Vaccine Information: Vaxchora

VAXCHORA- cholera vaccine, live, oral
Emergent Travel Health Inc.

1 INDICATIONS AND USAGE

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in persons 2 through 64 years of age traveling to cholera-affected areas.

1.1 Limitations of Use

The effectiveness of VAXCHORA has not been established in persons living in cholera-affected areas.

The effectiveness of VAXCHORA has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine.

VAXCHORA has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

2 DOSAGE AND ADMINISTRATION

For oral administration only.

2.1 Dose and Schedule

Administer a single oral dose of VAXCHORA a minimum of 10 days before potential exposure to cholera.

The safety and effectiveness of revaccination with VAXCHORA have not been established.

2.2 Restrictions on Eating and Drinking

Instruct recipients to avoid eating or drinking for 60 minutes before and after oral ingestion of VAXCHORA.

2.3 Preparation, Reconstitution and Administration

Prepare and administer VAXCHORA in a healthcare setting equipped to dispose of medical waste [see Disposal Instructions (2.4)].

1.
Remove the carton from the refrigerator [see Storage and Handling (16.2)]. Locate the 2 packets: the buffer component (Packet 1) and the active component (Packet 2).
2.
Pour 100 milliliters (mL) of cold or room temperature (41°F-72°F; 5°C-22°C) purified bottled or spring bottled water into a clean, disposable cup. Do not use tap water, sparkling (carbonated) water, non-purified or non-spring bottled water, other beverages, or other liquids.
3.
Use scissors to cut the top off the buffer component packet.
4.
Empty buffer component packet contents into cup. Effervescence will occur.
5.
Using a disposable stirrer, stir until the buffer component completely dissolves. For children less than 6 years of age, discard half of the buffer solution.
6.
Use scissors to cut the top off the active component packet.
7.
Empty the active component packet contents (lyophilized V. cholerae CVD 103-HgR) into the cup containing the buffer solution.
8.
Stir for at least 30 seconds and until active component disperses to form a slightly cloudy suspension that may contain some white particulates.
9.
VAXCHORA must be consumed within 15 minutes of reconstitution. The recipient should drink the full contents of the cup at once. Some residue may remain in the cup and should be discarded with the cup.

NOTE: If the packets are reconstituted in the improper order, the vaccine must be discarded [see Disposal Instructions (2.4)].

Image of the prep, reconstitution and administration of Vaxchora
(click image for full-size original)

2.4 Disposal Instructions

Dispose of the cup, packets, and stirrer according to standard procedures for medical waste.

Inactivate any spilled vaccine and clean any non-disposable equipment used in the preparation of VAXCHORA with 70% isopropyl alcohol or 10% bleach solution.

3 DOSAGE FORMS AND STRENGTHS

VAXCHORA is a suspension for oral administration. Before reconstitution, each dose of VAXCHORA is supplied as a foil packet of buffer and an accompanying foil packet of the active component (lyophilized V. cholerae CVD 103-HgR). After reconstitution, a single dose of VAXCHORA is 100 mL (50 mL for children less than 6 years of age).

4 CONTRAINDICATIONS

Do not use in persons who have a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient of VAXCHORA or to a previous dose of any cholera vaccine [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Altered Immunocompetence

The safety and effectiveness of VAXCHORA have not been established in immunocompromised persons [see Immunocompromised Individuals (8.6)].

5.2 Shedding and Transmission

VAXCHORA may be shed in the stool of recipients for at least 7 days. There is a potential for transmission of the vaccine strain to non-vaccinated close contacts (e.g., household contacts) [see Pharmacodynamics (12.2)]. Use caution when considering whether to administer VAXCHORA to individuals with immunocompromised close contacts.

6 ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 common adverse reactions for adults (incidence > 3%) were tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%) and diarrhea (4%).

The most common adverse reactions for children and adolescents (incidence ≥10%) were:

Cohort 1 — age 12 to <18 years: headache (45%), tiredness (41%), abdominal pain (38%), lack of appetite (29%) and nausea (22%).
Cohort 2 — age 6 to <12 years: tiredness (35%), abdominal pain (27%), headache (26%), lack of appetite (15%) and nausea (14%).
Cohort 3 — age 2 to <6 years: tiredness (31%), lack of appetite (19%), and abdominal pain (17%).

6.1 Clinical Trials Experience

Trials in Adults

The safety of VAXCHORA was evaluated in four randomized, placebo-controlled, multicenter clinical trials. A total of 3235 adults 18 through 64 years of age received one dose of VAXCHORA and 562 received placebo [physiologic saline (N=551) or lactose (N=11)]. Overall, the mean age was 32.5 years; 53.8% of trial participants were female; 67.1% were White, 27.3% were Black or African American, 1.8% were Asian, 1.7% were multiracial, 1.3% were other, 0.6% were American Indian or Alaskan Native and 0.3% were Native Hawaiian or Pacific Islander. There were 9.3% Hispanic or Latino participants.

