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Monday, 7 February 1994
Page: 500

(Question No. 860)

Senator Campbell asked the Minister for Health, upon notice, on 6 December 1993:

  With reference to the Commonwealth Serum Laboratories (CSL):

  (1) With reference to a pamphlet produced by CSL regarding triple antigen vaccine which states that "encephalopathy is an exceedingly rare sequel to pertussis immunisation", how rare is it and what information and research determined this claim.

  (2) Reference is made in this pamphlet to the fact that "a causal relationship has been reported but this conclusion has been disputed": (a) on what basis and information was the report made and by whom; and (b) who disputed the report and on what basis.

  (3) From what date did the instruction pamphlets accompanying the triple antigen vaccine include the statement that "encephalopathy is an exceedingly rare sequel to pertussis immunisation".

  (4) With reference to the fact that earlier batches of the vaccine contained 20,000 million organisms of B. pertussis with the adjuvant effected provided by the pertussis component, and more recent batches contained killed organisms of B. pertussis with the adjuvant effect being provided by aluminium phosphate: (a) what was the reasoning behind the changing of these components; and (b) what were the benefits.

  (5) Is the triple antigen vaccine produced by CSL the only triple antigen vaccine used on Australian infants; if not, what other manufacturers also produce the products for the Australian market.

  (6) Does the Commonwealth Government or CSL pay a patent fee for the production of triple antigen if so, to whom is it paid.

  (7) If a fee or a royalty payment is involved, how much has been paid since it was agreed to do so, and what were the payments for each of the past 5 years (1988-92).

Senator Richardson —The answer to the honourable senator's question is as follows:

  (1)&(2) The possibility of an association between pertussis vaccine and encephalopathy was first reported in 1933 with a further report in 1947. The latter report was contested in the medical literature but led to the inclusion of neurological disease as a contra indication to vaccination.

  Further reports which appeared in subsequent years were not conclusive and revealed no recognisable pattern of neurological damage that could be attributed to the vaccine, nor was there experimental evidence in humans or animals that either proved or disproved a causal relationship between pertussis vaccine and brain damage.

  Recently a U.S. Institute of Medicine Committee report quoted in the Journal of the American Medical Association concluded that there was insufficient evidence to indicate either the presence or absence of a causal relationship between pertussis vaccine and chronic neurological damage.

  The standard encyclopaedia of adverse reactions and drug interactions, Meyler's Side Effects of Drugs (1992) concludes that "there is insufficient evidence to indicate a causal relationship between pertussis vaccine and chronic neurological disease".

  The United Kingdom Department of Health and Social Security (DHSS) established panels of experts to investigate the question of safety of pertussis vaccine and a substantial report was made in 1974. These studies were both retrospective and prospective and again produced no conclusive evidence for the link.

  There have been two major court cases dealing with the issue. The first was run in the U.K. High Court in 1987. An exhaustive re-examination of written and oral submissions from recognised authorities from the U.K, the U.S. and Europe as well as literature and case reports was undertaken over a protracted period. Lord Justice Stuart Smith concluded that the plaintiff had failed to satisfy him that, on balance of probability, pertussis vaccine can cause damage in young children.

  In a second case the Irish High Court and Irish Supreme Court studied the evidence in relation to a particular plaintiff. The court ultimately awarded damages to the plaintiff; however, the batch of vaccine had not passed the supplier's own internal control tests.

  (3) Product leaflets from the introduction of the Triple Antigen in 1953 contain a statement regarding the possibility of encephalopathy following pertussis immunisation.

  (4) Adjuvants produce higher immunity with lower doses of antigen. The usual adjuvant used for vaccines is an aluminium mineral carrier. This has been included at times in the pertussis vaccine since as early as 1956.

  Early studies on pertussis vaccine showed that the larger the dose the more likely the child is to get an immune response. In 1941 the dosage recommended by some experts was a minimum of 80,000 million organisms given in increasing increments over a period of a few weeks. In the early 1950s an international standard for the vaccine was determined based on 20,000 million organisms.

  (5) The only currently licensed and marketed Triple Antigen is produced by CSL Limited. However, at times, there have been up to four manufacturers marketing the vaccine in Australia.

  (6)&(7) Neither the Commonwealth Government nor CSL pay any patent fees or royalties.