Canada

Use of Human Cell Lines in Pharmaceuticals – Canada

Various commercially available pharmaceutical products are derived from or cultivated on fetal cells lines that were obtained from abortions. Patients may have a biological, ethical or religious objection to products that come from human sources. The chart below allows us to provide information to patients to make informed decisions. It also makes known the fact the alternatives are available in other countries and should be available in Canada.

NOTE:

-All flu vaccines use non-human cell lines

-Immune-Globulin shots will provide temporary immunity (3-5 months) for Hepatitis-A and Rubella

Disease Drug Name Manufacturer Cell Line (Fetal) Alternative Drug/Manufacturer
Chickenpox Varilrix ®Varivax® GSKMerck & Co MRC-5WI-38, MRC-5 None Available
Hepatitis A Epaxal®Havrix ®Vaqta ®Avaxim ®Avaxim Pediatric ® Berna BiotechGSKMerck & CoSanofi PasteurSanofi Pasteur MRC-5MRC-5MRC-5MRC-5MRC-5 Aimmungen®KaketsukenVero (monkey)Available in Japan and Europe
Hepatitis A and Typhoid Fever Vivaxim ® Sanofi Pasteur MRC-5 As above for Hep A component
Hepatitis A & B Twinrix ® (Hep A Component) GSK MRC-5 As above for Hep A component, Hep B is derived from yeast
Measles, Mumps, Rubella Priorix ®MMR II ® GSKMerck & Co MRC-5RA27/3, WI-38 Attenuvax® (Measles)MerckChick embryoAvailabe in USMumpsvax ® (Mumps)

Merck

Chick embryo

Available in US

Takahashi (Rubella)

Kitasato Institute

Rabbit

Available in Japan and Europe
MMR + Chickenpox ProQuad ® Merck & Co. RA27/3, WI-38, MRC-5 None Available
Polio Inactived Poliomyelitis Vaccine – IPV ®Pentacel ®Quadracel ®Td Polio Adsorbed ® Sanofi Pasteur MRC-5 Infanrix-IPV, Infanrix Hexa & IPV/Hib®GSK (Europe) Vero CellsPediacel to be offered in Alberta March 2007

 
Rabies Imovax ® Sanofi Pasteur MRC-5 Rabavert®ChironChick EmbryoAvailable in Canada
Rheumatoid Arthiritis Enbrel ® Immunex(Amgen) WI-26 VA4 None Available
Sepsis Xigris ® Eli Lilly HEK-293 None Available

 

Reference:

1.        Varilirix Product Monograph. GlaxoSmithKline Inc. http://www.gsk.ca/en/products/vaccines/varilrix_pm.pdf. Accessed March 14, 2006.

2.        Varivax. Product Monograph. Merck. http://www.merck.com/product/usa/pi_circulars/v/varivax/varivax_pi.pdf. Accessed March 14, 2006.

3.        An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI). Supplementary Statement On Hepatitis A Vaccine (Acs-4). http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/00vol26/26sup/acs4.html. Accessed March 14, 2006.

4.        Vaqta Product Monograph. Merck. http://www.merck.com/product/usa/pi_circulars/v/vaqta/vaqta_pi.pdf Accessed March 14, 2006.

5.        Havrix. Product Monograph. GlaxoSmithKline Inc. http://www.gsk.ca/en/products/vaccines/havrix_pm.pdf.   Accessed March 14, 2006.

6.        Priorix Product Monograph. GlaxoSmithKline Inc. http://www.gsk.ca/en/products/vaccines/priorix_pm.pdf. Accessed March 14, 2006.

7.        MMR II Product Monograph. Merck. http://www.merckfrosst.ca/e/products/monographs/M-M-R_II-756-a_3_02-E.pdf. Accessed March 14, 2006.

8.        ProQuad Product Monograph. Merck. http://www.merck.com/product/usa/pi_circulars/p/proquad/proquad_pi.pdf . Accessed March 14, 2006.

9.        IPV Product Monograph. http://www.vaccineshoppecanada.com/secure/pdfs/ca/ipv_E.pdf . Accessed March 14, 2006.

10.     Imovax Product Monograph. http://198.73.159.214/statics/vaccines/english/IMOVAX_E.pdf. Accessed March 14, 2006.

11.     Enbrel. United States Patent. http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/srchnum.htm&r=1&f=G&l=50&s1=5,712,155.WKU.&OS=PN/5,712,155&RS=PN/5,712,155. Accessed March 14, 2006.

12.     Vaccines And Related Biological Products Advisory Committee. United States Of America Food And Drug Administration Center For Biologics Evaluation And Research. http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3750t1.rtf . Accessed March 14, 2006.

13.     Jacobs JP, et al.  Characteristics of a human diploid cell designated MRC-5. Nature. 1970;227(5254):168-70.

14.     Plotkin SA, Cornfield D, Ingalls TH. Studies of Immunization with living rubella virus: Trials in children with a strain cultured from an aborted fetus. Am J Dis Child.1965;110: 381-389.

15.     Plotkin S, et. al. Attenuation of RA27/3 Rubella Virus in WI-38 Human Diploid Cells. Am J Dis Child.1969;118:178-185.

16.     Weibel RE, et al. Clinical and laboratory studies of combined live measles, mumps, and rubella vaccines using the RA 27/3 rubella virus. Proc Soc Exp Biol Med. 1980:165(2):323-326.

17.     Hayflick L, et al. The serial cultivation of human diploid cell strains. Exp Cell Res. 1961;25:585-621.