This article appears in the February 1995 edition of the Catholic Medical Quarterly
Report on the Faith Communities Liaison Committee meeting.
Held on Tuesday 1st November 1994,
at Richmond House, 79
to discuss the Measles/Rubella Immunisation campaign.
The government became concerned at the public withdrawal of Ampleforth and Stonyhurst colleges from the MR vaccination campaign due to start in November 1994. As a result of the media coverage the Muslim community became aware that the rubella component was grown on a fetal cell line and threatened similar action. This prompted Dr Calman, the Chief Medical Officer, to call hurriedly a meeting to which religious leaders were invited. It was obvious that the government took this matter seriously because in addition to himself, the chief medical officers for Scotland, Northern Ireland and Wales were present. Also present were Mrs Ishmael, (Principal Nursing Officer), Dr Stephen Horsley (Chairman Measles/Rubella Campaign Implementation Group), Dr David Salisbury (HP(M)l), Miss Alman Mithani (HP(A)), Miss Veena Bahi (Ethnic Minorities Advisor) Dr Elizabeth Miller (Public Health Laboratory Service) Dr Philip Minor (National Institute for Biological Standards and Control), Professor Alex Campbell (Chairman of Joint Committee on Vaccination and Immunisation), Mr Michael Corr (Health Education Council) and Dr Robert Aston (Public Health Consultant who was responsible for the pilot programme in Bolton, on which the National campaign was based).
The participants from the Faith Communities were: Mr Nicholas Coote (Assistant General Secretary to the Catholic Bishops' Conference), Dr Michael Jarmulowicz (Guild of Catholic Doctors), Dr J Williamson (Issues Committee of the Catholic Union & also director of Public Health in Kingston & Richmond), Ms Mary Rhodes (Catholic Media Office), Dr Mughram Al-Ghamdi (Director General of the Islamic Cultural Centre), Mr Iqbal Sacranie (Convenor UK Action Committee on Islamic Affairs), Dr S A Darsh and Dr Shadjareh (Muslim Scholars), Mr Om Parkash Sharma (President of National Council of Hindu Temples), Mr Indarjit Singh (Sikh Council for Interfaith Relations), Archbishop David Douglas and Mr David Skidmore (Board of Social Responsibility, Church of England), Ms Philippa Taylor (Evangelical Alliance), Rev Christine Pocock (Society of Hospital Chaplain Board, Free Churches Federal Congress) and Ms Rhoda Goodman (Assistant Executive Director to the Office of the Chief Rabbi).
The meeting opened with a brief overview of immunisation programmes in general, together with specific examples of their success in preventing disease data showing the increase in incidence of measles following a concern about the safety of one vaccine resulting in poor uptake of all immunisations. Data was also given of an epidemic of polio in a community in Holland, which in principle rejects all immunisations. Despite a general widespread uptake of polio vaccination in Holland, this small tight-knit community was unprotected and suffered a devastating epidemic. At the conclusion of this presentation all agreed on the principle of immunisation programmes.
Dr Miller then presented data on the incidence of Rubella. In 1993 there was a sudden increase in Rubella in pregnancy, with 25 laboratory confirmed cases of which it is known that 13 have had abortions. Within the general population, the most marked increase was in males aged 15-25yrs. with approx. 700 laboratory confirmed cases. This compared with approx. 100 laboratory confirmed cases in 10-l4yr. old boys. Figures in girls/women are significantly lower. Of 12 recent cases of congenital rubella syndrome, 9 have been in women from ethnic minorities. All these women had entered the country in the last few years. This fact was used to illustrate the importance of herd immunity. In response to a question as to why the current campaign was limited (in England) to 5-16 year olds, as the majority of rubella was occurring in the 15+ aged male population, it was accepted that the main purpose of the campaign was to prevent a predicted measles outbreak in early 1995. The West coast of Scotland has already had a measles outbreak with 5000 cases of which 130 were admitted to a fever unit.
Dr Minor explained the principles of live virus vaccination. By growing a virus in carefully controlled laboratory conditions it becomes adapted to laboratory growth and so is less virulent when it infects humans. There is a careful balance between attenuation and virulence. The virus still has to be capable of infecting an individual but it must not cause disease. Previously, rubella vaccines were made using the Cendehill strain of rubella which was grown on Rabbit kidney cells. This virus was less effective (ie the vaccine did not take in a number of cases) and some individuals were allergic to rabbits. The Cendehill strain is no longer licensed for use. A further concern, which applies to all vaccines grown on animal cells, is that each batch of vaccine requires the slaughter of a new batch of animals. Even laboratory bred animals can asymptomatically harbour viruses, which, if present, may be passed on in a vaccine. Obviously all batches of cells are carefully checked for hidden viruses, but the theoretical concern of transmission remains. A few years ago there was a theory that the African AIDS epidemic was started by a trans formed simian immuno-deficiency virus which was transmitted with the polio vaccine This theory has now been disproved, but the theoretical possibility of such a scenario still exists.
Currently all UK manufacturers using human diploid cells, use the MRC5 cell line. These are lung fibroblasts derived from a 14 week male fetus of a 27 year old woman aborted in 1966 for 'psychiatric reasons'. This data is given in an article in Nature which detailed the characteristics of the cell line (Nature July 11th, 1970. vol 227 pages 168-70). When initially developed this cell line could undergo 40-50 cell divisions (population doublings). Culture media have now improved and population doublings of 60-70 are being achieved. Numerous batches of cells at different cell division stages have been deep frozen in liquid nitrogen, which explains why plentiful stocks of this cell line are available. Dr Minor stated that stocks were sufficient for the foreseeable future, and, when pressed further, quoted a time scale of 20-30 years. At this point Dr Calman stated that there would be no need to seek tissue from any other abortions. A participant asked about the WI38 fetal cell line, also licensed for use in vaccine production. It was stated that while all UK manufacturers use MRC5 cells, some companies in other countries use the WI38 cell line. In response to questions about the commercialisation of fetal tissue, and specifically the MRC5 cell line, Dr Minor reported that all manufacturers and laboratories needing this cell line are provided with it free of charge. It is used by some laboratories for virus isolation.
The virus used in the current Rubella vaccine is the RA27/3 strain. It was isolated in America from a fetus aborted because of congenital rubella in the early 1970s. The virus was then given to WHO by the man making the isolation with instructions to make it available to the world so as to prevent rubella. Dr Calman stressed, to ensure there was no confusion, that two abortions are associated with the rubella vaccine. One abortion in the UK, from which the MRC5 cells were produced, and another, different abortion in the USA, from which the rubella virus was isolated.
Dr Calman reminded the meeting that for those who had ethical problems with the MR vaccine, these would also apply to the MMR vaccine which has the identical rubella component in it. He also stated that the Hepatitis A vaccine (used as a travel vaccine) and Rabies vaccine (only used after a suspected contact with rabies) were also made on MRC cells. One manufacturer was making a polio vaccine on monkey kidney cells, but others had switched to MRC cells.
There was a wide ranging discussion, with many participants (particularly non-medical) seeking further explanations of technical points. All were answered with complete openness.
In his presentation on vaccine research and development, Dr Salisbury did indicate that newer technologies were on the horizon, including the possibility of growing the viruses in plant cells. But he expressed caution that even if a breakthrough were to be made now, it would be 7-10 years before this could be translated into a commercially available vaccine.
Various points emerged in response to questions. Some are open to the interpretation that they are contradictory. At an early stage Dr Calman stated that he would be writing to the vaccine manufacturers, urging them to explore continually new methods of vaccine production which would be ethically acceptable to all. He reminded the meeting that the government did not make their own vaccines; these were produced by multinational pharmaceuticals. The reason offered why details of the source of the rubella vaccine were not made generally available, was that, as the MMR vaccination program had been running since 1988 without complaint, the department was unaware that a problem existed. A participant did remind the meeting that Ann Winterton MP had put down a written parliamentary question in late 1992, which raised this issue. In addition most drug data sheets only specified 'human diploid cells', which to most doctors would give no clue to their fetal origin.
In response to a suggestion that the earlier Cendehill rubella vaccine grown on rabbit cells be reintroduced, Dr Salisbury replied that they had an ethical problem with this proposal. The drug indus try was always aiming to improve efficacy and safety. How could they market a product which was known to be less effective and safe than the currently available vaccine? To the suggestion that the patient could make an informed decision in the light of their beliefs, the problem of legal responsibility was raised. Would the patient absolve the doctor and vaccine manufacturer from any possible deleterious effects? In discussion about the development of vaccines using alternative methods Dr Miller raised ethical concerns about trials for such vaccines. The current rubella vaccine is apparently the most effective and safest vaccine so far developed, so would it be ethical to conduct trials, which were comparing efficacy and safety, with a product already known to be excellent in these areas?
One participant informed the meeting that the Japanese used a number of different rubella virus isolates. Dr Minor admitted that he was unaware of any further details.
Dr Calman concluded the meeting with a consensus summary of the main points. These were:
- Discussion had taken place in a friendly and open manner. Dr Calman was keen to continue dialogue and promised future consultation with the faith communities on bioethical matters.
The meeting started at 10:30 hrs. and ended at 12:40 hrs.
Dr Michael Jarmulowicz BSc. MB, MRCPath. (Hon. Secretary to the Guild of Catholic Doctors)