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Vaccine Manufacture

11 am

The Parliamentary Under-Secretary of State for Health (Ms Hazel Blears): I should like to make a statement about the use of animal products in the manufacture of vaccines. The purpose of this statement is to correct the public record and to inform Members that I have placed three detailed reports on these issues in the Library. Nothing in any of the reports alters the assessment of experts: there are no transmissible spongiform encephalopathy-related safety issues arising from the use of relevant animal-derived materials in the production of vaccines authorised for use in the United Kingdom. However, I thought it right to come to the House to apologise for any inaccurate information that has been provided, and to set out the actual position as clearly as possible. It is important in particular to provide clear assurances for the public that the vaccines that protect both children and adults from harm are manufactured to the highest and safest standards.

On 23 October 2000, my hon. Friend the Member for Pontefract and Castleford (Yvette Cooper), the former Minister for Public Health, reported to the House that an oral polio vaccine had been recalled. That action was a precautionary measure because the vaccine licensed to Medeva Pharma used UK-sourced bovine material in its routine manufacturing production. My hon. Friend informed the House that a full review would be undertaken of all the advice given to Ministers on BSE-related issues and vaccines since 1997 in order to ensure that all the information given to Parliament was correct. She also advised the House that she had asked the Government's expert advisory body, the Committee on Safety of Medicines, to produce a comprehensive assessment of BSE-related issues in vaccines.

Bovine—cattle—products are a traditional component of vaccine manufacture worldwide. Without them, it would not have been possible to have produced so many vaccines over the years that, literally, have been life-saving for millions of people. Routine childhood vaccines such as diphtheria, tetanus and pertussis, HiB—haemophilus influenzae b—and measles, mumps and rubella, will have involved the use of cattle products at early developmental stages in their production, and some of those might have been UK sourced.

The manufacture of vaccines is an extremely complex and technical process involving a number of different stages. For example, one bovine product, foetal calf serum, is regularly used at a number of stages in the manufacturing process of viral vaccines. It is used first at the earliest point, when stores of viruses and cells are first created. They are known as master seeds and master cell banks. Secondly, it is used when material is drawn from those stores to be grown further. Such materials are known as working cells and seeds. Thirdly, it is used during the phase when greater volumes of material are grown, which is known as bulking up. At the very final stage of vaccine production, inactive ingredients such as stabilisers are added, but they are highly processed and, as I say, inactive products. It is worth adding that the Medicines Control Agency advises that UK-sourced gelatin, which can be used as a stabiliser, is no longer used in pharmaceutical manufacture.

The oral polio vaccine that was withdrawn in October 2000 was the only vaccine then in use in the United Kingdom vaccine programme for which UK-derived

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cattle blood products had been used in the later stages of the manufacturing process. It transpired on investigation that one constituent of the vaccine had been produced using material drawn down from old stored stocks dating to 1985 which had been produced using UK calf serum. The material had been used in the routine production process, not just in the early developmental stages—the production of master and working cell and seed banks. That did not apply to other vaccines in use at the time. That is why OPV was different.

The chief medical officer has examined the circumstances of the production of that vaccine and its subsequent withdrawal. He concluded that, on a precautionary basis, the decision to withdraw was the correct one. However, he also concluded that the public health implications were reassuring for three reasons: first, because of the major dilution effect during purification and washing, which removed all but traces—estimated to a dilution of one part in 10 million—of serum; secondly, because foetal calf serum is a substance classified by the relevant 1999 European guideline as having "no detectable infectivity"; and thirdly, because the Committee on Safety of Medicines ad hoc working party on TSE and safety of vaccines concluded in October 2000 that the risk of Medeva oral polio vaccine transmitting new variant CJD was "incalculably small".

At Ministers' request, the Committee on Safety of Medicines has looked more widely at all vaccines available on the UK market. It was assisted by a working party of experts consisting of members of the Committee on Safety of Medicines and its sub-committee on biologicals, as well as experts in TSEs, vaccinology, epidemiology, paediatrics, molecular medicine, virology and biological medicines. The CSM drew the following conclusion:

In other words, after an exhaustive and rigorous review, the CSM found no source for concern in relation to TSEs about the safety of vaccines used in this country.

