Bovela (modified live bovine viral diarrhoea...) - QI02AD02
Updated on site: 08-Feb-2018
|Substance:||modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9 and modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93|
|Manufacturer:||Boehringer Ingelheim Vetmedica GmbH|
Bovine viral diarrhoea vaccine (modified live)
This document 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 document cannot replace a
What is Bovela?
Bovela is a veterinary vaccine that contains two types of a modified live bovine viral diarrhoea (BVD) virus
What is Bovela used for?
Bovela is used to protect cattle against BVD viral infection. In
The vaccine is given to cattle as a single injection into the muscle. Protection starts three weeks after vaccination and lasts for one year. To prevent the birth of a PI calf the vaccine should be given at least three weeks before insemination/mating.
How does Bovela work?
Bovela is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Bovela contains two BVDV strains (or types) modified by deletion of parts of two genes so that they can no longer cause disease. When Bovela is given to cattle the animals’ immune system recognises the virus strains as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to the virus the immune system will be able to respond more quickly. This will help protect the cattle against BVD infections.
How has Bovela been studied?
The effectiveness of the vaccine was first studied in a number of laboratory studies in cattle. The purpose of the studies was to establish how long it took for cattle to be fully protected, the length of time protection against BVD lasts, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine in calves.
The effectiveness of Bovela was further investigated in the field in eight dairy cattle herds of which five of them had a history of BVD or persistent infection at the beginning of the study. Approximately half of the cattle were vaccinated with Bovela and the rest received a dummy injection. The main measure of effectiveness was the reduction in the number of persistently infected newborn calves as determined by virus specific identification tests.
What benefit has Bovela shown during the studies?
In the laboratory studies Bovela prevented PI in 100% of calves while the animals that received no vaccination gave birth to 100% PI calves.
In the field study 98.5% of vaccinated cattle sampled (range
What is the risk associated with Bovela?
The most common side effect (seen in more than 1 in 100 cattle) was an increase in body temperature (within the normal range) within four hours of vaccination, which spontaneously resolves within 24 hours.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
In case of accidental
What is the withdrawal period?
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption. The withdrawal period for Bovela for cattle is zero days.
Why has Bovela been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Bovela exceed the risks for the approved indication and recommended that Bovela be given a marketing authorisation. The
Other information about Bovela:
The European Commission granted a marketing authorisation valid throughout the European Union, for Bovela on 22 December 2014. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated in October 2014.