HC Deb 06 November 1995 vol 265 cc607-14W
Mr. Llew Smith

To ask the Secretary of State for Health if the recommendation made by his departmental scientist and others that a second dose of measles, mumps and rubella vaccine should be administered before school age has been implemented. [40079]

Mr. Sackville

The Joint Committee on Vaccination and Immunisation's recommendation is presently under consideration.

Mr. Smith

To ask the Secretary of State for Health what assessment his Department has made of the likelihood of the adverse reactions to the administration of both MR and MMR vaccines; and what account is taken of the possibility of under-reporting of(a) rash, (b) fever, (c) arthritis in all children, (d) arthritis in females of child-bearing age, (e) meningitis, (f) encephalitis and (g) convulsions following such vaccinations. [40063]

Mr. Sackville

The measles and rubella components of the MR vaccine are the same as those in MMR and the profile of adverse reactions to these components of both vaccines is the same. Prior to the national introduction of MMR vaccine in the United Kingdom in 1988, post-immunisation symptoms were assessed, using active surveillance, in more than 10,000 children, including some for whom it was the second dose of measles. Published studies from the United States, which used active and passive reporting systems, have also been considered by my Department.

It is well established that there is under-reporting of suspected adverse reactions to any medicinal product, but serious conditions are more likely to be reported. This fact is taken into account when assessing data from spontaneous reports. However, in respect of MR vaccine, doctors were asked by the chief medical officer to report all reactions. It is likely that this, combined with the widespread awareness and magnitude of the campaign, led to enhanced compliance with the reporting of certain conditions that may not be casually related to the vaccine. The public health laboratory service is conducting on-going studies to look at MMR immunisation and meningitis, encephalitis and convulsions.

Mr. Smith

To ask the Secretary of State for Health what advice is given to parents of children who have suffered life-threatening anaphylaxis following egg ingestion before the planned administration of MR vaccine. [40071]

Mr. Sackville

The leaflet "Measles: Why every child in school needs to be protected from measles this autumn", containing a consent form, was sent to all parents before immunisation took place; it stated that MR injection should not be given if their child has had a serious life-threatening reaction after eating eggs. This advice was also given to all health professionals.

Mr. Smith

To ask the Secretary of State for Health what survey or other scientific information underlay his Department's press release of 28 July 1994 on the plans for a nationwide measles vaccine campaign. [40075]

Mr. Sackville

A list of articles and scientific papers will be placed in the Library, all of which have been published and underpinned the decision of the Joint Committee on Vaccination and Immunisation to recommend to Ministers that a measles immunisation campaign was necessary.

Mr. Smith

To ask the Secretary of State for Health what information he has as to the average length of the immunity established in children vaccinated with MMR or MR vaccinations. [40067]

Mr. Sackville

Follow-up of the first children to receive measles vaccine in the United Kingdom 30 years ago has shown that immunity to measles persists at least this length of time. Rubella vaccine for school girls and adult women was introduced 25 years ago and immunity has been shown to persist in this group for at least this long. The combined MMR vaccine was only introduced for young children in the UK in 1988 but studies in other countries show persistence of immunity in this age group for at least 20 years. However, most of this information relates to persistence under conditions where the natural diseases are still circulating and may be boosting immunity. Also, with each vaccine there is a proportion of children—5 to 10 per cent.—who do not develop immunity the first time that they are vaccinated.

Mr. Smith

To ask the Secretary of State for Health what plans he has to arrange for public access to the data held at the National Institute for Biological Standards on the effects of vaccines upon children known to suffer from allergies. [40081]

Mr. Sackville

The National Institute for Biological Standards and Control does not hold information on the effects of vaccines upon children known to suffer from allergies.

Mr. Smith

To ask the Secretary of State for Health what plans he has to establish a scheme to encourage parents or guardians to submit their own reports on suspected vaccine damage from MMR or MR directly to(a) the Committee on Safety of Medicines and (b) the Medicines Control Agency. [40065]

Mr. Sackville

We have no such plans. Parents and guardians are, however, recommended to discuss any concerns with their family doctor. Health professionals are encouraged to report suspected adverse reactions to the Medicines Control Agency. It is important that the details of the patient's medical condition and medication that has been taken are known. Therefore, it is most appropriate to obtain reports of suspected vaccine damage from the patient's doctor who will be able to supply all the information needed.

All reports of suspected adverse drug reactions are assessed by professional staff of the MCA. The Committee on Safety of Medicines is an independent expert committee that advises the licensing authority and Ministers on matters relating to the safety, quality and efficacy of medicines.

