FDA Comment Letter

Children of God for Life

4613 Barfield Crescent Rd

Murfreesboro, TN  37128

877-488-LIFE

November 1, 2008

Division of Dockets Management HFA-305

Food & Drug Administration

5630 Fishers Lane Room 1061

Rockville, MD  20852

Phone:  301 827-5101

Ref: Docket Number 2006D-0383:

Guidance to Industry for Development of Cell-Based Viral Vaccines

Dear FDA:

This letter is in response to the FDA invitation for public comment on the Industry Guidelines for development of cell-based viral vaccines.  We would like to comment on the use of human diploid cell lines, MRC-5, WI-38, HEK-293, IMR-90, PER C6 and any other cell substrates that may arise in the future which are derived from electively aborted fetuses.

We believe it is only fair to advise the FDA and the pharmaceutical industry as they are considering which cell substrates they might use in vaccine development, that a large number of Health Care Professionals, pharmacists and consumers will refuse to purchase any vaccine that utilizes aborted fetal cell lines.  You should be aware that a recent 2005 directive from the Vatican’s Pontifical Academy for Life instructs that Catholic physicians and patients have “a grave responsibility” to use ethically produced alternatives.  They further noted the duty to “take recourse, if necessary, to the use of conscientious objection with regard to the use of vaccines produced by means of cell lines of aborted human foetal origin”, and  to “oppose by all means – in writing, through the various associations, mass media, etc. – the vaccines which do not yet have morally acceptable alternatives, requesting  rigorous legal control of the pharmaceutical industry producers.”

What this will mean to the pharmaceutical industry for the future in the case of influenza and Avian Flu vaccines, for example, those that are currently under development using salmonella bacteria, chick embryo, Darby canine, Vero and insect cells, will be chosen over any that use the aborted fetal cell line, PER C6 or HEK-293.

While we understand that the FDA is concerned only with the safety and efficacy of the cell lines and final products, what benefit is there to the population if a large number of people cannot use them, as is the case for several of the aborted fetal vaccines on the market today?  The release of the Vatican statement last year is rapidly raising public awareness on this issue and it should present an equally growing concern for the pharmaceutical industry, the FDA and the CDC, who are responsible for maintaining public health and safety.

While we also understand that industry production costs may be part of the reasoning behind using these cell lines, the end result for utilizing them could have serious consequences for both our government and industry representatives. For government officials, it would demonstrate a lack of concern for moral values, the safety of society and a general disregard for the voice of the people.  For the pharmaceutical industry it will likewise produce a tarnished public image, followed by consumer product boycotts and a substantially reduced size of the vaccine market.

However, those pharmaceutical companies and products utilizing non-objectionable cell sources can expect to be promoted by a large majority of Christian, Catholic, Pro-Life consumers and Health Care professionals.  Considering that this would equate to at least 50% of the American population, the numbers should not be taken lightly.

To demonstrate the sincerity of this concern we are attaching over 800 letters from the public – just a small sampling of thousands we have received from consumers across the country who are deeply concerned with this issue.

These letters include comments from medical professionals, scientists, teachers, professors, clergy and families, none of who are opposed to immunizations in general.  In fact, one writer noted that the use of aborted fetal cell lines is actually fueling public sentiment and the cause of anti-vaccine groups.  And while we did not include letters from foreign countries for this FDA filing, it should be noted that an additional 37 foreign countries have sought our help to end this moral dilemma.

We ask that both the FDA and the pharmaceutical industry consider not only their moral sensitivities but also the health of the population that could be severely compromised by a lack of public cooperation if aborted fetal cell lines continue to be used in vaccine production.  We ask that you take into account the health and well being of all members of our society, not just those who see nothing wrong in benefiting from deliberately destroyed human life.

You have morally acceptable technology; please use it – for the good of all Americans, and the world population at large!

Sincerely,

Debra L. Vinnedge

Executive Director

CC:      Julie L. Gerberding, Director, Centers for Disease Control

Michael O. Leavitt, Secretary US Dept HHS