Solicited Adverse Reactions

Adults 18 through 45 years of age received VAXCHORA in a multi-center, double-blind, randomized (8:1), placebo-controlled trial conducted in the United States and Australia (Study 1). The safety analysis set included 2789 VAXCHORA recipients. Solicited adverse reactions were recorded daily for 7 days following vaccination. Table 1 presents the frequency and severity of solicited adverse reactions observed within 7 days following receipt of VAXCHORA or placebo in Study 1.

Table 1: Rates of Solicited Adverse Reactions Reported in VAXCHORA Trial Participants 18 to 45 Years of Age During 7 Days Post-Vaccination — Study 1a
Adverse Reaction VAXCHORA Placebo (Saline)
(N=2789)b (N=350)b
% %
a Data are derived from Study 1 (NCT02094586).b N represents number of subjects who completed a memory aid.

Tiredness

31.3

27.4

Mild

18.7

16.3

Moderate

12.0

9.9

Severe

0.7

1.2

Potentially life-threatening

0.0

0.0

Headache

28.9

23.6

Mild

18.9

14.6

Moderate

9.6

8.8

Severe

0.5

0.3

Potentially life-threatening

0.0

0.0

Abdominal Pain

18.7

16.9

Mild

12.1

12.0

Moderate

6.2

5.0

Severe

0.4

0.0

Potentially life-threatening

0.0

0.0

Nausea/Vomiting

18.3

15.2

Mild

13.3

11.4

Moderate

4.7

3.8

Severe

0.3

0.0

Potentially life-threatening

0.0

0.0

Lack of Appetite

16.5

16.6

Mild

11.7

12.2

Moderate

4.4

4.4

Severe

0.3

0.0

Potentially life-threatening

0.0

0.0

Diarrhea

3.9

1.2

Mild

2.4

0.9

Moderate

0.7

0.3

Severe

0.8

0.0

Potentially life-threatening

0.04

0.0

Fever

0.6

1.2

Mild

0.2

0.3

Moderate

0.3

0.9

Severe

0.07

0.0

Potentially life-threatening

0.04

0.0

Grading scales are defined as follows:

Tiredness, Headache, Abdominal Pain, Nausea, Lack of Appetite: Mild = no interference with activity, Moderate = Some interference with activity, Severe = significant, prevents daily activity, Potentially Life Threatening = emergency room (ER) visit or hospitalization.

Vomiting: Mild = 1-2 episodes/24 hours, Moderate = >2 episodes/24 hours, Severe = requires intravenous hydration, Potentially Life Threatening = ER visit or hospitalization for hypotensive shock.

Diarrhea: Mild = 4 loose stools/24 hours, Moderate = 5 loose stools/24 hours, Severe = ≥6 loose stools /24 hours, Potentially Life Threatening = ER visit or hospitalization.

Fever: Mild = 38.0-38.4°C/100.4-101.1°F, Moderate = 38.5-38.9°C/101.2- 102.0°F, Severe = 39.0-40.0°C/102.1-104.0°F, Potentially Life Threatening = >40.0 °C/104.0 °F.

Serious Adverse Events

In a pooled analysis of the four clinical studies, 0.6% (20/3235) of VAXCHORA recipients and 0.5% (3/562) of placebo recipients reported a serious adverse event within 6 months post-vaccination. None of these events were considered to be related to vaccination.

Pediatric Trial

The safety of VAXCHORA in children was evaluated in one randomized, placebo-controlled, multicenter clinical trial. A total of 468 children 2 through 17 years of age received one dose of VAXCHORA and 75 received placebo (physiologic saline). The mean age was 9.0 years; 51.6% were male; 59.5% were White, 31.3% were Black, 7.7% were multiracial, 0.9% were Asian, and 0.6% were American Indian/Alaskan Native. There were 8.7% Hispanic or Latino participants.

Solicited Adverse Reactions

Children 2 through 17 years of age received VAXCHORA in a multi-center, double-blind, randomized (6:1), placebo-controlled trial conducted in the United States (Study 5). Randomization was stratified by age, and children were enrolled in three separate age cohorts: 12 to < 18 years (Cohort 1), 6 to < 12 years (Cohort 2), and 2 to < 6 years (Cohort 3). The safety analysis set included 468 VAXCHORA recipients and 75 placebo recipients. Solicited adverse reactions were recorded daily for 7 days following vaccination. Table 2 presents the frequency and severity of solicited adverse reactions observed within 7 days following receipt of VAXCHORA or placebo in Study 5 for the 3 study cohorts.

