Vaxchora

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
  



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 This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vaxchora effervescent powder and powder for oral suspension 
Cholera vaccine (recombinant, live, oral) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each dose of vaccine contains 4 × 108 to 2 × 109 viable cells of V. cholerae live, attenuated strain CVD 
103-HgR1. 
1 Produced by recombinant DNA technology. 
 
This product contains genetically modified organisms (GMOs). 
 
Excipient(s) with known effect: each dose of vaccine contains lactose, sucrose, and 863 milligrams of 
sodium. 
 
For the full list of excipients see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Effervescent powder and powder for oral suspension. 
White-to-off-white buffer powder and white-to-beige active ingredient powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Vaxchora is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 
in adults and children aged 6 years and older. 
 
This vaccine should be used in accordance with official recommendations. 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults and children aged 6 years and older 
 
A single oral dose should be administered at least 10 days prior to potential exposure to V. cholerae 
O1. 
 
Revaccination 
 
No data are available on revaccination interval. 
 
Paediatric population 
 
The safety and efficacy of Vaxchora in children less than 6 years has not been established. No data are 
available. 



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Method of administration 
 
Oral use. 
 
For instructions on reconstitution of Vaxchora prior to administration, see section 6.6. 
 
Eating and drinking should be avoided for 60 minutes before and after oral ingestion of Vaxchora. 
The reconstituted vaccine forms a slightly cloudy suspension that may contain some white particulates. 
After reconstitution, the suspension should be drunk within 15 minutes. The recipient should drink the 
full contents of the cup at once. Some residue may remain in the cup. The cup should be washed with 
soap and hot water. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 
 
Allergic reaction to previous ingestion of Vaxchora. 
 
Individuals with congenital immune deficiency or receiving immunosuppressive drugs or treatments. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administrated product should be clearly recorded. 
 
Factors affecting protection 
 
Vaxchora confers protection specific to Vibrio cholerae serogroup O1. Immunisation does not protect 
against V. cholerae O139 or other species of Vibrio. 
 
Vaxchora does not provide 100% protection. Vaccinees should adhere to hygiene advice and exercise 
caution regarding food and water consumed in cholera-affected areas. 
 
No data are available in persons living in cholera-affected areas or in individuals with pre-existing 
immunity to cholera. 
 
The protection afforded by Vaxchora may be reduced in HIV-infected individuals. 
 
Potential risk to contacts 
 
Vaxchora shedding in the stools was studied for 7 days post-vaccination, and was observed in 11.3% 
of vaccine recipients. The duration of shedding of the vaccine strain is unknown. There is a potential 
for transmission of the vaccine strain to non-vaccinated close contacts (e.g., household contacts). 
 
Concomitant administration with antibacterial agents and/or chloroquine 
 
Concomitant administration with antibacterial agents and/or chloroquine should be avoided because 
protection against cholera may be diminished. Refer to section 4.5. 
 
Gastrointestinal Disease 
 
In individuals with acute gastroenteritis, vaccination should be postponed until after recovery, because 
protection against cholera may be diminished. The degree of protection and the effects of vaccination 
in individuals with chronic gastrointestinal disease are unknown. 



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Limitations of the clinical data 
 
Clinical trials were conducted in individuals age 6 to 64 years old. Efficacy was demonstrated using 
human cholera challenge at 10 days or 3 months post-vaccination in adults age 18-45 years and 
immunobridging to other populations based on seroconversion rate. Immunogenicity data are available 
for 6 months post-vaccination. There are no immunogenicity or efficacy data in individuals over 
64 years of age. 
 
Excipients 
 
The vaccine contains lactose and sucrose. Patients with rare hereditary problems of galactose 
intolerance, congenital lactase deficiency, glucose-galactose malabsorption, fructose intolerance, or 
sucrose-isomaltase insufficiency should not take this vaccine. 
 
The vaccine contains 863 mg of sodium per dose, equivalent to 43% of the WHO recommended 
maximum daily intake of 2 g of sodium for an adult. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed with, Vaxchora, however data and clinical experience 
from other vaccines can be applicable to Vaxchora. 
 
There should be an interval of 2 hours between the administration of Vaxchora and of typhoid vaccine 
Ty21a (gastro-resistant capsules) as the buffer administered with Vaxchora may affect the transit of 
the capsules through the gastrointestinal tract. 
 
