Vaccines and Fetal Tissue: There has been a certain level of controversy within some religious communities regarding the connection of certain vaccines to fetal tissue. The concern is related to the fact a number of vaccines are reported to have been derived from tissue cells that was originally derived from an aborted fetus. A vaccine is an antigenic preparation used to produce active immunity to a disease, in order to prevent or ameliorate the effects of infection by any natural or wild strain of the organism. ... An abortion is the removal or expulsion from the uterus of an embryo or fetus, resulting in or caused by its death. ... Fetus at eight weeks Foetus redirects here. ...

Varivax

Varivax, the chicken pox vaccine, is one of the vaccines derived from a fetal tissue cell line. The American pharmaceutical company, Merck, manufactures Varivax today. The history of Varivax was that it was originally derived from fetal tissue cells in the 1960s, with the first iteration of this vaccine available in 1974. Later vaccines have derived from this same [cell line], though they are now many generations removed. Pharmacology (in Greek: pharmacon is drug, and logos is science) is the study of how chemical substances interfere with living systems. ... Do you mean: Merck KGaA, the German pharmaceutical company; Merck & Co. ... The 1960s decade refers to the years from 1960 to 1969, inclusive. ... 1974 (MCMLXXIV) was a common year starting on Tuesday (the link is to a full 1974 calendar). ...

MRC-5 and WI-38

Two fetal tissue cell lines used as a medium for a number of other vaccines are MRC-5 and WI-38. Some groups, such as Right to Life (RTL.org), state that other drug manufacturers, such as GlaxoSmithKline (GSK.com) currently produce vaccines derived from these cell lines. In fact, the vaccine product monographs mention of these cell lines. The term right to life is a political term used in controversies over various issues that involve the taking of a life (or what is perceived to be a life). ... GlaxoSmithKline plc (LSE: GSK NYSE: GSK) is a British based pharmaceutical, biologicals, and healthcare company. ...

History

For over thirty years pharmaceutical companies in this country have been producing vaccines derived from tissues of aborted fetuses, a fact that was brought to light when several prominent Catholic newspapers published articles on the morality of using the vaccines. The trouble began when a new law in St. Louis County, Mo. required food handlers to obtain the Hepatitis-A vaccine for employment. When the source of the vaccine was revealed, many principled individuals objected and with good reason. As this information has become public, more and more physicians and parents are troubled by the ethical issues involved.

During the Rubella epidemic of 1964, some doctors advised exposed pregnant women to abort their children. The resulting virus strain developed was known in the science world as RA/27/3, where R=Rubella, A=Abortus, 27=27th fetus tested, 3=third tissue explant. There were actually 26 abortions prior to finding the right “species” with the active virus. The vaccine was then cultivated on the lung tissue of yet another aborted infant, WI-38. WI-38 (Wistar Institute 38) was taken from the lung tissue of an aborted female infant at 3 months gestation in the 1960s. A second human cell line, MRC-5 was derived from a male at 14 weeks gestation in the 1970s. They were used to cultivate the weakened virus strains of several diseases to produce immunizations. These two human cell lines cultivated in the lab continue to provide an ongoing source for many widely used vaccines

Propagation

Human cell cultures are batches of immature cells propagated artificially in a laboratory. These cells can be propagated indefinitely and are a reliable media in which viruses infectious to humans grow readily. Diploid cells have twice the number of chromosomes as sperm or egg cells. These cell lines have been replicated under laboratory conditions for over 30 years. For both, the cells are merely the medium on which the viruses are grown. These cells do not form a complete organism and do not constitute a human being. The signifier sperm can refer to: (mass noun, from Greek sperma = seed) a substance which consists of spermatozoa and which is a component of semen (mass noun) semen itself (informally, count noun with plural sperm or sperms) a single spermatozoon (= sperm cell) sperma ceti (Latin ceti, genitive of cetus = whale... A human ovum An ovum (from Latin, loosely, egg or egg cell) is a female sex cell or gamete. ...

The WI-38, MRC-5 and other cell lines do not require additional abortions to sustain the cell lines, nor to produce additional batches of vaccine. Fetal cells themselves are not ingredients of the vaccines.

Elective or not?

