Ervebo

1

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

Ervebo solution for injection
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (1 mL) contains:

Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP1,2 live, attenuated) ≥72 million pfu3
1Recombinant Vesicular Stomatitis Virus (rVSV) strain Indiana with a deletion of the VSV envelope 
glycoprotein (G) replaced with the Zaire Ebola Virus (ZEBOV) Kikwit 1995 strain surface 
glycoprotein (GP)
2Produced in Vero cells.
3pfu= plaque-forming units

This product contains genetically modified organisms (GMOs).
This vaccine contains a trace amount of rice protein. See section 4.3.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection
The solution is a colourless to slightly brownish-yellow liquid.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Ervebo is indicated for active immunization of individuals 18 years of age or older to protect against 
Ebola Virus Disease (EVD) caused by Zaire Ebola virus (see sections 4.2, 4.4 and 5.1).

The use of Ervebo should be in accordance with official recommendations.

4.2 Posology and method of administration

Ervebo should be administered by a trained healthcare worker.

Posology

Individuals 18 years of age or older: one dose (1 mL) (see section 5.1).

The need for a booster dose has not been established.

Paediatric population

The safety, immunogenicity and efficacy of Ervebo in children aged 1 to 17 years have not yet been 
established (see sections 4.8 and 5.1).

 



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Method of administration

For precautions to be taken before administering the vaccine, see section 4.4.

For precautions regarding thawing, handling and disposal of the vaccine, see section 6.6.

Ervebo should be administered by the intramuscular (IM) route. The preferred site is the deltoid area 
of the non-dominant arm or in the higher anterolateral area of the thigh. Do not inject the vaccine 
intravascularly. No data are available for administration via the subcutaneous or intradermal routes.

Cover the vaccination injection site or any vesicles with an adequate bandage (e.g. any adhesive 
bandage or gauze and tape) that provides a physical barrier to protect against direct contact (see 
sections 4.4 and 5.3). The bandage may be removed when there is no visible fluid leakage.

The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to rice 
protein listed in section 2.

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 administered product should be clearly recorded.

Hypersensitivity

Close monitoring is recommended following vaccination for the early signs of anaphylaxis or 
anaphylactoid reactions. As with all injectable vaccines, appropriate medical treatment and 
supervision should always be readily available in case of an anaphylactic event following the 
administration of the vaccine.

Duration of protection

Vaccination with Ervebo may not result in protection in all vaccinees. Vaccine efficacy has been 
established in the period ≥10 to ≤31 days after vaccination, however the duration of protection is not 
known (see section 5.1). The use of other Ebola control measures should therefore not be
interrupted.

Vaccination of contacts of Ebola cases should occur as soon as possible (see section 5.1).

Standard precautions when caring for patients with known or suspected Ebola disease 

Vaccination with Ervebo does not eliminate the necessity of standard precautions when caring for 
patients with known or suspected Ebola disease. All healthcare workers and other ancillary 
providers who have been vaccinated should not alter their practices with regard to safe 
injection, hygiene, and personal protective equipment (PPE) after vaccination.

Healthcare workers caring for patients with suspected or confirmed Ebola virus should apply extra 

infection control measures to prevent contact with the patient’s blood and body fluids and 

contaminated surfaces or materials such as clothing and bedding. Samples taken from humans and 

 



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animals for investigation of Ebola infection should be handled by trained staff and processed in 

suitably equipped laboratories.

Vaccine administrators should counsel vaccinees to continue to protect themselves with adequate 

measures.

Immunocompromised individuals

Safety and efficacy of Ervebo have not been assessed in immunocompromised individuals. 
Immunocompromised individuals may not respond as well as immunocompetent individuals to 
Ervebo. As a precautionary measure, it is preferable to avoid the use of Ervebo in individuals with 
known immunocompromised conditions or receiving immunosuppressive therapy, including the 
following conditions:

 Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined 
immunodeficiency, agammaglobulinemia, and AIDS or symptomatic HIV infection. A CD4+ 
T-lymphocyte count threshold for use in asymptomatic HIV-positive individuals has not been 
established.

 Current immunosuppressive therapy, including high doses of corticosteroid. This does not 
include individuals who are receiving topical, inhaled or low-dose parenteral corticosteroids 
(e.g. for asthma prophylaxis or replacement therapy).

 Diseases of the blood such as leukaemia, lymphomas of any type, or other malignant neoplasms 
affecting the haematopoietic and lymphatic systems.

 Family history of congenital or hereditary immunodeficiency, unless the immune competence of 
the potential vaccine recipient is demonstrated.

Pregnant and breast-feeding women

As a precautionary measure, it is preferable to avoid the use of Ervebo during pregnancy. See section 
4.6.

Transmission

Vaccine virus might be present in biological fluids such as blood, urine, saliva, semen, vaginal fluids, 
aqueous humor, breast milk, faeces, sweat, amniotic fluid, and placenta. Vaccine virus RNA has been 
detected by PCR in the plasma of most of the adult subjects. Vaccine virus RNA was mainly detected 
from Day 1 to Day 7. Shedding of vaccine virus has been detected by PCR in urine or saliva in 19 out 
of 299 adult subjects and in skin vesicles in 4 out of 10 adult subjects. The vaccine virus RNA was 
detected in a skin vesicle at 12 days post-vaccination in one of the four subjects.

Viral shedding was observed more frequently in children and adolescents (28/39) compared to adults.

Transmission of vaccine virus through close personal contact is accepted as a theoretical possibility.
Vaccine recipients should avoid close contact with and exposure of high-risk individuals to blood and 
bodily fluids for at least 6 weeks following vaccination. High-risk individuals include:

 Immunocompromised individuals and individuals receiving immunosuppressive therapy (see 
section above),

 Pregnant or breast-feeding women (see section 4.6),
 Children <1 year of age.

Individuals who develop vesicular rash after receiving the vaccine should cover the vesicles until they 
heal to minimize the risk of possible transmission of vaccine virus through open vesicles. Dispose of 
contaminated bandages following institutional guidelines or WHO healthcare waste management 
policy. See section 5.3.

 



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Inadvertent transmission of vaccine virus to animals and livestock is also theoretically possible, see 
below. 

Individuals administered Ervebo should not donate blood for at least 6 weeks post-vaccination.

Transmission to animals and livestock

Transmission of vaccine virus through close contact with livestock is accepted as a theoretical 
possibility. Vaccine recipients should attempt to avoid exposure of livestock to blood and bodily fluids 
for at least 6 weeks following vaccination. Individuals who develop vesicular rash after receiving the 
vaccine should cover the vesicles until they heal. Dispose of contaminated bandages following 
institutional guidelines or WHO healthcare waste management policy. See section 5.3.

Concurrent illness

Vaccination should be postponed in subjects experiencing moderate or severe febrile illness. The 
presence of a minor infection should not result in deferral of vaccination.

Thrombocytopenia and coagulation disorders

The vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation 
disorder because bleeding or bruising may occur following an intramuscular administration in these 
individuals.

Protection against filovirus disease

The vaccine will not prevent disease caused by Filoviruses other than Zaire Ebola virus.

Impact to serological testing 

Following vaccination with Ervebo, individuals may test positive for Ebola glycoprotein (GP) nucleic 
acids, antigens, or antibodies against Ebola GP, which are targets for certain Ebola diagnostic tests. 
Therefore, diagnostic testing for Ebola should target non-GP sections of the Ebola virus.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, and is considered to be
essentially sodium-free.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

As there are no data on co-administration of Ervebo with other vaccines, the concomitant use of 
Ervebo with other vaccines is not recommended.

Immune globulin (IG), blood or plasma transfusions should not be given concomitantly with Ervebo. 
Administration of immune globulins, blood or plasma transfusions administered 3 months before or up 
to 1 month after Ervebo administration may interfere with the expected immune response.

It is unknown whether concurrent administration of antiviral medication including interferons could 
impact vaccine virus replication and efficacy.

4.6 Fertility, pregnancy and lactation

Pregnancy

 



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There are limited amount of data (less than 300 pregnancy outcomes) from the use of Ervebo in 
pregnant women, or women who became pregnant after receiving the vaccine. The safety of Ervebo
has not been established in pregnant women.

As there are limitations to available data, including the small number of cases, caution should be 
exercised in drawing conclusions. Lack of reliable data on background rates of pregnancy and 
neonatal outcomes in the affected regions also makes a contextual assessment of the data challenging.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity 
(see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Ervebo during pregnancy. Nevertheless 
considering the severity of EVD, vaccination should not be withheld when there is a clear risk of 
exposure to Ebola infection.

Pregnancy should be avoided for 2 months following vaccination. Women of child-bearing potential
should use an effective contraceptive method. 

Breast-feeding

It is unknown whether the vaccine virus is secreted in human milk.

A risk to the newborns/infants from breast-feeding by vaccinated mothers cannot be excluded. 

Evaluation of the vaccine virus in animal milk has not been conducted. When Ervebo is administered 
to female rats, antibodies against the vaccine virus were detected in offspring, likely due to acquisition 
of maternal antibodies via placental transfer during gestation and via lactation. See section 5.3.

A decision must be made whether to discontinue breast-feeding or to abstain from Ervebo taking into 
account the benefit of breast feeding for the child and the benefit of therapy for the woman. In certain 
circumstances, where alternatives to breastfeeding are limited, the immediate need and health benefits 
to the infant should be taken into consideration and balanced with the mother’s need for Ervebo. Both 
may present compelling needs that should be considered before vaccination of the mother.

Fertility

There are no data on fertility effects in humans.

Animal studies in female rats do not indicate harmful effects (see section 5.3).

4.7 Effects on ability to drive and use machines

No studies on the effects of Ervebo on the ability to drive and use machines have been performed. 

Ervebo has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Summary of the safety profile

Anaphylaxis was reported very rarely (0.006%) in clinical trials. 

The most common injection-site adverse reactions were injection-site pain (70.3%), swelling (16.7%)
and erythema (13.7%).

The most common systemic adverse reactions reported following vaccination with Ervebo were 
headache (36.9%), pyrexia (34.3%), myalgia (32.5%), fatigue (18.5%), arthralgia (17.1%), nausea

 



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(8.0%), chills (6.3%), arthritis (3.7%), rash (3.6%), hyperhidrosis (3.2%), and abdominal pain (1.4%). 
In general, these reactions were reported within 7 days after vaccination, were mild to moderate in
intensity, and had short duration (less than 1 week).

Tabulated list of adverse reactions

Frequencies are reported as:
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). Within each frequency grouping, adverse reactions are presented in the order of decreasing 
seriousness.

Table 1: Tabulated summary of adverse reactions considered related to vaccination
MedDRA-System Organ Class Adverse Reactions Frequency
Immune system disorders: Anaphylactic reaction Very Rare

Nervous system disorders: Headache Very common

Gastrointestinal disorders: Abdominal pain
Nausea

Common

Skin and subcutaneous tissue 
disorders:

Rash§ Common

Musculoskeletal and 
connective tissue disorders:

Arthralgia§

Myalgia 
Very common

Arthritis§ Common
General disorders and 
administration site conditions:

Pyrexia
Fatigue
Injection site pain 
Injection site erythema
Injection site swelling

Very common

Chills
Hyperhidrosis (sweats)

Common

§See description of selected adverse reactions.

Description of selected adverse reactions

Arthralgia and arthritis
Arthralgia was generally reported in the first few days following vaccination, was mild to moderate in 
intensity, and resolved within one week after onset. Arthritis (arthritis, joint effusion, joint swelling, 
osteoarthritis, monoarthritis or polyarthritis) was generally reported within the first few weeks 
following vaccination. In clinical trials with reports of arthritis, the median onsets were between 10 
and 12 days (range from 0 to 25 days). Arthritis has been reported by subjects in clinical trials at a 
frequency that ranged from 0% in several protocols to 23.5% in one Phase 1 study. The majority of 
arthritis reactions were mild to moderate in severity. The median duration of arthritis across clinical 
trials in which arthritis was reported ranged from 2 days to 81.5 days (including duration of recurrent 
arthritis) with a maximum of 330 days. The reasons for differences in arthritis reporting across trials 
are not known but may be due to differences in study populations or outcome reporting. In the Phase 1 
study with the highest rate of arthritis, 6 of 24 patients (25%) who reported arthritis after vaccination 
had persistent joint symptoms two years after vaccination. In a small number of subjects, the vaccine 
virus was recovered from joint effusion samples, suggestive of a virally-mediated process post-
vaccination.