Concomitant administration of Vaxchora with systemic antibiotics active against V. cholerae should be 
avoided since these agents may prevent a sufficient degree of multiplication to occur in order to induce 
a protective immune response. Vaxchora should not be administered to patients who have received 
oral or parenteral antibiotics within 14 days prior to vaccination. Oral or parenteral antibiotics should 
be avoided for 10 days following vaccination with Vaxchora. 
 
Data from the study of a previous CVD 103-HgR-based vaccine indicate that immune responses to 
Vaxchora and protection against cholera may be diminished when Vaxchora is administered 
concomitantly with chloroquine. Administer Vaxchora at least 10 days before beginning antimalarial 
prophylaxis with chloroquine. There are no data regarding concomitant use of Vaxchora with other 
anti-malarial drugs. 
 
The vaccine is acid-labile and is administered with a buffer. Eating and drinking should be avoided for 
60 minutes before and after taking Vaxchora as this may interfere with the protective effect of the 
buffer. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are limited data from the use of Vaxchora in pregnant women. 
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). 
Vaxchora should be used during pregnancy only if the potential benefits to the mother outweigh the 
potential risks, including those to the foetus. 
 
Breast-feeding 
 
It is unknown whether Vaxchora is excreted in human milk. A risk to the breastfed child cannot be 
excluded. A decision must be made whether to discontinue breast-feeding or to abstain from using 



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Vaxchora taking into account the benefit of breast feeding for the child and the benefit of Vaxchora for 
the woman. 
 
Fertility 
 
No human or animal data on the effect of Vaxchora on fertility are available. 
 
4.7 Effects on ability to drive and use machines 
 
Vaxchora has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
The most frequent reported adverse reactions following Vaxchora administration are tiredness 
(30.2%), headache (28.3%), abdominal pain (18.4%), nausea/vomiting (17.7%), and lack of appetite 
(15.7%). 
 
Tabulated summary of adverse reactions 
The adverse reaction frequency classification used is as follows: Very common (≥1/10); common (≥
1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 
(<1/10,000), not known (cannot be estimated from the available data). 
 

Adverse Reactions Frequency 
Metabolism and nutrition disorders 
Decreased appetite Very common 
Nervous system disorders 
Headache Very common 
Dizziness Uncommon 
Gastrointestinal disorders 
Abdominal pain, nausea/vomiting Very common 
Diarrhoea Common 
Flatulence, constipation, abdominal distension, dyspepsia, abnormal faeces, 
dry mouth, eructation 

Uncommon 

Skin and subcutaneous tissue disorders 
Rash Uncommon 
Musculoskeletal and connective tissue disorders 
Arthralgia Uncommon 
Chills Rare 
General disorders and administration site conditions 
Fatigue Very common 
Pyrexia Uncommon 

 
Paediatric population 
A clinical trial was conducted in 374 children age 6 to <18 years. Based on the results of this trial the 
type of adverse reactions in children are expected to be similar to those in adults. Some adverse 
reactions were more common in children than adults, including headache (36.0% vs 28.3%), fatigue 
(37.9% vs 30.2%), abdominal pain (32.6% vs 18.4%), vomiting (5.3% vs 0.2%), decreased appetite 
(22.4% vs 15.7%) and pyrexia (2.5% vs 0.8%). 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 



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4.9 Overdose 
 
There have been reports of multiple doses of Vaxchora being administered several weeks apart. The 
adverse reactions reported were comparable to those seen after the recommended dose. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Bacterial vaccines, ATC code: J07AE02 
 
Mechanism of action 
Vaxchora contains live attenuated cholera bacteria (V. cholerae O1 classical Inaba strain CVD 103-
HgR) that replicate in the gastrointestinal tract of the recipient and induce serum vibriocidal antibody 
and memory B cell responses. Immune mechanisms conferring protection against cholera following 
receipt of Vaxchora have not been determined, however, rises in serum vibriocidal antibody 10 days 
after vaccination with Vaxchora were associated with protection in a human challenge study. 
 
