EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
D1 - Animal health and Standing Committees
Brussels, D1/MCG/mb (07) D/412950
Meeting with vaccine producers on availability of vaccines against bluetongue, Brussels 21 November 2007
Participants: IFAH-Europe, eight vaccine producers (Intervet, Pfizer, Fort Dodge, Syva, I.Z.S. Teramo, Calier, CZ Veterinaria, Merial, Ceva Santé Animal), SANCO/D1.
1. Conclusions of the meeting:
- All companies attending the meeting are currently developing vaccines against Bluetongue and some of them are already producing against certain serotypes
- Vaccines producers provided assurance that they have enough production capacity to supply vaccines for mass vaccination in the EU against bluetongue (considering that the need might be up to 220 million doses of all serotypes of which 150 million doses for BTV-8 according to the preliminary estimates made by the Member States).
- In order to be able to provide the necessary amount of vaccines, the industry needs the Member States to launch a call for tender in the Member States. This
- must be rapidly followed by confirmation of orders such that production can be commenced given that the lag time between orders being received and product being delivered may be up to 6 - 8 months
- Vaccine producers asked for coordination between EMEA, DG ENTR and DG SANCO on the authorisation of vaccines suitable for mass vaccination (multistrain dossiers and requirements for bluetongue vaccines in emergency vaccination are already addressed in EMEA working documents).
2. Companies that attended the meeting and data on vaccine production
The information below is only a preliminary indication of the capacity for vaccine supply:
Company Serotype Status Availability (date) Intervet BTV-8 developing May-2008 Pfizer BTV-8 developing Not for 2008 BTV-1 already marketing Fort Dodge BTV-4 BTV-4 BTV-8 developing May-2008 BTV-1 already marketing Syva BTV-4 already marketing BTV-8 developing May-2008 I.Z.S. Teramo BTV-1 already marketing BTV-8 finalizing dossier Dec-2008 Calier BTV-4 already marketing BTV-1 dossier presented licensing for CZ Veterinaria BTV-1 already marketing BTV-4 already marketing BTV-8 starting in Jan-2008 June-2008 Ceva Santé Animal developing Not for 2008 BTV-2 already marketing Merial BTV-4 already marketing BTV-8 developing May-June 2008