Coxevac

inactivated Coxiella burnetii vaccine, strain Nine Mile

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This is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Coxevac?

Coxevac is a veterinary vaccine that contains inactivated (killed) Coxiella burnetii bacteria. Coxevac is available as a suspension for injection.

What is Coxevac used for?

Coxevac is used in cattle to lower the risk of spreading Coxiella burnetii infection and in goats to reduce abortions caused by the infection as well as reduce spreading the infection. Coxiella burnetii is a bacterium that affects animals, including cattle and goats, and man. The disease it causes is known as Q-fever. In cattle and goats Q-fever can cause abortions, still births and pneumonia. The vaccine is given to cattle and goats from three months of age. The vaccine is given as two injections under the skin, three weeks apart. Nine months later, two additional injections should be given to cattle, again three weeks apart. For goats, one injection should be given one year later.

How does Coxevac work?

Coxevac is a bacterial vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When Coxevac is given to cattle and goats, their immune system recognises the bacteria contained in the vaccine as ‘foreign’ and makes antibodies to defend against them. In the future, if the animals are exposed to Coxiella burnetii bacteria, the immune system will be able to respond more quickly. This will help to protect against the disease.

This is of particular importance because Coxiella burnetii can lead to a disease in humans called Q-fever and decreasing the disease in animals will decrease the likelihood of transmitting the disease to humans.

How has Coxevac been studied?

The effectiveness of Coxevac was investigated in both laboratory and field studies.

A field study determined the effectiveness of the vaccine in cattle that came from farms where Coxiella burnetii was present. The effectiveness of the vaccine in goats has been determined in two field studies with pregnant goats exposed to Coxiella burnettii.

What benefit has Coxevac shown during the studies?

The studies conducted in cattle and goats showed that Coxevac reduces bacteria shedding (which is a major factor in spreading the disease) in vaginal discharge and milk, whilst in goats Coxevac reduced bacteria shedding in faeces and the placenta as well. The studies in goats also showed a lower proportion of abortions in the goats that were vaccinated compared with unvaccinated goats.

The duration of protection was established to be 280 days in cattle and one year in goats.

What is the risk associated with Coxevac?

In cattle it is very common to see a swelling of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days. The reaction gradually reduces and disappears without need for treatment.

In goats it is very common to see a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days. The reaction reduces and disappears without need for treatment. In goats it is also very common to observe a slight increase of rectal temperature for 4 days post-vaccination without other general signs.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

In the case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or the milk used for human consumption. The withdrawal period for Coxevac for meat and milk is zero days.

Why has Coxevac been approved?

The CVMP concluded that the benefits of Coxevac exceed the risks for the approved indication and recommended that Coxevac be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Coxevac was initially authorised under ‘exceptional circumstances’. This means that it was not possible to obtain complete information about Coxevac at the time of the initial authorisation. The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the efficacy of the vaccine. In 2014 the CVMP considered that the submitted data were adequate for the authorisation of Coxevac to convert to a normal status.

Other information about Coxevac

The European Commission granted a marketing authorisation valid throughout the European Union, for Coxevac on 30 September 2010. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Coxevac : EPAR - Summary for the public BG = bălgarski 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public ES = español 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public CS = čeština 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public DA = dansk 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public DE = Deutsch 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public ET = eesti keel 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public EL = elliniká 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public EN = English 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public FR = français 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public IT = italiano 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public LV = latviešu valoda 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public LT = lietuvių kalba 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public HU = magyar 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public MT = Malti 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public NL = Nederlands 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public PL = polski 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public PT = português 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public RO = română 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public SK = slovenčina 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public SL = slovenščina 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public FI = suomi 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public SV = svenska 14/10/2010 18/03/2015
Coxevac : EPAR - Summary for the public HR = Hrvatski 14/10/2010 18/03/2015

This EPAR was last updated on 12/08/2015 .

Authorisation details

Product details

Product details for Coxevac
NameCoxevac
Agency product numberEMEA/V/C/000155
Active substance

inactivated Coxiella burnetii vaccine, strain Nine Mile

International non-proprietary name (INN) or common name

inactivated Coxiella burnetii vaccine

Species GoatsCattle
Anatomical therapeutic chemical veterinary (ATCvet) codeQI02AB

Publication details

Publication details for Coxevac
Marketing-authorisation holder

Ceva Sante Animale

Revision5
Date of issue of marketing authorisation valid throughout the European Union30/09/2010

Contact address:

Ceva Sante Animale
10 avenue de la Ballastiere
33500 Libourne
France

Product information

Product information

31/07/2015  Coxevac -EMEA/V/C/000155 -R/0009

Name Language First published Last updated
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015
Coxevac : EPAR - Product Information HR = Hrvatski 14/10/2010 12/08/2015

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015
Coxevac : EPAR - All Authorised presentations HR = Hrvatski 14/10/2010 18/03/2015

Pharmacotherapeutic group

Immunologicals for bovidae, inactivated bacterial vaccines for cattle

Therapeutic indication

Cattle:

For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-pregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus.

Onset of immunity: not established.

Duration of immunity: 280 days after completion of the primary vaccination course.

Goats:

For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta.

Onset of immunity: not established.

Duration of immunity: one year after completion of the primary vaccination course.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Coxevac : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 11/08/2011 12/08/2015
Coxevac-V-C-155-S-0007 : EPAR - Assessment Report HR = Hrvatski 18/03/2015  

Initial marketing-authorisation documents

Name Language First published Last updated
Coxevac : EPAR - Procedural steps taken before authorisation HR = Hrvatski 14/10/2010  
Coxevac : EPAR - Scientific Discussion HR = Hrvatski 14/10/2010  
CVMP summary of positive opinion for Coxevac HR = Hrvatski 16/07/2010