Efficacy against cholera challenge 
Vaxchora efficacy against cholera was demonstrated in a human challenge study conducted in 197 
healthy adult volunteers mean age 31 years (range 18 to 45, 62.9% male, 37.1% female) in which a 
subset of Vaxchora or placebo recipients were challenged with live V. cholerae at 10 days post-
vaccination (n=68) or 3 months post-vaccination (n=66). Protective efficacy against moderate to 
severe diarrhoea is shown in Table 1. 
 
In individuals with blood group O only, the protective efficacy against moderate or severe diarrhoea 
was 78.4% in the 10 day challenge group (n=19) and 82.5% in the 3 month challenge group (n=20). 
 
Table 1: Protective Efficacy in the Prevention of Moderate to Severe Diarrhoea Following 

Challenge with V. cholerae O1 El Tor Inaba at 10 Days and 3 Months Post-Vaccination 
(Intent-to-Treat Population) 

 

Parameter 

Vaxchora 10 Day 
Challenge 

N=35 

Vaxchora 3 Month 
Challenge 

N=33 

Combined Placebo 10 
Day or 3 Month 

Challenge 
N=66 

Number of Subjects with 
Moderate or Severe 
Diarrhoea (Attack Rate) 

2 (5.7%) 4 (12.1%) 39 (59.1%) 

Protective Efficacy % 
[95% CI] 

90.3% 
[62.7%, 100.0%] 

79.5% 
[49.9%, 100.0%] 

- 

 
Immunogenicity 
The human challenge study showed that vibriocidal seroconversion, defined as a four-fold or greater 
rise in serum vibriocidal antibody titres from baseline measured 10 days after vaccination, had a nearly 
one-to-one correlation with protection against moderate-to-severe diarrhoea. Seroconversion was 
therefore selected as the immunologic bridge between adults age 18 to <46 years in the challenge 
study and other populations, i.e. older adults and paediatric subjects. Three additional studies evaluated 
immunogenicity: a large trial in 3146 healthy adults age 18 to<46 years (mean age 29.9, range 18-46, 
45.2% male, 54.8% female); a trial in 398 healthy older adults age 46 to <65 years (mean age 53.8, 
range 46-64, 45.7% male, 54.3% female); and a paediatric trial in healthy subjects age 6-17 years. 
Prespecified immunobridging analyses, based on differences in seroconversion rates, were determined 
to demonstrate non-inferiority in seroconversion rate between older adults or paediatric subjects and 
the adults age 18 to <46 in the large immunogenicity trial. 



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The seroconversion rates in vaccine and placebo recipients from each trial, as well as immunobridging 
results, are summarised in Tables 2 and 4. Seroconversion rates in older adults and paediatric subjects 
were non-inferior to those in younger adults. 
 
In the three adult studies significant increases in the percentage of anti-O1 lipopolysaccharide (LPS) 
IgA and IgG memory B cells and anti-cholera toxin IgG memory B cells were seen at 90 and 180 days 
after vaccination. No relationship between age and memory B cell response was observed. Geometric 
mean titres (GMTs) of serum vibriocidal antibodies in vaccinated subjects were also significantly 
higher than the respective GMTs of placebo recipients at 90 and 180 days after immunisation in all age 
groups. The duration of protection is not known. 
 
Table 2: Vibriocidal Antibody Seroconversion Against Classical Inaba V. cholerae Vaccine 

Strain at 10 Days Post-Vaccination in Adults 
 

Study Vaxchora Recipients Placebo Recipients 

Immunobridging: 
Difference in 

Seroconversion 
Rate Compared 
to Large Trial in 
18-45 year olds 

(age in years) Nb 

Seroconversiona 
% 

[95% CI] Nb 

Seroconversiona 
% 

[95% CIc] 
%d 

[95% CIc] 

Challenge Trial 
(18 – 45) 

93 90.3% 
[82.4%, 95.5%] 

102 2.0% 
[0.2%, 6.9%] 

- 

Large Trial 
(18 – 45) 

2687 93.5% 
[92.5%, 94.4%] 

334 4.2% 
[2.3%, 6.9%] 

- 

Older Adults 
(46 – 64) 

291 90.4% 
[86.4%, 93.5%] 

99 0% 
[0.0%, 3.7%] 

−3.1% 
[−6.7%, 0.4%] 

a Seroconversion is defined as the percentages of subjects who had at least a 4-fold rise in vibriocidal antibody 
titer at 10 days post-vaccination compared to baseline. 

b N=number of subjects with analyzable samples at Day 1 and Day 11. 
c CI=confidence interval. 
d Non-inferiority criteria: lower bound of the two-sided 95% confidence interval on the difference in 

seroconversion rates compared with adults age 18 to <46 years had to be greater than –10 percentage points 
and the lower bound of the two-sided 95% confidence interval on the proportion of vaccinees who 
seroconverted 10 days after vaccination had to be equal to or exceed 70%. 

