Vaccine Information: Prevnar 20

PREVNAR 20- streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 4 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 5 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6b capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 7f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 8 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 9v capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 10a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 11a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 12f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 14 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 15b capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 18c capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 19a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 19f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 22f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 23f capsular polysaccharide diphtheria crm197 protein conjugate antigen and streptococcus pneumoniae type 33f capsular polysaccharide diphtheria crm197 protein conjugate antigen injection, suspension
Wyeth Pharmaceutical Division of Wyeth Holdings LLC

1 INDICATIONS AND USAGE

Prevnar 20 is a vaccine indicated for active immunization for the prevention of pneumonia and 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 adults 18 years of age and older.

This indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

2 DOSAGE AND ADMINISTRATION

For intramuscular administration only.

2.1 Preparation

Do not mix Prevnar 20 with other vaccines/products in the same syringe.

Step 1. Resuspend drug product Hold the pre-filled syringe horizontally between the thumb and the forefinger and shake vigorously until the vaccine is a homogeneous white suspension. Do not use the vaccine if it cannot be re-suspended.
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Step 2. Visual inspection Visually inspect the vaccine for large particulate matter and discoloration prior to administration. Do not use if large particulate matter or discoloration is found. If the vaccine is not a homogeneous suspension, repeat Steps 1 and 2.
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Step 3. Remove syringe cap Remove the syringe cap by slowly turning the cap counterclockwise while holding the Luer lock adapter.Avoid pressing the syringe plunger rod while removing the syringe cap.Image
Step 4. Attach a sterile needle Hold the Luer lock adapter and attach a needle appropriate for intramuscular administration to the pre-filled syringe by turning clockwise.

2.2 Administration

For intramuscular injection only.

Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied pre-filled syringe.

2.3 Vaccination Schedule

Prevnar 20 is administered as a single dose.

3 DOSAGE FORMS AND STRENGTHS

Prevnar 20 is a suspension for intramuscular injection available in a 0.5 mL single-dose pre-filled syringe.

4 CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20 or to diphtheria toxoid [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment and supervision used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Prevnar 20.

5.2 Altered Immunocompetence

Safety and immunogenicity data on Prevnar 20 are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis.

Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20.

6 ADVERSE REACTIONS

In adults 18 through 59 years of age, the most commonly reported solicited adverse reactions >10% were pain at the injection site (>70%), muscle pain (>50%), fatigue (>40%), headache (>30%), and arthralgia and injection site swelling (>10%).

In adults 60 years of age and older, the most commonly reported solicited adverse reactions >10% were pain at the injection site (>50%), muscle pain and fatigue (>30%), headache (>20%), and arthralgia (>10%).

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

The safety of a single dose of Prevnar 20 in adults 18 years of age and older was evaluated in five randomized, active-controlled, multicenter clinical trials and one open-label, multicenter clinical trial. All of the trials were conducted in the United States and 2 of the trials also enrolled participants (N=172) in Sweden. Across the 6 trials, 4552 adults received Prevnar 20 and 2496 received active control vaccine.

Pneumococcal Vaccine Naïve Adults 18 Years of Age and Older

The safety of Prevnar 20 in adults 18 years of age and older with no history of pneumococcal vaccination was evaluated in five studies (Studies 1–5). In the main cohort of Study 1 (NCT03760146) and in Study 2 (NCT03313037), participants ≥60 years of age and participants 60 through 64 years of age, respectively, received a single dose of Prevnar 20 followed 1 month later with administration of saline placebo or received a single dose of Prevnar 13 followed 1 month later with a dose of PNEUMOVAX® 23 (PPSV23). The 2 other cohorts of Study 1, participants 50 through 59 years of age and participants 18 through 49 years of age, received a single vaccination with Prevnar 20 or Prevnar 13. In Study 3 (NCT03828617), participants 18 through 49 years of age received a single vaccination with Prevnar 20 or Prevnar 13. In Studies 4 (NCT02955160) and 5 (NCT03642847), which were smaller studies conducted early in the clinical development of Prevnar 20, participants 18 through 49 years of age received a single dose of Prevnar 20 or an active control (Tdap or Prevnar 13).