Part of the discord around this issue relates to whether the fetuses were aborted in an elective fashion, or were due to a medical condition. The Right to Life organization cites quotes from two scientists and one from Nature magazine, that indicate that it was elective abortions that were the basis for the MRC-5 and WI-38 cells, with, in one case, it being due to the mother's preference not to bring her fetus to term due to the fetus having a genetic abnormality. This component is much more difficult to confirm through other sources and journals. Some individuals are concerned about this issue because of incorrect information they have encountered on the Internet such as ongoing abortions are needed to manufacture vaccines and that vaccines are contaminated with fetal tissue. Below are the opening paragraphs of the Manufacturer's Package Inserts for Hepatitis-A (Merck & Glaxo Smithkline) MMR and Varicella (Chickenpox) Vaccines.

(HEPATITIS A VACCINE, INACTIVATED)

VAQTA

DESCRIPTION

VAQTA [Hepatitis A Vaccine, Inactivated] is an inactivated whole virus vaccine derived from hepatitis A virus (HAV) grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques developed at the Merck Research Laboratories, formalin inactivated, and then adsorbed onto aluminum hydroxide. One milliliter of the vaccine contains approximately 50 units (U) of hepatitis A virus antigen, which is purified and formulated without a preservative. Within the limits of current assay variability, the 5OU dose of VAQTA contains less than 0.1 mcg of non-viral protein, less than 4 x 10 mcg of DNA, less than 10 rncg of bovine albumin, and less than 0.8 mcg of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb).

GLAXO SmithKline

DESCRIPTION PRESCRIBING INFORMATION (PACKAGE INSERT) Hepatitis A Vaccine, Inactivated Havrix

Havrix (Hepatitis A Vaccine, Inactivated) is a noninfectious hepatitis A vaccine developed and manufactured by SmithKline Beecham Biologicals. The virus (strain HM175) is propagated in MRC5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation.

Havrix contains a sterile suspension of inactivated virus; viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.).

Havrix is supplied as a sterile suspension for intramuscular administration. The vaccine is ready for use without reconstitution; it must be shaken before administration to assure a uniform suspension. After shaking, the vaccine is a homogeneous white turbid suspension. Each 1 mL adult dose of vaccine consists of not less than 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum, as aluminum hydroxide. There are two pediatric dose formulations, each with its own dosing schedule (see DOSAGE AND ADMINISTRATION).

The formulations are: not less than 360 EL.U. of viral antigen/0.5 mL; not less than 720 EL.U. of viral antigen/0.5 mL. Each dose is adsorbed onto 0.25 mg of aluminum, as aluminum hydroxide.

The vaccine preparations also contain 0.5% (w/v) of 2-phenoxyethanol as a preservative. Other excipients are: amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). Residual MRC5 cellular proteins (not more than 5 mcg/adult dose) and traces of formalin (not more than 0.1 mg/mL) are present.

M-M-R II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE)

DESCRIPTION

M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) is a live virus vaccine for vaccination against measles (rubeola), mumps and rubella (German measles). M-M-R II is a sterile lyophilized preparation of (1) ATTENUVAX' (Measles Virus Vaccine Live), a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; (2) MUMPSVAX* (Mumps Virus Vaccine Live), the Jerl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture; and (3) MERUVAX'll (Rubella Virus Vaccine Live), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts.

The growth medium for measles and mumps is Medium 199 (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and human albumin) as stabilizer and neomycin.

The growth medium for rubella is Minimum Essential Medium (MEM) [a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum] containing human serum albumin and neornycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.

The cells, virus pools, fetal bovine serum, and human albumin are all screened for the absence of adventitious agents. Human albumin is processed using the Cohn cold ethanol fractionation procedure.

The reconstituted vaccine is for subcutaneous administration. Each 0.5 mL dose contains not less than 1,000 TCID(tissue culture infectious doses) of measles virus; 20,000 TCID of mumps virus; and 1,000 TCID of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), fetal bovine serum (<l ppm), other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative.

VARIVAX

[Varicella Virus Vaccine Live (Oka/Merck)]

DESCRIPTION

VARIVAX [Varicella Virus Vaccine Live (Oka/Merck)] is a preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with natural varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.

VARIVAX, when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.5 mL dose contains the following: a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted and stored at room temperature for 30 minutes, approximately 25 mg of sucrose, 12.5 mg hydrolyzed gelatin, 3.2 mg sodium chloride, 0.5 mg monosodium L-glutamate, 0.45 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, 0.08 mg of potassium chloride; residual components of MRC-5 cells including DNA and protein; and trace quantities of sodium phosphate monobasic, EDTA, neomycin, and fetal bovine serum. The product contains no preservative.