 
Available data on seroconversion rates against other biotypes and serotypes of V. cholerae are shown 
in Table 3. Seroconversion rates for these biotypes and serotypes were not determined in children. 
 



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Table 3: Seroconversion Rates 10 Days Post-Vaccination for the Four Major V. cholerae O1 
Serogroup Biotypes and Serotypes [Immunogenicity Evaluable Population] 

 

Cholera Strain 

Younger Adults 
(18 through 45 year olds) 

Vaxchora 

Older Adults 
(46 through 64 year olds) 

Vaxchora 

Na %
b 

[95% CIc] N
a % [95% CI] 

Classical Inabad 93 90.3% [82.4%, 95.5%] 291 
90.4% 

[86.4%, 93.5%] 

El Tor Inaba 93 91.4% [83.8%, 96.2%] 290 
91.0% 

[87.1%, 94.1%] 

Classical Ogawa 93 87.1% [78.5%, 93.2%] 291 
73.2% 

[67.7%, 78.2%] 

El Tor Ogawa 93 89.2% [81.1%, 94.7%] 290 
71.4% 

[65.8%, 76.5%] 
a N=number of subjects with measurements at baseline and 10 days post-vaccination. One subject in the younger 

adults study did not have a Day 11 measurement and was dropped from the analysis. 
b Seroconversion is defined as the percentages of subjects who had at least a 4-fold rise in vibriocidal antibody 

titer at 10 days post-vaccination compared to the titer measured at baseline. 
c CI=confidence interval. 
d Vaxchora contains the classical Inaba strain of V. cholerae O1. 
 
 
Paediatric population 
An immunogenicity trial was conducted in 374 healthy children age 6 to <18 years (mean age 11.5, 
range 6-17, 52.4% male, 47.6% female). The seroconversion results in vaccine and placebo recipients 
and immunobridging results are shown in Table 4. 
 
Table 4: Vibriocidal Antibody Seroconversion Against Classical Inaba V. cholerae Vaccine 

Strain at 10 Days Post-Vaccination in Children 
 

Study Vaxchora Recipients Placebo Recipients 

Immunobridging: 
Difference in 

Seroconversion 
Rate Compared 
to Large Trial 
in 18-45 year 

olds 

(age in years) Nb 

Seroconversiona 
% 

[95% CI] Nb 

Seroconversiona 
% 

[95% CIc] 
%d 

[96.7% CI] 

Paediatric Trial 
(6 – 17) 

296 98.6% 
[96.6%, 99.5%] 

47 2.1% 
[0.4%, 11.1%] 

5.1% 
[2.6%, 6.5%]c 

a Seroconversion is defined as the percentages of subjects who had at least a 4-fold rise in vibriocidal antibody 
titer at 10 days post-vaccination compared to baseline. 

b N=number of subjects with analyzable samples at Day 1 and Day 11. 
c CI=confidence interval. 
d Non-inferiority criteria: lower bound of the two-sided 98.3% confidence interval on the difference in 

seroconversion rates compared with adults ages 18 to <46 years had to be greater than –10 percentage points 
and the lower bound of the two-sided 98.3% confidence interval on the proportion of vaccinees who 
seroconverted 10 days after vaccination had to be equal to or exceed 70%. 

 



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The European Medicines Agency has deferred the obligation to submit the results of studies with 
Vaxchora in one or more subsets of the paediatric population in the prevention of cholera (see 
section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3 Preclinical safety data 
 
No preclinical safety data are available for Vaxchora. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Buffer, sachet 1: 
Sodium bicarbonate 
Sodium carbonate 
Ascorbic acid 
Lactose 
 
Active ingredient, sachet 2: 
Sucrose 
Hydrolysed casein 
Ascorbic acid 
Lactose 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products. 
 
6.3 Shelf life 
 
18 months. 
 