Rash
Rash was characterized in a variety of ways including generalized rash (2.3%), vesicular rash (0.5%), 
dermatitis (0.3%), or cutaneous vasculitis (0.01%) in clinical trials. In different trials, rash was 
reported with median onsets of 7.5 to 10.5 days (range from 0 to 47 days). The median durations 

 



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reported were between 6 to 18 days. In 6 out of 18 subjects tested, the vaccine virus was detected in 
rashes (described as dermatitis, vesicles or cutaneous vasculitis lesions) suggesting a virally mediated 
process post-vaccination.

Transient decrease in white blood cells
Transient decreases in counts of lymphocytes, neutrophils and total white blood cells in the first 3 days 
following vaccination have been observed very commonly in Phase 1/2 studies; these events generally
resolved after the first week post-vaccination. No adverse events of infections were observed in Phase 
1/2 trials.

Paediatric population

Across the Phase 1 through Phase 3 trials, 234 children and adolescents 6 to 17 years of age received a 
dose of Ervebo.

The safety profile of Ervebo in children and adolescents 6 to17 years of age was generally similar to 
that observed in adults. 

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.

4.9 Overdose

No cases of overdose have been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vaccines, Viral Vaccine, ATC code: J07BX02

Mechanism of action

Ervebo consists of a live, attenuated recombinant vesicular stomatitis virus-based vector expressing 
the envelope glycoprotein gene of Zaire Ebola virus (rVSV∆G-ZEBOV-GP). Immunization of 
subjects with the vaccine results in an immune response and protection from Zaire Ebola Virus 
Disease (EVD). The relative contributions of innate, humoral and cell-mediated immunity to 
protection from Zaire Ebola virus are unknown.

Clinical efficacy

The clinical development program included four Phase 2/3 (Protocols 009-012) clinical trials. All 
subjects received a single dose of vaccine. Clinical efficacy of Ervebo was assessed in Protocol 010.

Protocol 010 (Ring vaccination study) was a Phase 3 open-label cluster-randomized trial of ring 
vaccination (vaccinating contacts and contacts of contacts [CCCs] of index Ebola cases) which
evaluated efficacy and safety of Ervebo in Guinea. In this trial, 9,096 subjects ≥18 years of age who 
were considered CCCs of an index case with laboratory-confirmed EVD were randomized to 
immediate (4,539 subjects in 51 clusters) or 21 days delayed (4,557 subjects in 47 clusters) 
vaccination with Ervebo. Of those 9,096 subjects, 4,160 received Ervebo (2,119 subjects were 
vaccinated in the immediate arm and 2,041 subjects were vaccinated in the delayed arm). The median 
age of consenting CCCs was 35 years old. The final primary analysis included 2,108 subjects (51 

 

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clusters) vaccinated in the immediate arm and 1,429 subjects (46 clusters) eligible and consented on 
Day 0 in the delayed arm.

The final primary analysis was to assess efficacy against laboratory confirmed EVD by comparing 
incidence of cases occurring 10 to 31 days post-randomization for those vaccinated in the immediate 
vaccination rings versus incidence of cases for subjects who consented on Day 0 in the delayed 
vaccination rings. Vaccine efficacy was 100% (unadjusted 95% CI: 63.5% to 100%; 95% CI adjusted 
for multiplicity: 14.4% to 100%) (0 cases in the immediate arm; 10 cases in 4 rings in the delayed 
arm). Randomization was stopped after an interim analysis with a p=0.0036 that did not meet the pre-
specified alpha level of 0.0027. Of the 10 cases, 7 were in contacts, and 3 in contacts-of-contacts.
Uncertainties remain as to the level, duration and type of protection given the methodological 
limitations and the exceptional circumstances experienced during the trial. 

Clinical immunogenicity

No immune correlates of protection have been defined to date.

Protocol 009 Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) was a Phase 2 
randomized, double-blind, placebo-controlled trial which evaluated the safety and immunogenicity of 
Ebola vaccine candidates including Ervebo. This trial compared Ervebo to normal saline placebo in 
1,000 adults ≥18 years of age in Liberia.

Protocol 011 named Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was a Phase 
2/3 randomized open-label trial which evaluated safety and immunogenicity of Ervebo in adults 
≥18 years of age working in healthcare facilities or on frontline activities related to the Ebola response 
in Sierra Leone. In this trial, 8,673 adult subjects were enrolled and 8,651 with valid consents 
randomized to immediate (within 7 days of enrolment) or deferred (18 to 24 weeks after enrolment) 
vaccination with Ervebo. An immunogenicity sub-study included 508 subjects who were vaccinated 
and provided samples for the assessment of immunogenicity.

Protocol 012 was a Phase 3 randomized, double-blind, placebo-controlled trial which evaluated the 
safety and immunogenicity of three consistency lots and a high dose lot (approximately five times 
higher than the dose in consistency lots and dose used in other Phase 2/3 trials) of Ervebo compared to 
normal saline placebo. A total of 1,197 healthy subjects 18 to 65 years of age were enrolled in the US, 
Canada, and Spain.

Immunogenicity testing has been performed in Protocol 009, Protocol 011 and Protocol 012, and 
includes the assessment of binding immunoglobulin G (IgG) specific to purified Kikwit ZEBOV GP 
by validated enzyme linked immunosorbent assay (GP-ELISA) as well as validated neutralization of 
vaccine virus by a plaque reduction neutralization test (PRNT).

As shown in Tables 2 and 3, the geometric mean titers (GMT) of GP-ELISA and PRNT increased 
from pre-vaccination to post-vaccination. Over 93.8% of vaccine recipients met seroresponse criteria 
defined as a ≥2-fold increase from baseline and ≥200 EU/mL at any time post-vaccination by GP-
ELISA and over 80.4% of subjects met seroresponse criteria defined as a ≥4-fold increase from 
baseline at any time post-vaccination by PRNT. Over 80.1% of subjects continued to meet the 
seroresponse criteria for GP-ELISA and over 63.5% of vaccine recipients continued to meet 
seroresponse criteria for PRNT at 12 months. The clinical relevance of the immunogenicity data is 
currently not known.

Efficacy data was obtained in Protocol 010 in Guinea and immunogenicity data was obtained in 
Protocol 009 in Liberia, Protocol 011 in Sierra Leone, and Protocol 012 in the United States, Canada, 
and Europe. Baseline seropositivity, gamma irradiation of specimens to reduce risk of wild-type Ebola 
virus infection of laboratory workers, and other factors may impact the immune response to vaccine, 
which results in a higher immune response in Protocol 012. Although the clinical relevance of the GP-
ELISA GMT as well as seroresponse is currently not known, based on available data it is expected that 

 



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vaccine efficacy would apply to subjects from Guinea, Liberia, Sierra Leone, the United States, 
Canada, Europe, or other parts of the world.

Table 2. Summary of Geometric Mean Titers for the GP-ELISA
from Protocols 009, 011 and 012 Clinical Trials

Trial Baseline 
GMT (n) 
[95% CI]

Month 1
GMT (n) 
[95% CI]

Month 6
GMT (n) 
[95% CI]

Month 12* 
GMT (n) 
[95% CI]

Month 24 
GMT (n) 
[95% CI]

Protocol 009§
117.9 (464)

[107.9, 128.7]
994.7 (475)

[915.0, 1,081.3]
712.2 (477)

[659.4, 769.3]
661.4 (475)

[613.2, 713.4]
NA

Protocol 011§
92.7 (503)

[85.3, 100.9]
964.3 (443)

[878.7, 1,058.3]
751.8 (383)

[690.6, 818.4]
760.8 (396)

[697.6, 829.8]
NA

Protocol 012

Combined 
Consistency Lots 
Group

< 36.11 (696)
[<36.11, <36.11]

1,262.0 (696)
[1,168.9, 1,362.6]

1,113.4 (664)
[1,029.5, 1,204.0]

1,078.4 (327)
[960.6, 1,210.7]

920.3 (303)
[820.4, 1,032.3]

High Dose Group
< 36.11 (219)

[<36.11, <36.11]
1,291.9 (219)

[1,126.9, 1,481.2]
1,189.5 (215)

[1,036.7, 1,364.9]
1,135.5 (116)

[934.8, 1,379.3]
1,009.1 (105)

[830.0, 1,226.7]

Placebo Group
< 36.11 (124)

[<36.11, <36.11]
< 36.11 (124)

[<36.11, <36.11]
< 36.11 (123)

[<36.11, <36.11]
< 36.11 (65)

[<36.11, <36.11]
< 36.11 (65)

[<36.11, <36.11]

The Full Analysis Set population was the primary population for the immunogenicity analyses in Protocols 009 and 011 and consists of all 

vaccinated subjects with serology data and had a serum sample collected within an acceptable day range.

The Per-Protocol Immunogenicity Population was the primary population for the immunogenicity analyses in Protocol 012 and includes all 

subjects who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample at one or more 

timepoints collected within an acceptable day range.

n = Number of subjects contributing to the analysis.

CI = Confidence interval; GP-ELISA = Anti-Glycoprotein Human Enzyme-Linked Immunosorbent Assay (EU/mL); GMT = Geometric mean 
titer

*Protocol 011 from Month 9-12

§
Protocols 009 and 011 used gamma irradiation of specimens to reduce risk of wild-type Ebola virus infection of laboratory workers

Table 3. Summary of Geometric Mean Titers for the PRNT
from Protocols 009, 011 and 012 Clinical Trials

Trial Baseline 
GMT (n) 
[95% CI]

Month 1
GMT (n) 
[95% CI]

Month 6
GMT (n) 
[95% CI]

Month 12* 
GMT (n) 
[95% CI]

Month 24 
GMT (n) 
[95% CI]

Protocol 009§
< 35 (428)
[<35, <35]

116.8 (477)
[106.0, 128.8]

76.8 (477)
[69.9, 84.4]

100.4 (476)
[91.4, 110.3]

NA

Protocol 011§
< 35 (438)
[<35, <35]

116.0 (437)
[105.7, 127.4]

95.3 (382)
[86.3, 105.3]

119.9 (396)
[107.9, 133.2]

NA

Protocol 012

Combined 
Consistency Lots 
Group

< 35 (696)
[<35, <35]

202.1 (696)
[187.9, 217.4]

266.5 (664)
[247.4, 287.0]

271.4 (327)
[243.4, 302.7]

267.6 (302)
[239.4, 299.2]

High Dose Group
< 35 (219)
[<35, <35]

236.1 (219)
[207.4, 268.8]

302.1 (215)
[265.2, 344.1]

323.7 (116)
[269.5, 388.8]

342.5 (105)
[283.4, 414.0]

Placebo Group
< 35 (124)
[<35, <35]

< 35 (123)
[<35, <35]

< 35 (123)
[<35, <35]

< 35 (65)
[<35, <35]

< 35 (65)
[<35, <35]

The Full Analysis Set population was the primary population for the immunogenicity analyses in Protocols 009 and 011 and consists of all 

vaccinated subjects with serology data and had a serum sample collected within an acceptable day range.

The Per-Protocol Immunogenicity Population was the primary population for the immunogenicity analyses in Protocol 012 and includes all 

subjects who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample at one or more 

 



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timepoints collected within an acceptable day range.

n = Number of subjects contributing to the analysis.

CI = Confidence interval; GMT = Geometric mean titer; PRNT = Plaque Reduction Neutralization Test

*Protocol 011 from Month 9-12

§
Protocols 009 and 011 used gamma irradiation of specimens to reduce risk of wild-type Ebola virus infection of laboratory workers

Paediatric population

Efficacy in children has not been assessed. In a Phase 1 trial in children 6 to 17 years of age (median 
age = 10), non-validated ELISA and Pseudovirion Neutralization Assay (PsVNA) results at Day 28 
and Day 180 post-vaccination were similar to those observed in adults in the same study (see also 
sections 4.4 and 4.8).

