Note: If you are interested in Gardasil for boys and men, please see more recent posts:
here (9/9/09) and here (9/10/09)
FDA Weighs Gardasil for Boys and Men
In late December pharmaceutical giant Merck filed for FDA approval to market its controversial Gardasil vaccine to boys and men.
The move was not unexpected, given that a Merck study of 4,000 boys ages 16 to 26 showed Gardasil to be effective in preventing 90 percent of cases of penile cancer and genital warts, caused by the same four strains of HPV that currently cause 70 percent of cases of cervical cancer.
The FDA will take up to two months to decide whether Merck’s application meets its standards; it could then take ten months or more to review the data.
Although Merck might have a tough job persuading heterosexual males to undergo the expensive and painful series of shots, homosexual men are expected to be a big market as Gardasil may well be an effective weapon against anal cancer.
Presumably men will experience the same side effects of the shots as women. Gardasil has been associated with Guillain-Barré Syndrome, pancreatitis, seizures, paralysis and blood clots in the heart, lungs, and legs, among other issues: the majority of side effects reported to VAERS thus far, however, are pain at the injection site and fainting.
Gardasil is currently being marketed to girls as young as nine. The CDC recommends that it be routinely given to 11 and 12 year-olds or before sexual activity begins.
Merck’s stock is still down after the FDA denied its application for Gardasil to be marketed to older women, citing the need for further data and completion of a 48-month study. MRK is trading at less than half of its one year high.
What do you think? Would you get Gardasil’s 3-shot vaccine for your sons? Or have you yourself, or your daughter, experienced any side effects from the shot?