Vaxchora stored in the outer carton is stable at 25°C for up to 12 hours. 
 
After reconstitution (see section 6.6), the suspension should be drunk within 15 minutes. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Store in the original package. 
Avoid exposure to temperatures above 25°C. 
 
6.5 Nature and contents of container 
 
Carton box containing one active ingredient sachet and one buffer sachet. 
The active ingredient sachet contains 2 g of powder for oral suspension. 
The buffer sachet contains 4.5 g of effervescent powder. 
The active ingredient sachet is made from four-ply multilayer foil containing an outer layer of paper, a 
layer of low-density polyethylene, a layer of aluminium foil and an inner layer of low-density 
polyethylene. 



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The buffer sachet is made from three-ply multilayer foil containing an outer layer of paper, a middle 
layer of aluminium foil and an inner layer of low-density polyethylene. 
 
Pack size: 1 set of 2 sachets. 
 
6.6 Special precautions for disposal of used medicinal product or waste materials and other 

handling of the product 
 
This medicinal product contains genetically modified organisms. Unused medicinal product must be 
disposed of in compliance with the local biosafety guidelines. 
 
To prepare the vaccine for administration the Vaxchora active and buffer component sachets are 
removed from the refrigerator no more than 12 hours at 25°C prior to reconstitution. 
It is important to mix the sachets in the order described. First, the contents of the buffer sachet 1 (a 
white-to-off-white powder) are mixed with 100 mL of cold or room temperature (≤25°C) bottled 
non-carbonated drinking water in a cup. Second, the contents of the active component sachet 2 (a 
white-to-beige powder) are then added and the mixture is stirred for at least 30 seconds. The 
reconstituted vaccine forms a slightly cloudy suspension that may contain some white particulates. The 
dose should be administered within 15 minutes of reconstitution. 
 
Note: if the sachets are reconstituted in the incorrect order, the vaccine must be discarded. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Emergent Netherlands B.V. 
Strawinskylaan 411 
1077XX Amsterdam 
Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER 
 
EU/1/20/1423/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 01 April 2020 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{DD month YYYY} 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  



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ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) 
AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 



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A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer(s) of the biological active substance(s) 
 
Emergent BioSolutions Berna GmbH 
Oberriedstrasse 68 
CH-3174 Thörishaus 
Switzerland 
 
Name and address of the manufacturer(s) responsible for batch release 
 
IL-CSM GmbH 
Marie-Curie-Strasse 8 
D-79539 Lörrach 
Germany 
 
Emergent BioSolutions UK Ltd. 
Building 3, Chiswick Park 
566 Chiswick High Road 
London, W4 5YA 
United Kingdom 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
• Official batch release 
 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken 
by a state laboratory or a laboratory designated for that purpose. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 
6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 



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The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
• Additional risk minimisation measures 
 
Prior to the launch of Vaxchora in each Member State the Marketing Authorisation Holder (MAH) 
must agree about the content and format of the educational programme, including communication 
media, distribution modalities, and any other aspects of the programme, with the National Competent 
Authority. 
 
The educational programme is aimed at minimising the risk of medication errors during the 
reconstitution and use of the product. 
 
The MAH shall ensure that in each Member State where Vaxchora is marketed, all healthcare 
professionals and patients/carers who are expected to prescribe and use Vaxchora have access to/are 
provided with the following educational package: 
 
• Physician educational material 
• Patient information pack 
 
Physician educational material: 
• The Summary of Product Characteristics 
• Guide for healthcare professionals 
• Patient Guide 
• Guide for healthcare professionals key messages: 

• That there is an important risk of medication errors during the reconstitution and use of 
Vaxchora, 

• The patients/caretakers should be informed about and follow the reconstitution 
instructions as advised 

• The healthcare professionals should council the patients and their caretakers on how to 
reconstitute and administer Vaxchora 

• Detailed description of the administration procedures of Vaxchora 
 
The patient information pack: 

• Patient information leaflet 
• A patient/carer guide 

• Patient/carer guide key messages: 
• That it is important that Vaxchora is reconstituted and administered as instructed 
• Detailed description of the modalities used for the self-administration of Vaxchora 
• The importance of reporting medication errors. 

