Package Insert Samples

Samples of Current Manufacturer’s Product Inserts
Using Aborted Fetal or Embryonic Cell Lines

 

Highlighted portions list the aborted fetal cell lines.  Translated these components are:

– RA273 – Rubella virus strain taken from the kidney of the 27th electively aborted fetus in a control study group during the 1964 rubella epidemic (7 week gestation – embryonic)

– WI-38 – Taken from the lung tissue of a 3 month gestation electively aborted female

– MRC-5 – Taken from the lung tissue of a 14 week gestation electively aborted male

– An “established human cell line”  HEK – Human embryonic kidney; information was obtained by filing a Freedom of Information Act Request.

(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 MRC 5 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.

Xigris™ (Lilly)
Drotrecogin alfa (activated)

DESCRIPTION
Xigris™ (drotrecogin alfa (activated)) is a recombinant form of human Activated Protein C. An established human cell line possessing the complementary DNA for the inactive human Protein C zymogen secretes the protein into the fermentation medium. Fermentation is carried out in a nutrient medium containing the antibiotic geneticin sulfate. Geneticin sulfate is not detectable in the final product. Human Protein C is enzymatically activated by cleavage with thrombin and subsequently purified. Drotrecogin alfa (activated) is a serine protease with the same amino acid sequence as human plasma-derived Activated Protein C. Drotrecogin alfa (activated) is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Drotrecogin alfa (activated) and human plasma-derived Activated Protein C have the same sites of glycosylation, although some differences in the glycosylation structures exist.

Xigris is supplied as a sterile, lyophilized, white to off-white powder for intravenous infusion. The 5 and 20 mg vials of Xigris contain 5.3 mg and 20.8 mg of drotrecogin alfa (activated), respectively. The 5 and 20 mg vials of Xigris also contain 40.3 and 158.1 mg of sodium chloride, 10.9 and 42.9 mg of sodium citrate, and 31.8 and 124.9 mg of sucrose, respectively.

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.

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.

 

SAMPLE OF REVISED PACKAGE INSERT

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 from elective abortion of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts from elective abortion.

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.