Table 2: Rates of Solicited Adverse Reactions Reported in VAXCHORA Pediatric Trial (Study 5) Participants 2 to 17 Years of Age During 7 Days Post-Vaccination by Age cohort
a Data are derived from Study 5 (NCT03220737).b N represents number of subjects with a completed a memory aid.c Includes 1 case evaluated in the emergency room for an associated viral pharyngitis considered not related to vaccination.d Includes 1 case with temperature greater than 40°C considered not related to vaccination

Adverse Reaction

Cohort 1 Ages 12 to <18 years VAXCHORA (N=165)b %

Cohort 1 Ages 12 to <18 years Placebo (Saline) (N=24)b %

Cohort 2 Ages 6 to <12 years VAXCHORA (N=157)b %

Cohort 2 Ages 6 to <12 years Placebo (Saline) (N=25)b %

Cohort 3 Ages 2 to <6 years VAXCHORA (N=146)b %

Cohort 3 Ages 2 to <6 years Placebo (Saline) (N=26)b %

Tiredness

40.6

37.5

35.0

32.0

30.8

23.1

Mild

31.5

33.3

22.3

20.0

19.2

15.4

Moderate

8.5

0.0

12.1

12.0

11.6

7.7

Severe

0.6 c

4.2

0.6

0.0

0.0

0

Headache

44.8

45.8

26.1

24.0

8.9

7.7

Mild

34.5

45.8

19.1

20.0

6.8

3.8

Moderate

9.7

0.0

5.7

4.0

2.1

3.8

Severe

0.6

0.0

1.3

0.0

0.0

0.0

Abdominal Pain

37.6

16.7

27.4

24.0

17.1

15.4

Mild

28.5

12.5

23.6

16.0

14.4

15.4

Moderate

8.5

4.2

3.8

8.0

2.7

0.0

Severe

0.6

0.0

0.0

0.0

0.0

0.0

Lack of Appetite

29.1

12.5

15.3

20.0

19.2

11.5

Mild

23.6

12.5

12.7

16.0

12.3

7.7

Moderate

5.5

0.0

1.9

4.0

6.8

3.8

Severe

0.0

0.0

0.6

0.0

0.0

0.0

Nausea

22.4

25.0

14.0

16.0

6.8

15.4

Mild

17.0

20.8

12.1

8.0

6.2

15.4

Moderate

4.8

4.2

1.9

8.0

0.7

0.0

Severe

0.6

0.0

0.0

0.0

0.0

0.0

Vomiting

5.5

0.0

4.5

0.0

1.4

11.5

Mild

3.6

0.0

2.5

0.0

1.4

7.7

Moderate

1.2

0.0

1.9

0.0

0.0

3.8

Severe

0.6

0.0

0.0

0.0

0.0

0.0

Fever

1.2

0.0

3.2

4.0

2.1

3.8

Mild

0.6

0.0

0.0

0.0

0.7

0.0

Moderate

0.0

0.0

0.6

4.0

0.7

0.0

Severe

0.6

0.0

2.5

0.0

0.7 d

3.8

Diarrhea

3.6

4.2

0.0

0.0

0.7

0.0

Mild

1.8

0.0

0.0

0.0

0.7

0.0

Moderate

0.0

4.2

0.0

0.0

0.0

0.0

Severe

1.8

0.0

0.0

0.0

0.0

0.0

Pediatric Grading scales are defined as follows:

Tiredness, Headache, Abdominal Pain, Nausea, Lack of Appetite: Mild = no interference with activity, Moderate = Some interference with activity, Severe = significant, prevents daily activity, Potentially Life Threatening = emergency room (ER) visit or hospitalization.

Vomiting: Mild = 1-2 episodes/24 hours, Moderate = >2 episodes/24 hours, Severe = requires intravenous hydration, Potentially Life Threatening = ER visit or hospitalization for hypotensive shock.

Diarrhea: Mild = 4 loose stools/24 hours, Moderate = 5 loose stools/24 hours, Severe = ≥6 loose stools /24 hours, Potentially Life Threatening = ER visit or hospitalization.

Fever: Mild = 38.0-38.4ºC/100.4-101.1ºF, Moderate = 38.5-38.9ºC/101.2-102.0ºF, Severe = 39.0‑40.0ºC/102.1-104.0ºF, Potentially Life Threatening = >40.0 ºC/104.0 ºF.

In total, 13.2% of VAXCHORA recipients reported an unsolicited adverse event that was considered related to study treatment, compared to 9.3% for placebo recipients.

The most frequent unsolicited adverse event for VAXCHORA was loose stool in Cohort 1 (13.9%), Cohort 2 (11.5%) and Cohort 3 (5.5%).

Serious Adverse Events

In Study 5, 0.2% (1/468) of VAXCHORA recipients and 1.3% (1/75) of placebo recipients reported a serious adverse event within 6 months post-vaccination. None of these events were considered to be related to vaccination.

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