HPV Vaccine

[mustangsally65]

There's a thread in Pre-Allo about vaccinations, and someone asked today if anyone knew about any HPV vaccine websites, specifically about clinical trials.

I was reading on the CDC website that two vaccines are being reviewed by the FDA right now and could be available summer or fall of 2006.

What do you guys know about the clinical trials, and is the vaccine really going to be available sometime this year?

Here's the thread I was referring to.

Thanks!

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[3dtp]

There's a thread in Pre-Allo about vaccinations, and someone asked today if anyone knew about any HPV vaccine websites, specifically about clinical trials.

I was reading on the CDC website that two vaccines are being reviewed by the FDA right now and could be available summer or fall of 2006.

What do you guys know about the clinical trials, and is the vaccine really going to be available sometime this year?

Here's the thread I was referring to.

Thanks!

If it works it'll be great. I'll probably put me out of business, then I can buy that fishing pole I've always dreamed of....

The second issue is getting people to take the vaccine. Some people think that vaccines are dangerous and don't get them, forgetting that tetanus, diptheria, polio that have largely disappeared are dangerous too.

So, on second thought, maybe I won't get a new fishing pole.

 

[mysophobe]

You're also forgetting that most people doing know cervical cancer comes from HPV. I saw some commercial on tv about that, and I asked all my friends that are girls, and none of them knew anything about it.

 

[pruritis_ani]

Let me start by saying that I think the vaccine is wonderful and will save LOTS of lives, but I do have some concerns about the HPV vaccine...mainly I worry that it is only good for the HPV 16, which (if I remember correctly) is responsible for 50% of cervical cancers. What I worry about is the fact that that leaves a LOT of women still at risk. So, what will the new pap screening protocol be? Is there not the potential for an actual increase in mortality from this if women stop getting paps because they are vaccinated and feel safe, and then present later in the disease with cervical cancer from another strain of HPV?

I think it is great, but the screening protocols likely should not be changed too much. There is still a lot of HPV out there, and a lot of risk for cervical cancer.

 

[mysophobe]

Half is better than nothing. Like you said though, screening protocols shouldn't change at all, and patients need to be educated that the vaccine doesn't give them a 100% elimination of risk.

 

[3dtp]

Let me start by saying that I think the vaccine is wonderful and will save LOTS of lives, but I do have some concerns about the HPV vaccine...mainly I worry that it is only good for the HPV 16, which (if I remember correctly) is responsible for 50% of cervical cancers. What I worry about is the fact that that leaves a LOT of women still at risk. So, what will the new pap screening protocol be? Is there not the potential for an actual increase in mortality from this if women stop getting paps because they are vaccinated and feel safe, and then present later in the disease with cervical cancer from another strain of HPV?

I think it is great, but the screening protocols likely should not be changed too much. There is still a lot of HPV out there, and a lot of risk for cervical cancer.

I think they'll be pretty much the same guidelines. I think that most women who are consciencious enough to get the vaccine will continue to take care of themselves. Besides, they need to get a refill on the ocps. In the developing world, paps are not common and cervical cancer is quite common, so, if the vaccine is effective and cheap enough we can definitely improve the epidemiology in Africa.

In the west, I think that initially guidelines will stay the same. I don't know what ACOG is thinking about this. So, paps annually unless no prior abnormals, mutually monogamous, or celibate, then space out to three years. If there's an abnormal, either repeat pap in 6 or HR hpv testing and repeat in 12 months. If abnormal in six months off to colpo.

One of the real concerns with the current recommendations is that women who meet criteria to space out the paps to 3 years may a.) forget and they never get done, b.) will not have other components of an annual done potentially missing other potentially serious health issues (like a new breast lump) c.) other cervical and vaginal cancers have not been associated with HPV and might not be detected in the potentially curable stages. (ie non-squamous cell pathologies such as adenocarcinoma, melanoma, lymphomas).

 

[GED MD]

Sadly, even if the vaccine passes all the trials, it still might not make it on the market until 2009. This is from an interview Susan Wood did with the Sanford Univ Medical Center. (Susan Wood being one of the top docs at the FDA who resigned in protest over the handling of Plan B.)

