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RUBELLA VACCINE REGISTRATION
We have an opportunity to import the untainted
rubella vaccine from Japan under FDA guidelines regarding personal import. The Japanese Takahashi Rubella
Vaccine has been on the market in Europe and Asia since 1986. Unlike the
Merck MMR/Meruvax, which uses the RA273 virus obtained from aborted babies and
cultivated on WI-38, a lung tissue cell line also obtained from aborted
babies, the Japanese version uses rabbit cell lines to cultivate the virus,
which was taken from the throat of an infected child. The FDA can allow
importation of a product into the US when there is no comparable drug here -
and for those parents refusing to use aborted fetal cell line vaccines for
religious reasons, there IS NO US drug available.
UPDATE MARCH 2006 On February 28th Children of God for Life sent all parents
letters to the FDA in a large 3 ring binder accompanied by our cover letter
and detailed plans for personal import of the untainted rubella vaccine from
Japan. The package included 2 suggestions for ease of import, all physicians
names and contact information; packaging details in accord with industry
standards, the Japanese product insert and details for ensuring full FDA
compliance. Click here to read our letter to the
FDA. NOTE: If you are filing a complaint
with your Congressman due to lack of response by the FDA please provide them
with a copy of this letter to the FDA which spells out the Federal guidelines
- AND your rights. ------ Original Message ------ Because the FDA denied our request for personal import on a technicality - that each request must be filed individually - we are about to blast them with more information than they ever wanted to come across their desks!
The FDA noted that the person applying had to state that the vaccine
is for their own use and then list the name, address and phone no of their
physician who would be giving the vaccine. But because of the cost of
import shipping from Japan and because we knew the FDA would be worried
about the continued refrigeration of the product once it came into the US,
we set up geographic locations across the US with the greatest need,
hoping parents would be able to travel to the closest site. We also set
up physicians in each area who have offered to administer the shots.
We do not yet know if the FDA will approve the vaccine being shipped
to each of your personal doctors or whether they will prefer the central
sites so I need each of you to do the following.
First, go to our website at
www.cogforlife.org/rubellaadmin.htm where we have set up a special
link with instructions and a letter that will be sent to the FDA by
Children of God for Life. ALL FAMILIES NEEDING THE VACCINE MUST
FILL OUT THIS LETTER FORM.
You will note the CC to Liberty Counsel attorneys and our attorney - do
not worry about sending them a copy - we don't want to blitz them! I will
send them a consolidated list of names under one letter. But I will be
printing each of your letters and sending them to the FDA in one very
large box!
You will note we are also proposing that you CC your own Federal level
Congressman or Senator - whomever is most pro-life will work best -
whichever you prefer. We would like you to mail the letter copy directly
to that Congressman or Senator.
Next, check the list of proposed vaccination Regions to see if you are
able to travel to one of the cities listed. Please be honest. I know most
of you would prefer to simply get the shot at your own doctor's office,
but this might not be possible. If it is not possible and the FDA will
only allow the option of using centralized sites we still need to
know because the number of vaccines is critical to balance out the cost of
shipping. Right now, based on headcount, we anticipate the cost to be
approximately $20.00 per dose, but that could rise dramatically if
a large number of people are unable to travel and the FDA will not allow
shipping directly to your own doctor.
God bless you all,
Debi Vinnedge
Children of God for Life
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