First I would like to correct some of the information presented in this article. Gardasil was not approved by the FDA on June 8, 2008 but June 8, 2006. It is not approved for ages 11 to 26, but 9 to 26. And, while a reaction certainly can be reported to the FDA, it is the CDC which maintains VAERS (the Vaccine Adverse Event Reporting System) to collect and evaluate such complains of adverse reactions.
The comment was made that:
“With a clinical trial on the vaccine that lasted five years, Merck didn’t take the time to test for possible side effects that could become apparent—both short-term and over a longer period of time.”
This seems more like an editorial comment than fact. “Merck didn’t take the time….”? According to whom. Merck’s studies continue to be ongoing with respect to the long term effectiveness of the vaccine as well as potential side effects.
Last September, the FDA updated the documentation for the vaccine to include protection against vaginal and vulvar dysplasias and cancers. Unfortunately, they did not include anal cancer, 90 to 99% of which are shown to be caused by HPV. Hopefully in the near future, this will be updated once again. After all, it is these strains of the virus which the vaccine protects against not which area it happens to affect.
As the mother of a 17-year-old daughter, who has received the vaccine, my heart breaks for any parent and their child having to deal with such symptoms. However, as a woman having dealt with the ravages of HPV for 22 years including invasive anal cancer I know that I do not want my daughter to go through the pain, anguish (both mentally and physically) the sheer hell that I have gone through because of this virus.
Everything is relative. There are side effects and 32 deaths (only 25 confirmed by death certificate) attributable to the vaccine. This must be viewed in light of the 23 million vaccines distributed for use by the end of 2008. While the body’s immune system does suppress the virus in most cases there are still about 10% (not the 35% listed) which go on to develop dysplasia and/or cancer. Considering that there are over six million new cases of HPV diagnosed each year and allowing for 50% of those being women that still equates to 300,000 women a year in the US alone! The number of cases of lung cancer diagnosed annually is less than that.
Yes, Gardasil protects against two of the high risk HPV strains which cause dysplasia and cancer. However, these are just the two strains which have been shown to cause the majority of these conditions. Should we not vaccinate against the two main culprits for fear another strain will take its place? I think not.
Changes in labeling may be required when such side effects are deemed to be caused by the vaccine. This would be expected. I am willing to weigh those risks against what, from personal experience, I know to be the devastating consequences of this virus and the vaccine will win out every time.
Comment Reply
First I would like to correct some of the information presented in this article. Gardasil was not approved by the FDA on June 8, 2008 but June 8, 2006. It is not approved for ages 11 to 26, but 9 to 26. And, while a reaction certainly can be reported to the FDA, it is the CDC which maintains VAERS (the Vaccine Adverse Event Reporting System) to collect and evaluate such complains of adverse reactions.
The comment was made that:
“With a clinical trial on the vaccine that lasted five years, Merck didn’t take the time to test for possible side effects that could become apparent—both short-term and over a longer period of time.”
This seems more like an editorial comment than fact. “Merck didn’t take the time….”? According to whom. Merck’s studies continue to be ongoing with respect to the long term effectiveness of the vaccine as well as potential side effects.
Last September, the FDA updated the documentation for the vaccine to include protection against vaginal and vulvar dysplasias and cancers. Unfortunately, they did not include anal cancer, 90 to 99% of which are shown to be caused by HPV. Hopefully in the near future, this will be updated once again. After all, it is these strains of the virus which the vaccine protects against not which area it happens to affect.
As the mother of a 17-year-old daughter, who has received the vaccine, my heart breaks for any parent and their child having to deal with such symptoms. However, as a woman having dealt with the ravages of HPV for 22 years including invasive anal cancer I know that I do not want my daughter to go through the pain, anguish (both mentally and physically) the sheer hell that I have gone through because of this virus.
Everything is relative. There are side effects and 32 deaths (only 25 confirmed by death certificate) attributable to the vaccine. This must be viewed in light of the 23 million vaccines distributed for use by the end of 2008. While the body’s immune system does suppress the virus in most cases there are still about 10% (not the 35% listed) which go on to develop dysplasia and/or cancer. Considering that there are over six million new cases of HPV diagnosed each year and allowing for 50% of those being women that still equates to 300,000 women a year in the US alone! The number of cases of lung cancer diagnosed annually is less than that.
Yes, Gardasil protects against two of the high risk HPV strains which cause dysplasia and cancer. However, these are just the two strains which have been shown to cause the majority of these conditions. Should we not vaccinate against the two main culprits for fear another strain will take its place? I think not.
Changes in labeling may be required when such side effects are deemed to be caused by the vaccine. This would be expected. I am willing to weigh those risks against what, from personal experience, I know to be the devastating consequences of this virus and the vaccine will win out every time.
August 14, 2009 - 6:11pmThis Comment
Reply