The Pharmaceutical Journal
Vol 269 No 7206 p46
13 July 2002

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Withdrawal of an oral polio vaccine: analysis of events and implications (PDF 320K)

MCA misled Ministers on vaccine

The Medicines Control Agency supplied Government ministers and, through them, Parliament with misleading information about vaccines made with calf serum.

Hazel Blears, Parliamentary Under-Secretary of State for Health, admitted to the House of Commons that Ministers had made statements on the basis of incorrect advice from the MCA. Contrary to advice to Ministers from the MCA, guidelines on the use of bovine material for vaccine manufacture did not entirely rule out the use of UK-derived bovine material. The MCA had also said that it would not license products that did not meet the guidelines when it could in fact do so if a risk assessment had been carried out. Thirdly not all licence holders were able to show 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 were not used to make vaccines when they were.

As a result of an investigation by the Department of Health's chief medical officer Professor Sir Liam Donaldson into the circumstances surrounding the withdrawal of an oral polio vaccine (OPV) in October 2000 (PJ, 28 October 2000, p638), the MCA is now expected to review its procedures.

Sir Liam found that the errors were caused, in part, by the MCA's dependence on manufacturers for information, compounded by weaknesses in its own information management system. Staff had also failed to reflect the relevant guidelines accurately to ministers and had drawn on early drafts rather than published guidelines.

Sir Liam said that it was apparent to many that the transfer of OPV manufacture from Wellcome to Evans in 1991 could be problematic and that the MCA might have been expected to know this and to have taken extra care. Also, there had been insufficient awareness of the seriousness of the situation and of the importance of reviewing the need for precautionary action (ie, withdrawal) as opposed to further fact finding.

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