Vaccine Information: Vaxchora

VAXCHORA- cholera vaccine, live, oral
Paxvax, Inc.

1 INDICATIONS AND USAGE

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 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 Dosage 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.
Reconstitution should be completed within 15 minutes of removing 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 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.
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. The active component may not dissolve completely.
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)
Image of the prep, reconstitution and administration of Vaxchora

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 milliliters (mL).

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

6.1 Clinical Trials Experience

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 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 1 *
VAXCHORA Placebo (Saline)
Adverse Reaction (N=2789) (N=350)
% %
*
Data are derived from Study 1 (NCT02094586).
N represents number of subjects who completed a memory aid.
Severe category includes both grade 3 (severe) and grade 4 (potentially life-threatening) adverse events.

Tiredness

31.3

27.4

Mild

18.7

16.3

Moderate

12.0

9.9

Severe

0.7

1.2

Headache

28.9

23.6

Mild

18.9

14.6

Moderate

9.6

8.8

Severe

0.5

0.3

Abdominal Pain

18.7

16.9

Mild

12.1

12.0

Moderate

6.2

5.0

Severe

0.4

0.0

Nausea/Vomiting

18.3

15.2

Mild

13.3

11.4

Moderate

4.7

3.8

Severe

0.3

0.0

Lack of Appetite

16.5

16.6

Mild

11.7

12.2

Moderate

4.4

4.4

Severe

0.3

0.0

Diarrhea

3.9

1.2

Mild

2.4

0.9

Moderate

0.7

0.3

Severe

0.84

0.0

Fever

0.6

1.2

Mild

0.2

0.3

Moderate

0.3

0.9

Severe

0.11

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.

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