TM Owner Bavarian Nordic A/S
Vaxchora 2g Oral Suspension
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Indications & Clinical Uses
- Vaxchora is a live, oral cholera vaccine containing a weakened strain of Vibrio cholerae serogroup O1 (CVD 103-HgR), given as a single dose.
- It is approved in the US for active immunisation against disease caused by Vibrio cholerae serogroup O1 in people aged 2 through 64 years who are travelling to cholera-affected areas.
- Its effectiveness has not been established in people living in cholera-endemic areas or in people who have had cholera or been exposed before.
- The pack contains two powder packets (a buffer packet and an active vaccine packet) that are mixed with 100 mL of bottled water (50 mL for children aged 2 to 5 years) and drunk.
- The US licence holder is Bavarian Nordic A/S.
- There is no boxed warning.
Side Effects
- The most common reactions in adults (more than 3%) were tiredness (31%), headache (29%), abdominal pain (19%), nausea or vomiting (18%), loss of appetite (17%) and diarrhoea (4%).
- In adolescents aged 12 to under 18 years, headache (45%), tiredness (41%), abdominal pain (38%), loss of appetite (29%) and nausea (22%) were most common.
- In children aged 6 to under 12 years, tiredness (35%), abdominal pain (27%), headache (26%), loss of appetite (15%) and nausea (14%) were reported, and in children aged 2 to under 6 years, tiredness (31%), loss of appetite (19%) and abdominal pain (17%).
- The label has no boxed warning.
- Seek urgent help for signs of a severe allergic reaction, such as swelling of the face or throat or trouble breathing.
Precautions & Warnings
- Do not use Vaxchora if you have had a severe allergic reaction, including anaphylaxis, to any ingredient or to a previous dose of a cholera vaccine.
- The vaccine strain can be shed in the stool for at least 7 days and may spread to unvaccinated close contacts, so take care around people with weakened immune systems.
- Safety and effectiveness have not been established in immunocompromised people.
- Do not eat or drink for 60 minutes before and after the dose.
- The vaccine is not systemically absorbed, so fetal or infant exposure is not expected in pregnancy or breastfeeding, although the strain may be passed to a newborn during vaginal delivery.
- Keep the packets refrigerated at 2°C to 8°C until use.
Avoid Interactions
- Medicines and foods that reduce the vaccine response or safety: systemic antibiotics (oral or injected) - the vaccine should not be given within 14 days after an antibiotic; chloroquine antimalarial prophylaxis - the vaccine should be given at least 10 days before chloroquine starts; immunosuppressive treatments, which can weaken the immune response; and any food or drink within 60 minutes before or after the dose.
- Mix only with bottled water (purified, spring or carbonated) as described in the label.
- Tell your healthcare provider about all medicines, especially antibiotics, antimalarials and immunosuppressants.
References
Frequently Asked Questions
Vaxchora (live, oral cholera vaccine) protects against cholera caused by Vibrio cholerae serogroup O1 in people aged 2 to 64 years who are travelling to cholera-affected areas. It is a single oral dose. It has not been shown to work in people living in cholera-endemic areas.
Vaxchora is a single oral dose of live cholera vaccine. Two packets are mixed with 100 mL of bottled water (50 mL for children aged 2 to 5) and drunk. Do not eat or drink for 60 minutes before or after the dose.
The most common Vaxchora (cholera vaccine) side effects in adults are tiredness (31%), headache (29%), stomach pain (19%), nausea or vomiting (18%) and loss of appetite (17%). Teenagers reported headache and tiredness most often. Seek urgent help for signs of a severe allergic reaction.
Avoid systemic antibiotics for 14 days before Vaxchora (cholera vaccine). Start chloroquine malaria prevention at least 10 days after vaccination. Do not eat or drink for 60 minutes before or after the dose. Do not take it if you have had a severe allergy to the vaccine.
Yes. The live Vaxchora (cholera vaccine) strain can be shed in the stool for at least 7 days and may pass to unvaccinated close contacts. Take care around people with weakened immune systems. Safety in immunocompromised people has not been established, so tell your healthcare provider before vaccination.
Vaxchora (cholera vaccine) is not absorbed into the blood, so it is not expected to reach the baby during pregnancy or through breast milk. The vaccine strain may be shed in stool and could pass to a newborn during vaginal delivery. Discuss timing with your healthcare provider.
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