Mvabea

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP

Available from:

Janssen-Cilag International N.V.   

ATC code:

J07BX

INN (International Name):

Ebola vaccine (MVA-BN-Filo [recombinant])

Therapeutic group:

Vaccines

Therapeutic area:

Hemorrhagic Fever, Ebola

Therapeutic indications:

Active immunization for prevention of disease caused by Ebola virus (Zaire Ebolavirus species) in individuals ≥ 1 year of age.,

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2020-07-01

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
MVABEA SUSPENSION FOR INJECTION
EBOLA VACCINE (MVA-BN-FILO [RECOMBINANT])
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 OR YOUR CHILD IS
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 doctor, pharmacist or
nurse.

This vaccine has been prescribed for you or your child only. Do not
pass it on to others.

If you or your child 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 Mvabea is and what it is used for
2.
What you need to know before you or your child are given Mvabea
3.
How Mvabea is given
4.
Possible side effects
5.
How to store Mvabea
6.
Contents of the pack and other information
1.
WHAT MVABEA IS AND WHAT IT IS USED FOR
WHAT IS MVABEA
Mvabea is a vaccine used to protect against Ebola virus disease in the
future.
It is given to people aged 1 year and older who may possibly come into
contact with Ebola virus.
Mvabea is given as the second dose of a 2-dose course of vaccinations
to protect you from getting
Ebola virus disease caused by the _Zaire ebolavirus_, which is a type
of Filovirus. This vaccine will not
protect you against the other types of Filovirus.
Because Mvabea does not contain the whole Ebola virus, it cannot give
you Ebola virus disease.
The 2-dose course of vaccinations consists of:

a first dose of Zabdeno vaccine,

followed around 8 weeks later by a dose with Mvabea vaccine.
Even after you have had the course of Zabdeno and Mvabea vaccination
you should be VERY CAREFUL
not to come into contact with Ebola virus. As with all vaccinations,
the vaccina

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Mvabea suspension for injection
Ebola vaccine (MVA-BN-Filo [recombinant])
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Modified Vaccinia Ankara Bavarian Nordic Virus* encoding the:
_Zaire ebolavirus_ (EBOV) Mayinga variant glycoprotein (GP)
_Sudan ebolavirus_ Gulu variant GP
_Taï Forest ebolavirus_ nucleoprotein
_Marburg marburgvirus_ Musoke variant GP
Not less than 0.7 x 10
8
infectious units (Inf.U)
*
Produced in chicken embryo fibroblast cells and by recombinant DNA
technology.
This product contains genetically modified organisms (GMOs).
This vaccine contains trace residues of gentamicin (see section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Light yellow, clear to milky suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mvabea, as part of the Zabdeno, Mvabea vaccine regimen, is indicated
for active immunisation for
prevention of disease caused by Ebola virus (_Zaire ebolavirus_
species) in individuals ≥1 year of age
(see sections 4.4 and 5.1).
The use of the vaccine regimen should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Mvabea should be administered by a trained healthcare worker.
Mvabea is the second vaccination in the prophylactic 2-dose
heterologous Ebola vaccine regimen
which consists of vaccination with Zabdeno followed by a second
vaccination with Mvabea given
approximately 8 weeks later (see sections 4.4 and 5.1) (refer to the
SmPC for Zabdeno).
3
Posology
PRIMARY VACCINATION
A dose (0.5 mL) of Zabdeno (red cap vial) vaccine should be
administered as the first vaccination
(refer to the SmPC for Zabdeno).
A dose (0.5 mL) of