Vaxchora (Cholera) Vaccine, Live, Oral: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VAXCHORA safely and effectively. See full prescribing information for VAXCHORA.

See full insert sheet at this link at the Natural News Reference website.

VAXCHORA™ (Cholera Vaccine, Live, Oral)

Suspension for Oral Administration

Initial U.S. Approval: 2016

INGREDIENTS AND EXCIPIENTS

VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. CVD 103-HgR was constructed from the serogroup O1 classical Inaba strain 569B by deleting the catalytic domain sequence of both copies of the ctxA gene, which prevents the synthesis of active cholera toxin (CT). This attenuated strain remains able to synthesize the immunogenic non-toxic B subunit of CT (encoded by the ctxB gene). In addition, a marker was inserted into the hemolysin gene locus (hlyA) to enable differentiation of the vaccine strain from wild type V. cholerae O1.

The vaccine strain is grown in fermentors under controlled conditions in medium containing casamino acids, yeast extract, mineral salts, and an anti-foaming agent. The bacteria are collected by filtration, diafiltered, and concentrated before addition of a stabilization solution containing ascorbic acid (an antioxidant), Hy-Case SF (hydrolyzed casein [a protein derived from cow’s milk], a cryoprotectant), sodium chloride (a stabilizer), and sucrose (a cryoprotectant). The stabilized bacteria are lyophilized, milled, and blended with dried lactose (a desiccant and bulking agent). The active component blend is filled into packets.

The buffer component is manufactured by blending together sodium bicarbonate (a gastric acid neutralizer), sodium carbonate (a buffer), ascorbic acid (a buffer and water chlorine neutralizer), and dried lactose (a manufacturing flow aid). The buffer component blend is filled into packets. One buffer component packet and one active component packet are packaged into individual single dose cartons for distribution.

After reconstitution, VAXCHORA contains 4 x 108 to 2 x 109 colony forming units (CFU) of live attenuated V. cholerae CVD 103-HgR. The resulting suspension should be slightly cloudy and may contain white particulates. The active and buffer ingredients are shown in Table 2.

Table 2: Vaccine Composition

Ingredient	Quantity/packet
Active Component Packet
V. cholerae CVD 103-HgR	4 x 108 to 2 x 109 CFU
Sucrose	≤ 165.37 mgb
Sodium chloride	≤ 17.11 mg
Hy-Case SF (hydrolyzed casein)	≤ 17.11 mg
Ascorbic acid	≤ 8.55 mg
Dried lactose	≤ 2.09 gc
Buffer Component Packet
Sodium bicarbonate	2.16–2.41 g
Sodium carbonate	0.24-0.49 g
Ascorbic acid	1.50–1.80 g
Dried lactose	0.18–0.22 g

INDICATIONS AND USAGE

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas. (1) Limitations of Use:

• The effectiveness of VAXCHORA has not been established in persons living in cholera-affected areas. (1.1)

• 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. (1.1)

• VAXCHORA has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups. (1.1)

DOSAGE AND ADMINISTRATION

For oral administration only.

• Prepare and administer VAXCHORA in a healthcare setting equipped to dispose of medical waste. (2.3)

• Prepare VAXCHORA by reconstituting the buffer component in 100 milliliters (mL) of purified bottled water; then add the active component (lyophilized V. cholerae CVD 103-HgR). (2.3) After preparation, a single dose of VAXCHORA is 100 mL. (3)

• Instruct recipients to avoid eating or drinking for 60 minutes before or after oral ingestion of VAXCHORA. (2.2)

• Administer VAXCHORA a minimum of 10 days before potential exposure to cholera. (2.1)

DOSAGE FORMS AND STRENGTHS

Suspension for oral administration supplied as a packet of the buffer component and a packet of the active component (lyophilized V. cholerae CVD 103-HgR). After preparation, a single dose of VAXCHORA is 100 mL. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to any ingredient of VAXCHORA or to a previous dose of any cholera vaccine. (4)

WARNINGS AND PRECAUTIONS

The safety and effectiveness of VAXCHORA have not been established in immunocompromised persons. (5.1)

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 nonvaccinated close contacts (e.g., household contacts). Use caution when considering whether to administer VAXCHORA to individuals with immunocompromised close contacts. (5.2)

ADVERSE REACTIONS

The most common adverse reactions (incidence > 3%) were tiredness (30%), headache (28%), abdominal pain (18%), nausea/vomiting (17%), lack of appetite (16%) and diarrhea (4%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact PaxVax, Inc. at 1-800-533-5899 or [email protected] or VAERS at 1-800-222-7967 or www.vaers.hhs.gov.

DRUG INTERACTIONS

Avoid concomitant administration of VAXCHORA with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer VAXCHORA to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination. (7.2)

Immune responses to VAXCHORA may be diminished when VAXCHORA is administered concomitantly with chloroquine. Administer VAXCHORA at least 10 days before beginning antimalarial prophylaxis with chloroquine.(7.2)

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VAXCHORA during pregnancy. To enroll in or obtain information about the registry, please call PaxVax at 1-800-533-5899.

Risk Summary

VAXCHORA is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

Maternal cholera disease is associated with adverse pregnancy outcomes including fetal death.

Fetal/neonatal adverse reactions

The vaccine strain may be shed in the stool of the vaccinated mother for at least 7 days, with a potential for transmission of the vaccine strain from mother to infant during vaginal delivery.

LACTATION

Risk Summary

VAXCHORA is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to VAXCHORA.

Pediatric Use

The safety and effectiveness of VAXCHORA have not been established in children and adolescents younger than 18 years.

Geriatric Use

The safety and effectiveness of VAXCHORA have not been established in adults 65 years of age or older.

Immunocompromised Individuals

The safety and effectiveness of VAXCHORA have not been established in immunocompromised individuals. The immunologic response to VAXCHORA may be diminished in immunocompromised individuals [see Drug Interactions (7.3)].

Pregnancy Registry: available at 1-800-533-5899. (8.1)

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM506235.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Vaxchora-Cholera-Vaccine.pdf