We should also remember, when considering the safety profile of these vaccines, that they are manufactured for a global market. We import from other EU States and the rest of the world, and we export UK-manufactured vaccines to them. The vaccines that are available globally have been the subject of similar safety reviews by the United States Food and Drug Administration and its Centre for Biologics Evaluation and Research, the Committee for Proprietary Medicinal Products at the European Medicines Evaluation Agency, and the Australian Therapeutic Goods Administration. They have all independently arrived at similar conclusions.

Ministers have now received three reports, which together provide a comprehensive analysis and account of the issues related to TSEs and vaccines. They have today been placed in the Library. The first is the chief medical officer's report into the issues surrounding the withdrawal of the Evans/Medeva oral polio vaccine. The second is the consolidated review of TSE agents and the safety of UK-authorised human vaccines, which was undertaken by the Committee on Safety of Medicines at Ministers' request. The third is a report by the Medicines Control Agency, which explains in detail the development of the guidance and the agency's approach to its implementation.

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It is clear from those reports that some statements have been made in Parliament that have been either incorrect or misleading. Ministers made the statements on the basis of incorrect advice and information given to them at the time by the Medicines Control Agency, which licenses medicines for the UK market and monitors the safety of medicines in use. I repeat my apologies to the House and convey those of my predecessors for the fact that incorrect or misleading information was thus given to Parliament, albeit in good faith.

I have placed in the Library a detailed index of the written answers that are being corrected or clarified. I have today written to Members who asked those questions, explaining how events occurred and setting the record straight. Copies are available in the Library. I have also answered a written question tabled by the hon. Member for Lewes (Norman Baker) about the rules that apply to the use of animal material in the production of vaccines.

There are five areas in which statements made by Ministers based on advice and information from the MCA have been shown to be incorrect or misleading. As I have mentioned, full details of those errors are available to Members in the Library. These factual errors arose through misinterpretations, in the advice to Ministers, of the highly technical and continually evolving guidelines governing the use of animal products in medicines, together with the difficulties of establishing a clear audit trail for vaccines whose manufacture may date back decades.

The first area to clarify is that, contrary to earlier advice from the MCA, the guidelines have never entirely ruled out the use of UK-derived bovine material. Secondly, statements indicated that the MCA would not license any product that did not comply with the guidelines. In fact, the MCA can in certain circumstances license products that do not fully comply, provided that the necessary risk assessment has been carried out. Thirdly, contrary to information supplied by the MCA, not all licence holders were able to demonstrate through documentary evidence that all their materials complied with the guidelines.

Fourthly, dates cited for switching from UK-derived materials were inaccurate, and so were expiry dates given for some vaccines. Finally, statements indicated or implied that bovine-derived excipients are not used in the manufacture of vaccines. In fact, excipients, which as I said are highly processed and inactive substances and which may be derived from bovine materials, are sometimes present in finished vaccines.

Guidelines aimed at minimising the risk of transmitting animal spongiform encephalopathies via medicinal products have been in existence since 1989, first in the UK. TSE guidelines have increasingly applied Europe- wide and have evolved over time. Since March 2001, they have had the force of European law for all licensed medicinal products.

A major exercise is now taking place under the auspices of the European licensing authorities to ensure that all vaccines are assessed for compliance against a revised set of guidelines, which we expect to be introduced this summer. That will apply to all European countries, not just the UK. The revised European guidelines will allow working seeds and working cell banks for which relevant animal material has been used to comply, provided that

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they are subjected to a properly conducted risk assessment by a competent authority in the country concerned—in the United Kingdom's case, the MCA.

Many vaccines will be technically in breach of European guidance until the new guidelines are adopted. There are 95 licensed vaccines in the United Kingdom. Of those, 26 are still completing the process. However, in the United Kingdom, the appropriate risk assessment has already been carried out on all licensed vaccines, including those 26, and no TSE-related risks have been found.

The House can be assured that public health and safety is a top priority for the Government. We will continue to ensure that the public health implications of the use of animal materials in the manufacture of all medicines are rigorously evaluated and that any concerns identified are referred to the relevant domestic and European scientific committees for consideration and resolution. If any new public health concerns come to light, we will not hesitate to act in a precautionary manner, as indeed we did in the case of the oral polio vaccine in October 2000.

Let us be in no doubt that vaccination is the single most important public health measure of modern times. Vaccines save millions of lives around the world every year. When we think about the terrible unsolved health problems of the developing world, we look to vaccines to conquer disease and death, and in our own country vaccines continue to save lives.

I am grateful for the opportunity to come to the House to correct the parliamentary record and to provide the fullest possible information to hon. Members and the public on this important subject.

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