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Advisory notice relating to reported lack of efficacy with Scabivax, including voluntary recall of one batch

Notice type: Advisory

Date: 28/05/2015

 During the spring of 2015, a high number of lack of expected efficacy reports associated with one batch of the product, recording a lack of vaccine take has been notified to the HPRA. To date, no quality issue has been confirmed for batch 103XFL2, but, as a precautionary measure, this batch has been voluntarily recalled by the Marketing Authorisation Holder.

Product name or type:
Scabivax Contagious Pustular Dermatitis (Orf) Vaccine

Authorisation Number:
VPA 10996/256/001

Serial Or Batch Number And Expiry Date:
Batch Number: 103XFL2; Expiry date: 05-2015

Authorisation Holder:
MSD Animal Health, Leopardstown, Dublin 18 (formerly Intervet Ireland Ltd, Dublin 24)

Prescription Required:
Yes

Target Audience:
Veterinary practitioners, pharmacists, licensed merchants and farmer users

Problem Or Issue:
During the spring of 2015, a high number of lack of expected efficacy reports associated with one batch of the product, recording a lack of vaccine take has been notified to the HPRA. To date, no quality issue has been confirmed for batch 103XFL2, but, as a precautionary measure, this batch has been voluntarily recalled by the Marketing Authorisation Holder.

Background Information Or Related Documents:
Scabivax is a live vaccine that is used to immunise sheep to reduce the lesions of Orf (also known as contagious pustular dermatitis). 

Actions To Be Taken:
Users are requested to report any reports of suspected lack of efficacy of the product to their veterinary practitioner or MSD Animal Health. Suppliers should ensure that any such reports reported to them are forwarded immediately to MSD Animal Health. Veterinary practitioners should report any suspected reactions, including reports of lack of efficacy, to the HPRA or to MSD Animal Health. 

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