§ Mr. BellinghamTo ask the Secretary of State for Health how much he estimates it would cost clinically to test the smallpox vaccine to be supplied by Powderject. [67542]
§ Mr. HuttonThe Government have made no estimate of the cost of clinical trials for this vaccine, as the costs of any such trials normally fall to the supplying company.
There are currently no proposals for clinical trials of this vaccine in the United Kingdom, and the Government are not meeting any costs for any future limited clinical trials that might be required in fulfillment of an application for a product licence for smallpox vaccine supplied by Powderject Pharmaceuticals.
Since smallpox does not currently exist in the population, trials of protective efficacy are not possible. Therefore, the likely protective efficacy of a new 669W smallpox vaccine must be inferred from other parameters. Clinical trials are not mandatory for unlicensed vaccines.
The National Institute for Biological Standards and Control are conducting independent potency and quality checks on the new vaccine prior to the vaccine being finally accepted.