At Long Last! An HPV Update!
There hasn't been an HPV update in a really long time, mainly because there hasn't been any HPV news in a really long time. No real progress on the vaccine or the virus itself, either in curing or in understanding. We already understood it pretty well and things seemed to reach a plateau. But today, I have 2 fairly major updates!
1) There is now a vaccine that covers 9 strains of the virus! The original, Gardasil, covered 4 strains - the two most common strains known to cause cancer (HPV 16 & 18) and the two most common strains known to cause genital warts (HPV 6, & 11), while the main competitor Ceravix covered the two cancer-causing strains. There are dozens, perhaps hundreds of strains of HPV, but 16 & 19 were known to cause something like 70% of all the hpv-caused cancer cases and a smiliar number of genital warts, so the researchers understandably focused on those strains first. There has been some evidence that Gardasil was 50% effective against several other strains as well, but it was approved for those 4, for which it's about 90~% effective.
Now, however, there will be a new vaccine, called Gardasil 9 that covers HPV-31, 33, 45, 52 and 58 in addition to the original 4 strains. That is estimated to protect against 90% of the cancer-caused-by-HPV cases in vaccine-protected women! The test shows that there were slightly more side effects after taking the vaccine, but the side effects were completely within the range of expected side effects for any vaccine - namely that if you stick someone with a needle, they might faint or feel sore at the injection site. Duh!
2) The CDC has compiled a report analyzing adverse reactions to the HPV vaccine. And, guess what? It's exactly as predicted - totally safe! More than 23 million (MILLION!!) doses were administered in the US since it became licensed in 2006. There were just over 12,000 adverse reactions reported in the 2 years that this study covers. Out of those 12,000~ adverse reactions, 94% were not serious and the usual sorts of things you'd expect when you get jabbed with a needle - fainting, soreness, redness at the injection site, dizziness, etc.
Out of the 6% that were classified as "serious", 32 were deaths. I know, 32 dead is an awful number. But remember, that's 32 out of MILLIONS of doses. AND, on top of that, not a single one of those deaths can be tied to the vaccine itself. They had to do with illicit drug use, diabetes, a known heart condition that resulted in heart failure, etc. Remember, VAERS - the Vaccine Adverse Event Reporting System - collects data about, literally ANYTHING that happens to someone after a vaccine. I wrote about the Phase III trials in India a bunch of years ago, where 6 girls died after taking the vaccine, but that included several suicides by drowning and a fatal snake bite. And yet, the system is designed to count anything bad that happens, so they got counted. Even if all 32 of them could be linked to HPV due to some quirk of genetics or something, that's still only 32 out of millions, and that's still a risk worth taking. And yes, I do take these risks myself.
After analyzing all the data, the summary concludes that there is no evidence to support the vaccine causing a single one of those serious adverse reactions. There are, however, several cases that the study recommends further investigation, although I would like to reiterate that it recommends further investigation EVEN THOUGH there is currently no evidence to suggest those reactions were a result of the vaccine. This is science working - if the evidence doesn't reach a certain level of confidence, they keep looking at it. There rarely is any black & white, yes / no answers in science. There is, however, margins of error and robust vs. weak spectrums. And the evidence for the safety and efficacy of the HPV vaccine has pretty much slammed the needle on the "robust" side supporting the vaccine.
However, even with the safety evidence continuing to mount, the CDC and the FDA both have amended their warning recommendations to better reinforce safety protocols, such as keeping a better watch on patients for 15 minutes after receiving the vaccine to make sure that they don't fall and hit their head if they get dizzy from being stabbed with a sharp pointy object.
So, the bottom line is that the HPV vaccine is as safe as any vaccine out there - which is to say pretty damn safe; pretty much no one has been harmed by it any more than one would expect to be harmed by being poked with a big needle even with no vaccine at all; they continue to watch and evaluate and refine the process; and there will shortly be an even better vaccine available that I heartily recommend to everyone who can afford it.
