February 21, 2007

The Fine Print

Regarding the newly approved HPV vaccine

“………….Fact 2: It was noted in the FDA labeling: Carcinogenesis, Mutagenesis, Impairment of Fertility GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity. In other words, this vaccine could cause fertility problems down the line, but the drug maker is not sure. It could also, itself, cause cancer but they’re not sure. See link for more information on the FDA’s findings: http://www.fda.gov/cber/label/hpvmer060806LB.htm.

Fact 3: The pregnancy category for this vaccine is B. It is noted that it is not known whether Gardasil can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity.

Fact 4: Merck&Co. is so unsure about this that Merck & Co., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to GARDASIL. Patients and health care providers are encouraged to report any exposure to GARDASIL during pregnancy by calling (800) 986-8999.

Fact 5: When it comes to lactation, they’re not sure either. According to the FDA’s report: It is not known whether vaccine antigens or antibodies induced by the vaccine are excreted in human milk.

And more regarding the lactation that should concern those faced with the decision to vaccinate or not: Overall, 17 and 9 infants of subjects who received GARDASIL or placebo, respectively (representing 3.4% and 1.8% of the total number of subjects who were breast-feeding during the period in which they received GARDASIL or placebo, respectively), experienced a serious adverse experience. None was judged by the investigator to be vaccine related. How can we be sure it wasn’t vaccine related, since it followed on the heels of the vaccine?

In clinical studies, a higher number of breast-feeding infants (n = 6) whose mothers received GARDASIL had acute respiratory illnesses within 30 days post-vaccination of the mother as compared to infants (n = 2) whose mothers received placebo. I think the first number is one worth consideration, don’t you, especially since it was only evaluated over a four-year period?………..” full article: Yolandabarnes.vox.com