Pregsure BVD is an inactivated vaccine for the immunisation of cattle at breeding age to prevent bovine viral diarrhoea virus type 1 (cytopathogenic strain 5960) transplacental infection and the birth of bovine viral diarrhoea virus type 1 persistently infected calves.
Due to concerns regarding adverse event reports of bovine neonatal pancytopenia following use of Pregsure BVD in dams, Germany triggered a procedure under Article 78 of Directive 2001/82/EC on 29 April 2010.
The procedure started on 20 May 2010. The rapporteur and co-rapporteur appointed were Dr Manfred Moos and Dr Frederic Descamps, respectively. A written explanation was provided by the representative of the marketing authorisation holders on 7 June 2010 and an oral explanation was given during the 15-17 June 2010 CVMP meeting.
Based on the rapporteurs' assessment of the data available from pharmacovigilance reports, epidemiological and laboratory studies, the CVMP concluded that although the aetiology of bovine neonatal pancytopenia has yet to be determined there was evidence to suggest that Pregsure BVD may be associated with bovine neonatal pancytopenia and that the benefit-risk balance for the product was unfavourable. The Committee adopted on 15 July 2010 an opinion recommending that the marketing authorisations for Pregsure BVD and associated names should be suspended until scientific evidence is available to demonstrate that the administration of the vaccine to dams according to authorised conditions of use does not lead to an increased risk of bovine neonatal pancytopenia or that risk mitigation measures ensuring the safe use of the product can be implemented. In addition, the CVMP recommended that all batches of the product be recalled at wholesale level.
The list of product names concerned is given in Annex I. The scientific conclusions and grounds for suspension of the marketing authorisations are provided in Annex II.
The final opinion relating to the temporary measures was converted into a Decision by the European Commission on 10 August 2010 and the final measures were adopted by the European Commission on 7 October 2010.
|International non-proprietary name (INN) or common name||
Inactivated Bovine Viral Diarrhoea (BVD) type 1 virus, cytopathogenic strain 5960
Pharmacovigilance urgent measures: initiated when, as a result of the evaluation of veterinary pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure.
European Commission final decision
|EC decision date||
Opinion following an Article 78 procedure for Pregsure BVD and associated names: Background information (PDF/46.69 KB)
First published: 26/08/2010
Last updated: 22/10/2010
Pregsure BVD - Article 78 referral - Annexes I, II (PDF/67.21 KB)Adopted
First published: 26/08/2010
Last updated: 26/08/2010
- Opinion - contains the CVMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents may not always be available:
- Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
- Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies