FDA CMA Letter

Division of Dockets Management HFA-305

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD  20852

December 11, 2006

Ref: Docket Number 2006D-0383

Guidance to Industry for Development of Cell-Based Viral Vaccines

To the FDA:

The Catholic Medical Association (CMA) offers this response to the FDA invitation for public comment on the Industry Guidelines for development of cell-based vaccines. The CMA is the nation’s largest professional organization of Catholic physicians.

First of all, as medical physicians, we acknowledge the validity of the statement of the Centers for Disease Control and Prevention regarding vaccinations, “Among all the medical advances of the last century, the benefits of immunization far outweigh the benefits of antibiotics, surgery, and organ transplants. In fact, the only technology that has improved the length and quality of human life more than vaccines has been a sanitary water supply.”[i] However, we have serious ethical concerns regarding the development of vaccines based upon cell lines derived from elective abortions of human fetuses which have been and continue to be used to provide cell substrates for the manufacture of various vaccines.

We refer in particular to the human diploid cell lines: MRC-5, WI-38, HEK-293, IMR-90, WI-26, RA273, which have been used in the manufacture of vaccines for varicella, rubella, hepatitis A and rabies and, most recently, for varicella-zoster.  PER C6, derived from an elective abortion in the late 1980s, was introduced into the United States for vaccine research and development in 2003.  And the federal government also has recently signed more than $1 billion in contracts with vaccine manufacturers for development of flu vaccines using this cell-based technology.

While we applaud the effort to develop new vaccines, we object to the use of any biological material derived from electively aborted human fetuses for vaccine development.  While Catholics are permitted to use current vaccines prepared from cells derived from aborted human fetuses where no alternative exists, on a temporary basis . . . in order to avoid serious risk,” they also have a “grave responsibility” to “oppose . . . vaccines which do not yet have morally acceptable alternatives” and may “abstain from using these vaccines if it can be done without causing children, and indirectly the population as a whole, to undergo significant risks to their health.”[ii] We intend to use every legitimate means available to bring pressure to bear on the pharmaceutical industry to prepare vaccines from morally legitimate sources.

At the same time, we think it is important that the FDA recommend to pharmaceutical companies that they consider ethical issues in developing and manufacturing vaccines and, more specifically, that they address and correct their reliance on cell lines derived from elective abortion.  Safe, effective vaccines for everything except varicella exist already in Europe and/or Japan.  And it is eminently feasible to develop new cell lines for current and future vaccines from sources other than those originating in elective abortions.  In fact, it is not only ethical, but also advisable for the FDA to encourage the research, development and manufacture of vaccines derived only from morally legitimate sources.  Failure to do so could undermine widespread public support for universal vaccination as information about the connection between abortion and vaccines becomes known by more people.

The Catholic Medical Association appreciates the opportunity to present these comments to the FDA in a spirit of cooperation and in an effort to uphold public health, human dignity, and the common good.

Sincerely,

Thomas Pitre, M.D.,

President, Catholic Medical Association

333 E. Lancaster Ave., #348

Wynnewood, PA  19096