Q: You've said that the religious right has hijacked the FDA. Are there other examples aside from the Plan B controversy?

Wood: The case people have been asking me about lately -- which I hope winds up not being a similar case -- is the HPV vaccine against cervical cancer. The same people who opposed emergency contraception also oppose the HPV vaccine because it will counter the abstinence message. The issue is pending before the FDA, and the Centers for Disease Control and Prevention is also looking at it. The decisions are due in June. I'm reasonably hopeful that the scientists at FDA will be allowed to do their job properly, and the decision will be made based on the evidence. But I do worry.​

For those interested, here's the link http://biz.yahoo.com/bw/060504/20060504005923.html?.v=1

 

[mysophobe]

Are you serious? This religion crap is getting ridiculous. Not everybody is a diehard christian. If you don't want it, don't get it. I hate when these people try and force their beliefs on the entire country like this.

/rant

 

[tiredmom]

...mainly I worry that it is only good for the HPV 16

One of the HPV vaccine brands is only against 16, I think. There is also a quadravalent vaccine by a different pharm. company currently being tested. Here's a link and excerpt.

A vaccine that appears to protect against four common strains of human papillomavirus virus -- two that cause cervical cancer and two that cause genital warts -- is under study at the Medical College of Georgia in women age 24-45. ... The quadrivalent vaccine currently under study protects against types 6 and 11, the top two wart-causing strains, and types 16 and 18, the two most-common cancer-causing strains.
http://scienceblog.com/cms/node/3219

The effectiveness is supposed to be great from the numbers I saw at a recent conference.

 

[lilycat]

In reference to the Susan Wood post...

I read an article about the HPV vaccine in the NY Times about a year ago, and among the various ob/gyns and epidemiologists they interviewed, there seemed to be a general consensus that even if/once the vaccine reaches market, there could be great difficulty in implementation. Basically, for it to be effective, the vaccine should be given in childhood well before sexual activity begins, but at the same time, it's anticipated that a large number of parents will have serious objections to the possiblity of their elementary school-age daughter being vaccinated for a sexually transmitted virus.

I wonder what the reaction would be if an HIV vaccine is developed...

 

[tiredmom]

serious objections to the possiblity of their elementary school-age daughter being vaccinated for a sexually transmitted virus.

I wonder what the reaction would be if an HIV vaccine is developed...

Was there much trouble implementing Hepatitis B vaccinations? I was in high school and my mom didn't even bat an eye, and I was a good catholic girl
I know it's not just sexually transmitted, but that or IV drug use are the main risk factors now.

 

[lilycat]

Was there much trouble implementing Hepatitis B vaccinations? I was in high school and my mom didn't even bat an eye, and I was a good catholic girl
I know it's not just sexually transmitted, but that or IV drug use are the main risk factors now.

That's why I added the hypothetical HIV vaccine query -- I can't imagine there would be much of an outcry over that vaccine, but so far what I've read about the HPV vaccine (and as referenced in the Susan Wood interview), it seems like that (the nature of transmission and timing of the vaccine) is an area of concern.

Out of curiosity, how old are you tiredmom? I'm pretty old (29 this summer), but I wasn't required to get an HBV vaccine until starting med school. I know they are now part of the standard vacc. series, but it wasn't something I had to deal with until it became an occupational hazard.

As for the lack of outcry for HBV vaccine, part of me wonders if it was easier to slip in "under the radar" so to speak since the average person on the street doesn't really know how it is transmitted, and can get it easily confused with Hep A, along with the controversy over HCV and tattoo needles.

 

[tiredmom]

I'm 29 now, 30 this summer! My pediatrician told us when it came out that he was giving it to all his teenagers and his infants, and catching those in between when they became teens. So I guess I was in 10th grade when received the series.
I've got kids, and would get them immunized in a heartbeat with an HPV or HIV vaccine if they were safe (and didn't have preservatives in them).

 

[lilycat]

I've got kids, and would get them immunized in a heartbeat with an HPV or HIV vaccine if they were safe (and didn't have preservatives in them).

I agree, but I'm not sure if my opinion is in the mainstream. I would think it represents the majority of people out there, but then again, I'm egocentric that way. I also don't get the people who are so freaked out about autism being related to thimerosol that they are against almost all childhood vaccinations, including MMR, etc.

 

[cpw]

I don't think the pap protocols would change (hopefully) at all. The HPV vaccine, from what I've read, is only effective before exposure... right ?

Therefore, anybody older than about age 12 at the time it's released is still at risk.

 

[tiredmom]

I agree, but I'm not sure if my opinion is in the mainstream. I would think it represents the majority of people out there, but then again, I'm egocentric that way. I also don't get the people who are so freaked out about autism being related to thimerosol that they are against almost all childhood vaccinations, including MMR, etc.

My son actually has autism. We went ahead and had our daughter vaccinated, but altered the schedule a bit. I didn't want her getting 4-5 immunizations (many of which were combinations of multiple targets) at the same time. We chose to split them up - get one every 6 weeks instead of at one visit. It meant more work in getting her to the doctor's office, but it made me feel better that I wasn't overwhelming her immune system. I verified prior to each injection that there wasn't thimerosol in the vaccine. We also held her MMR until after she turned 2 years old and had normal denver II testing. My son started regressing 2 weeks before his 2nd birthday - so I don't know if the schedule changes were more for my sanity and peace of mind than anything else. I think it's a good example of working with your patients, regardless of if you feel they are being neurotic . Upon moving for medical school, each doctor we saw (long story, several changed jobs within 6 months of us starting care with them) argued with me about splitting up the shots, so I told a little white lie that "she had a high fever with getting more than 1 shot, so we split them up". Nobody has argued with me with that story, so I guess it works! I would never consider not getting them vaccinated unless they had a serious vaccine reaction. I do think it's pretty stupid to inject children with methyl mercury unnecessarily - since it's only purpose was to allow multidose vials. I think my son's autism probably has more to do with the pertussis he caught in the pediatrician's waiting room when we checked in for his 4 month old visit/shots - since it does have a neurotoxin associated, but it's just a guess.
I think some of the hysteria behind the vaccinations is that as a parent, I was unaware that the vaccines had preservatives in the first place when I consented for them. There was no mention of mercury or thimerosol on the consents or the handouts. As a parent to a really difficult kid, I completely understand not wanting another with the same problem (he's all I could handle!).

 

[lilycat]

Tiredmom - my half-brother and his wife have a son with autism as well - they were actually the ones that I was thinking of when I wrote my earlier post because they have decided to hold off on vaccines for their second son (he's now 2), except for DTaP and MMR, despite the discontinuation of thimerosol in vaccines here since 2001 (all except adult influenza, right?). They're contemplating adding polio, but haven't decided, and are resisting HITB, HBV and VZV. I can't really fault them, or any parent, for feeling and reacting that way necessarily, but it reminds me that it's hard to predict in advance what outcry or resistance might develop towards different medical issues.

By the way, my hat is off to you balancing the demands you have at home with the demands of med school. My sister-in-law is a stay-at-home mom, and the demands of taking care of their eldest son has still put a huge strain on their household.

 

[tiredmom]

Actually, you still have to check about the thimerosol. Last year, less than 10% of the flu vaccine was thimerosol free. Odd, since AAP recommended removing from vaccines for kids... who are now recommended for the flu shot. Some of the DTaP versions have it, its all still very brand specific - that's why I ask to see the vial and package insert prior to drawing up the injection.
You might suggest our compromise about checking and separating the vaccines. Most of the vaccination schedule is grouped to catch people while they are already at the office. If your nephew is at home with mom, he's probably low risk for hep b - so it can hold off until later. I wouldn't miss the HIB or the Prevnar vaccines - since meningitis can really screw you up! The MMR hasn't ever had thimerosol in it, ironically. The fuss is from some questionable research that showed vaccine strain measles growing in peyer's patches in biopsy specimens from kids with autism.
Another issue is when school starts, depending on what state they live in. The school district really makes it hard on you to not vaccinate with all required vaccines. So if they do want to spread out the vaccines, they probably need to start soon to get the doses in by the time he's 5. In Texas, it's a nightmare to get the note from the doctor, for every vaccine spelled out, every year. They won't accept a blanket letter stating the child would be harmed by vaccines for life.
Thanks for the encouragement. It's trying at times, but I've got a wonderful husband. I heard from another mom the other day, that our second children are so wonderful because it's "God's way of saying 'Sorry I overestimated you!'"