Mr. Smith

To ask the Secretary of State for Health if he will list the scientific papers on the association between the RA 27/3 rubella vaccine and arthritis of which his Department took account in formulating the national campaign of MR vaccination last November. [40080]

Mr. Sackville

A comprehensive list of papers is contained in the publication "Adverse effects of pertussis and rubella vaccine" published by the United States National Academy Press, ISBN 0 309 0449 5. A copy of the extract will be placed in the Library.

Mr. Smith

To ask the Secretary of State for Health what follow-up his Department has established in respect of reported cases of convulsions linked to vaccinations. [40064]

Mr. Sackville

Follow-up is carried out after a serious reaction is reported under the yellow card system to obtain further details of the patient's medical history and other factors relevant to the reaction, in order to assess whether the reaction is likely to be associated with the vaccine. This procedure is carried out by the professional staff of the Medicines Control Agency.

Mr. Smith

To ask the Secretary of State for Health what proportion of the children for whom there are reports of suspected damage from the administration of MR vaccine were known to have a history of(a) asthma, (b) allergies and (c) fitios febrile convulsions. [40070]

Mr. Sackville

Over 8 million children in the United Kingdom have been immunised with MR vaccine. By October 1995, the Medicines Control Agency had received 2,735 suspected adverse reactions affecting 1,202 children. Some children were reported as having more than one reaction. However, the receipt of a report of a reaction does not necessarily mean that it has been caused by the vaccine.

Of the 1,202 children with suspected reactions to MR vaccine, 41 were reported as having a history of asthma—or chest symptoms suggestive of asthma—32 were reported as having preexisting allergic conditions and four febrile convulsions.

Mr. Smith

To ask the Secretary of State for Health in how many instances financial penalties have been applied to the manufacturers of the measles-rubella vaccine used in the vaccination campaign begun in November 1994 because of an identified fault in the supply of vaccines or instruments as to its preparation. [40078]

Mr. Sackville

None. Deliveries of the vaccine and the immunisation equipment were made on time. Surplus stocks of vaccine occurred because of an excess in the amount of diluent provided. These surplus stocks have been returned to the supplier and credits have been received.

Mr. Smith

To ask the Secretary of State for Health, what information he has received in regard to the number of children who have suffered physical or psychological trauma as a suspected result of immunisation against measles. [40365]

Mr. Sackville

To October 1995, the Medicines Control Agency has received reports of 2,690 physical reactions relating to the MMR campaign, out of approximately 8 million children who received MR vaccine in the United Kingdom. For MMR vaccine, since 1987, the MCA have received 4,264 reports of physical reactions and 38 psychiatric/psychological reactions. Some 9.6 million doses of MMR have been distributed in the UK since the vaccine was introduced. However, the receipt of a report of a reaction does not necessarily mean that it has been caused by the vaccine.

Mr. Smith

To ask the Secretary of State for Health what studies have been carried out by his Department of the effects of booster shots of measles vaccinations. [40266]

Mr. Sackville

Studies have been carried out by the public health laboratory service since 1987 in this country and there are a number of other international publications.

Mr. Smith

To ask the Secretary of State for Health what specialist medical advice is available from the health service to counsel and support children who have suffered from the suspected adverse effects of measles vaccination. [40269]

Mr. Sackville

All children with illness, of whatever sort, receive advice and support from appropriate medical specialists.

Mr. Smith

To ask the Secretary of State for Health if he will place in the Library copies of all letters received by his Department's principal medical officer from(a) the United States Government's health authorities and (b) the US national immunisation program in the past year on measles immunisation programmes; and if he will make a statement on the advice received from his American counterpart on measles immunisation. [40287]

Mr. Sackville

[holding answer 31 October 1995]: The Department's principal medical officer has not received letters from the United States Government's health authority or the US national immunisation programme in the past year on measles immunisation.

In 1994, advice on adverse reactions following a second dose of MMR was received from US authorities and this was included in information sent to all doctors in September 1994; a copy of this information is in the Library.

Mr. Smith

To ask the Secretary of State for Health what plans he has to establish a structured interview programme in respect of families alleging deleterious effects from immunisation against measles. [40270]

Mr. Sackville

There is already a well-established satisfactory system in place for monitoring adverse reactions to all medicines, including vaccines.

Mr. Smith

To ask the Secretary of State for Health if he will set out(a) the month of manufacture of the component constituents, (b) the date of cultivation of the viruses and (c) the dates of alteration of the viruses used in the measles and rubella vaccination campaign launched in November 1994. [40284]

Mr. Sackville

[holding answer 31 October 1995]: Two manufacturers supplied the vaccines used in the measles and rubella vaccination campaign. The finished batch products, produced in August and September 1994 were manufactured from a number of bulk component constituents each of which was made over a period of several months in 1989, 1992, 1993 and 1994. Cultivation of the viruses used in these batches occurred during manufacture of the bulk component constituents. The viruses were obtained from master seed viruses attenuated some 25 to 30 years ago.