 
  



14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 



16 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Single carton box 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vaxchora 
Effervescent powder and powder for oral suspension 
Cholera vaccine (recombinant, live, oral) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
4×108 to 2×109 viable cells of V. cholerae strain CVD 103-HgR. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sucrose, lactose, and sodium. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 sachet powder for oral suspension 
1 sachet effervescent powder 
One dose. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Mix the effervescent powder (sachet 1) with bottled non-carbonated drinking water then add the active 
ingredient (sachet 2) and mix prior to taking. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
This medicine contains genetically modified organisms. Unused medicine must be disposed of in 
compliance with the local biosafety guidelines. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Emergent Netherlands B.V. 
Strawinskylaan 411 
1077XX Amsterdam 
Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1423/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Vaxchora 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Sachet 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Vaxchora active ingredient 
powder for oral suspension 
cholera vaccine strain 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
To be used with effervescent powder dissolved in bottled non-carbonated drinking water. 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.0 g 
 
 
6. OTHER 
 
2 
 
Please see other side for instructions. 
 
Sachet 2 of 2. Use last. 
 
Emergent Netherlands B.V. 
  



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Sachet 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Sodium hydrogen carbonate effervescent powder 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
To be mixed with bottled non-carbonated drinking water and Vaxchora active ingredient. 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
4.5 g 
 
 
6. OTHER 
 
1 
 
Please see other side for instructions. 
 
Sachet 1 of 2. Use first. 
 
 
Emergent Netherlands B.V. 
 
 
  



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B. PACKAGE LEAFLET 



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Package leaflet: Information for the user 
 

Vaxchora effervescent powder and powder for oral suspension 
cholera vaccine (recombinant, live, oral) 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you take this vaccine because it contains important 
information for you. 
– Keep this leaflet. You may need to read it again. 
– If you have any further questions, ask your doctor, pharmacist, or nurse. 
– This vaccine has been prescribed for you only. Do not pass it on to others. 
– If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Vaxchora is and what it is used for 
2. What you need to know before you take Vaxchora 
3. How to take Vaxchora 
4. Possible side effects 
5. How to store Vaxchora 
6. Contents of the pack and other information 
 
 
1. What Vaxchora is and what it is used for 
 
Vaxchora is an oral vaccine against cholera that stimulates the immunological defence in the gut. The 
vaccine is used for protection from cholera in adults and children aged 6 years and older. The vaccine 
must be taken at least 10 days before travelling to a cholera-affected area. 
 
How Vaxchora works 
 
Vaxchora prepares the immune system (the body’s defences) to defend itself against cholera. When a 
person takes the vaccine, the immune system makes proteins called antibodies against the cholera 
bacterium and its toxin (harmful substance) that causes diarrhoea. In this way the immune system is 
ready to fight cholera bacteria if the person comes into contact with it. 
 
 
2. What you need to know before you take Vaxchora 
 
Do not take Vaxchora: 
– if you are allergic to any of the ingredients in this medicine (listed in section 6). 
– if you had allergic reactions when you previously took Vaxchora. 
– if you have a weakened immune system, for example, if you were born with a weakened 

immune system or if you are having treatments such as high-dose corticosteroid treatment, 
cancer medicines or radiotherapy that can weaken the immune system. 

 
Warnings and precautions 
Talk to your doctor, pharmacist, or nurse before taking Vaxchora. 
 
Not everyone taking Vaxchora will be fully protected against cholera. It is important to continue to 
follow hygiene advice and take special care with food and water in cholera-affected areas. 
 
Vaxchora may be less effective if you have HIV. 



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Bacteria from the vaccine may be present in your stool for at least 7 days after you take the vaccine. 
To prevent any contamination, wash your hands thoroughly after visiting the toilet and before 
preparing food for at least 14 days after you take Vaxchora. 
 
Children and adolescents 
Do not give this vaccine to children younger than 6 years of age because it is not known how well it 
works in this age group. 
 
Other medicines and Vaxchora 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines or vaccines. This includes medicines obtained without a prescription, including herbal 
medicines. This is because Vaxchora can affect the way some other medicines and vaccines work. 
 
In particular tell your doctor, pharmacist or nurse if you are taking: 
• antibiotics – Vaxchora may not work if you take it while you are also taking antibiotics. Take 

Vaxchora no earlier than 14 days after the last dose of an antibiotic. Avoid antibiotics for 
10 days after taking Vaxchora. 

