Re: Re: New Cerv cancer vacc label

[Guest guest]

on 6/8/06 4:33 PM, King at medfordkings1@... wrote:

225 mcg Aluminum

ok- stupid question time- is that above the limit?

[Guest guest]

You may not get cervical cancer, but your family will be able to fry an egg on you. King <medfordkings1@...> wrote: 225 mcg Aluminum>> http://www.fda.gov/cber/label/hpvmer060806LB.pdf> __________________________________________________

[Guest guest]

,

As per 21 CFR 610.15(a) (with CAPITALIZATION

added for emphasis):

>Sec. 610.15 Constituent materials.

>

> ( a) Ingredients, preservatives, diluents,

>adjuvants. All ingredients used in a licensed

>product, and any diluent provided as an aid

>in the administration of the product, shall

>meet generally accepted standards of purity

>and quality. Any preservative used shall be

>sufficiently nontoxic so that the amount

>present in the recommended dose of the

>product will not be toxic to the recipient,

>and in the combination used it shall not

>denature the specific substances in the

>product to result in a decrease below the

>minimum acceptable potency within the dating

>period when stored at the recommended

>temperature. Products in multiple-dose

>containers shall contain a preservative,

>except that a preservative need not be added

>to Yellow Fever Vaccine; Poliovirus Vaccine

>Live Oral; viral vaccines labeled for use

>with the jet injector; dried vaccines when

>the accompanying diluent contains a

>preservative; or to an Allergenic Product in

>50 percent or more volume in volume (v/v)

>glycerin. An adjuvant shall not be introduced

>into a product unless there is satisfactory

>evidence that it does not affect adversely the

>safety or potency of the product. THE AMOUNT

>OF ALUMINUM IN THE RECOMMENDED INDIVIDUAL DOSE

>OF A BIOLOGICAL PRODUCT SHALL NOT EXCEED:

> (1) 0.85 MILLIGRAMS IF DETERMINED BY ASSAY;

> (2) 1.14 MILLIGRAMS IF DETERMINED BY

>CALCULATION on the basis of the amount of

>aluminum compound added; or

> (3) 1.25 milligrams determined by assay

>provided that data demonstrating that the

>amount of aluminum used is safe and necessary

>to produce the intended effect are submitted

>to and approved by the Director, Center for

>Biologics Evaluation and Research.

>

OBVIOUSLY:

a) 225 micrograms per dose is 0.225

MILLIGRAMS PER DOSE and

WELL BELOW:

i) the 850 micrograms (0.85 milligrams)

per dose in 21 CFR 610.15(a)(1) or

ii) the 1140 micrograms (1.14 milligrams

in 21 CFR 610.15(a)(2).

Thus, the level in the vaccine is well below

the current limits.

However, the failure to determine, and the FDA's

approval without a determination of, whether, or

not, the vaccine has long-term carcinogenicity

and/or genotoxicity [GARDASIL Package Insert, page

8, near the bottom of the page] should be a major

concern GIVEN the nature of this vaccine (self-

assembled virus-like particles produced from

fermentations in Saccharomyces cerevisiae [page 1

of the package insert).

Respectfully,

Dr. King

http://www.dr-king.com

++++++++++++++++++++++++++++++++++++++++++++

At 16:45 6/8/06 -0400, christine zichittella-heeren wrote:

>

>on 6/8/06 4:33 PM, King at medfordkings1@... wrote:

>>

>>225 mcg Aluminum

>>

>>

>

>ok- stupid question time- is that above the limit?

>

>

>

>

>