§ Mr. BellinghamTo ask the Secretary of State for Health whether during the negotiations for the smallpox vaccine contract he was informed of which company was to manufacture the smallpox vaccine should Powderject be awarded the contract. [67541]
§ Mr. HuttonI refer the hon. Member to the answer I gave to the hon. Member for Lewes (Mr. Baker) on 3 July 2002,Official Report, column 454W.
§ Mr. BellinghamTo ask the Secretary of State for Health whether Powderject has guaranteed that the smallpox vaccine to be supplied by them will be free of BSE. [67539]
§ Mr. HuttonThe smallpox vaccine to be supplied by Powderject is not manufactured using bovine cell culture. If a manufacturer wished to produce smallpox vaccine using virus culture in bovine cells, the appropriate regulatory guidance on cell characterisation and storage would have to be followed.
European legislation demands that an application for marketing authorisation of a medicinal product in the European Union must include satisfactory demonstration of compliance with the European Note for Guidance on 1391W minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.