Adults ≥65 Years of Age Previously Immunized with a Pneumococcal Vaccine

The safety of Prevnar 20 in adults 65 years of age and older with pneumococcal vaccination given as routine care prior to enrollment was assessed in Study 6 (NCT03835975). Participants were enrolled into 1 of 3 cohorts based on their prior pneumococcal vaccination history (PPSV23 only ≥1 to ≤5 years prior to enrollment, Prevnar 13 only ≥6 months prior to enrollment, or Prevnar 13 followed by PPSV23 [with PPSV23 given ≥1 year prior to enrollment]). Participants in 2 of the cohorts received a single vaccination with Prevnar 20 or control pneumococcal vaccine (Prevnar 13), and the other cohort received a single vaccination with Prevnar 20. only.

Demographics of Trial Participants

In the three main trials (Studies 1, 3, and 6), participants were predominantly female (52.0% to 65.9%) across groups defined by age and prior pneumococcal vaccination status within the Prevnar 20 and control vaccine groups. Across all 3 trials combined, 59.8% of participants were 60 years of age and older, 6.9% were 50 through 59 years of age, and 33.3% were 18 through 49 years of age. In Studies 1 and 3, participants were 80.7% White, 14.2% Black, 2.1% Asian, and 10.3% Hispanic. In Study 6, participants were predominantly White (92.4%). Participants were primarily from the United States; however a portion of participants 65 years of age and older were enrolled from Sweden in Study 1 (5.7% of participants 60 years of age and older in that study) and also in Study 6 (35.5% of participants with prior PPSV23 only).

In the three main trials, participants with pre-existing underlying diseases were enrolled if the medical condition was stable (did not require a significant change in therapy in the 6 weeks before receipt of study vaccine or any hospitalization for worsening disease within 12 weeks before receipt of study vaccine). In Study 1, approximately one-third of all participants had risk factors that placed them at increased risk for serious pneumococcal disease, including smoking (12.9%), stable medical conditions of chronic cardiovascular disease (5.5%), chronic pulmonary disease including asthma (8.7%), chronic liver disease (0.4%), and diabetes mellitus (13.9%).

Safety Monitoring

Solicited adverse reactions for Prevnar 20 in the three main trials were monitored in participants recording daily into an electronic diary their local adverse reactions for 10 consecutive days and systemic reactions for 7 consecutive days following vaccination. Across all trials, serious and nonserious adverse events were collected for 1 month after each vaccination. Safety follow-up of serious adverse events (SAEs) continued through 6 months after vaccination with Prevnar 20 or Prevnar 13 (or other appropriate control vaccine), as applicable. Newly diagnosed chronic medical conditions occurring within 6 months after vaccination were also collected via telephone contact.

Serious Adverse Events

Across all 6 clinical trials combined, performed in adults of all ages, naïve to and with prior pneumococcal vaccination, the proportion of participants reporting 1 or more SAEs within 6 months after vaccination with Prevnar 20 was 1.5% (67 of 4552 participants). This was similar to the proportion of participants with SAEs after vaccination with Prevnar 13 or other applicable control vaccine (1.8%, 44 of 2496). The proportions of participants with SAEs occurring within 1 month after vaccination with Prevnar 20 or with Prevnar 13 or other applicable control vaccine were both 0.4% (19 of 4552 participants and 11 of 2496 participants, respectively). There were no notable patterns or imbalances between vaccine groups for specific categories of serious adverse events that would suggest a causal relationship to Prevnar 20.

