Studies demonstrating HPV vaccine is both safe and effective - Page 4

[kathymuggle]

Originally Posted by prosciencemum 

I'm not sure that's true. ….

 This website (http://www.patentlens.net/daisy/adjuvants/Background/Adjuvant_types.html) talks about how aluminium salts have been used as adjuvants since the 1930s. 

Or maybe it is.  

A quick look showed this, which implied it was a new formulation:

http://www.medicalnewstoday.com/releases/47226.php

"The immune response against the virus that causes cervical cancer is stronger and sustained following vaccination with GlaxoSmithKline's (GSK) candidate HPVvaccine formulated with the innovative AS04 adjuvant compared to using the same vaccine formulated with a conventional aluminium salt adjuvant. "

It is an interesting area to sort out for those interested in adjuvants, and their role in efficacy and vaccine safety.

[Minerva23]

Originally Posted by kathymuggle 

Or maybe it is.  

A quick look showed this, which implied it was a new formulation:

http://www.medicalnewstoday.com/releases/47226.php

"The immune response against the virus that causes cervical cancer is stronger and sustained following vaccination with GlaxoSmithKline's (GSK) candidate HPVvaccine formulated with the innovative AS04 adjuvant compared to using the same vaccine formulated with a conventional aluminium salt adjuvant. "

It is an interesting area to sort out for those interested in adjuvants, and their role in efficacy and vaccine safety.

Ah, very interesting. I haven't come across AS04 yet which is still different from the AAHS used in Gardasil but apparently was also selected for a stronger immune response. Makes me wonder whether the immune system is really making antibodies against HPV or just the adjuvant bound to HPV.

http://www.ncbi.nlm.nih.gov/pubmed/17581283

[Taximom5]

Here is information on ASO4, which, contrary to prosciencemum's insistence, has NOT been in use for 70 years.  In fact, it is new:

http://www.landesbioscience.com/journals/13/TagliabueHV4-5.pdf

It was approved for human use in 2008--along with squalene. (My understanding is that squalene-containing vaccines have still not been officially approved

Even in 2008, it appears that the question of vaccine-induced inflammation--specifically, ADJUVANT-induced inflammation--was of concern:

"Notably, genes for inflammatory cytokines were activated. Thus we still remain with the fundamental question whether it is possible to activate immunity without causing inflammation."

[prosciencemum]

Sorry is AS04 the same thing as AAHS that Mirzam23 was talking about? I agree these aluminium salt names are a bit confusing. 

I found a discussion addressing parents concerns about aluminium content of vaccines from the American Acadamy of Pediatrics which may be helpful to some: http://pediatrics.aappublications.org/content/112/6/1394.full

(it's actually got sections covering many of the concerning ingredients in vaccines, so you can just scroll down to adjuvants). 

 So it looks like about 6 years ago, after 70 years of using the same aluminium salt adjuvants there was some development of new adjuvants which are combinations of aluminium salts and other substances (which allow the aluminium content to be lowered, while the adjuvant efficacy is increased). AS04 seems to be one of these 2 "new" (6+ year old) adjuvants. If you look at the rules on licensing new adjuvants I posted up thread they must have been extensively safety tested to be licensed.

 Have there been any studies indicating they might be dangerous? 

[kathymuggle]

I found this study on miscarriage rate post HPV vaccine.  I did not find it overly re-assuring.  The whole study is available.

http://www.bmj.com/content/340/bmj.c712.long

 "The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination."

Edited by kathymuggle - 11/15/12 at 7:18am

[WildKingdom]

Originally Posted by kathymuggle 

I found this study on miscarriage rate post HPV vaccine.  I did not find it overly re-assuring.  The whole study is available.

http://www.bmj.com/content/340/bmj.c712.long

 The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination.

I'm confused.  Why do you not find it to be reassuring?  It shows no significant difference between the two arms.

[kathymuggle]

Originally Posted by WildKingdom 

I'm confused.  Why do you not find it to be reassuring?  It shows no significant difference between the two arms.

Significant is the key word.  

9.1 % miscarriage rate in the control arm versus 14.7% in the HPV arm for pregnancies that started within 3 months of the shot is pretty significant to me.  

