Bluetongue has been present in Central Europe since October 2023 following four years of absence. The bluetongue virus serotype 3 (BTV3), which is currently circulating, can cause severe symptoms in infected sheep (including death) and cattle (e.g. massive decline in milk yield). Due to the current weather conditions, it can be assumed that the number of infections will continue to increase in Germany. However, no bluetongue vaccines are currently authorised in the European Union (EU). After an accelerated benefit-risk assessment, the Paul-Ehrlich-Institut has designated three vaccines for prophylaxis against BTV3 infections: BULTAVO 3, BLUEVAC-3, and Syvazul BTV 3. The use of these vaccines has been authorised via emergency decree by the Federal Ministry of Food and Agriculture (Bundesministerium für Ernährung und Landwirtschaft, BMEL) for the protection of sheep and cattle for a period of six months, as long as no vaccines are authorised in the meantime.
The Paul-Ehrlich-Institut, following an accelerated assessment, designated the following three vaccines for the potential containment of infections currently triggered by the bluetongue virus serotype 3:
These companies and the vaccine manufacturers already have experience in the production of BTV vaccines. They possess valid GMP certificates. The vaccines are therefore produced in accordance with the principles of Good Manufacturing Practice (GMP).
The emergency decree allows use of the vaccines for an initial six month period, up to and including 6 December, 2024. It only applies as long as no vaccines are authorised.
The BTV3 vaccines are inactivated vaccines, which means they do not contain a virus that is capable of reproduction. In order to achieve a sufficient immune response in the vaccinated animal, the vaccines contain the long-established adjuvant combination of aluminium hydroxide and saponin (Quil A). There is no waiting period for BTV3 vaccines.
The vaccines are packaged in multi-dose vials, so thimerosal is added as a preservative. Thimerosal stops potential bacterial growth in the period that inevitably elapses between when the vaccine vial is opened and when the last dose is inoculated. The amount of thimerosal used corresponds to the amount contained in numerous other vaccines for sheep and cattle.
Bluetongue is a viral disease that is non-contagious, i.e. not directly transmissible from animal to animal, to which sheep, goats, cattle, and wild ruminants are particularly susceptible. Gnats, small blood-sucking insects, transmit the disease between animals. The bluetongue virus is harmless to humans.
At least 24 bluetongue virus serotypes are currently known. The disease manifests itself in different ways depending on the animal species and virus serotype. Bluetongue received its name from the typical symptoms of severe disease progression observed in sheep.
After an incubation period of only a few days, a high fever causes swelling of the mucous membranes of the head, inflammation in the mucous membranes of the mouth and nose, and a swollen tongue with blue discoloration. However, this discoloration is not regularly observed. Painful inflammation around the hooves leads to lameness.
Cattle, goats, and wild ruminants do not get sick as often as sheep and their symptoms are usually milder. In the case of a severe disease course, however, their symptoms are similar to those experienced by sheep.
Bluetongue virus serotype 3 (BTV3) was detected in the fall of 2023 in Europe, in particular in the Netherlands, Belgium, and some German federal states (North Rhine-Westphalia, Lower Saxony, Bremen, and Rhineland-Palatinate).
BTV3 infections are accompanied by considerable pain and suffering in the affected animals, as has been reported by severely affected countries such as the Netherlands. Severe symptoms can occur in sheep, and infections can even lead to death. Symptoms in cattle include a massive decrease in milk yield. This ultimately leads to high economic losses on account of the disease.
The Paul-Ehrlich-Institut keeps a centralised record of reports of adverse events (AEs) after the use of vaccines in veterinary medicine and evaluates the reports (pharmacovigilance). This also applies to reports submitted in connection with vaccinations against BTV3. The goal of the evaluations is to analyse the benefit-risk ratio of the non-authorised BTV3 vaccines when used properly, while also considering the urgent situation and the currently limited availability of data.
Reports of suspected adverse events after the use of BTV3 vaccines can, as with all veterinary vaccines, be submitted to the Paul-Ehrlich-Institut in a structured manner via the online reporting portal or communicated directly via email
(vetmittelsicherheit@pei.de).
Updated: 21.06.2024