Solicited Adverse Reactions

The frequency and severity of the local adverse reactions (redness, swelling, and pain at the injection site) prompted daily in the 10 days after Prevnar 20 vaccination in adults naïve to pneumococcal vaccination (Study 1) and in adults with prior pneumococcal vaccination (Study 6) are shown in Table 1 and Table 2, respectively. The frequency and severity of the systemic adverse reactions (fever, fatigue, headache, muscle pain, and joint pain) prompted daily in the 7 days after Prevnar 20 vaccination in adults naïve to pneumococcal vaccination (Study 1) and in adults with prior pneumococcal vaccination (Study 6) are shown in Table 3 and Table 4, respectively.

Table 1. Percentage of Participants With Solicited Local Adverse Reactions, by Maximum Severity, Within 10 Days After Vaccination in Pneumococcal Vaccine-Naïve Adults — Study 1*
18–49 Years of Age 50–59 Years of Age ≥60 Years of Age
Vaccine Group
Prevnar 20(N =335)% Prevnar 13(N =112)% Prevnar 20(N =331)% Prevnar 13(N =111)% Prevnar 20/Saline(N =1505)% Prevnar 13/PPSV23(N =1483)%
Local Reaction
*
Study 1 was conducted in the United States and in Sweden (NCT03760146).
N = number of participants with any e-diary data reported after vaccination (after Vaccination 1 [Prevnar 20 or Prevnar 13] for Study 1 participants 60 years of age and older). This value is the denominator for the percentage calculations.
Mild = does not interfere with activity; moderate = interferes with activity; severe = prevents daily activity.
§
“Any” includes all participants who reported a reaction as “mild”, “moderate”, or “severe” during Day 1 to Day 10 after vaccination.
Diameters were measured in caliper units of whole numbers from 1 to 21 or 21+. One caliper unit = 0.5 cm. Measurements were rounded up to the nearest whole number. Intensity of redness and swelling were then characterized as follows: mild is >2.0 to 5.0 cm; moderate is >5.0 to 10.0 cm; severe is >10.0 cm.
#
“Any local reaction” includes all participants who reported any injection site reaction (pain, swelling, or redness) as “mild”, “moderate”, or “severe” during Day 1 to Day 10 after vaccination.
Pain at injection site
Any § 81.2 82.1 72.5 69.4 55.4 54.1
Mild 42.7 52.7 53.5 52.3 45.3 44.6
Moderate 38.2 28.6 17.8 16.2 9.9 9.2
Severe 0.3 0.9 1.2 0.9 0.2 0.3
Swelling
Any (>2.0 cm)§ 11.6 12.5 8.8 10.8 7.5 8.0
Mild 7.2 8.9 5.7 7.2 4.8 4.9
Moderate 4.5 3.6 3.0 3.6 2.4 2.8
Severe 0 0 0 0 0.3 0.3
Redness
Any (>2.0 cm)§ 9.0 9.8 8.2 5.4 7.3 6.2
Mild 3.0 5.4 5.1 2.7 3.7 3.8
Moderate 5.4 4.5 2.7 2.7 2.8 2.2
Severe 0.6 0 0.3 0 0.8 0.2
Any local reaction # 81.2 82.1 72.8 70.3 57.4 56.0
Table 2. Percentage of Participants With Solicited Local Adverse Reactions, by Maximum Severity, Within 10 Days After Vaccination in Adults 65 Years of Age and Older With Prior Pneumococcal Vaccination – Study 6*,
Prior Pneumococcal Vaccination Status
PPSV23 Prevnar 13 Prevnar 13 and PPSV23
Vaccine Group
Prevnar 20(N §=253)% Prevnar 13(N §=121)% Prevnar 20(N §=245)% PPSV23(N §=126)% Prevnar 20(N §=125)%
Local Reaction
*
Study 6 was conducted in the United States and in Sweden (NCT03835975)
Open-label administration of Prevnar 20.
Includes participants who previously received either PPSV23 ≥1 to ≤5 years before enrollment (PPSV23), Prevnar 13 ≥6 months before enrollment (Prevnar 13), or Prevnar 13 followed by PPSV23 ≥1 year before enrollment (Prevnar 13 and PPSV23) in the study.
§
N = number of participants with any e-diary data reported after vaccination. This value is the denominator for the percentage calculations.
Mild = does not interfere with activity; moderate = interferes with activity; severe = prevents daily activity.
#
“Any” includes all participants who reported a reaction as “mild”, “moderate”, or “severe” during Day 1 to Day 10 after vaccination.
Þ
Diameters were measured in caliper units of whole numbers from 1 to 21 or 21+. One caliper unit = 0.5 cm. Measurements were rounded up to the nearest whole number. Intensity of redness and swelling were then characterized as follows: mild is >2.0 to 5.0 cm; moderate is >5.0 to 10.0 cm; severe is >10.0 cm.
ß
“Any local reaction” includes all participants who reported any injection site reaction (pain, swelling, or redness) as “mild”, “moderate”, or “severe” during Day 1 to Day 10 after vaccination.
Pain at the injection site
Any # 50.2 43.0 61.2 56.3 52.8
Mild 45.8 38.8 54.7 40.5 47.2
Moderate 4.3 3.3 6.1 14.3 5.6
Severe 0 0.8 0.4 1.6 0
Swelling Þ
Any (>2.0 cm)# 9.9 6.6 9.4 14.3 4.0
Mild 5.1 6.6 5.7 6.3 1.6
Moderate 3.6 0 3.7 7.1 2.4
Severe 1.2 0 0 0.8 0
Redness Þ
Any (>2.0 cm)# 7.9 2.5 8.6 12.7 4.8
Mild 3.6 1.7 2.9 4.8 1.6
Moderate 3.2 0.8 5.3 7.1 3.2
Severe 1.2 0 0.4 0.8 0
Any local reaction ß 53.0 43.8 64.1 57.9 54.4
Table 3. Percentage of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Vaccination in Pneumococcal Vaccine-Naïve Adults – Study 1*
18 through 49 Years of Age 50 through 59 Years of Age ≥60 Years of Age
Vaccine Group
Prevnar 20(N =335)% Prevnar 13(N =112)% Prevnar 20(N =331)% Prevnar 13(N =111)% Prevnar 20/Saline(N =1505)% Prevnar 13/PPSV23(N =1483)%
Systemic Reaction
*
Study 1 was conducted in the United States and in Sweden (NCT03760146).
N = number of participants with any e-diary data reported after vaccination (after Vaccination 1 [Prevnar 20 or Prevnar 13] for Study 1 participants 60 years of age and older). This value is the denominator for the percentage calculations.
Mild = does not interfere with activity; moderate = some interference with activity; severe = prevents daily activity.
§
“Any” includes all participants who reported a reaction as “mild”, “moderate”, or “severe” during Day 1 to Day 7 after vaccination.
“Any systemic reaction” includes all participants who reported any fever ≥38.0°C or any other systemic reaction (fatigue, headache, joint pain, or muscle pain) as “mild”, “moderate”, or “severe” during Day 1 to Day 7 after vaccination.
#
Severity was not collected for use of antipyretic or pain medication. The numbers listed reflect “yes” responses (i.e., number of reactions reported).
Muscle pain
Any § 66.6 74.1 49.8 49.5 39.1 37.3
Mild 36.4 42.0 33.8 31.5 28.9 26.8
Moderate 29.0 31.3 15.4 17.1 9.8 10.0