Mr. Smith

To ask the Secretary of State for Health what evaluation was made by his Department of the reasons why the Trivirix MMR vaccine was withdrawn from use in Canada in May 1990; what considerations led to his Department's to withdraw the MMR vaccine from use in the United Kingdom; and when it was withdrawn. [40288]

Mr. Sackville

[holding answer 31 October 1995]: The decisions that were taken by the Canadian authorities to discontinue using Urabe strain mumps vaccines were known to other licensing authorities. At that time, there was insufficient evidence of a problem with the strain of mumps vaccine in the United Kingdom for a change in vaccine policy to be advised.

Alerted to the existence of a potential problem of mumps vaccine virus meningitis by the Canadians, the Department of Health commissioned the public health laboratory service to undertake a study which allowed the detailed monitoring of possible vaccine associated cases. The studies undertaken were of an intensity that had not been undertaken anywhere else in the world. This involved 13 health districts. Some 28 vaccine associated cases were identified, all in recipients of MMR vaccines containing the Urabe mumps strain, indicating a risk of one in 11,000 with the vaccines.

As soon as data were available confirming the extent of the risk, showing that an alternative vaccine did not have this level of risk and was equally effective, and adequate alternative supplies were available, the Urabe vaccines were replaced. This occurred in September 1992.

Mr. Smith

To ask the Secretary of State for Health if he will make a statement on the evidence his Department has evaluated in respect of suspected links between vaccinations administered for tuberculosis and(a) epileptic fits and (b) febrile convulsions. [40730]

Mr. Sackville

[holding answer 1 November 1995]: All reports of suspected adverse reactions to vaccines are regularly reviewed by professional staff of the Medicines Control Agency. The report of a reaction does not necessarily mean it was caused by the vaccine.

Since 1963, reactions have been reported in 795 people who had received BCG vaccine. In 11 children suspected reaction were classified as "convulsions". Six of these reactions were closely related to immunisation and were associated with fainting. The number that were febrile convulsions cannot be identified from the available information. Approximately 500,000 BCG vaccinations are given each year mostly in schoolchildren aged 10 to 13 years.

Mr. Smith

To ask the Secretary of State for Health what plans exist to introduce improved vaccine monitoring of the side effects of the administration of MMR vaccinations. [40069]

Mr. Sackville

My right hon. Friend the Secretary of State has no plans to change the monitoring of the side effects of the administration of MMR vaccine. There is a well-established satisfactory system in place already for monitoring adverse reactions to all medicines, including vaccines.

Mr. Smith

To ask the Secretary of State for Health what survey his Department has conducted of children vaccinated against measles, mumps and rubella in the past year in regard to the numbers and the proportion suffering from a reaction rash to the administration of the vaccine. [40072]

Mr. Sackville

Between 26 October 1994 and 26 October 1995, there have been 220 spontaneous reports in the United Kingdom of suspected adverse reactions in patients who have received measles, mumps and rubella vaccine. Of these, 67 were rashes or other similar skin reactions. However, the receipt of a report of a reaction does not necessarily mean that it has been caused by a vaccine. There have been 950,000 doses of MMR distributed in the UK in the past year.

Mr. Smith

To ask the Secretary of State for Health what studies have been done by his Department, or consultants to his Department, into the causes of sub-acute sclerosing panencephalitis; and what steps have been taken to combat this disease. [40076]

Mr. Sackville

Sub-acute sclerosing panencephalitis was shown to be due to wild measles virus in 1967 by a United Kingdom virologist working in Belfast. The effects on SSPE of the introduction of measles vaccination in 1968 has been investigated by the public health laboratory service which keeps a register of all cases. This surveillance has shown that the vaccine protects against SSPE and that the incidence of this condition has dramatically decreased since routine measles immunisation was introduced.

Mr. Smith

To ask the Secretary of State for Health what study his Department has set up to correlate vaccination records for MMR with(a) school attendance records, (b) hospital admission records and (c) general practitioners' records. [40068]

Mr. Sackville

The public health laboratory service is conducting studies to look at adverse events associated with MMR vaccination using hospital admissions data and general practioners' records. Pilot studies in single districts with hospital records have been published. Larger studies using both data sets are in progress. MMR is given routinely at 12 to 15 months, an age when children do not attend school. No study has been set up to look at school attendance records.