The European Medicines Agency has deferred the obligation to submit the results of studies with 
Ervebo in one or more subsets of the paediatric population in prevention of Ebola disease (see section 
4.2 for information on paediatric use).

---

This medicinal product has been authorised under a so-called ‘conditional approval’ scheme.
This means that further evidence on this medicinal product is awaited.
The European Medicines Agency will review new information on this medicinal product at least every
year and this SmPC will be updated as necessary.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose 
toxicity and toxicity to reproduction and development.

When Ervebo was administered to female rats, antibodies against the vaccine virus were detected in 
foetuses and offspring, likely due to trans-placental transfer during gestation and with the acquisition 
of maternal antibodies during lactation, respectively (see section 4.6).

Ervebo administered to female rats had no effects on mating performance, fertility, or 
embryonic/foetal development.

Ervebo administered to female rats had no effects on development or behaviour of the offspring.

Environmental Risk Assessment (ERA)

The vaccine virus is a Genetically Modified Organism (GMO). An ERA was conducted to determine 
the potential impact of this vaccine on human health and the environment. Because this vaccine is 
based on VSV, a known pathogen in livestock (e.g. horses, cattle, pigs), the risk assessment included 
species that are relevant for the wild type (wt) VSV backbone of this vaccine.

In a biodistribution study conducted in non-human primates, vaccine virus RNA was detected in 
lymphoid organs up to 112 days post-vaccination. However, infectious virus was detected at Day 1 
and persistent infectious virus was not detected at any subsequent timepoints measured (Days 56, 84
and 112).

Based on limited shedding in adults, the results of a toxicity study in non-human primates, and lack of 
horizontal transmission in pigs, the overall risk of Ervebo to human health and the environment is 

 



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considered negligible. However, as a precaution, vaccinees should attempt to avoid exposure of 
livestock to blood and bodily fluids for at least 6 weeks following vaccination to avoid the theoretical 
risk of spread of the vaccine virus. People who develop vesicular rash after receiving the vaccine 
should cover the vesicles until they heal. Cover the vaccination site or any vesicles with an adequate 
bandage (e.g. any adhesive bandage or gauze and tape) that provides a physical barrier to protect 
against direct contact with vesicle fluid (see section 4.2). The bandage may be removed when there is 
no visible fluid leakage. To avoid unintended exposure to livestock, ensure medical waste and other 
cleaning materials do not come in contact with livestock.

See sections 4.4 and 6.6 for further information.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Recombinant human serum albumin
Trometamol buffer
Water for injections
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store and transport frozen at -80°C to -60°C.

After thawing, the vaccine should be used immediately; however, in-use stability data have
demonstrated that once thawed, the vaccine can be stored for up to 14 days at 2°C to 8°C prior to use.
At the end of 14 days, the vaccine should be used or discarded. Upon removal from the freezer, the 
product should be marked with both the date that it was taken out of the freezer and also a new discard 
date (in place of the labelled expiry date). Once thawed, the vaccine cannot be re-frozen.

Keep the vial in the outer carton in order to protect from light.

6.5 Nature and contents of container 

Solution for 1 dose in a vial (type I glass) with a stopper (chlorobutyl) and a flip-off plastic cap with 
aluminium seal.

Pack size of 10 vials.

6.6 Special precautions for disposal and other handling

 The vaccine is stored frozen at -80°C to -60°C and should be removed from the freezer and 
thawed in less than 4 hours until no visible ice is present. Do not thaw the vial in a refrigerator
as it is not guaranteed that the vial will thaw in less than 4 hours. The thawed vial should then 
be gently inverted several times prior to withdrawal with the syringe. The vaccine should appear 

 



13

as a colourless to slightly brownish-yellow liquid with no particulates visible. Discard the 
vaccine if particulates are present.

 Withdraw the entire content of the vaccine from the vial using a sterile needle and syringe.

If feasible, the waste liquid from eye washes should be collected and decontaminated before 
discarding into the drain.

Any unused vaccine or waste material should be disposed in compliance with the institutional 
guidelines for genetically modified organisms or biohazardous waste, as appropriate.

If breakage/spillage were to occur, disinfectants such as aldehydes, alcohols and detergents are proven 
to reduce viral infection potential after only a few minutes.

7. MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1392/001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: {DD month YYYY}

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

 



14

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

E. SPECIFIC OBLIGATION TO COMPLETE POST-
AUTHORISATION MEASURES FOR THE CONDITIONAL 
MARKETING AUTHORISATION

 



15

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)

Burgwedel Biotech GmbH
Im Langen Felde 5
30938 Burgwedel
Germany

Name and address of the manufacturer(s) responsible for batch release

Burgwedel Biotech GmbH
Im Langen Felde 5
30938 Burgwedel
Germany

In view of the declared Public Health Emergency of International Concern and in order to ensure early 
supply this medicinal product is subject to a time-limited exemption allowing reliance on batch control 
testing conducted in the registered site(s) that are located in a third country. This exemption is subject 
to annual review and in any case ceases to be valid on 31 July 2022. Implementation of EU based 
batch control arrangements, including the necessary variations to the terms of the marketing 
authorisation, has to be completed by the 31 July 2022 at the latest, in line with the agreed plan for this 
transfer of testing. A progress report has to be included in the annual renewal application.

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Characteristics, section 4.2).

 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)

 



16

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.

E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES
FOR THE CONDITIONAL MARKETING AUTHORISATION

This being a conditional marketing authorisation and pursuant to Article 14-a(4) of Regulation (EC) 
No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:

Description Due date
The MAH should provide additional data to confirm that the active substance (AS)
process is properly validated. Process and batch data from at least 3 representative 
AS batches should be provided.

29 May 2020

The MAH should provide additional data to confirm that the finished product (FP)
process is properly validated. Process and batch data from at least 3 representative 
FP batches should be provided.

30 Oct 2020

The MAH should provide comprehensive comparability data confirming that the 
commercial product manufactured at the Burgwedel site is representative of the 
material used in the clinical trials.

