2006D-0383

Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

FDA Comment Number :

EC2410

Submitter :

Mr. Paul Fraundorfer

Date & Time:

12/01/2006 08:12:34

Organization :

Hospital of St Raphael

Category :

Health Professional

Issue Areas/Comments

GENERAL

Dear FDA officials,

I am a pharmacist at a Hospital in New Haven, Connecticut and the father of a small child. I would like to voice my concern over the proposed production of vaccines from cell lines such as PER C6, WI-38 and RA 273 which were developed from aborted fetal tissue. Considering the source material for these viral vaccines, ethical alternatives to them would be preferable for use in my pharmacy and for administration to my young daughter and to any of my future children. Also, vaccines produced using ethical biological starting materials (e.g. Vero monkey cells, chick embryo cells) would also be recommended to my patients.

I would ask you to consider the moral sensibilities of many in the United States when making any further approval of unethical cell line use for vaccine production. A long history of effective vaccine manufacture in ethical tissues exists. Please consider promotion of viral vaccine production in these cell lines. Readily available vaccines produced in ethically derived cell lines would be used, without objection, by most if not all Americans.

This would ensure that the best vaccines are readily available to the public with the added benefit that even more extensive use would occur in this country and throughout the world. Continue the strong and beneficial vaccination regimen in the US. Do not make many of us choose between vaccines derived from aborted fetal cell lines and our overriding moral concerns.

Sincerely,

Paul Fraundorfer, R.Ph., Ph.D.

370 Milford Point Road

Milford, CT 06460

jenjoypaul@sbcglobal.net