Family & Life

Family & Life’s Campaign for Ethical Vaccines

As part of Family & Life’s campaign to see ethical vaccines made available in Ireland we are supporting US campaign to register complaints and suggestions with the Food and Drug Administration (FDA).

Please read the following material; use information from the model letter; clink on the FDA link at the bottom of the page; register your opinions.

1) Background Information

The FDA has issued new guidelines for the pharmaceutical industry regarding the use of various types of cell lines that are being used and will be used in the future for the manufacture of vaccines. These cell lines include several ethical sources as well as ABORTED FETAL CELL LINES.

Since the FDA has invited the general public to respond through December 28, 2006, we are urging all concerned citizens, medical professionals, pharmacists and pro-life groups to let your voices be heard! It is imperative that the FDA receives a massive amount of public protest on the use of aborted fetal cell lines as your response may very well dictate the direction pharmaceutical companies will move in the future.

THIS DOES NOT INVOLVE ONLY CHILDHOOD VACCINES!

Currently, the National Institutes of Health is working with pharmaceutical companies to develop new vaccines for Ebola, HIV, Regular Influenza and Avian Flu in the event of a pandemic outbreak! Some companies such as Merck and Sanofi Pasteur are using aborted fetal cell lines. Others are using ethical cell substrates such as salmonella bacteria, insect cell lines and chick embryo.

We need to let our preference be known now before these products come to market!

- Your Submission Will Become Part of the Official Public Record -

The Pharmaceutical Industry Will See Your Comments NOW IS THE TIME TO LET THEM KNOW HOW YOU FEEL!

THINK WE'RE NOT MAKING A DIFFERENCE?

Consider what Crucell NV had to say to their shareholders in December 2005 on using aborted fetal cell lines:

"The use of genetic technology and materials derived from human fetal tissue, such as PER.C6* technology, may raise ethical, legal and social issues that could hinder regulatory approval, patentability or market acceptance of our technologies and products developed using them. ...

Advocacy groups have taken issue in the past and may take issue in the future with the use of genetic technology or materials derived from human fetal tissue, which may hinder or adversely affect regulatory approval or market acceptance of our technologies and products developed using them.... We rely on license and other revenues from the licensing of our potential products, PER.C6 and our other technologies. If our licensees or partners do not continue to use our potential products, PER.C6 technology or other technologies, or if they terminate their agreements with us, we will earn less or no revenue from our agreements with them...If we or our licensees do not develop potential products based on our core technologies that are approved for sale and are commercially successful, we may be forced to cease operations."

* Note: PER C6 is the newest aborted fetal cell line being used in development of several vaccines. It was taken from the retinal tissue of an 18-week gestation aborted baby.

2) Model Letter

Letter from COG

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

3)Contact the FDA now: CLICK TO READ MORE.....

Source: All information above was taken from the COG website.