29 May 2020

The MAH should complete master cell banks (MCB)/working cell bank (WCB)
qualification to include also tests for specified viruses.

30 Oct 2020

The MAH should provide additional qualification data for the critical reagent used 
in the identity test (quality control release test for AS and FP).

31 Jan 2020

The MAH should develop and introduce an active substance in-process control for 
total protein with appropriate acceptance.

29 May 2020

 



17

ANNEX III

LABELLING AND PACKAGE LEAFLET

 



18

A. LABELLING

 



19

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

SOLUTION FOR INJECTION IN VIAL - PACK OF 10

1. NAME OF THE MEDICINAL PRODUCT

Ervebo solution for injection
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One dose (1 mL):
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live attenuated) ≥72 million pfu

3. LIST OF EXCIPIENTS

Recombinant human serum albumin, trometamol buffer, water for injections, hydrochloric acid, 
sodium hydroxide

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
10 vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store and transport frozen at -80°C to -60°C. 
Do not thaw the vial in a refrigerator. Do not refreeze.
Keep the vial in the outer carton to protect from light.

 



20

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

This product contains genetically modified organisms.
Any unused vaccine or waste material should be disposed of in compliance with the institutional 
guidelines for genetically modified organisms or biohazardous waste, as appropriate.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/19/1392/001 - pack of 10

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN

 



21

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Ervebo solution for injection
rVSV∆G-ZEBOV-GP, live
IM

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose

6. OTHER

This product contains GMO.

 



22

B. PACKAGE LEAFLET

 



23

Package leaflet: Information for the user

Ervebo Solution for injection
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)

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 are vaccinated 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 healthcare worker.
 If you get any side effects, talk to your healthcare worker. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Ervebo is and what it is used for
2. What you need to know before you receive Ervebo
3. How Ervebo is given
4. Possible side effects
5. How to store Ervebo
6. Contents of the pack and other information

1. What Ervebo is and what it is used for

 Ervebo is a vaccine for adults who are 18 years of age and older.
 Ervebo is given to protect you from getting Ebola virus disease caused by the Zaire Ebola virus, 

which is a type of Ebola virus. This vaccine will not protect you against the other types of Ebola 
virus.

 Because Ervebo does not contain the whole Ebola virus, it cannot give you Ebola virus disease.

Your healthcare worker may recommend that you receive this vaccine in an emergency involving the 
spread of Ebola virus disease.

What is Ebola?
 Ebola is a serious disease caused by a virus. If you get Ebola, it can kill you. People catch Ebola 

from people or animals who are infected with Ebola or who died from Ebola.
 You can catch Ebola from blood and body fluids like urine, stools, saliva, vomit, sweat, breast 

milk, semen and vaginal fluids of people who are infected with Ebola virus.
 You can also catch Ebola from things that have touched the blood or body fluids of a person or 

animal with Ebola (like clothes or objects in direct contact).
 Ebola is not spread through the air, water or food.

Your healthcare worker will talk to you and then together you can decide if you should receive this 
vaccine.

2. What you need to know before you receive Ervebo

Do not receive Ervebo if you:
 are allergic to Ervebo, rice, or any of the other ingredients of this vaccine (listed in section 6).
You should not receive Ervebo if any of the above apply to you. If you are not sure, talk to your 
healthcare worker.

 



24

Warnings and precautions
This vaccine might not protect everyone who receives it and the length of time you are protected from 
Ebola by Ervebo is not known.

Continue to follow your healthcare worker’s recommendations to protect yourself from Ebola 
infection after you get this vaccine.

Washing your hands correctly is the most effective way to prevent the spread of dangerous germs, like 
Ebola virus. It reduces the number of germs on the hands and so reduces their spread from person to 
person.

Proper hand washing methods are described below.
 Use soap and water when hands are soiled with dirt, blood, or other body fluids. There is no 

need to use antimicrobial soaps for washing hands.
 Use alcohol-based hand sanitiser when hands are not dirty. Do not use alcohol-based hand 

sanitiser when hands are soiled with dirt, blood, or other body fluids.

While in an area affected by Ebola, it is important to avoid the following:
 Contact with blood and body fluids (such as urine, faeces, saliva, sweat, vomit, breast milk, 

semen, and vaginal fluids).
 Items that may have come in contact with an infected person’s blood or body fluids (such as 

clothes, bedding, needles, and medical equipment).
 Funeral or burial rituals that require handling the body of someone who died from Ebola.
 Contact with bats, apes and monkeys or with blood, fluids and raw meat prepared from these 

animals (bushmeat) or meat from an unknown source.
 Contact with semen from a man who had Ebola. You should follow safe sex practices until you 

know the virus is gone from the semen.

If you get a rash where the skin is broken after receiving Ervebo, cover it until it heals. Put the used 
plasters and bandages in a sealed container, if possible, and throw them in the waste bin to to make 
sure that people with a weak immune system or animals do not come into contact with the plasters and 
bandages.

Talk to your healthcare worker before you receive Ervebo if you:

Have had allergic reactions to vaccines or medicines
 If you have ever had an allergic reaction to a vaccine or medicine, talk to your healthcare 

worker before you receive this vaccine.

Have a weak immune system
If your immune system is weak (which means your body is less able to fight off diseases), you might 
not be able to receive Ervebo. You might have a weak immune system if:
 you have HIV infection or AIDS,
 you are taking certain medicines that make your immune system weak such as 

immunosuppressants or corticosteroids,
 you have cancer or a blood problem that makes your immune system weak,
 a member of your family has a weak immune system.
If you think you might have a weak immune system, ask your healthcare worker if you should receive
this vaccine. If you do get the vaccine and have a weak immune system, the vaccine may not work as 
well as in people with a normal immune system.

Are in contact with vulnerable individuals
Tell your healthcare worker if in the 6 weeks after you receive Ervebo you might be in close contact 
with or in the same household as:
 babies who are less than 1 year old, 

 



25

 someone who may be pregnant or breast-feeding,
 someone who has a weak immune system.
This is because you could pass on the virus in the vaccine to them through your body fluids.

