REVISTA-MSP FEBRERO 2025

Smallest Trim size: 15” x 10.5”

In Study 2 (NCT05464420), individuals 18 through 49 years of age who had not previously received a pneumococcal vaccine were enrolled and randomized to receive a single dose of CAPVAXIVE or PNEUMOVAX 23. The percentage of individuals 18 through 49 years of age with solicited adverse reactions that occurred within 5 days postvaccination of CAPVAXIVE or PNEUMOVAX 23 is shown in Table 2. Brief Summary of the Prescribing Information for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) ( continued )

Table 3: Individuals with Solicited Local and Systemic Adverse Reactions Within 5 Days Postvaccination in Individuals 50 Years of Age and Older with Prior Pneumococcal Vaccination – Study 3 Individuals 50 Years of Age and Older Who Previously Received Pneumococcal Vaccines Study 3 (NCT05420961) enrolled individuals 50 years of age and older who had previously received a pneumococcal vaccine at least 1 year prior to enrollment. Participants were enrolled into 1 of 3 cohorts based on their pneumococcal vaccination history (cohort 1: PNEUMOVAX 23, cohort 2: Prevnar 13, or cohort 3: PNEUMOVAX 23 followed by or preceded by Prevnar 13, PNEUMOVAX 23 preceded by VAXNEUVANCE, or VAXNEUVANCE alone). Participants in cohort 1 were randomized to receive CAPVAXIVE or VAXNEUVANCE, participants in cohort 2 were randomized to receive CAPVAXIVE or PNEUMOVAX 23, and participants in cohort 3 received CAPVAXIVE. The percentage of individuals with solicited adverse reactions that occurred within 5 days postvaccination of CAPVAXIVE or active comparator is shown in Table 3.

Brief Summary of Prescribing Information for CAPVAXIVE DOSAGE AND ADMINISTRATION For intramuscular use. Dosage Administer a single 0.5 mL dose. Administration CAPVAXIVE is a colorless, clear to opalescent solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed. Administer intramuscularly. DOSAGE FORMS AND STRENGTHS CAPVAXIVE is an injection. A single dose is 0.5 mL. CONTRAINDICATIONS Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid. WARNINGS AND PRECAUTIONS Management of Allergic Reactions Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of CAPVAXIVE. Altered Immunocompetence Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE. ADVERSE REACTIONS 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 most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). Safety Assessment in Clinical Studies The safety of CAPVAXIVE was assessed in four clinical studies (Studies 1-4) conducted across the Americas, Europe, and Asia Pacific, which included individuals ranging in age from 18 to 97 years. Across all 4 studies, 4,556 individuals received CAPVAXIVE and 2,021 individuals received an active comparator vaccine. Safety was monitored using an electronic Vaccination Report Card for 30 days postvaccination. Injection-site adverse reactions, systemic adverse reactions, and body temperature were solicited Day 1 through Day 5 postvaccination. Unsolicited adverse events were reported Day 1 through Day 30 postvaccination. Serious adverse events (SAEs) were reported through 6 months postvaccination in all studies. Demographics of Individuals in Clinical Studies Across all studies, the mean age of the individuals who were randomized and vaccinated was 53.5 years, and 57.2% were female. The racial distribution was as follows: 76.0% were White, 10.2% were Black or African American, 9.9% were Asian, and 0.5% were American Indian or Alaska Native; 20.6% were of Hispanic or Latino ethnicity. Approximately 34% of vaccinated individuals had one or more prespecified chronic medical conditions known to increase the risk of pneumococcal disease (i.e., diabetes, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease including asthma, smoking, alcoholism). Pneumococcal Vaccine-Naïve Individuals 18 Years of Age and Older In a double-blind study, Study 1 (NCT05425732), individuals 18 years of age and older who had not previously received a pneumococcal vaccine were enrolled and randomized to receive a single dose of CAPVAXIVE or Prevnar 20. The percentage of individuals 18 through 49 years of age and 50 years of age and older who reported solicited adverse reactions that occurred within 5 days postvaccination of CAPVAXIVE or Prevnar 20 is shown in Table 1. Solicited adverse reactions following administration of CAPVAXIVE lasted a median of 2 days with 81.3% of reactions lasting ≤3 days for individuals 18 through 49 years of age and a median of 1 day with 86.5% of reactions lasting ≤3 days for individuals 50 years of age and older.

Table 1: Individuals With Solicited Local and Systemic Adverse Reactions Within 5 Days Postvaccination in Pneumococcal Vaccine-Naïve Individuals 18 through 49 Years of Age and 50 Years of Age and Older – Study 1

Table 2: Individuals with Solicited Local and Systemic Adverse Reactions Within 5 Days Postvaccination in Pneumococcal Vaccine-Naïve Individuals 18 through 49 Years of Age – Study 2 CAPVAXIVE n (%) PNEUMOVAX 23 n (%) Individuals in population* 1,616 541 Local adverse reactions † Severity

18 through 49 Years of Age 50 Years of Age and older CAPVAXIVE n (%) Prevnar 20 n (%) CAPVAXIVE n (%) Prevnar 20 n (%)

Cohort 1*

Cohort 2 †

Cohort 3 ‡

CAPVAXIVE n (%)

VAXNEUVANCE n (%)

CAPVAXIVE n (%)

PNEUMOVAX 23 n (%)

CAPVAXIVE n (%)

Individuals in population*

200

100

1177

1175

Individuals in population §

230

117

174

105

Local adverse reactions †

Severity

Local adverse reactions ¶

Severity

Any

1,184 (73.3)

328 (60.6)

Any

143 (71.5)

74 (74.0)

464 (39.4)

607 (51.7)

Mild

759 (47.0)

234 (43.3)

Any

82 (35.7)

51 (43.6)

72 (41.4)

40 (47.1)

46 (43.8)

Mild

95 (47.5)

49 (49.0)

361 (30.7)

504 (42.9)

Pain

Moderate

395 (24.4)

86 (15.9)

Mild

65 (28.3)

43 (36.8)

52 (29.9)

30 (35.3)

37 (35.2)

Moderate

46 (23.0)

25 (25.0)

102 (8.7)

Pain

Severe

30 (1.9)

8 (1.5)

Moderate

16 (7.0)

8 (6.8)

20 (11.5)

10 (11.8)

9 (8.6)

Severe

2 (1.0)

1 (0.1)

Any

219 (13.6)

41 (7.6)

Severe

1 (0.4)

74 (6.3) ‡

Any

31 (15.5)

13 (13.0)

64 (5.4) ‡

Mild (≤5.0 cm)

143 (8.8)

30 (5.5)

Any

17 (7.4)

9 (7.7)

13 (7.5)

8 (9.4)

8 (7.6)

Mild (≤5.0 cm)

23 (11.5)

10 (10.0)

51 (4.3)

59 (5.0)

Moderate (>5.0 to ≤10.0 cm) Severe (>10.0 cm)

Erythema

Mild (≤5.0 cm)

10 (4.3)

6 (5.1)

5 (2.9)

2 (2.4)

4 (3.8)

Erythema

57 (3.5)

8 (1.5)

Moderate (>5.0 to ≤10.0 cm)

7 (3.5)

3 (3.0)

10 (0.8)

12 (1.0)

Erythema

Moderate (>5.0 to ≤10.0 cm)

5 (2.2)

2 (1.7)

6 (3.4)

6 (7.1)

3 (2.9)

19 (1.2)

3 (0.6)

Severe (>10.0 cm)

1 (0.5)

2 (0.2)

Severe (>10.0 cm)

2 (0.9)

1 (0.9)

2 (1.1)

0 (0.0)

1 (1.0)

Any

213 (13.2)

41 (7.6)

Any

28 (14.0)

14 (14.0)

71 (6.0)

98 (8.3)

Any

19 (8.3)

10 (8.5)

8 (4.6)

14 (16.5)

11 (10.5)

Mild (≤5.0 cm)

148 (9.2)

29 (5.4)

Mild (≤5.0 cm)

20 (10.0)

9 (9.0)

53 (4.5)

79 (6.7)

Mild (≤5.0 cm)

15 (6.5)

9 (7.7)

6 (3.4)

7 (8.2)

6 (5.7)

Swelling

Moderate (>5.0 to ≤10.0 cm) Severe (>10.0 cm)

Swelling

Moderate (>5.0 to ≤10.0 cm)

55 (3.4)

10 (1.8)

7 (3.5)

5 (5.0)

15 (1.3)

17 (1.4)

Swelling

Moderate (>5.0 to ≤10.0 cm)

4 (1.7)

1 (0.9)

2 (1.1)

7 (8.2)

4 (3.8)

Severe (>10.0 cm)

1 (0.5)

3 (0.3)

2 (0.2)

10 (0.6)

2 (0.4)

Severe (>10.0 cm)

1 (1.0)

Systemic adverse reactions †

Severity

Systemic adverse reactions †

Systemic adverse reactions ¶

Severity

Any

81 (40.5)

34 (34.0)

237 (20.1)

230 (19.6)

Any

573 (35.5)

184 (34.0)

Any

33 (14.3)

20 (17.1)

33 (19.0)

11 (12.9)

23 (21.9)

Mild

50 (25.0)

21 (21.0)

167 (14.2)

153 (13.0)

Mild

338 (20.9)

119 (22.0)

Fatigue

Mild

25 (10.9)

11 (9.4)

24 (13.8)

6 (7.1)

19 (18.1)

Moderate

29 (14.5)

11 (11.0)

70 (5.9)

72 (6.1)

Moderate

201 (12.4)

60 (11.1)

Fatigue

Moderate

8 (3.5)

9 (7.7)

8 (4.6)

5 (5.9)

4 (3.8)

Severe

2 (1.0)

2 (2.0)

5 (0.4)

Severe

34 (2.1)

5 (0.9)

Severe

1 (0.6)

Any

59 (29.5)

