§ Mrs. SpelmanTo ask the Secretary of State for Health what plans he has to review the existing arrangements with Medeva Pharma for supply of the BCG vaccine. [107989]
§ Yvette CooperMedeva Pharma is the sole United Kingdom licensed manufacturer of BCG vaccine. The shortage of this vaccine is clearly unsatisfactory. The previous Secretary of State for Health, my right hon. Friend the Member for Holborn and St. Pancras (Mr. Dobson), met senior staff from Medeva twice in 1999 asking them to provide detailed explanations for their manufacturing problems and sought details of the plans for their resolution. The Department continues to be in close contact with316W Medeva monitoring the manufacturing progress. It is of considerable concern that despite numerous interventions supply of BCG vaccine is not forthcoming. Opportunities for alternative supplies from across the world are being investigated.
§ Mrs. SpelmanTo ask the Secretary of State for Health for what reasons there is a shortage in the supply of manufactured BCG vaccine; what action he will like to restart the programme of vaccination in schools; and how he will ensure that supplies of the vaccine remain(a) constant and (b) sufficient. [107997]
§ Yvette CooperThere is only one licensed manufacturer of BCG vaccine in the United Kingdom—Medeva Pharma. Over the past months, this company has experienced severe manufacturing problems with their BCG production facility in Speke, Liverpool. Medeva has indicated to the Department that the production volumes are not currently sufficient to support the routine schools programmes. Until manufacturing resumes in sufficient quantities, stocks are being used specifically for those at higher risk of tuberculosis. The Department has had no alternative but to request health authorities to suspend their routine schools immunisation programme.
As soon as the problems with the manufacturing facility have been resolved and this has been demonstrated by stocks becoming available in sufficient quantities, the Department will advise health authorities to recommence their routine schools programmes.
Since vaccines are biological products whose manufacture can never be guaranteed, continuity of supply can only be assured by having sufficient stock manufactured in advance, preferably from more than one manufacturer. The Department is in contact with Medeva Pharma to offer any assistance in resolving their manufacturing problems. The Department is also investigating the possibility of alternative suppliers who can produce licensed, batch released vaccine for the UK market.
§ Mr. PicklesTo ask the Secretary of State for Health, pursuant to his answer of 27 January 2000,Official Report, column 335W, on BCG vaccinations, what is the procedure for a doctor to apply for BCG vaccinations; to whom the application is made; who takes the decision on issuing the vaccination; and who monitors and records the results of the vaccination programme. [108673]
§ Yvette CooperBCG vaccine is ordered in the same way as for childhood vaccines. This may be direct from the distributor, Farillon, or via a local hospital pharmacy, dependent on local policy.
317WBCG will continue to be issued as now, as it becomes available, for higher risk groups, in particular to maintain selective neonatal immunisation of infants at higher risk of exposure to tuberculosis.
Uptake of BCG vaccine is recorded by National Health Service trusts and the information collated by the Department on central return KC50. Figures are published annually in the Department's Statistical Bulletin, "NHS Immunisation Statistics". Surveillance of tuberculosis is the responsibility of the Public Health Laboratory Service, Communicable Disease Surveillance Centre. Vaccine uptake and the incidence of tuberculosis are monitored by both the Department and the Joint Committee on Vaccination and Immunisation, the independent expert committee that advises the United Kingdom Health Departments on immunisation matters.