If you get a rash where the skin is broken after receiving Ervebo, cover it until it heals. Put the used 
plasters and bandages in a sealed container, if possible, and throw them away in the garbage bin to 
avoid having people with a weak immune system come into contact with the plasters and bandages.

Plan to donate blood
 Do not donate blood for at least 6 weeks after you receive this vaccine.

Are in contact with farm animals
 Make sure your blood or body fluids do not come into close contact with farm animals for at 

least 6 weeks after you receive this vaccine. This is because of a possibility that you could pass 
on the virus in the vaccine to the animals.

 If you get a rash where the skin is broken after receiving Ervebo, cover it until it heals.
 Put the used plasters and bandages in a sealed container, if possible, and throw them away in the 

garbage bin to avoid having animals come into contact with the plasters and bandages.

Have a fever (high temperature)
 If you have a fever (high temperature), you should talk to your healthcare worker before 

receiving Ervebo. The vaccination may have to be delayed until your fever is gone.
 A minor infection such as a cold should not be a problem but talk to your healthcare worker

before receiving Ervebo.

Have a bleeding disorder or bruise easily
 Tell your healthcare worker if you have a problem with bleeding or you bruise easily. Ervebo

might make you bleed or bruise where the vaccine is injected.

Testing for Ebola after you receive Ervebo
 You may test positive for Ebola virus after you receive Ervebo. This does not mean that you 

have Ebola. Tell your healthcare worker that you have received Ervebo. Your healthcare worker
might need to do another test.

If any of the above warnings and precautions apply to you (or you are not sure), talk to your healthcare 
worker before receiving Ervebo.

Children and adolescents
If you or your child is under 18 years old, talk to your healthcare worker. It is not known if it is safe 
and works in children and adolescents.

Other medicines and Ervebo
Tell your healthcare worker if you are taking, have recently taken or might take any other medicines or 
vaccines.

No studies have looked at how other medicines or vaccines and Ervebo might interact with each other.
Use of Ervebo with other vaccines is not recommended.

If you plan to receive blood or blood products
Do not receive this vaccine at the same time that you get blood or blood products. Ervebo might not 
work as well if you get blood or blood products 3 months before or up to 1 month after vaccination.

Pregnancy and breast-feeding
 If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 

ask your healthcare worker for advice before you receive this vaccine. They will help you decide if 
you should receive Ervebo.

 



26

 Do not become pregnant for 2 months after you receive Ervebo. Women who are able to become 
pregnant should use an effective method of birth control. It is not known if Ervebo will harm you 
or your unborn baby. It is also not known if it can pass to your baby through your breast milk.

 If you might be in close contact with, or in the same household as someone who may be pregnant 
or breast-feeding during the 6 weeks after you receive Ervebo, tell your healthcare worker. This is 
because you could pass the vaccine to them through your body fluids.

Ervebo contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium–
free’.

3. How Ervebo is given

Ervebo is given by a healthcare worker. It is given as a single injection (dose of 1 mL) in the top of 
your arm or the outside of your thigh.

If you have any further questions on the use of this vaccine, ask your healthcare worker.

4. Possible side effects

Like all vaccines, Ervebo can cause side effects, although not everybody gets them.

Serious side effects are rare. Get medical care right away if you have symptoms of an allergic reaction, 
which may include:

 wheezing or trouble breathing,
 swelling of the face, lips, tongue, or other parts of the body,
 generalized itching, redness, flushing or itchy bumps on the skin.

Other side effects:
Very common (may affect more than 1 in 10 people):
 Headache,
 Joint pain,
 Muscle aches,
 Fever,
 Feeling tired,
 Pain, swelling, or redness at the injection site.

Common (may affect up to 1 in 10 people):
 Stomach pain, 
 Nausea,
 Skin rash,
 Joint swelling,
 Chills, 
 Excessive sweating.

Certain white blood cell counts can decrease below normal after vaccination but this decrease has not 
resulted in illness and the counts return to normal.

Most side effects go away within a few days. Joint pain and swelling may last for weeks or months in 
some people. In some people joint pain and swelling may come back after initially going away.

 



27

Tell your healthcare worker if you get any of the side effects listed above.

Additional side effects in children and adolescents
The vaccine has been studied in a small number of children and adolescents who were 6 to 17 years of 
age. Overall, the side effects in children and adolescents were similar to those in adults.

Reporting of side effects
If you get any side effects, talk to your healthcare worker. 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.

5. How to store Ervebo

 Keep this medicine out of the sight and reach of children.
 Do not use this medicine after the expiry date which is stated on the vial label and the outer 

carton after ‘EXP’. The expiry date refers to the last day of that month.
 Store and transport frozen at -80°C to -60°C.
 After thawing, the vaccine should be used immediately. However, once thawed, the vaccine can 

be stored for up to 14 days at 2°C to 8°C before use. Discard the vaccine if it is not used by the 
end of 14 days. Once thawed, the vaccine cannot be re-frozen.

 Upon removal from the freezer, the product should be marked with both the date that it was 
taken out of the freezer and also a new discard date (in place of the labelled expiry date).

 Keep the vial in the outer carton in order to protect from light.
 Do not use this vaccine if you notice particles in the liquid.
 Do not throw away any medicines via wastewater or household waste. Ask your healthcare 

worker how to throw away medicines you no longer use. These measures will help protect the 
environment.

6. Contents of the pack and other information

What Ervebo contains

The active substance is a living Vesicular Stomatitis Virus. The surface protein of the virus has been 
replaced with that of Zaire Ebola Virus (rVSV∆G-ZEBOV-GP).

One dose (1 mL) contains:

Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP1,2 live, attenuated) ≥72 million pfu3
1Recombinant Vesicular Stomatitis Virus (rVSV) strain Indiana with a deletion of the VSV envelope 
glycoprotein (G) replaced with the Zaire Ebola Virus (ZEBOV) Kikwit 1995 strain surface 
glycoprotein (GP)
2Produced in Vero cells.
3pfu= plaque-forming units

This product contains genetically modified organisms (GMOs).
This vaccine contains a trace amount of rice protein.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose.

The other excipients are recombinant human serum albumin, trometamol buffer, water for injections, 
hydrochloric acid, sodium hydroxide.

