The good news and bad news about Prevnar, Wyeth’s anti-pneumococcal vaccine, may have worrisome implications for Gardasil. Like Gardasil, Prevnar (PCV7) only targets a few selected strains of the pathogen it seeks to vanquish.
The very good news is that since it was adopted as a routine childhood vaccine, rates of a deadly form of meningitis have fallen by 30 percent in children and adults. Because kids no longer pass the disease on to the adults they’re in contact with, they confer a sort of “herd immunity” on those adults.
The bad news is that a team of researchers led by Dr. Lee Harrison of the University of the Pittsburgh School of Medicine found that by 2005 non-PCV7 strains of meningitis had increased by 60.5%. And worse news: the percentage of strains not sensitive to penicillin rose from 19.4 percent in 2003 to 30.1 percent in 2005.
When only selected strains of a pathogen are targeted, a vaccine can create a “replacement disease” as non-targeted strains fill the void and fulfil the principle that “Nature abhors a vacuum.”
Critics of Gardasil have long been concerned that this could happen with the new vaccine, which targets only four of many strains of HPV.
Wyeth, meanwhile, is testing a new version of Prevnar that will cover an additional 13 strains of pneumococcal bacteria. Harrison believes that the new vaccine, if approved, should take care of about half of the disease that remains.
Harrison’s study can be found in the New England Journal of Medicine.
If you are considering having the Gardasil vaccinations, or have already had them, do you think replacement disease is a concern as well as side-effects that may be unknown or under-reported?
Wednesday, January 14, 2009
FDA Weighs Gardasil for Boys and Men
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?
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?
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