§ Mr. Ashley
asked the Secretary of State for Social Services (1) what is his estimate of the number of women who have been vaccinated with faulty rubella vaccines since May;
(2) what is his estimate of the number of schoolgirls who have been vaccinated with faulty rubella vaccines since last May;
(3) what steps he has taken to trace the women and schoolgirls who have been vaccinated with faulty rubella vaccines; and what further steps he proposes to take, assuming that all those concerned have not yet been traced;
(4) what is his estimate of the total cost of tracing all doses of faulty rubella vaccine; and how much time will be involved for the doctors concerned;
(5) how many doses of faulty rubella vaccine have been issued since May; when it was discovered that they were faulty; how many have been traced and recalled; and if he will make a statement;
(6) if any financial assistance was offered by Smith, Kline and French to assist in tracing its faulty rubella vaccines; if so, when it was offered; and how much money was involved;
(7) if he will list in the Official Report the number of previous occasions before May when any faulty rubella vaccines were issued; how many were involved; what steps were taken to trace them; and with what success;
(8) what checks were in operation to prevent the distribution of faulty rubella vaccines; why they did not operate successfully in all cases; and what steps have been taken to prevent a recurrence;
(9) if he is satisfied that the National Institute for Biological Standards and Controls is conducting adequate checks of rubella vaccines;
(10) how many women and schoolgirls vaccinated with the faulty rubella vaccine have now been re-vaccinated;
(11) what is his estimate of the number of women vaccinated by a faulty rubella vaccine since May who have since 317W become pregnant; and what steps is he taking to ensure that they are not re-vaccinated;
(12) what funds he has allocated from his Department for tracing all doses of faulty rubella vaccine distributed since May.
§ Dr. Vaughan
Vaccines are not released for distribution unless they are found to be satisfactory following extensive checks and testing by the manufacturer; and examination of manufacturers' protocols and testing of samples by the National Institute for Biological Standards and Control. These controls, which I am satisfied are adequate, were applied to the rubella vaccine of Smith, Kline and French before the batch of 35,359 mono-dose vials and 5,582 10-dose vials concerned was released.
Further tests for potency were carried out by the Institute in July 1979 and found to be satisfactory. Preliminary findings of possible loss of potency became available early in October and as a precautionary measure further distribution of the batches of vaccine were stopped immediately.
Tracing and recall of all vials in the suspect batch was initiated by the company in October and is proceeding. To date 3,662 mono-dose vials and 1,154 10-dose vials have been returned or are being returned to the company.
The financial responsibility for such action rests entirely with the company; thus the question of allocating funds for this purpose by the Department does not arise.
The company's rubella vaccine has been on the market for many years and this is the first occasion on which testing has suggested that a batch was below standard.
The vials in question were not issued until 18 June and 7 August 1979 respectively. There is, therefore, no question of the use of vaccine from this batch before 18 June. In view of the incidence of school holidays the number of schoolgirls who received this vaccine is likely to be very small. I cannot, however, make any estimate of the numbers vaccinated until the recall is complete.
A press notice was issued by the Department on 6 November. Women who are vaccinated against rubella are 318W advised not to become pregnant within three months of vaccination. In view of the date of issue the number of women who might have become pregnant before the notice was issued would be small.
Smith, Kline and French have contacted all doctors and pharmacies in the United Kingdom. Further action, including the question of re-vaccination is a matter for the responsible doctors. We are not asking them to provide any statistics of the action taken, so that I can give no figures of the numbers re-vaccinated and the expenditure involved.