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 :

EC3657

Submitter :

Mr. Pavel Tikhonov

Date & Time:

12/19/2006 09:12:10

Organization :

Mr. Pavel Tikhonov

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

We, Pavel M. Tikhonov from the Russian Fedration and his family, are very much concerned with ethical issues regarding the use of aborted fetal cell lines by

vaccine manufacturers around the world.

Some of such vaccines are imported by the Russian Government, from the USA as well (MMR II, Vaqta 25 & Vaqta 50). We are facing freedom of conscience

violation when are trying to escape morally objectionable vaccine sources. Many people (including us) are ready to take health risks and other trouble just

to escape from taking vaccines derived from aborted fetal cells. We think that both manufacturers and consumers will benefit from the use of

non-objectionable sources.

We ask you to promote the use of non-objectionable materials and cell substrates in vaccines. We know many russian families who cannot write a comment in

English but share the same concerns. We also request for fair labeling of vaccines to indicate their contents for the consumers to make informed decisions.

The current regulatory requirements for labeling do not give adequate information to the consumer on whether human embryos, human embryonic stem cells or

materials derived from embryos or stem cells are used in the manufacture or testing of pharmaceuticals or not.

We call everyone who regulate the vaccine manufacturing or pharmaceutical industry for help.

Best regards,

Pavel M. Tikhonov,

Anna V. Tikhonova.