Severe 1.2 0.9 0.6 0.9 0.4 0.5
Fatigue
Any § 42.7 43.8 39.3 36.0 30.2 30.7
Mild 18.8 20.5 21.1 18.0 16.1 17.5
Moderate 22.1 19.6 17.2 15.3 12.8 11.9
Severe 1.8 3.6 0.9 2.7 1.2 1.2
Headache
Any § 38.8 33.9 32.3 36.0 21.5 23.3
Mild 21.5 16.1 20.5 21.6 15.5 17.0
Moderate 14.6 17.0 10.9 13.5 5.4 5.9
Severe 2.7 0.9 0.9 0.9 0.7 0.3
Joint pain
Any § 13.4 17.9 15.4 20.7 12.6 13.7
Mild 6.3 8.9 10.6 12.6 6.9 7.1
Moderate 7.2 8.0 4.8 7.2 5.4 6.3
Severe 0 0.9 0 0.9 0.3 0.2
Fever
≥38.0°C 1.2 1.8 1.5 0.9 0.9 0.8
≥38.0°C to 38.4°C 0.6 0 0.6 0.9 0.3 0.4
>38.4°C to 38.9°C 0.3 0 0.3 0 0.3 0.2
>38.9°C to 40.0°C 0.3 1.8 0.3 0 0 0
>40.0°C 0 0 0.3 0 0.3 0.2
Any systemic reaction 79.4 83.0 69.5 67.6 55.2 55.4
Use of antipyretic or pain medication # 25.7 23.2 24.5 27.9 18.5 20.4
Table 4. Percentage of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Vaccination in Adults 65 Years of Age and Older With Prior Pneumococcal Vaccination – Study 6*,
Prior Pneumococcal Vaccination Status
PPSV23 Prevnar 13 Prevnar 13 and PPSV23
Vaccine Group
Prevnar 20(N §=253)% Prevnar 13(N §=121)% Prevnar 20(N §=245)% PPSV23(N §=126)% Prevnar 20(N §=125)%
Systemic Reaction
*
Study 6 was conducted in the United States and in Sweden (NCT03835975).
Open-label administration of Prevnar 20.
Includes participants who previously received either PPSV23 ≥1 to ≤5 years before enrollment (PPSV23), Prevnar 13 ≥6 months before enrollment (Prevnar 13), or Prevnar 13 followed by PPSV23 ≥1 year before enrollment (Prevnar 13 and PPSV23) in the study.
§
N = number of participants with any e-diary data reported after vaccination. This value is the denominator for the percentage calculations.
Mild = does not interfere with activity; moderate = interferes with activity; severe = prevents daily activity.
#
“Any” includes all participants who reported a reaction as “mild”, “moderate”, or “severe” during Day 1 to Day 7 after vaccination.
Þ
“Any systemic reaction” includes all participants who reported any fever ≥38.0°C or any other systemic reaction (fatigue, headache, joint pain, or muscle pain) as “mild”, “moderate”, or “severe” during Day 1 to Day 7 after vaccination.
ß
Severity was not collected for use of antipyretic or pain medication. The numbers listed reflect “yes” responses (i.e., number of reactions reported).
Muscle pain
Any # 32.0 31.4 33.9 46.0 37.6
Mild 26.1 24.0 25.3 31.7 28.0
Moderate 5.5 5.0 8.6 11.9 8.8
Severe 0.4 2.5 0 2.4 0.8
Fatigue
Any # 28.9 22.3 31.0 33.3 32.8
Mild 17.8 9.9 19.6 19.8 19.2
Moderate 11.1 9.9 10.2 13.5 12.0
Severe 0 2.5 1.2 0 1.6
Headache
Any # 17.8 18.2 13.5 21.4 19.2
Mild 12.6 12.4 9.8 20.6 12.8
Moderate 4.7 5.8 3.7 0.8 5.6
Severe 0.4 0 0 0 0.8
Joint pain
Any # 6.7 10.7 11.8 15.9 16.8
Mild 4.7 5.0 7.8 10.3 12.8
Moderate 2.0 5.0 4.1 5.6 4.0
Severe 0 0.8 0 0 0
Fever
≥38.0°C 0.8 0 0 1.6 0
≥38.0°C to 38.4°C 0.8 0 0 0.8 0
>38.4°C to 38.9°C 0 0 0 0.8 0
>38.9°C to 40.0°C 0 0 0 0 0
>40.0°C 0 0 0 0 0
Any systemic reaction Þ 51.8 43.8 50.2 59.5 52.8
Use of antipyretic or pain medication ß 15.8 14.9 17.1 19.8 17.6
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