What Ervebo looks like and contents of the pack

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


28

 Ervebo is a solution for injection.
 Ervebo is a colourless to slightly brownish-yellow liquid.
 Ervebo is available in a pack of 10 vials.

Marketing Authorisation Holder Manufacturer
Merck Sharp & Dohme B.V. Burgwedel Biotech GmbH
Waarderweg 39 Im Langen Felde 5
2031 BN Haarlem 30938 Burgwedel
The Netherlands Germany

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel.: +370.5.2780.247
msd_lietuva@merck.com

България
Мерк Шарп и Доум България ЕООД, 
тел.: + 359 2 819 3737
info-msdbg@merck.com

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tél/Tel: +32 (0) 27766211
dpoc_belux@merck.com

Česká republika
Merck Sharp & Dohme s.r.o. 
Tel.: +420 233 010 111
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft.
Tel.: + 36.1.888.5300
hungary_msd@merck.com

Danmark
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.com

Malta
Merck Sharp & Dohme Cyprus Limited.
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 
(+31 23 5153153)
medicalinfo.nl@merck.com

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
msdnorge@msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

Polska
MSD Polska Sp. z o.o.
Tel.: +48.22.549.51.00
msdpolska@merck.com

 

mailto:msdpolska@merck.com
mailto:msd_info@merck.com


29

France
MSD VACCINS
Tél: +33 (0)1 80 46 40 40
information.medicale@msd.com

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
inform_pt@merck.com

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 66 11 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L
Tel: + 4021 529 29 00
msdromania@merck.com

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 2998700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386.1.520.4201
msd.slovenia@merck.com

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o
Tel: +421 2 58282010
dpoc_czechslovak@merck.com

Italia
MSD Italia S.r.l. 
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
cyprus_info@merck.com

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: +371.67364.224
msd_lv@merck.com

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com

This leaflet was last revised in MM/YYYY

This medicine has been given ‘conditional approval’. This means that there is more evidence to come 
about this medicine.
The European Medicines Agency will review new information on this medicine at least every year and 
this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

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

<------------------------------------------------------------------------------------------------------------------------>

The following information is intended for healthcare professionals only:

Standard precautions when caring for patients with known or suspected Ebola disease

 

mailto:cyprus_info@merck.com
mailto:medicalinformation.it@merck.com
mailto:msd.slovenia@merck.com
mailto:croatia_info@merck.com


30

Vaccination with Ervebo does not eliminate the necessity of standard precautions when caring for 
patients with known or suspected Ebola disease. All healthcare workers, and other ancillary 
providers who have been vaccinated, should not alter their practices with regard to safe 
injection, hygiene, and personal protective equipment (PPE) after vaccination.

Standard precautions, as outlined by WHO, include the following:

 Basic hand hygiene
 Respiratory hygiene
 Use of PPE (to block splashes or other contact with infected materials)
 Safe injection practices
 Safe burial practices

Healthcare workers caring for patients with suspected or confirmed Ebola virus should apply extra 

infection control measures to prevent contact with the patient’s blood and body fluids and 

contaminated surfaces or materials such as clothing and bedding. When in close contact (within 1 

metre) of patients with Ebola Virus Disease, healthcare workers should wear face protection (a face 

shield or a medical mask and goggles), a clean, non-sterile long-sleeved gown, and gloves (sterile 

gloves for some procedures).

Laboratory workers are also at risk. Samples taken from humans and animals for investigation of 

Ebola infection should be handled by trained staff and processed in suitably equipped laboratories.

Vaccine administrators should counsel vaccinees to continue to protect themselves with the following 

measures:
 Hand washing 
 Avoid contact with blood and body fluids 
 Safe burial practices
 Safe sex
 Avoid contact with bats and non-human primates or blood, fluids and raw meat prepared from 

these animals (bushmeat) or meat from an unknown source.

Instructions on the handling of the vaccine before administration

 Ervebo is stored frozen at -80°C to -60°C and should be removed from the freezer and thawed 
in less than 4 hours until no visible ice is present. Do not thaw the vial in a refrigerator as it is 
not guaranteed that the vial will thaw in less than 4 hours. The thawed vial should then be gently 
inverted several times prior to withdrawal with the syringe.

 After thawing, Ervebo should be used immediately; however, in-use stability data have 
demonstrated that once thawed, the vaccine can be stored for up to 14 days at 2°C to 8°C prior 
to use. At the end of 14 days, the vaccine should be used or discarded. Upon removal from the 
freezer, the product should be marked with both the date that it was taken out of the freezer and 
also a new discard date (in place of the labelled expiry date). Once thawed, the vaccine cannot 
be re-frozen.

 Ervebo is a colourless to slightly brownish-yellow liquid. Discard the vaccine if particulates are 
present.

 Ervebo should be administered intramuscularly. Do not inject the vaccine intravascularly. No 
data are available for administration via the subcutaneous or intradermal routes.

 Ervebo should not be mixed in the same syringe with any other vaccines or medicinal products.
 Withdraw the entire content of Ervebo from the vial using a sterile needle and syringe. The 

preferred injection site is the deltoid area of the non-dominant arm or in the higher anterolateral 
area of the thigh. Cover the injection site with gauze or bandage (e.g. any adhesive bandage or 
gauze and tape) that provides a physical barrier to protect against direct contact with vesicle 
fluid. The bandage may be removed when there is no visible fluid leakage.

 



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 Any unused vaccine or waste material should be disposed of in compliance with the institutional 
guidelines for genetically modified organisms or biohazardous waste, as appropriate. If 
breakage/spillage were to occur, disinfectants such as aldehydes, alcohols and detergents are 
proven to reduce viral infection potential after only a few minutes. If feasible, the waste liquid 
from eye washes should be collected and decontaminated before discarding into the drain.

 



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ANNEX IV

CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING 
AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY

 



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Conclusions presented by the European Medicines Agency on:

 Conditional marketing authorisation

The CHMP having considered the application is of the opinion that the risk-benefit balance is 

favourable to recommend the granting of the conditional marketing authorisation as further 

explained in the European Public Assessment Report.

 


	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
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
	CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY