The FDA has once again denied Merck’s application for its Gardasil vaccine to be used for women aged 27 to 45, asking that the drug company first complete a 48-month study and submit the data. Frankly, it’s only surprising that Merck even applied at this point.
Not only does Gardasil not cure existing cases of HPV but it can also apparently create a problem if you already have HPV—as do many, or even most, sexually active women at some point in their lives—when you get vaccinated.
Nearly all cases of HPV, caused by any of perhaps 35 different viruses, are self-limiting. In other words, they fix themselves unless for some reason you have a weakened immune system. But background information provided for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) back in May 2006 reveals that when the vaccine is administered to a woman with a dormant or harmless form of HPV, the virus can become activated, increasing the likelihood of precancerous lesions developing by a whopping 44.6 percent. Ouch. Merck played with the figures after deciding that the groups were "unbalanced," eliminating women who were at higher risk anyway because of, say, a smoking habit. That put the Gardasil advantage slightly into the positive territory. After the numbers were all reconciled, the added risk was some 11 percent.
If that doesn’t give pause for thought, then potential issues with pregnancy might.
Merck initially reported to the FDA that 27 percent of pregnant women had an adverse reaction to the shot and noted that "it is not known whether Gardasil can cause fetal harm when administered to a pregnant woman."
The Vaccine Adverse Event Reporting System (VAERS) further reports 45 cases of spontaneous abortion, or miscarriage, following vaccination with Gardasil. And when the vaccine was approved, five babies had been born with congenital birth defects after their mothers had been immunized with Gardasil within 30 days of conception, as opposed to a placebo group that had zero. Reports now put that number at anywhere up to 40.
To be honest, one can only wonder why the vaccine is approved for women in their teens or twenties. It would seem more intelligent to require that anyone getting the vaccine get a virginity test, a pregnancy test, and an HPV test before being jabbed…unlikely though that possibility is.
What do you think? Should Gardasil be approved for older women? Should HPV and pregnancy tests be mandatory before each of the three shots?
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