): The most common systemic adverse effects reported after initial vaccination with PPSV23 (Pneumovax(R) 23) are headache (18%), asthenia/fatigue (13%), and myalgia (12%). Following revaccination with PPSV23 (Pneumovax(R) 23) approximately 3-5 years after the initial vaccine dose, the most common systemic adverse effects were headache (18%), asthenia/fatigue (18%), and myalgia (17%). Rash, urticaria, and erythema multiforme have been reported following vaccination with PPSV23 (Pneumovax(R) 23). Anaphylactoid reactions, serum sickness, and angioedema also have been reported. Other systemic reactions reported following vaccination with PPSV23 (Pneumovax(R) 23) during clinical studies or postmarketing experience include fever, chills, arthralgia, arthritis, malaise, diarrhea, dyspepsia, nausea, and vomiting. In addition, there have been postmarketing reports of lymphadenitis, lymphadenopathy, thrombocytopenia (in patients with stabilized idiopathic thrombocytopenic purpura), hemolytic anemia (in patients who have had other hematologic disorders), and leukocytosis. There also have been postmarketing reports of adverse nervous system effects, including paresthesia, radiculoneuropathy, Guillain-Barre syndrome, and febrile seizures. Data from one study in adults indicate that the incidence of systemic adverse effects in those 50-64 years of age is similar following initial vaccination (36%) and revaccination (38%). However, the incidence of systemic reactions is higher following revaccination than following initial vaccination in those >=65 years of age.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of PCV13 (Prevnar 13(R)) have not been established in infants younger than 6 weeks of age.
The manufacturer of PCV13 (Prevnar 13(R)) states that the immune response to the vaccine in preterm infants has not been adequately studied to date. Although the vaccination schedule differed from the US recommended schedule, there is some evidence from a study in preterm infants (gestational age less than 37 weeks) that immunoglobulin G (IgG) antibody responses to some of the pneumococcal vaccine serotypes were lower after the third and fourth vaccine dose compared with responses in term infants (gestational age 37 weeks or greater).
The manufacturer of PCV15 (Vaxneuvance(R)) states that the immune responses and safety profile in preterm infants receiving a 4-dose series were similar to those observed in term infants in clinical studies. However, the effectiveness of PCV15 (Vaxneuvance(R)) in premature infants has not been established.
Safety of PCV20 (Prevnar 20(R)) has been established in individuals 6 weeks through 17 years of age. The effectiveness of PCV20 for the prevention of invasive disease caused by S.pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F has been established in individuals 6 weeks through 17 years of age. The effectiveness of PCV20 for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F also has been established in individuals 6 weeks through 5 years of age. However, the effectiveness of PCV20 for the prevention of pneumonia has not been established in individuals younger than 18 years of age. The safety and effectiveness of Prevnar 20 have not been established in individuals younger than 6 weeks of age.
Safety and efficacy of PCV21 (Capvaxive(R)) have not been established in individuals younger than 18 years of age.
Safety and efficacy of PPSV23 (Pneumovax(R) 23) have not been established in children younger than 2 years of age. Such children may not have a satisfactory antibody response to PPSV23 (Pneumovax(R) 23).
Data are insufficient to date regarding use of pneumococcal vaccines in pregnant females to inform vaccine-associated risks during pregnancy.
ACIP states that the safety of PPSV23 during the first trimester of pregnancy has not been evaluated, although no adverse consequences have been reported among newborns whose mothers were inadvertently vaccinated during pregnancy.
Animal developmental and reproduction studies in female rabbits using PCV13 (Prevnar 13(R)) at doses 20 times the human dose based on body weight did not reveal evidence of fetal harm or impaired female fertility. There are no adequate and well-controlled studies using PCV13 (Prevnar 13(R)) in pregnant females.
Animal reproduction studies have not been conducted with PPSV23 (Pneumovax(R) 23). It is not known whether PPSV23 (Pneumovax(R) 23) can cause fetal harm when administered to a pregnant females or can affect reproductive capacity. PPSV23 (Pneumovax(R)) should be administered during pregnancy only when clearly needed.
ACIP, AAP, and other experts state that PPSV23 (Pneumovax(R) 23) may be used when indicated in pregnant females at increased risk for pneumococcal disease. ACIP has not addressed pregnancy recommendations for PCV15, PCV20, or PCV21 at this time.
AAP states that pneumococcal vaccination generally should be deferred during pregnancy, but the risk of severe pneumococcal disease in a pregnant female who has not received PPSV23 (Pneumovax(R) 23) within the previous 5 years and has an underlying medical condition that increases the risk of invasive pneumococcal disease should prompt immunization with PPSV23 (Pneumovax(R) 23).
It is not known if antigens contained in PCV13 (Prevnar 13(R)), PCV15 (Vaxneuvance(R)), PCV20 (Prevnar 20(R)), PCV21 (Capvaxive(R)), or PPSV23 (Pneumovax(R) 23) are distributed into milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition (the susceptibility to disease prevented by the vaccine).
ACIP states that, because inactivated vaccines do not multiply within the body, they should not pose any unusual problems for lactating women or their infants.
No specific dosage recommendations.
Antibody responses to PCV13 (Prevnar 13(R)) in adults 65 years of age or older are lower compared with antibody responses in adults 50 through 59 years of age. There are no overall differences in safety outcomes in adults 65 years of age or older compared with adults 50 through 59 years of age.
Several clinical studies evaluating PPSV23 (Pneumovax(R) 23) included individuals 65 years of age or older. In one study, the rate of vaccine-related systemic adverse effects was similar following primary vaccination and revaccination in adults 50-64 years of age, but was higher following revaccination than primary vaccination in those 65 years of age or older. The possibility that some older adults may exhibit a higher frequency and/or greater severity of adverse reactions to the vaccine cannot be ruled out.
Clinical studies of PCV15 (Vaxneuvance(R)) included individuals who were 65 years and older, and individuals who were 75 years and older. No clinically meaningful differences in the safety profile or immune responses were observed in the groups of older individuals (65-74 years and >=75 years of age) when compared to younger individuals.
In safety studies of PCV20 (Prevnar 20(R)) in adults, 26.7% were 65 years of age and older and 1.7% were 80 years of age and older. Prevnar 20(R) recipients 70-79 years of age and >=80 years of age had lower antibody responses for all pneumococcal serotypes compared to Prevnar 20(R) recipients 18-49, 50-59, and 60-64 years of age.
In safety studies of PCV21 (Capvaxive(R)) in adults, 32.6% were 65 years of age and older and 7.4% were 75 years of age and older. PCV 21 (Capvaxive(R)) recipients >=65 years of age had lower opsonophagocytic activity (OPA) responses for all pneumococcal serotypes compared to PCV21 recipients <65 years of age.
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Last reviewed · Source: First Databank (FDB) drug data
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