Rubella Vaccine

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From Meryl Dorey...

This is the first instance that I have ever come across of a true double-blind study of any vaccine. They have actually used a true placebo rather than another vaccine or a vaccine adjuvant. This Dr. Tingle has been investigating the rubella vaccine for many years. I've read some of his earlier studies where he found that 1/3 of the cases of rheumatoid arthritis he saw at the hospital showed the involvement of live rubella virus . Perhaps this is one of the reasons for the explosion in juvenile arthritis. Especially when the package insert itself says that up to 23% of those who get this vaccine will develop arthritis or arthralgia - and a percentage of them will be chronic.

Rubella; Adverse Effects Of Rubella Immunization
Source: Antiviral Weekly

Rubella (German measles) immunization has been available since the 1960s. Since then, reports have shown that between 10 and 40 percent of women who previously had no immunity to rubella experience joint disorders after immunization that can cause pain in joints such as the ankles and knees. In the May 5 issue of the Lancet, Professor Aubrey Tingle and colleagues from Vancouver, British Columbia, Canada, reported their investigation of the association of acute and recurrent joint and neurological manifestations in previously healthy women who were immunized shortly after giving birth.

A total of 546 women were immunised within 3 months of giving birth. To compare the rate of adverse events in the joints that could be associated with the vaccine, 270 women were given a rubella vaccine and 276 women were injected with saline. The women did not know which kind of immunization they received. Before the women gave birth, they were visited in their homes, at which time a detailed medical history was taken and a rheumatological examination was done to check for previous joint disorders. Four weeks after immunisation, patients were visited in the home again and any joint or muscle pain that they had experienced was recorded by a trained nurse. Similar reports were taken from patients at 3, 6, 9, and 12 months, when a final physical assessment was made.

The authors found that there were significant differences in the rate of occurrence of acute adverse joint manifestations between the vaccine and placebo groups and that there were very slight differences for recurrent manifestations. "Although the numbers of women assessed and length of follow-up revealed only marginally significant differences in persistent or recurrent joint manifestations between rubella vaccine and placebo recipients, it is possible that susceptible women who are given rubella vaccination may experience this outcome," said Tingle et al.

The corresponding author for this study is Dr. Leslie Ann Mitchell, British Columbia Institute for Child and Family Health, Vancouver, British Columbia, Canada; tel +1 604 875 2476.

Rubella; "Randomised Double-Blind Placebo-Controlled Study on Adverse Effects of Rubella Immunisation in Seronegative Women."
Source: Antiviral Weekly

According to the authors' abstract of an article published in Lancet, BACKGROUND: The objective of our study was to investigate the association of adverse clinical musculoskeletal and neurological events in healthy postpartum women with live attenuated (RA27/3 strain) rubella-virus vaccine, and to assess the frequency of acute and recurrent arthralgia and arthritis and associations with acute and recurrent muscle pain (myalgia) and neurological manifestations (paraesthesias).

METHODS: We used a randomised placebo-controlled, double-blind design in a community setting. 636 women were enrolled and, after 90 women dropped out, 546 healthy women aged 18-41 years, who were rubella seronegative on routine screening were immunized parenterally with either monovalent live attenuated (RA27/3 strain) rubella vaccine (n=270) or saline placebo (n=276) in the postpartum period. Outcome measures were the occurrence of acute and persistent or recurrent joint manifestations (arthralgia or arthritis) at 1, 3, 6, 9, and 12 months after immunisation. Occurrence of muscle pain (myalgia), and neurological symptoms (paraesthesia) was also assessed at the same times. FINDINGS: 543 women completed 1-month follow-up, 456 women completed the 12-month assessment. There were no differences at the time of immunisation between rubella vaccine and placebo groups in distribution of age, ethnic origin, parity, time between delivery and immunisation, breastfeeding history, or histories of earlier rubella vaccination or joint complaints. Results indicated a significantly higher incidence (p=0.006; odds ratio=1.73 [95% CI=1.17-2.57]) of acute joint manifestations in rubella-vaccine recipients (30%) than in placebo recipients (20%). Frequency of chronic (recurrent) arthralgia or arthritis was only marginally significant (p=0.042; 1.58 [1.01- 2.45]).

