[holding answer 26 January 2009]: Responsibility for licensing veterinary medicines in the UK, including Bluetongue vaccine, rests with the Veterinary Medicines Directorate (VMD). In licensing a product, the VMD assesses data on safety, quality and efficacy on all species for which the vaccine is intended (in this case cattle and sheep), and establishes whether the advantages and efficacy of the product outweigh any risks in deciding whether to issue a Marketing Authorisation. Once a product has been marketed the VMD monitors its safety and efficacy through reports of suspected adverse reactions, and through on-going data requirements from the authorisation holder.
Sales data from the supply chain suggest enough vaccine was sold in 2008 in the South and East of England, where Bluetongue serotype 8 was circulating in 2007, to vaccinate over 90 per cent. of the susceptible animal population. Experts at the Institute for Animal Health advise that this level of vaccination in previously affected counties was effective in controlling BTV-8 and its possible spread to the rest, of the country. No circulating disease was detected in 2008.