Gennem mere end otte måneder har journalist Frederik Joelving arbejdet med at afdække, hvordan producenten af Gardasil, Merck. har registreret formodede bivirkninger i forbindelse med de kliniske studier, der lå forud for vaccinens godkendelse.
I hans artikel, som netop er udkommet på online-mediet Slate, kommer det frem, hvordan det har været op til de læger, der varetog opfølgningen på de vaccinerede piger at vurdere, om de symptomer pigerne oplevede, kunne have relation til vaccinen. Blandt andet har Frederik Joelving fulgt den danske pige Keisa Lyng, der oplever invaliderede symptomer efter 2. vaccination, og tilstanden forværres yderligere efter 3. vaccine, men Lyngs symptomer registreres ikke som bivirkninger i den journal, der udarbejdes i forbindelse med studiet. Og det samme gør sig gældende for flere andre piger, der deltager i studiet.
Dermed har myndighederne ikke noget retvisende grundlag at vurdere vaccinens sikkerhed. Producenten Merck forsvarer sig med, at studiet lever op til de krav, myndighederne stiller. Og en af de danske læger, der har medvirket i studiet, nemlig Susanne Krüger Kjær, som ofte udtaler sig offentligt om, at vaccinens effekt overgår risikoen, henviser til, at hun blot har fulgt studiets tilrettelæggelse i forhold til registrering af eventuelle bivirkninger.
Du finder hele artiklen her – den er lang, men absolut læsværdig.
Elizabeth Hart skriver
In his article Frederik Joelving refers to the work of Gerd Wallukat and ‘agonisitic autoantibodies’.
In regard to antibodies, is the potentially deleterious impact of the unnaturally high antibodies induced by HPV vaccination being considered/investigated?
In a review paper published in 2010, Ian Frazer, a co-inventor of the technology enabling the HPV vaccines, states:
“HPV immunization induces peak geometric mean antibody titers that are 80- to 100-fold higher than those observed following natural infection . Furthermore, after 18 months, mean vaccine-induced antibody titers remain 10- to 16-fold higher than those recorded with natural infection , and these levels appear to be preserved over time, suggesting that immunization may provide long-term protection against infection…” (See page S9.)
HPV ‘immunization’ inducing antibody titres that are 80- to 100-fold higher than those observed following natural infection seems to be a very unnatural response.
Is this a good thing? Does anybody know?
Frazer’s review paper is titled Measuring serum antibody to human papillomavirus following infection or vaccination, published in Gynecologic Oncology 118 (2010) S8-S11, and funded by Merck & Co. Inc. His reference for his high antibody titre comment is a paper by Diane M Harper et al – Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial, published in The Lancet, Vol 364 November 13, 2004, and funded and co-ordinated by GlaxoSmithKline Biologicals.
In their paper Harper et al state:
“Geometric mean titres for vaccine-induced antibodies to HPV antibodies were over 80 and 100 times greater than those seen in natural infections with HPV-18 and HPV-16, respectively. Vaccine-induced titres remained substantially raised at 18 months, and were still 10-16 times higher than those seen in women with natural HPV-16 or HPV-18 infections, respectively.” (See page 1763.)
And on page 1764:
“We have shown that the HPV-16/18 virus-like particle vaccine adjuvanted with AS04 induces a level of antibody production against HPV-16/18 that is much higher than that induced by natural infection. Previous work has shown that combinations of the adjuvants MPL and aluminium salts induce an enhanced immune response compared with antigen alone or adjuvanted with only aluminium, at both the humoral and cellular level. These findings suggest that the immune responses induced in vaccinated women may provide a longer duration of protection than the protective effects induced by natural HPV infection; however, a protective antibody level has not been established nor is there sufficient data currently available to estimate the duration of vaccine-induced protection.”
Should we be concerned that HPV vaccines produce antibodies over 80 and 100 times greater than those seen in natural infections with HPV-18 and HPV-16 respectively, and which remain substantially raised months after vaccination?
Thank you for your comments. We have forwarded your input to Dr. Jesper Mehlsen who is doing research in anti-bodies found in girls injured after the HPV-vaccine. We will revert with his reply.
Elizabeth Hart skriver
Thanks for your response Trine.
As mentioned in my previous comment, in regards to HPV ‘immunisation’ inducing antibody titres that are 80- to 100- fold higher than those observed following natural infection, Ian Frazer (2010) cites a paper by Diane Harper et al regarding the bivalent HPV vaccine (2004), i.e. presumably Cervarix. (This study was funded and coordinated by GlaxoSmithKline Bioglogicals.)
It appears Frazer generalises about high antibody titres after HPV vaccination, i.e. Gardasil and Cervarix, from Harper et al’s paper about Cervarix.
In a later review paper (2008), Diane Harper refers to high antibody titres after both vaccines, i.e. “the peak response to vaccination was robustly 100-200-fold higher than natural infection titers for both vaccines in neutralizing type-specific antibody titers for both HPV 16 and 18”, although in a later paper (2009) Harper says peak titre after Gardasil vaccination is 104-fold higher than natural infection for HPV 16, and 27-fold higher than natural infection titres for HPV 18.
In essence though, it appears HPV vaccination with both vaccines creates a much higher antibody response than natural infection, and from my layperson’s perspective I wonder if there is any downside to this unnatural response?
In her 2008 review paper, Harper also states: “Despite both vaccines having a 100% seroconversion 1 month after three doses of vaccine, the mechanism of immunogenicity from a scientific perspective is poorly understood. The measure of antibody induction by geometric mean titers (GMTs) is dependent on the assay system used, and is not comparable between HPV types within one manufacturer or for identical HPV types between manufacturers.”
It is concerning that the novel virus-like particle (VLP) vaccine products Gardasil and Cervarix have been fast-tracked globally, when “the mechanism of immunogenicity from a scientific perspective is poorly understood”.
In her 2008 review paper, Harper states: “…both vaccines contain a proprietary adjuvant system to improve the immunologic response to the VLP antigens. The adjuvant system, AS04, in Cervarix contains both an aluminium salt and a toll-like receptor-4 agonist (monophosphoryl lipid A); the adjuvant system in Gardasil contains an aluminium salt called aluminium hydroxyphosphate sulfate. Clinical trials in humans show that the HPV 16/18 VLPs adjuvanted with AS04 induce a significantly greater initial antibody response than do the HPV16/18 VLPs adjuvanted with aluminium hydroxide alone, and this superior response continues for at least 4 years…Experiments in mice show that the Merck proprietary amorphous aluminium hydroxyphosphate sulfate used in Gardasil induces a greater initial antibody response to HPV16 VLPs than does the aluminium hydroxide adjuvant alone…”
A VacZine Analytics press release titled “GSK and Cervarix – is AS04 a double edged sword?” (2007) says the novel adjuvant AS04 contained in Cervarix “is a combination of standard aluminium hydroxide and the new component, monophospholipid A (MPL). MPL is a derivative of the lipid A molecule found in gram-negative bacteria and is considered one of the most potent immune system stimulants known”.
Merck’s proprietary amorphous aluminium hydroxyphosphate sulfate used in Gardasil also appears to be more potent than aluminium hydroxide adjuvant alone.
Harper says the purpose of the adjuvant “is to prolong the immune response for as long as possible with the smallest amount of antigen (VLP) possible”.
Again, I register my concern that the novel Gardasil and Cervarix VLP HPV vaccine products have been fast-tracked around the world, particularly as “the mechanism of immunogenicity from a scientific perspective is poorly understood”.
If children and their parents were properly informed of the unnaturally high antibody titre induced by both the novel aluminium adjuvanted Gardasil and Cervarix vaccine products, and that scientists such as Diane Harper admit the mechanism of immunogenicity of these products is poorly understood from a scientific perspective, I wonder if they would consent to this still experimental medical intervention?
1. Ian H Frazer. Measuring serum antibody to human papillomavirus following infection or vaccination. Gynecologic Oncology 118 (2010) S8-S11.
2. Diane M Harper et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet, 2004; 364: 1757-65.
3. Diane M Harper. Prophylactic human papillomavirus vaccines to prevent cervical cancer: review of the Phase II and III trials. Therapy (2008) 5(3), 313-324.
4. Diane M Harper. Currently Approved Prophylactic HPV Vaccines. Expert Rev Vaccines. 2009; 8 (12): 1663-1679).
5. GSK and Cervarix – is AS04 a double edged sword? Press Release. VacZine Analytics. Posted on 19 Dec 2007.
Elizabeth Hart skriver
In my previous comments I expressed concern about the unnaturally high titres induced by the novel VLP HPV vaccine products Gardasil and Cervarix.
Millions of children around the world have been urged to have three doses of these vaccine products.
In regards to the three dose HPV vaccine regimen, in December 2016 I contacted Professor Diane Harper, an author of the study re the bivalent HPV vaccine (i.e. Cervarix), published in The Lancet in 2004, to ask her if titres were measured after individual doses or after all three doses in that study.
I was surprised when Professor Harper responded that “The titers were measured one month after the third dose.”
Professor Harper’s response indicates that titres were not measured after each individual dose.
So it appears it was not proven that three doses of Cervarix HPV vaccine were required.
In her email response to me, Professor Harper said: “The need for long-term protection drove the fear that three doses would be needed. As we learned one dose of cervarix provides high titers as well and has proven efficacy. It is unfortunate that the WHO would not recommend one dose of cervarix worldwide.”
In regards to Professor Harper’s statement “As we learned one dose of cervarix provides high titers…”, another study re Cervarix, published in 2013 states: “Antibody levels following one-dose remained stable from month 6 through month 48. Results raise the possibility that even a single dose of HPV VLPs will induce long-term protection.” This study was followed up with further analysis in 2015 which also indicates there is no evidence to support the three dose Cervarix HPV vaccine regimen.
It is shocking to discover there was no evidence to support the three dose HPV vaccine regimen.
While the studies I have referred to are about the Cervarix HPV vaccine, this leads to questions about the Gardasil HPV vaccine – what is the evidence supporting vaccination with three doses of the Gardasil HPV vaccine product?
In regards to unnaturally high titres after HPV vaccination, what are the possibly deleterious effects of revaccinating with multiple doses of novel, turbo-charged aluminium-adjuvanted VLP HPV vaccines, i.e. do repeat shots increase the risk of an adverse reaction? Is there any reliable data, including post-marketing surveillance, to check on this?
HPV vaccination has been fast-tracked around the world. Children have been pressed to have three doses of novel, turbo-charged aluminium-adjuvanted VLP HPV vaccines which produce unnaturally high titres. Scientists such as Professor Harper admit “the mechanism of immunogenicity from a scientific perspective is poorly understood”.
Children are being used as guinea pigs in a massive international experiment – is this ethical? What are the implications here in regards to informed consent?
Were three doses of HPV vaccines suggested to justify the cost of these vaccine products?
As for Professor Harper’s suggestion that Cervarix “has proven efficacy”, as far as I am aware, there is as yet no independent and objective systematic review of the efficacy of HPV vaccination in preventing cervical cancer, i.e. untainted by pharma influence or bias.
I suggest the public is being misled about the promoted ‘efficacy’ of globally fast-tracked HPV vaccination. At this time we have no idea of the long-term effects of this very questionable medical intervention, particularly if the risks will outweigh the touted benefits.
In my opinion the benefits of HPV vaccination are being over-hyped, and children and their parents are being grossly misinformed about HPV vaccination. At this time there is no independent and objective analysis validating HPV vaccination, and no scientific basis for the three dose regimen.
This is a massive international scandal.
1. Diane M Harper et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet. Vol. 364. November 13 2004.
2. Email response from Diane Harper to Elizabeth Hart, 11 December 2016.
3. Mahboobeh Safaeian et al. Durable Antibody Responses Following One Dose of the Bivalent Human Papillomavirus L1 Virus-Like Particle Vaccine in the Costa Rica Vaccine Trial. Cancer Prev Res; 6(11) November 2013.
4. Aimee R Kriemer et al. Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials. The Lancet Oncology Vol 16, July 2015.
5. Diane M Harper. Prophylactic human papillomavirus vaccines to prevent cervical cancer: review of the Phase II and III trials. Therapy (2008) 5(3), 313-324.