INTERPRETATION: RA27/3 rubella vaccine given to seronegative women during the postpartum period was significantly associated with development of acute arthralgia or arthritis. Although the numbers of women assessed and length of follow-up revealed only marginally significant differences in persistent or recurrent joint manifestations between rubella vaccine and placebo recipients, it is possible that susceptible women who are given rubella vaccination may experience this outcome."

The corresponding author for this study is: LA Mitchell, British Columbia Inst, Child & Family Hlth, Ctr Evaluat Studies, 950 W 28th Ave, Vancouver, BC V5Z 4H4, Canada. For subscription information for this journal contact the publisher: Lancet Ltd, 42 Bedford Square, London, England WC1B 3SL.

AUTHORS: Tingle, A.J.; Mitchell, L.A.; Grace, M.; Middleton, P.; Mathias, R.; Macwilliam, L.; Chalmers, A.

SOURCE: Lancet, May 3, 1997;349(9061):1277-128

by Laurence F. Roberge, M.S.

Recent media reports from England and from the group, Ohio Parents for Vaccine Safety, have stirred a conflict amongst pro-life groups. In England, a Catholic prep school refused to participate in the British government program to vaccinate children against Rubella (German Measles) because the Rubella component was originally derived from aborted babies.(1) Dr. Kristine Severyn, director of the Ohio Parents group, reported that the US version of the Rubella vaccine (MERUVAX, manufactured by Merck & Co.) also is manufactured with components originating from aborted fetuses. (2) This conflict is further complicated by the fact that no vaccine alternative exist in the United States. In the UK a Rubella vaccine made from chicken egg exists, but it is less reliable and is subject to serious side effects.

Over the past 50 years, vaccine technology has provided children and adults with protection from epidemics that kill or permanently injure. Rubella, although not usually fatal if contracted during childhood, can severely injure or kill a preborn child during the first trimester of the pregnancy. Children born with Congenital Rubella Syndrome may be blind, deaf, mentally retarded, or have heart defects.

Vaccine Production: During the 1964 Rubella epidemic, many women were advised to abort babies if the moths contract Rubella during pregnancy. The Rubella virus strain, RA 27/3, was obtained from an infected aborted fetus. (3) Since the 60's, this virus strain has been used as the chief component of the Rubella vaccine. To make this vaccine, the Rubella virus is cultivated in a weakened or "attenuated" state, so as to not cause the disease but to stimulate an immune response in the recipient and prevent subsequent Rubella infections.

The production of the Rubella virus requires the culture of human cells, referred to as a cell line. As the human cells grow in a specific nutrient-rich solution (AKA culture medium), the virus grows within the cells and is later released into the culture medium.. The virus is purified from the medium for subsequent use as a vaccine. The human cell lines used in Rubella vaccine manufacture were obtained in the 60's from aborted fetuses. Human cell line WI-38 was obtained from the lung of an aborted 3 month old female fetus.(4) Another cell line used is MRC-5 obtained from the lung of a 14-week old male aborted fetus in 1966 (5) Most other vaccines produced do not require human cell lines. Only viral vaccines require cells within which the virus will reproduce. Many viral vaccines (e.g. Polio, Mumps) can use chicken embryos or monkey kidney cell lines. Bacterial vaccines (e.g. Diphtheria, Tetanus) require the cultivation of the bacteria in a culture medium only.

Moral Issues: Various moral dilemmas arise from this issue. A position adopted by the bioethics committee of the British Catholic Bishops' conference stated that there is considerable separation between the abortion act and the current production of the vaccine.(6) Since the tissue was removed after the aborted fetus was clinically dead, individuals involved in the vaccine production were not involved in the abortion. As long as there is no support for abortion, then it would be morally acceptable for individuals to use the vaccine. The British Catholic Media Office stated that Catholic teaching would oppose the development of new vaccines, therapies, and studies from aborted fetal tissue. Catholic teaching is clear that we may never do harm so that good may come of it. Unfortunately many would be tempted to justify or reduce the evil of abortion with the reasoning that aborted tissue saves lives. This reasoning could be used to make palatable future abortions used for harvesting fetal tissue for research or medical products.

This issue is further complicated in light of the fact that tissue from "spontaneous abortions" is useless for cell culture for vaccine manufacture. This is because the cause of the spontaneous abortion (e.g. viral or bacterial infection, chromosome defect, etc.) would render the tissue useless for the strict standards of vaccine manufacture. Also, the present stocks of cell lines will eventually be depleted in the future. Yet if the population is not maintaining a certain level of vaccinations, the return of viral epidemics may become a reality. Future vaccine manufacturing needs may require development and testing of new cell lines. Eventually, we may see cell biologists return to experiment on aborted fetuses to obtain them.

Alternatives: Fortunately, alternatives to fetal cell lines do exist for some vaccines. These included use of animal-based cell lines, such as monkey cell lines or chicken embryo egg culture. Further research is warranted, especially as the vaccine needs of our society increase with the appearance of new diseases and the development of antibiotic resistance by known disease organisms. The greatest promise to remove fetal tissue completely from the vaccine picture lies in biotechnology. At present, the viral vaccine for Hepatitis B is made from yeast. Since the Hepatitis B virus is difficult to culture, biotechnology used a protein from the outer coat of the virus as the vaccine. This protein is made from yeast that has the gene for the Hepatitis B protein inserted into the yeast genetic code. The yeast is easily cultured and subsequently the protein is extracted, purified and packaged.

It will be dependent upon Catholic and other pro-life advocates to encourage (or pressure, if necessary) the vaccine industry and government regulatory agencies (e.g. U.S. Food and Drug Administration, World Health Organization, British Ministry of Health, etc.) to adopt alternative strategies to avoid returning to aborted fetuses for vaccine components. Encouraging alternative vaccine research for vaccine development will provide a strong incentive to dissuade the future justification of further abortions and fetal research for vaccine components.

REFERENCES: 1) "Catholic School Refuses Vaccinations," Milwaukee Sentinel, 27 Oct 1994 "Rubella Vaccine Creates Problems," Daily Citizen, 17 Nov 1994 "Vaccine Breeds Moral Dilemmas In Britain," Daily Citizen, 19 Nov 1994 "Rubella Vaccine Riles Pro-Lifers," Sunday Star-Times (NZ) 27 Nov 1994 "Shot Down:Prep School Rejects Rubella Vaccine," AtlantaConstitution 27 Nov 1994

2) "Aborted Babies Used As Source For Rubella Vaccine," Press Release OPVS 251 W. Ridgeway Drive, Dayton, OH 45459, tel: 513-435-4750 9 Dec 1994

3) S.A. Plotkin, "Development of RA 27/3 attenuated rubella virus grown in WI-38 cells," International Symposium on Rubella Vaccines, London 1968: Symp. Series Immunobio Standard., 11,249-260, Karger, Basel/New York 1969.

4) L. Hayflick and P.S. Moorhead, "The serial cultivation of human diploid cell strains," Exp. Cell Res. 25 (1961), 585-621

5) J.P. Jacobs, "Characteristics Of A Human Diploid Cell Designated MRC5", Nature 227 (1970 168-170

6) M. Jarmulowicz, "Use of Fetal Cell Lines In Vaccine Production," CMO, Nov 1994 26-28

VACCINES AND THEIR SOURCE CELL LINES (From the Physicians Desk Reference 49ED. (Medical Economics: Montvalle, NJ, 1995)

BIAVAX (binary vaccine) (Rubella & Mumps): WI-38 (fetal cell line) uses RA 27/3 virus derived from fetus for the Rubella part of the vaccine. MURUVAX: WI-38 (fetal cell line) uses RA 27/3 virus derived from fetus

MUMPS: uses chick embryo cell line

POLIO: uses bacterial culture

HEMAPHILLUS B: uses bacterial culture

PERTUSSIS: uses bacterial culture

TETANUS: uses bacterial culture

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