Pharmaceutical Name

Trade (marketing or proprietary) name: Vaxneuvance (PCV15), Prevnar 20

Generic (nonproprietary or active ingredient) name: PCV15, PCV20

Indication and Usage

Reason the product has been approved for sale on the market.

Vaxneuvance (PCV15) is a vaccine indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.

Prevnar 20 is a vaccine indicated for

• active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.
• active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age.
• active immunization for the prevention of pneumonia 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 in individuals 18 years of age and older. The indication for the prevention of pneumonia caused by S.pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

Vaxneuvance (PCV15): Each 0.5 mL dose contains 2.0 mcg each of S. pneumoniae polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4.0 mcg of polysaccharide serotype 6B, 30 mcg of CRM197 carrier protein, 1.55 mg L histidine, 1 mg of polysorbate 20, 4.50 mg sodium chloride, and 125 mcg of aluminum as aluminum phosphate adjuvant. VAXNEUVANCE does not contain any preservatives.

Prevnar 20: Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 μg of each of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F saccharides, 4.4 μg of 6B saccharides, 51 μg CRM197 carrier protein, 100 μg polysorbate 80, 295 μg succinate buffer, 4.4 mg sodium chloride, and 125 μg aluminum as aluminum phosphate adjuvant.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Do not administer VAXNEUVANCE/Prevnar 20 to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE/Prevnar 20 or to diphtheria toxoid.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Management of Allergic Reactions: Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of VAXNEUVANCE/Prevnar 20.

Altered Immunocompetence: Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE/Prevnar 20.

Apnea in Premature Infants: Apnea following intramuscular vaccination has been observed in some infants born prematurely. A decision about when to administer VAXNEUVANCE/Prevnar 20 to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.

Immunosuppressive Therapies: Individuals with impaired immune responsiveness due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents) may not respond optimally to Prevnar 20.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Vaxneuvance (PCV15): The insert does not have the post-marketing adverse reaction section, likely because this product was recently added to the CDC schedule. However, here are the adverse reactions reported before the product was brought to market in clinical trials:

• The most commonly reported solicited adverse reactions in children vaccinated with a 4-dose series at 2, 4, 6, and 12 through 15 months of age, provided as a range across the series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%) and injection-site swelling (11.3% to 13.4%).
• The most commonly reported solicited adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%) and injection site induration (6.8%).
• The most commonly reported solicited adverse reactions in adults 18 through 49 years of age were: injection-site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection-site swelling (21.7%), injection-site erythema (15.1%) and arthralgia (12.7%).
• The most commonly reported solicited adverse reactions in adults 50 years of age and older were: injection-site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection-site swelling (15.4%), injection-site erythema (10.9%) and arthralgia (7.7%).

Prevnar 20

• Blood and lymphatic system disorders: Lymphadenopathy localized to the region of the injection site
• Cardiac disorders: Cyanosis (pediatric populations only)
• General Disorders and Administration Site Conditions: Vaccination-site dermatitis, vaccination-site pruritus, vaccination-site urticaria
• Immune System Disorders: Anaphylactic/anaphylactoid reaction, including shock
• Nervous system disorders: Hypotonia (pediatric populations only
• Respiratory: Apnea (pediatric populations only)
• Skin and Subcutaneous Tissue Disorders: Angioneurotic edema, Erythema multiforme
• Vascular disorders: Pallor (pediatric populations only)

Specific Populations

Pregnancy

There are no adequate and well-controlled studies of VAXNEUVANCE/Prevnar 20 in pregnant women. Available data on VAXNEUVANCE/Prevnar 20 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

Breastfeeding

Human data are not available to assess the impact of VAXNEUVANCE on milk production, its presence in breast milk, or its effects on the breastfed child.

It is not known whether Prevnar 20 is excreted in human milk. Data are not available to assess the effects of Prevnar 20 on the breastfed infant or on milk production/excretion.

Fertility

VAXNEUVANCE/Prevnar 20 has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.

Pediatric

The safety and effectiveness of VAXNEUVANCE in individuals younger than 6 weeks of age have not been established. The effectiveness of VAXNEUVANCE in infants born prematurely has not been established. The effectiveness of VAXNEUVANCE in children with sickle cell disease has not been established. The effectiveness of VAXNEUVANCE in HIV-infected children has not been established. The effectiveness of VAXNEUVANCE in HIV-infected adults has not been established. The effectiveness of VAXNEUVANCE in recipients of allo-HSCT has not been established.

The effectiveness of Prevnar 20 for the prevention of pneumonia has not been established in individuals younger than 18 years of age. The safety and effectiveness of Prevnar 20 in individuals younger than 6 weeks of age have not been established.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

Vaxneuvance (PCV15): Protection against invasive disease is conferred mainly by antibodies (Immunoglobulin G [IgG] directed against capsular polysaccharides) and opsonophagocytic activity (OPA) against S. pneumoniae. VAXNEUVANCE induces IgG antibodies and OPA against the serotypes contained in the vaccine.

Prevnar 20: Protection against pneumococcal disease is conferred mainly by antibodies (immunoglobulin G [IgG] directed against capsular polysaccharides) and OPA killing of S. pneumoniae. Prevnar 20 induces IgG antibodies and OPA against the 20 vaccine serotypes. An opsonic antibody titer or serotype-specific IgG concentration that is predictive of protection against invasive pneumococcal disease or pneumococcal pneumonia has not been established.

Analytical Deep Dive

From PCV 13 (the previous Pneumococcal vaccine recommended by the CDC):

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Alternatives

For product alternatives, please visit the Influenza webpage.