 

[bubblegumbezoar]

Tiredmom-

I think that with hepatitis B people are more accepting because it is easy for kids at daycare of school to become exposed to another child's blood if someone falls off playground equipment, etc. But in terms of the HPV vaccine, it's sexually transmitted only.

I know that in Chile, they were proposing it to be given at 11 months. I saw that during a conference down there a few months ago. The real issue is that most people don't want to think about an 11 month-old baby girl as growing up and becoming a sexual being. Also, pediatricians don't do many pap smears, so some of them feel a bit out of water counseling parents on this.

Also, there are some diehard Christians who won't vaccinate to varicella because it is made my the same company that manufactures MMR (which they will also not vaccinate against) because the MMR vaccine originally came from an aborted fetus.

I hope that people will become more accepting of the HPV vaccine, but other questions to think about are if we make a vaccine to HPV 16, 18, 31, 33, 35, will HPV 6 and 11 mutate into some oncogenic form without competition from the other big five?

 

[bubblegumbezoar]

Tiredmom-

I think that with hepatitis B people are more accepting because it is easy for kids at daycare of school to become exposed to another child's blood if someone falls off playground equipment, etc. But in terms of the HPV vaccine, it's sexually transmitted only.

I know that in Chile, they were proposing it to be given at 11 months. I saw that during a conference down there a few months ago. The real issue is that most people don't want to think about an 11 month-old baby girl as growing up and becoming a sexual being. Also, pediatricians don't do many pap smears, so some of them feel a bit out of water counseling parents on this.

Also, there are some diehard Christians who won't vaccinate to varicella because it is made by the same company that manufactures MMR (which they will also not vaccinate against) because the MMR vaccine originally came from an aborted fetus.

I hope that people will become more accepting of the HPV vaccine, but other questions to think about are if we make a vaccine to HPV 16, 18, 31, 33, 35, will HPV 6 and 11 mutate into some oncogenic form without competition from the other big five?

 

[tiredmom]

Tiredmom-

I think that with hepatitis B people are more accepting because it is easy for kids at daycare of school to become exposed to another child's blood if someone falls off playground equipment, etc. But in terms of the HPV vaccine, it's sexually transmitted only.

I know that in Chile, they were proposing it to be given at 11 months. I saw that during a conference down there a few months ago. The real issue is that most people don't want to think about an 11 month-old baby girl as growing up and becoming a sexual being. Also, pediatricians don't do many pap smears, so some of them feel a bit out of water counseling parents on this.

Also, there are some diehard Christians who won't vaccinate to varicella because it is made by the same company that manufactures MMR (which they will also not vaccinate against) because the MMR vaccine originally came from an aborted fetus.

I hope that people will become more accepting of the HPV vaccine, but other questions to think about are if we make a vaccine to HPV 16, 18, 31, 33, 35, will HPV 6 and 11 mutate into some oncogenic form without competition from the other big five?

I've actually seen HPV spread nonsexually as well... at least according to the attending. He said that the kid with warts around the anus was from someone wiping her rear without washing their hands first. It's at least plausible, especially if you've ever taken your kid to a public bathroom with you (for you non-parents... you share the stall, so you don't get to the sink before you've both gone). Plus, as previously mentioned, a lot of folks don't realize that hpv causes cervical cancer.
The above mentioned HPV quadravalent vaccine (which our gyn onc feels will be the more popular one offered) will cover 6,11,16, and 18. But your last comment is a scary thought!

 

[tiredmom]

FDA expert committee recommended the quadrivalent HPV vaccine for approval today. It's said it will cost between $300-$500!!!!

 

[Poety]

I'm 29 now, 30 this summer! My pediatrician told us when it came out that he was giving it to all his teenagers and his infants, and catching those in between when they became teens. So I guess I was in 10th grade when received the series.
I've got kids, and would get them immunized in a heartbeat with an HPV or HIV vaccine if they were safe (and didn't have preservatives in them).

me too, like we're that ignorant to think our daughters will never have sex? I can't stand these extreme ideas - UGG Wheres the balance in politics?