Bovine Material in Vaccine Manufacture (Hansard, 23 October 2000)

§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)

European guidelines issued in 1999 made clear that the manufacturing process for medicinal products should not use bovine materials from countries in which there are known cases of Bovine Spongiform Encephalopathy. The first guidance on this subject was issued by the Committee on Safety of Medicines in 1989. From 1989 onwards, the Medicines Control Agency sought and received assurances from drug companies that they were implementing this guidance and subsequent guidance produced at a European level on a phased basis.

On the advice of the MCA, I informed the House on 4 May 2000 that the 1989 guidelines obliged all pharmaceutical companies to source bovine material from outside the United Kingdom. I am now advised by the MCA that these 1989 guidelines did not have the full force of law and that they applied to injectable 6WA medicines and medicines applied to the eyes or open wounds. However, the 1999 guidelines do apply to bovine materials and pharmaceuticals generally. From March 2001, these guidelines, which at present are not legally binding, will have the full force of the law.

I also informed the House on 4 May 2000 that vaccines that use bovine material in the manufacturing process manufactured since March 1989 had used bovine material from non-UK sources and that the MCA had established that the latest date that vaccines manufactured before the guidelines came into force could have been used was November 1993. On 28 March 2000, my honourable friend the Parliamentary Under-Secretary for Public Health informed Parliament on the advice of the MCA that from April 1989 no bovine materials sourced in the United Kingdom were introduced as an element of the manufacturing process for vaccines produced at that time. In particular, she told the other place on the advice of the MCA that all vaccines manufactured by Wellcome after 1989 used bovine material from New Zealand. She also informed the other place on 19 October 1999 on the advice of the MCA that since 1993 all vaccines in use were manufactured without UK-sourced bovine material. I have now been advised that the advice from the MCA that formed the basis of these statements was incorrect. The MCA was provided with information by manufacturers.

The MCA advised Ministers last week that in the case of the Wellcome oral polio vaccine, the assurances given by the company have proved inaccurate. This oral polio vaccine was originally produced by Wellcome. Part of Wellcome's vaccine business was transferred over to Medeva in 1991. Part of the oral polio vaccine was manufactured in 1985 using growth medium containing foetal calf serum of UK bovine origin, and this element continued to be used in the production process after 1989.

This oral polio vaccine continued to be used up until 2000, in specific breach of the 1999 guidance. The Department of Health has therefore recalled this oral polio vaccine manufactured by Medeva (supplied by Medeva under the brand name Evans).

The MCA has carried out a risk assessment and people who have received this oral polio vaccine in the past can be advised that the breach is of guidance which has been formulated on a precautionary basis; under the European guidelines. Foetal calf serum is in category IV (no detectable infectivity); the processes used in manufacturing are designed to remove all but a remote trace of unwanted proteins such as foetal calf serum. The MCA, taking all these points together, have advised that any risk associated with this Medeva oral polio vaccine is incalculably small.

My honourable friend the Parliamentary Under-Secretary for Public Health asked the CSM in March to produce a comprehensive assessment of BSE-related issues in vaccines. The Government are committed to publishing the assesssment. In the light of the new information, we are also reviewing the advice given to Ministers on this issue to ensure that all the information given to Parliament is correct.