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Dept of Health

Answer

Norman Baker: To ask the Secretary of State for Health if he will remove (a) formaldehyde, (b) mercury, (c) foetal calf serum and (d) monkey kidney cells from UK childhood vaccines. [210276] Miss Melanie Johnson: Formaldehyde is used as an inactivating agent to eliminate poliovirus infectivity. Also, it is used to inactivate diphtheria and tetanus toxins. Gluteraldehyde, a closely related chemical, is used to inactivate acellular pertussis toxins. The quantities present in the new vaccines are low, and less than 0.1 milligrams of formaldehyde and less than 0.02 mg gluteraldehyde per 0.5 millilitre dose. Formaldehyde is present naturally in the human body at levels of about 2.5 micrograms per ml of blood. For a two month old child, this is about 10 times as much as in the amount present in a single dose of vaccine. There is no evidence that these quantities pose a risk to health and there are no plans to remove these substances from vaccines. None of the current vaccines used in the childhood immunisation programme contain mercury. Thiomersal, which releases ethylmercury, has played an important role either as a preservative or in the initial stages of the manufacture of some vaccines for over 60 years. Thiomersal was contained in the diphtheria, tetanus and whole cell pertussis (DTwP) and diphtheria and tetanus vaccines. However, with the introduction of the new vaccine Pediacel on 27 September 2004, the routine childhood immunisation programme no longer includes mercury-containing vaccines. Foetal bovine serum is an essential growth supplement for the cells used for the propagation of live viruses. The bovine serums used have demonstrated compliance with European Union regulations for minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicines. The serum is used solely in the early stage of the manufacturing process of the vaccine and is reduced to trace amounts during purification and dilution steps. The monkey kidney cell line used for the production of inactivated poliovirus in the new vaccines has been extensively examined for contaminating viruses. The cell line meets the requirements of the World Health Organisation and European Pharmacopoeia. To exclude the risk of extraneous viral contamination each production lot is examined for contaminating viruses during the production process. The viral inactivation process has been fully validated. No monkey kidney cells are present in the final vaccine.

Secondary information

Type

Written question

Reference

210276; 430 c1686-7W

Session

2004-05

Subjects

Children Animal products Safety Vaccination Mercury Formaldehyde

Link

View this Written question on www.publications.parliament.uk