§ Lord Lucas
asked Her Majesty's Government:
Which vaccines or other injectable medical products in use in the United Kingdom contain bovine serum derivatives from (a) United Kingdom sources or (b) abroad; and, if none (in either case), when was the last known date that such products were in use in the United Kingdom. [HL1827]
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)
No vaccines or other injectable medicines in use in the United Kingdom contain bovine serum derivatives as ingredients in the finished products.
Some vaccines use bovine material such as foetal calf serum and bovine albumin as nutrients to promote the growth of microbial organisms in culture media. Some injectable medicines use bovine serum derivatives in the manufacturing process. Subsequent purification is designed to remove all materials from such vaccines and injectable medicines that are associated with the manufacture but not required in the finished product. Manufacturers are required to provide validation of these processes to the Medicines Control Agency (MCA).192WA
In 1989, the Southwood Committee considered the potential for the transmission of bovine spongiform encephalopathy between cattle and other species, including man, through the use of medicinal products and concluded that the risk was remote. The Committee on Safety of Medicines (CSM) accepted this advice but as a precautionary measure issued guidelines to the pharmaceutical industry in March 1989 that gave advice on sourcing of bovine material used in the manufacture of pharmaceuticals. After these guidelines were issued, all pharmaceutical companies were obliged to source bovine material from outside the UK.
Vaccines that use bovine material in the manufacturing process manufactured since March 1989 have used bovine material from non-UK sources. The MCA has established that the latest date that vaccines manufactured before the guidelines came into force could have been used was November 1993.
The guidelines on sourcing and processing issued by the Committee on Safety of Medicines also applied to injectable medicines. All manufacturers of injectable medicines which used bovine material in manufacture changed to non-UK sourced materials after the guidelines were issued in March 1989. The MCA does not hold precise dates on which manufacturers of injectable medicines which may have used UK bovine material switched to sourcing such material from outside the UK. However, the MCA's records show that all manufacturers had changed their sourcing practices away from the UK in July 1992.