• chloroquine for malaria prevention – Vaxchora may not work if you take it while you are also 
taking chloroquine. Take Vaxchora at least 10 days before starting chloroquine or 14 days after 
taking chloroquine. 

• the typhoid vaccine Ty21a – Vaxchora may not work if it is taken at the same time as Ty21a. 
You should take Vaxchora at least 2 hours before or after taking Ty21a. 

 
If any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Vaxchora. 
 
Vaxchora with food and drink 
You must not eat or drink for 60 minutes before and after taking Vaxchora as this may reduce the 
vaccine’s effectiveness. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Driving and using machines 
Vaxchora is not likely to affect your ability to drive or use machines. However, do not drive or use any 
machines if you are feeling unwell. 
 
Vaxchora contains lactose, sucrose, and sodium 
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor 
before taking this medicinal product. 
 
This vaccine contains 863 mg of sodium (the main component of cooking/table salt) per dose. This is 
equivalent to 43% of the recommended daily dietary intake of sodium for an adult. Please take this 
into account if you are on a controlled sodium diet. 
 
 
3. How to take Vaxchora 
 
Always take this vaccine exactly as your doctor, pharmacist or nurse has told you. Check with your 
doctor, pharmacist or nurse if you are not sure. 
 
The recommended dose is the contents of both sachets in the carton. 
 
Protection against cholera is established within 10 days after taking Vaxchora. Your doctor, 
pharmacist or nurse will tell you how soon before travelling to take the vaccine. 
 



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Instructions: 
 

PREPARE THIS VACCINE EXACTLY AS DESCRIBED IN THIS LEAFLET 
 
Please read the following before you begin: 
Vaxchora may not work if the following occurs: 
• Incorrect storage; the vaccine must be stored in the refrigerator. 
• Using the incorrect amount of water; 100 mL must be used. 
• Using the incorrect type of water; bottled water that is cold or room temperature and non-

carbonated must be used. 
• Mixing the sachets in the wrong order; sachet 1 must be added to the water first. If the sachets 

are mixed in the wrong order you must discard the vaccine and request a replacement dose. 
• Eating or drinking; must be avoided 60 minutes before and after taking the vaccine, eating or 

drinking can reduce the effectiveness of the vaccine. 
 
Do not touch your eyes when you prepare the vaccine to avoid contamination. 
 
If any powder or liquid gets spilt, clean the surface with hot water and soap or an antibacterial 
disinfectant. 
 
If there is a significant spill (more than a few drops of liquid or grains of powder), dispose of the 
vaccine and get a new one from your doctor or pharmacist; DO NOT take the remaining medication. 
Step 1  Gather materials: 

• Clean cup 
• Utensil to stir 
• Bottled water (non-carbonated, cold or 

room temperature, 25°C or less) 
• Item to measure 100 mL of bottled water 

(e.g. measuring jug) 
• Scissors 

Step 2 

 

Remove the vaccine from the refrigerator. 
 

Step 3 

 

Locate the two sachets: the sachets are labelled 
1 and 2. 
 
Sachet 1 contains “Sodium hydrogen 
carbonate effervescent powder” (buffer) and is 
black and white. Sachet 2 contains “Vaxchora® 
Active ingredient” and is blue and white. 
 
If a sachet is not intact, do not use either 
sachet and contact your doctor, pharmacist or 
nurse about acquiring a replacement dose; 
using a sachet that is not intact can reduce the 
effectiveness of the vaccine. 



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Step 4 

 

Measure 100 mL of bottled cold or room 
temperature non-carbonated drinking water 
and pour into a clean cup. 
 
Using bottled water is necessary for the 
vaccine to be effective – using non-bottled 
(e.g. tap water) may render the vaccine 
ineffective. 

Step 5 

 

Use scissors to cut off the top of sachet 1. 
 
Do not put your fingers into the sachet. Wash 
your hands if you touch the sachet contents, in 
order to reduce the chance of contamination. 

Step 6 

 

Empty the contents of sachet 1 into the water 
in the cup. It will fizz. 

Step 7 

 

Stir until the powder completely dissolves. 

Step 8 

 

Use scissors to cut off the top of sachet 2. 
 
Do not put your fingers into the sachet. Wash 
your hands if you touch the sachet contents, in 
order to reduce the chance of contamination. 

