§ Mr. Robert JacksonTo ask the Secretary of State for Health whether the existing UK stocks of smallpox vaccine have undergone tests for efficacy and safety, with particular reference to TSE, in line with recommendations by the Medicines Control Agency and EMEA. [32972]
§ Mr. Hutton[holding answer 5 January 2002]: Existing United Kingdom stocks of smallpox vaccine are held on behalf of the Secretary of State for Health, but do not have a current marketing authorisation (licence) issued by the Medicines Control Agency (MCA). There were originally three licences for smallpox vaccine held by my right hon. Friend, the Secretary of State. At the request of the licence holder, these licences were cancelled in the early 1990s.
The UK stocks of vaccine have been tested on a regular basis for potency. Last year the Department asked the holder of the stocks to recheck the viability of the virus in the vaccine and to repeat the safety and quality control tests originally performed on vaccine stocks as described in the World Health Organisation recommendations on smallpox vaccine manufacture.
Because of the particular nature of the disease for which this vaccine was developed it has never been possible to conduct formal clinical trials in humans to demonstrate efficacy in the prevention of smallpox that would normally support an application for a licence for a medicinal product.
The vaccines held in stock are no longer licensed medicinal products and were not therefore included in the exercise undertaken in all member states of the European Union, by way of implementing Commission Directive 1999/82/EC, to require all marketing authorisation (licence) holders to demonstrate that their products comply with the current guideline. Compliance with these guidelines has been a legal requirement for new licence applications since 1 July 2000 and for products already on the market since 1 March 2001.