Eravac

Eravac is available as an injection and can only be obtained with a prescription. The vaccine is given to rabbits from 30 days of age as a single injection under the skin of the side of the chest. Protection starts one week after vaccination and lasts nine months.

For further information, see the package leaflet.

Eravac is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Eravac contains rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 which has been inactivated so it cannot cause the disease. When it is given to rabbits the immune system recognises the virus as ‘foreign’ and makes antibodies against it. In the future if rabbits are exposed to rabbit haemorrhagic disease type 2 virus, the immune system will be able to produce antibodies more quickly. This will help protect them against the disease.

Eravac contains an adjuvant (mineral oil) to enhance the immune response.

The effectiveness of the vaccine was compared with that of a placebo (dummy) vaccine in three laboratory studies involving 301 rabbits. After vaccination the rabbits were artificially infected with rabbit haemorrhagic disease type 2 virus. The studies showed the vaccine to be effective in reducing death. In one study all Eravac vaccinated rabbits survived compared with a 37% survival rate in the group that received the placebo vaccine. In the second study survival of Eravac vaccinated rabbits was 93% compared with 50% for rabbits given placebo. In the third study all Eravac vaccinated rabbits survived compared with less than 70% of the rabbits in the control group, when rabbits were artificially infected with rabbit haemorrhagic disease type 2 virus nine months after vaccination.

The most common side effects with Eravac (which may affect more than 1 in 10 rabbits) are a short-lived increase in body temperature to slightly above 40 ºC which may occur between two or three days following vaccination and nodules or swellings (less than 2 cm in size) at the injection site. The slight temperature increase resolves spontaneously without treatment within 5 days and the local reactions resolve spontaneously within 24 hours.

Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – this could result in the loss of the finger if prompt medical attention is not given. If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected. The package leaflet should be shown to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.

The withdrawal period for meat from rabbits treated with Eravac for is ‘zero’ days, which means there is no mandatory waiting time.

The European Medicines Agency decided that Eravac’s benefits are greater than its risks and that it can be authorised for use in the EU.

Eravac received a marketing authorisation valid throughout the EU for Eravac on 22 September 2016.

Further information on Eravac can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.