[nia82]

Squalene was in use in H1n1 vaccines in Europe, namely the reactive Pandemrix (which also is preserved with thimerosal). My sister was forced by her hospital (she's a MD) to get it against her will and was sick for 2 weeks close to hospitalization. She also got a big talk to tell everyone to get it. Anyways, Pandemrix's adjuvant, AS03 is a mixture of squalene, polysorbate 80 (which allows crossing of blood brain barrier, as known in drugs for brain tumors and such) and vitamin E. The vaccine itself has been implicated in causing narcolepsy (see Finland; also most people didn't want it and many EU countries ended up burning millions of doses).

[Mirzam]

Originally Posted by kathymuggle 

Originally Posted by WildKingdom 

I'm confused.  Why do you not find it to be reassuring?  It shows no significant difference between the two arms.

Significant is the key word.  

9.1 % miscarriage rate in the control arm versus 14.7% in the HPV arm for pregnancies that started within 3 months of the shot is pretty significant to me.  

Both groups got vaccines with aluminum; the control got a Hep A vax.

Quote:

 Women received either the HPV 16/18 vaccine formulated with the AS04 adjuvant system or a control hepatitis A vaccine consisting of 720 ELISA units of inactivated viral antigen with Alum, formulated in 0.5 ml doses.

[kathymuggle]

Originally Posted by Mirzam 

Both groups got vaccines with aluminum; the control got a Hep A vax.

Yup.

It still looks like a HPV vaccine  was worse  than Hep A, when if came to miscarriage rate in the following 3 months.  I think this does give us some valuable information, but I would love to see a control group that was unvaxxed.  

[prosciencemum]

We can compare to general miscarriage rates to get some idea. A quick Google on that comes up with this page: 

http://miscarriage.about.com/od/pregnancyafterloss/qt/miscarriage-rates.htm

Which suggests in the first 20 weeks of pregnancy 10-20% of women miscarry. So it would appears these numbers of 9-14% of the women having a miscarriage in a period of 3 months are sadly nothing unusual.

[WildKingdom]

Originally Posted by kathymuggle 

Yup.

It still looks like a HPV vaccine  was worse  than Hep A, when if came to miscarriage rate in the following 3 months.  I think this does give us some valuable information, but I would love to see a control group that was unvaxxed.  

No, it doesn't. It showed no significant difference. You're right. Significant is the key word. They are talking about statistical significance. If the difference is not statistically significant, and it wasn't with that P value, it means that there is no difference between the two groups.

[kathymuggle]

Originally Posted by prosciencemum 

We can compare to general miscarriage rates to get some idea. A quick Google on that comes up with this page: 

http://miscarriage.about.com/od/pregnancyafterloss/qt/miscarriage-rates.htm

Which suggests in the first 20 weeks of pregnancy 10-20% of women miscarry. So it would appears these numbers of 9-14% of the women having a miscarriage in a period of 3 months are sadly nothing unusual.

But they were still higher than the Hep A vaccine rate, which clocked  in at 9.1%.  This is not a small study - what accounts for the discrepancy between the Hep A stat and the HPV vaccine? (oh, I  know, the HPV vaccine they were given…,)

The general miscarriage rate would not cut it - the study was for 15-25 year olds from Costa Rica.  Finding the miscarriage rate among 15-25 year old Costa Ricans would be best, but 15-25 year olds is a good starting point.

This article puts the miscarriage rate for women in their 20's at about 10%.

http://www.babycenter.com/0_age-and-fertility-getting-pregnant-in-your-20s_1494692.bc

[WildKingdom]

Originally Posted by kathymuggle 

But they were still higher than the Hep A vaccine rate, which clocked  in at 9.1%.  This is not a small study - what accounts for the discrepancy between the Hep A stat and the HPV vaccine? (oh, I  know, the HPV vaccine they were given…,)

The general miscarriage rate would not cut it - the study was for 15-25 year olds from Costa Rica.  Finding the miscarriage rate among 15-25 year old Costa Ricans would be best, but 15-25 year olds is a good starting point.

This article puts the miscarriage rate for women in their 20's at about 10%.
http://www.babycenter.com/0_age-and-fertility-getting-pregnant-in-your-20s_1494692.bc

Again, the rate was NOT higher in the hep a arm. There was NO STATISTICALLY SIGNIFICANT DIFFERENCE! You quoted the P value yourself as being .16!

[kathymuggle]

Originally Posted by WildKingdom 


Again, the rate was NOT higher in the hep a arm. There was NO STATISTICALLY SIGNIFICANT DIFFERENCE! You quoted the P value yourself as being .16!

The P value related to the first set of data (bolded).  

I am more interested the second set of data  (italics), which does not mention P value.  

Originally Posted by kathymuggle 

I found this study on miscarriage rate post HPV vaccine.  I did not find it overly re-assuring.  The whole study is available.

http://www.bmj.com/content/340/bmj.c712.long

 "The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination."

[kathymuggle]

This is how this very mainstream site interpreted the findings of the study I posted  (bolding mine):

http://general-medicine.jwatch.org/cgi/content/full/2010/318/7   (division of New England Journal of Medicine)

"Comment: These findings are reasonably reassuring that Cervarix vaccination does not materially raise risk for miscarriage. However, the data leave some uncertainty about a slightly elevated risk among women who conceive within 3 months of vaccination. Additional studies are warranted to settle this question."

[WildKingdom]

Originally Posted by kathymuggle 


The P value related to the first set of data (bolded).  

I am more interested the second set of data  (italics), which does not mention P value.  

Read the whole paper. The P value is in there. It's .033. Still not significant, using the standard of .025.

[Chicharronita]

Originally Posted by Taximom5 


Oh, but you are jumping to incorrect conclusions.

We don't know that there's no difference in major events which require hospitalization following the vaccine.

Most "studies" set up by pharmaceutical companies are deliberately set up to hide evidence of problems. See the recent whistleblower lawsuit against Merck by Merck's own virologists for a good example. That kind of thing is KNOWN in the industry to be standard procedure.

Severe reactions to vaccines do not always require hospitalizations, and severe reactions might happen within a short time frame--or several weeks later.

This study did not compare vaccinated vs unvaccinated for hospitalizations. It compared vaccinated vs. vaccinated. Basically, it compared the likelihood of hospitalization immediately after vaccination with the likelihood of hospitalization somewhat later after vaccination.

They were very careful not to let us know that the hospitalization rate is significantly higher in those who have received the vaccine.

Yeah, that's really reassuring.

Quote:

Originally Posted by Mirzam 

Yet another piece of junk science designed to mislead and hide the dangers of vaccination. Thankfully more people are waking up to this hoax and are just saying NO.

Yep. My daughter WILL NEVER get this vaccine, or any other, as long as dh and I are in charge of her health.

[Minerva23]

Originally Posted by prosciencemum 

Sorry is AS04 the same thing as AAHS that Mirzam23 was talking about? I agree these aluminium salt names are a bit confusing. 

I found a discussion addressing parents concerns about aluminium content of vaccines from the American Acadamy of Pediatrics which may be helpful to some: http://pediatrics.aappublications.org/content/112/6/1394.full

(it's actually got sections covering many of the concerning ingredients in vaccines, so you can just scroll down to adjuvants). 

 So it looks like about 6 years ago, after 70 years of using the same aluminium salt adjuvants there was some development of new adjuvants which are combinations of aluminium salts and other substances (which allow the aluminium content to be lowered, while the adjuvant efficacy is increased). AS04 seems to be one of these 2 "new" (6+ year old) adjuvants. If you look at the rules on licensing new adjuvants I posted up thread they must have been extensively safety tested to be licensed.

 Have there been any studies indicating they might be dangerous? 

No AS04 and AAHS are not the same. Both are new adjuvants and other than in Cervarix (AS04) and Gardasil (AAHS), I have not seen it listed as being used in other vaccines. So an adjuvant with 'just' 6 years under its belt and almost exclusively used in teenage girls, is not what I would consider safe and sound. About the extensive safety tests that you mention, I would like to learn more about it and would like to know when and how these were undertaken. So have there been studies for AAHS and AS04 that are available?

Just because one aluminium salt may be injected without doing immediate harm does not mean all other salts containing aluminium are therefore safe to use. Just take barium as an example. All barium salts are toxic except for barium sulfate which is used as an X-ray contrast agent.

[Minerva23]

Originally Posted by WildKingdom 


Again, the rate was NOT higher in the hep a arm. There was NO STATISTICALLY SIGNIFICANT DIFFERENCE! You quoted the P value yourself as being .16!

The P value related to the first set of data (bolded).  

I am more interested the second set of data  (italics), which does not mention P value.  

Originally Posted by kathymuggle 

I found this study on miscarriage rate post HPV vaccine.  I did not find it overly re-assuring.  The whole study is available.

http://www.bmj.com/content/340/bmj.c712.long

 "The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination."

In October 2007 the European Medicines Agency listed the estimated rate of miscarriage as 11.0 % in the HPV arm and as only 5.7 % in the control arm. Unfortunately the URL is no longer available. So was the PATRICIA study retaken or did they adjust the findings?