Mr. Smith

To ask the Secretary of State for Health what assessment has been made by his Department of secondary complications arising from(a) measles, (b) mumps and (c) rubella. [40077]

Mr. Sackville

A number of investigations have been carried out by the public health laboratory service over the last 30 years that have looked at the severity and complications of natural measles, mumps and rubella infection. These studies have been based on hospital admissions and laboratory confirmed cases. Numerous other studies, both in this country and abroad, have also been conducted and these have been considered by my Department. Studies continue to confirm that there is significant morbidity associated with measles and mumps infection and with rubella infection during pregnancy.

Mr. Smith

To ask the Secretary of State for Health what variation has been recorded in the incidences of congenital rubella syndrome in the United Kingdom since 1986. [40073]

Mr. Sackville

The number of reported cases of congenital rubella in the United Kingdom since 1986 is shown in the table.

Number of Cases
1986 30
1987 40
1988 25
1989 15
1990 13
1991 3
1992 17
1993 3
1994 7
1Includes triplets (thus, number of affected pregnancies = 5).

These was a substantial drop in the number of cases following the introduction of MMR in October 988 and an increase in 1994. The figures for the most recent years—1990 onwards—are not complete as some affected children are not diagnosed or reported until they are older.

Mr. Smith

To ask the Secretary of State for Health what assessment hid Department has made as to whether natural measles normally convey life-long immunity. [40061]

Mr. Sackville

It is established medical fact that measles is a serious disease which does convey life-long immunity for those who survive it.

Mr. Smith

To ask the Secretary of State for Health when his Department was informed of the likelihood of a measles epidemic in the winter of 1994–95. [40268]

Mr. Sackville

Evidence was presented to the Joint Committee on Vaccination and Immunisation in November 1993 that pointed to an epidemic between 1996 and 1997. By the middle of 1994, it became apparent that an epidemic could occur earlier.

Mr. Smith

To ask the Secretary of State for Health what recent information he has received from the World Health Organisation in regard to its assessment of the spread of measles. [40271]

Mr. Sackville

The conclusions and recommendations of the 10th meeting of the World Health Organisation's European advisory group on the expanded programme on immunisation held in Copenhagen on 24 to 25 April statedsingle dose measles immunisation strategies would not reach the Regional targets and with such strategies there would continue to be recurrent epidemics. The alternative augmented strategies will impose higher resources requirements but will be cost-effective by preventing cyclical epidemics".

Mr. Smith

To ask the Secretary of State for Health (1) what was the(a) expected and (b) actual number of deaths from measles in each year since 1987; what is the expected number of deaths for the next year; and what is the mortality rate from measles; [40272]

(2) which historic outbreaks of measles were considered when assessing the number of children expected to die of measles before the establishment of the measles immunisation campaign in November 1994; and how many deaths occurred in each such epidemic. [40676]

Mr. Sackville

[holding answer 1 November 1995]: Measles has been a notifiable disease since 1940. Epidemics, with associated deaths occurred regularly until the introduction of vaccine in 1968. This historic data, along with notifications and deaths from 1968 to 1993, were used in making predictions for future epidemics. Details of deaths since 1987 are shown in the table.

In predicting deaths in future epidemics, consideration was given to the expectation than an epidemic would primarily affect older individuals than previously. In such individuals, case fatality rates from measles are much higher.

Deaths recorded at Office of Population Censuses and Surveys having measles as an underlying cause for all ages in England and Wales 1987–94
Year Total expected Total observed
1987 6 6
1988 1 16
19891 7 3
19901 2 1
19911 1 1
19921 1 2
19931 1 4
19941 3 21
1 After the introduction of MMR vaccine in 1988, measles notification are not an accurate measure of the incidence of disease (Brown et al, British Medical Journal 1994, so for 1989–94 notifications are corrected for misdiagnosis before applying mortality rates.
2 Provisional figure.

No deaths due to indigenously acquired acute measles are expected within the five to 16 year age group in 1996.

The age specific case fatality rates from measles during the period of 1971–88 were:

Age group Deaths per 100,000 cases
<1 year 41
1–4 years 16
5–9 years 10
10–14 years 32
15–24 years 89
25+ years 92

Mr. Smith

To ask the Secretary of State for Health what resources were given to each area health authority to support the vaccination campaign against measles and rubella started in November 1994. [40286]

Mr. Sackville

[holding answer 31 October 1995]: District health authorities were supplied free of charge with measles and rubella vaccine, syringes, needles, sharps containers and publicity materials. Implementation costs were met from existing national health service resources.