Friday, March 23, 2007

Human Technology Manufacturing Platforms Part I. The Paediatric Vaccination Question.

After some thought, I have decided to reproduce an essay I published last fall in the National Catholic Bioethics Quarterly here. There is a little risk in this, because it will also be a chapter in my book, and one can only reproduce the same material so many times. But I think this is an important topic, even more important than the embryonic stem cell problem because, unlike stem cells (whose applications are, at this point, science fiction) this is upon us now. Also, this is a long essay, well over 7000 words, and the internet just isn't a great medium for long writings (I don't like reading things more than 1000 words or so on a computer screen; gives me a headache). So, like the stem cell series (which has not been published elsewhere, but is forming the basis of the stem cell chapter in the book) I will break it up into bite sized chunks over the next several weeks. We'll see how it goes, so here goes: Human Technology Manufacturing Platforms, Part I (of VII or so parts).

The topic of vaccines manufactured using cell lines which have their origin in aborted babies has received a fair amount of attention in the Catholic press, and the topic again became prominent with the publication of a Vatican letter on the topic in July, 2005. This essay will review the vaccination issue for the uninitiated, and go through the Vatican letter in some detail. However, up until now the discussion has largely been confined to a handful of vaccines used in routine pediatric vaccination programs, and so the moral issues have been largely confined to parents of vaccination - age children. I believe that the issue is poised to move out of this relatively circumscribed arena to affect virtually everyone, and quite soon. This is because numerous new vaccines using illicit human cell lines as culture media, including new vaccines against influenza A and B, and the avian flu vaccine, are well into the development phase, and in some cases already entering clinical trials. These are vaccines which are, or will be, widely distributed. In addition, numerous other types of medical therapies, such as monoclonal antibody cancer therapies manufactured on these lines, are in development. But we will begin by discussing vaccines, and given the occasionally contentious nature of the topic of vaccination, I need to make perfectly and explicitly clear a couple of items right up front. First, I absolutely acknowledge the usefulness, in general, of vaccination and mass vaccination programs. After sanitation, mass vaccination has done more to improve the overall health and well being of individuals and of populations than any other single measure, and it would be profoundly unwise to jettison something which has worked so well. Second, I don't contest the authority of a government, in principle, to require mass vaccinations under certain circumstances.[1] Finally, I am not going to discuss vaccine safety. Vaccine safety is a profoundly important issue since, in a population - wide program, even rare events turn into large numbers: a tiny fraction of a huge number is a big number. Every effort should be made to monitor, ensure, and improve vaccine safety, and if questions regarding a vaccine or a component of a vaccine come up, they should be rigorously investigated. But I am not addressing vaccine safety here. In general, the vaccine is far, far safer than the disease it is attempting to prevent.[2] To repeat: the first point of this paper is to review the issue of the moral status of parents who use vaccines manufactured with cell cultures derived from aborted babies. The second point is that, since the number of vaccines derived from the cell cultures of aborted babies is on the threshold of expanding exponentially, this issue will no longer be confined to a relatively small group of parents agonizing over whether, in vaccinating their children, they are cooperating with evil. Rather, the issue will apply to vast segments of the population and, possibly, virtually everyone. And, the third point is that other therapies which could even eclipse the vaccines in number and importance are in the works. Central to all of these points is the issue of moral coercion of conscience[3]. In other words, persons whose well formed Catholic consciences indicate that using these vaccines could represent cooperation with evil are nevertheless required against their will to use the products. But first, a review of the facts.

The pediatric vaccination question.
In the United States, two vaccines in the routine pediatric immunization schedule utilize human diploid cell cultures in their manufacturing process. They are the vaccine against rubella (German measles), and the vaccine against varicella (chickenpox). The first vaccine, rubella, is usually given as a component of the combined measles/mumps/rubella vaccine M-M-R II (Merck.), and the rubella vaccine component uses a live, attenuated rubella virus strain designated RA 27/3, grown in the human diploid cell line WI-38.[4] The rubella vaccine is also available as a single injection from the same manufacturer under the trade name MERUVAX, and also uses the WI-38 cell line.[5] The measles and mumps vaccine components in the combination M-M-R II vaccines are grown in chick embryo cultures, and therefore don't present a moral problem. The second major vaccine is a vaccine against varicella, VARIVAX (Merck). Introduced in 1995, it uses both the WI-38 and MRC-5 human cell lines.[6] A new combination vaccine comprised of M-M-R II and a beefed up version of VARIVAX, trade name ProQuad (Merck) was licensed by the FDA 6 September 2005.[7]

In addition to the rubella and varicella vaccines, there are other vaccines which, though not part of the pediatric series, are in routine use and do use "tainted" cell lines. The vaccines against Hepatitis A, known as HAVRIX (GlaxoSmithKline Biologicals)[8] and VAQTA (Merck),[9] both utilize the MRC-5 human diploid fibroblast cell line to culture their Hepatitis A viral strain; the viral particles are then inactivated and suspended for injection. While Hepatitis A is not part of the routine pediatric series, it is required frequently for people who work in the food handling and other industries. HAVRIX is also offered in combination with the Hepatitis B vaccine, trade name TWINRIX (GlaxoSmithKline).[10] The Hepatitis B vaccine component does not rely on viral culture; it uses recombinant DNA technology. For rabies, there are two vaccines licensed and marketed in the U.S., RabAvert (Chiron) which uses chicken fibroblast cell lines for culture media,[11] and IMOVAX (Aventis Pasteur), which uses the MRC-5 human cell line.[12]

The moral problem is this: the WI-38 and MRC-5 human diploid cell lines used for viral culture, as well as the RA 27/3 rubella viral strain used in the rubella vaccine, are derived from babies aborted decades ago. Although a detailed and well annotated history of the abortions related to the development of these lines are available in Debra L. Vinnedge's document, "Aborted Fetal Cell Lines and the Catholic Family," available at the Children of God for Life website, I will give a brief synopsis here.[13] In the early 1960's, researchers at the Wistar Institute in Philadelphia, and the Merck Research Institute collaborated with physicians at the Karolinska Institute in Stockholm, Sweden, in attempts to develop human cell lines for, among other things, vaccine viral culture media. The researchers were specifically looking for parents with no medical problems either in themselves or (presumably) their unborn child, but who wanted to abort the baby for "social reasons"; the social reason usually given was, "too many children". The abortions were, of course, in Sweden, as abortion at that time was illegal in the U.S. It took the researchers 37 attempts - representing 20 Swedish abortions - to develop a cell line that grew; this successful line was designated Wistar Insitute 38: WI-38. In addition to a viable cell culture line, the researchers needed a strain of the rubella virus which had been demonstrated to cross the placenta and successfully infect an unborn child. A word on the reason for rubella immunization is in order here. The purpose of childhood rubella vaccination is not to protect the child, as German measles is a mild illness in children, and, as with chickenpox in children, natural infection confers lifelong immunity. The reason rubella is a public health issue is because if a pregnant mother who is unimmunized (either via natural infection or vaccination) is exposed to a child with active rubella, she will get the illness, and it can be passed to her unborn child. "Congenital Rubella Syndrome" (CRS), the constellation of defects associated with congenital German measles infection, can be mild, but it can also be devastatingly severe. CRS of some level of severity results from up to 85% of maternal infections that occur during the very early first trimester, but drops dramatically by the 8th week of gestation; if the mother is infected after the 20th week, the incidence of CRS is zero.[14] The reason for vaccinating children against rubella is not to protect the child, but to prevent the transmission of the disease from an infected child to an unimmunized, pregnant mother and from there, possibly, to her unborn child where it could cause CRS. Since not all maternal rubella infections result in CRS, a rubella strain which had been demonstrated to cross the placenta and successfully infect an unborn child was necessary. During a rubella outbreak in Pennsylvania in 1964, pregnant mothers who had no immunity to rubella underwent abortions for fear of CRS. Organs from 26 of these aborted babies were cultured for rubella; only with the 27th aborted fetus was the virus successfully grown. This strain was then successfully cultured in WI-38, and designated RA 27/3, for Rubella Abortus number 27, 3rd tissue explant. As noted above, it is the RA 27/3 rubella strain, grown in WI-38 human diploid cell culture, which is used in the Merck product. Vinnedge estimates that no fewer than 47 elective abortions were involved in the development of the MERUVAX vaccine: 19 from the failed WI cell lines, one for the WI-38 line itself, plus the 27 to culture the virus. A few years later, the Medical Research Council of England used similar techniques to develop the MRC-5 human diploid cell line from lung tissue of an aborted fetus.

Next week: Levels of cooperation and the Vatican document.

[1] This is not to say that any vaccine that a government wants to initiate should not be viewed with scrutiny. There was much debate within the medical community concerning the usefulness of the H. flu vaccine, and the varicella vaccine, and the debate continues to this day. But, in principle, it is not reasonable to contest the right of a government to require a vaccination program.
[2] Again, with regard to specific vaccines, such as varicella, this is debatable. But it is also a medical and public health question, not a moral one.
[3] The phrase "moral coercion of conscience" is not mine; it exists in the concluding paragraph of the pontifical document, “Moral reflections on vaccines prepared from cells derived from human aborted human foetuses.” referenced below (Endnote #37)
[4] Package insert, M-M-R II, Merck & Co., 1999. Available at Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St. Room W5041, Baltimore, MD 21205;
[5] Package insert, MERUVAX, Merck & Co., 1999. Institute for Vaccine Safety.
[6] Package insert, VARIVAX, Merck & Co., 2001. Institute for Vaccine Safety.
[7] "Notice to Readers: Licensure of a Combined Live Attenuated Measles, Mumps, Rubella, and Varicella Vaccine." Morbidity and Mortality Weekly Reports Vol. 54, #47, 2 Dec 2005.
[8]"HAVRIX Prescribing Information," GlaxoSmithKline, 2005. Institute for Vaccine Safety.
[9] Package insert, VAQTA, Merck & Co., 2005. Institute for Vaccine Safety.
[10] "TWINRIX Prescribing Information," GlaxoSmithKline, 2003. Institute for Vaccine Safety.
[11] Package insert, RabAvert, Chiron Corporation, 2002. Institute for Vaccine Safety.
[12] Package insert, IMOVAX, Aventis Pasteur, 1991. Institute for Vaccine Safety.
[13] Vinnedge, D.L. “Aborted Fetal Cell Lines and the Catholic Family: A Moral and Historical Perspective.”Children of God for Life, Dec. 2004,
[14] Maxcy-Rosenau-Last Public Health and Preventive Medicine 14th Ed. Wallace, R.B. (Ed.) Appleton & Lange, 1998. See “Rubella,” pg. 95ff.

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