24 (24.0)

135 (11.5)

152 (12.9)

Any

440 (27.2)

116 (21.4)

Any

16 (7.0)

11 (9.4)

18 (10.3)

10 (11.8)

9 (8.6)

Mild

275 (17.0)

70 (12.9)

Mild

44 (22.0)

17 (17.0)

102 (8.7)

106 (9.0)

Headache

Mild

10 (4.3)

9 (7.7)

10 (5.7)

7 (8.2)

9 (8.6)

Moderate

151 (9.3)

43 (7.9)

Moderate

14 (7.0)

7 (7.0)

33 (2.8)

45 (3.8)

Headache

Moderate

5 (2.2)

2 (1.7)

8 (4.6)

3 (3.5)

Severe

14 (0.9)

3 (0.6)

Severe

1 (0.5)

1 (0.1)

Severe

1 (0.4)

Any

264 (16.3)

47 (8.7)

Any

33 (16.5)

14 (14.0)

70 (5.9)

79 (6.7)

Any

17 (7.4)

3 (2.6)

17 (9.8)

8 (9.4)

9 (8.6)

Mild

146 (9.0)

33 (6.1)

Mild

15 (7.5)

9 (9.0)

40 (3.4)

42 (3.6)

Myalgia

Mild

9 (3.9)

2 (1.7)

7 (4.0)

4 (4.7)

7 (6.7)

Myalgia

Moderate

103 (6.4)

12 (2.2)

Myalgia

Moderate

15 (7.5)

4 (4.0)

30 (2.5)

36 (3.1)

Moderate

8 (3.5)

1 (0.9)

9 (5.2)

4 (4.7)

2 (1.9)

Severe

15 (0.9)

2 (0.4)

Severe

3 (1.5)

1 (1.0)

1 (0.1)

Severe

1 (0.6)

≥38.0°C (100.4°F)

48 (3.0)

12 (2.2)

≥38.0°C (100.4°F)

7 (3.5)

1 (1.0)

15 (1.3)

≥38.0°C (100.4°F)

4 (1.7)

3 (2.6)

5 (2.9)

1 (1.2)

≥38.0°C (100.4°F) to <38.5°C (101.3°F) ≥38.5°C (101.3°F) to <39.0°C (102.2°F)

3 (1.5)

7 (0.6)

≥38.0°C (100.4°F) to <38.5°C (101.3°F) ≥38.5°C (101.3°F) to <39.0°C (102.2°F)

31 (1.9)

4 (0.7)

Pyrexia §

2 (0.9)

1 (0.6)

2 (1.0)

6 (0.5)

5 (0.4)

Pyrexia ‡

Pyrexia #

≥39.0°C (102.2°F)

2 (1.0)

1 (1.0)

2 (0.2)

3 (0.3)

11 (0.7)

2 (0.4)

2 (0.9)

2 (1.7)

2 (1.1)

1 (1.2)

*Every individual is counted a single time for each applicable row and column. † Injection-site erythema, injection-site pain, injection-site swelling, fatigue, headache, and myalgia were solicited from Day 1 through Day 5 postvaccination. ‡ Includes one individual with an event of missing/unknown intensity. § Pyrexia was defined as temperature ≥38.0°C (100.4°F) solicited from Day 1 through Day 5 postvaccination. Percentages are based on the number of individuals with temperature data: 18 through 49 years of age: CAPVAXIVE, n=199, Prevnar 20, n=100. 50 years of age and older: CAPVAXIVE, n=1169, Prevnar 20, n=1170. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

≥39.0°C (102.2°F)

6 (0.4)

6 (1.1)

≥39.0°C (102.2°F)

1 (0.9)

2 (1.1)

*Every individual is counted a single time for each applicable row and column. † Injection-site erythema, injection-site pain, injection-site swelling, fatigue, headache, and myalgia were solicited from Day 1 through Day 5 postvaccination. ‡ Pyrexia was defined as temperature ≥38.0°C (100.4°F) solicited from Day 1 through Day 5 postvaccination. Percentages are based on the number of individuals with temperature data: CAPVAXIVE, n=1,606; PNEUMOVAX 23, n=541. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity

*Cohort 1 prior vaccination with PNEUMOVAX 23 † Cohort 2 prior vaccination with Prevnar 13 ‡ Cohort 3 prior vaccination with Prevnar 13+PNEUMOVAX 23 (n=45), or VAXNEUVANCE+PNEUMOVAX 23 (n=5), or PNEUMOVAX 23+Prevnar 13 (n=54), or VAXNEUVANCE (n=1) or Prevnar 20 (n=0) § Every individual is counted a single time for each applicable row and for each column. ¶ Injection-site erythema, injection-site pain, injection-site swelling, fatigue, headache, and myalgia were solicited from Day 1 through Day 5 postvaccination. # Pyrexia was defined as temperature ≥38.0°C (100.4°F) solicited from Day 1 through Day 5 postvaccination. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity

Revista Puertorriqueña de Medicina y Salud Pública

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