For more on HPV vaccine safety, I refer you to a previous post that includes a graphic from the Information Is Beautiful site that elegantly explains, using easy-to-grasp graphics, the relative risk vs. safety and efficacy of the vaccine. I also recommend clicking on the STI tag below to see all my older posts on the subject.
1) There is now a vaccine that covers 9 strains of the virus! The original, Gardasil, covered 4 strains - the two most common strains known to cause cancer (HPV 16 & 18) and the two most common strains known to cause genital warts (HPV 6, & 11), while the main competitor Ceravix covered the two cancer-causing strains. There are dozens, perhaps hundreds of strains of HPV, but 16 & 19 were known to cause something like 70% of all the hpv-caused cancer cases and a smiliar number of genital warts, so the researchers understandably focused on those strains first. There has been some evidence that Gardasil was 50% effective against several other strains as well, but it was approved for those 4, for which it's about 90~% effective.
Now, however, there will be a new vaccine, called Gardasil 9 that covers HPV-31, 33, 45, 52 and 58 in addition to the original 4 strains. That is estimated to protect against 90% of the cancer-caused-by-HPV cases in vaccine-protected women! The test shows that there were slightly more side effects after taking the vaccine, but the side effects were completely within the range of expected side effects for any vaccine - namely that if you stick someone with a needle, they might faint or feel sore at the injection site. Duh!
2) The CDC has compiled a report analyzing adverse reactions to the HPV vaccine. And, guess what? It's exactly as predicted - totally safe! More than 23 million (MILLION!!) doses were administered in the US since it became licensed in 2006. There were just over 12,000 adverse reactions reported in the 2 years that this study covers. Out of those 12,000~ adverse reactions, 94% were not serious and the usual sorts of things you'd expect when you get jabbed with a needle - fainting, soreness, redness at the injection site, dizziness, etc.
Out of the 6% that were classified as "serious", 32 were deaths. I know, 32 dead is an awful number. But remember, that's 32 out of MILLIONS of doses. AND, on top of that, not a single one of those deaths can be tied to the vaccine itself. They had to do with illicit drug use, diabetes, a known heart condition that resulted in heart failure, etc. Remember, VAERS - the Vaccine Adverse Event Reporting System - collects data about, literally ANYTHING that happens to someone after a vaccine. I wrote about the Phase III trials in India a bunch of years ago, where 6 girls died after taking the vaccine, but that included several suicides by drowning and a fatal snake bite. And yet, the system is designed to count anything bad that happens, so they got counted. Even if all 32 of them could be linked to HPV due to some quirk of genetics or something, that's still only 32 out of millions, and that's still a risk worth taking. And yes, I do take these risks myself.
After analyzing all the data, the summary concludes that there is no evidence to support the vaccine causing a single one of those serious adverse reactions. There are, however, several cases that the study recommends further investigation, although I would like to reiterate that it recommends further investigation EVEN THOUGH there is currently no evidence to suggest those reactions were a result of the vaccine. This is science working - if the evidence doesn't reach a certain level of confidence, they keep looking at it. There rarely is any black & white, yes / no answers in science. There is, however, margins of error and robust vs. weak spectrums. And the evidence for the safety and efficacy of the HPV vaccine has pretty much slammed the needle on the "robust" side supporting the vaccine.
However, even with the safety evidence continuing to mount, the CDC and the FDA both have amended their warning recommendations to better reinforce safety protocols, such as keeping a better watch on patients for 15 minutes after receiving the vaccine to make sure that they don't fall and hit their head if they get dizzy from being stabbed with a sharp pointy object.
So, the bottom line is that the HPV vaccine is as safe as any vaccine out there - which is to say pretty damn safe; pretty much no one has been harmed by it any more than one would expect to be harmed by being poked with a big needle even with no vaccine at all; they continue to watch and evaluate and refine the process; and there will shortly be an even better vaccine available that I heartily recommend to everyone who can afford it.
For more on HPV vaccine safety, I refer you to a previous post that includes a graphic from the Information Is Beautiful site that elegantly explains, using easy-to-grasp graphics, the relative risk vs. safety and efficacy of the vaccine. I also recommend clicking on the STI tag below to see all my older posts on the subject.