Step 9 

 

Empty the contents of sachet 2 into the cup. 



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Step 10 

 

Stir for at least 30 seconds. The powder from 
sachet 2 may not dissolve completely. It will 
form a slightly cloudy mixture with some 
white particles. 

Step 11 

 

If you have spilled any material, DO NOT take 
the remaining dose and contact your doctor, 
pharmacist, or nurse about acquiring a 
replacement dose. 
 
Drink the full contents of the cup within 
15 minutes of preparing it. Some residue may 
remain in the cup and must be discarded. 

Step 12 

 

Dispose of the empty sachets according to 
local biosafety guidelines. 
Ask your doctor, pharmacist or nurse how to 
throw away medicine waste material. 

Step 13 

 

If a spill occurs while stirring or drinking the 
medication, or there is any residue (powder or 
liquid left behind from a stirring utensil, cup, 
or other object) on the mixing surface, clean 
up spilled material or residue preferably with a 
disposable paper towel/cloth using hot water 
and soap or antibacterial disinfectant. Discard 
the paper towel together with the sachets (see 
above). 

Step 14 

 

Wash the cup and spoon or stirrer with soap 
and hot water.  



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Step 15 

 

Wash your hands thoroughly with soap and 
hot water to prevent contamination. 

 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse. 
 
 
4. Possible side effects 
 
Like all vaccines, this vaccine can cause side effects, although not everybody gets them. 
 
Contact a doctor immediately if you get the following serious side effects: 
• serious allergic reactions causing swelling of the face or throat,hives, itchy rash, breathlessness 

and/or a drop in blood pressure and fainting. 
 
Other side effects: 
Very common side effects (may affect up to 1 in 10 people) 
• headache, 
• stomach pains, 
• feeling or being sick, 
• lack of appetite, 
• tiredness. 
 
Common side effects (may affect up to 1 in 100 people) 
• diarrhoea. 
 
Uncommon side effects (may affect up to 1 in 1,000 people) 
• flatulence, 
• constipation, 
• bloating (abdominal distension), 
• indigestion, 
• abnormal faeces, 
• dry mouth, 
• burping, 
• fever, 
• dizziness, 
• joint pain, 
• rash. 
 
Rare side effects (may affect up to 1 in 10,000 people): 
• chills 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 



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5. How to store Vaxchora 
 
Keep this vaccine out of the sight and reach of children. 
 
Do not use Vaxchora after the expiry date which is stated on the carton. The expiry date refers to the 
last day of that month. 
 
Store in a refrigerator (2°C – 8°C). 
Store in the original package. 
Vaxchora in the original package is stable for up to 12 hours at 25°C. Avoid exposing Vaxchora to 
temperatures above 25°C. 
 
Do not use this vaccine if you notice the sachets are damaged and contact your doctor, pharmacist, or 
nurse for a replacement dose. 
 
This medicine contains genetically-modified organisms. Local biosafety guidelines should be followed 
for unused medicine or waste material. Ask your doctor, pharmacist or nurse how to throw away 
medicines you no longer use or waste material. 
 
 
6. Contents of the pack and other information 
 
What Vaxchora contains 
– Each dose contains 4×108 to 2×109 viable cells of V. cholerae strain CVD 103-HgR. 
– The other ingredients are sucrose, hydrolysed casein, ascobic acid, lactose, sodium bicarbonate, 

and sodium carbonate. 
– This vaccine contains genetically modified organisms (GMOs). 
 
What Vaxchora looks like and contents of the pack 
The carton contains two sachets. One sachet contains white-to-off-white buffer sodium hydrogen 
carbonate effervescent powder. The other sachet contains white-to-beige active ingredient vaccine 
powder. 
 
Marketing Authorisation Holder 
 
Emergent Netherlands B.V, Strawinskylaan 411, 1077XX Amsterdam, Netherlands. 
 
Manufacturer 
 
IL-CSM GmbH 
Marie-Curie-Strasse 8 
D-79539 Lörrach 
Germany 
 
Emergent BioSolutions UK Ltd. 
Building 3, Chiswick Park 
566 Chiswick High Road 
London, W4 5YA 
United Kingdom 
 
This leaflet was last revised in MM/YYYY. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 



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This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET