European Medicines Agency holds workshop on vaccines development against Schmallenberg virus

22 March 2012

The European Medicines Agency is holding a one-day workshop on 10 April to discuss issues related to the development of inactivated vaccines against the Schmallenberg virus. The goal of the workshop is to ensure that in the event of a European Commission or Member State decision to vaccinate against the virus, the appropriate framework is in place to allow for the timely development of safe and efficacious vaccines.

The Schmallenberg virus is a new, emerging livestock disease discovered in late 2011 that has been detected in Germany, the Netherlands, Belgium, the United Kingdom and France. In adult animals, it is associated with mild signs of disease such as fever and reduced milk yield, while in newborn animals it results in birth defects and stillbirths. No vaccines currently exist.

Bringing together members of the Committee for Medicinal Products for Veterinary Use (CVMP) and its Immunologicals Working Party, and European experts from academia and industry, the workshop's objectives include:

• presentation and discussion of the latest epidemiological developments of the Schmallenberg virus;
• discussion of the experiences and challenges of producing vaccines under both normal and emergency circumstances in response to avian influenza and bluetongue outbreaks and how these lessons learned can be considered in the context of vaccine development for the Schmallenberg virus;
• providing an opportunity to hear the views of vaccine manufacturers on how the Agency could support the process of bringing inactivated vaccines to the market through the development of appropriate regulatory advice and scientific guidance.

The workshop will be held at the European Medicines Agency in London. This is an invitation-only event, but the Agency would consider expressions of interest to participate in the workshop from those who can actively contribute to the discussions. Expressions of interest should be sent to [e-mail].

Outcomes from the workshop will be posted on the Agency's website.

The Agency has been working closely with its European partners since the start of the outbreak. The European Commission issued a guidance document on the priority actions to be under taken in the European Union in the next months on 7 February 2012, which includes information on the development of vaccines. The European Centre for Disease Prevention and Control (ECDC) performed a preliminary assessment on the zoonotic risks of the Schmallenberg virus on 22 December 2011.