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Effectiveness of quadrivalent human papillomavirus vaccine for the prevention of cervical abnormalities: case-control study nested within a population based screening programme in Australia

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1458 (Published 04 March 2014) Cite this as: BMJ 2014;348:g1458

Re: Effectiveness of quadrivalent human papillomavirus vaccine for the prevention of cervical abnormalities: case-control study nested within a population based screening programme in Australia

It’s not all about the effectiveness of HPV vaccines.

I will only address some figures in the article, such as consistently falling uptake of the second and third doses (84%, 79% and 70% for one, two and three doses, respectively, for school-based program, and 64%, 54% and 33%, for the community programs), indicating to me a high rate of reactions that prevented higher uptake and a conspicuously low vaccine effectiveness of 46%, 34% and 21%.

The word ‘estimate’ was used instead of ‘calculations’; this in my opinion weakens the impression for the reader about the effectiveness of the HPV vaccine to prevent HPV cancer lesions.

Is it possible that any vaccine can be effective in preventing the targeted condition/disease?

The preventative ability of the ‘classical’ vaccines in natural infectious diseases, such as diphtheria, pertussis and tetanus, polio and measles, mumps and rubella, and largely unnatural bacterial infections such as meningitides, has been tested in the real world for decades. They were all found lacking in the effectiveness to prevent such diseases, and their mass use resulted in outbreaks of the targeted diseases right from the beginning of mass vaccination. The predicted generational undesirable effect of vaccines in destroying transplacentally-transmitted immunity is also well-documented.

The reason is that any and all vaccine injections elicit anaphylaxis (sensitisation, increased susceptibility to the targeted diseases), not prophylaxis (prevention).

In 1905 Pirquet, a Viennese immunologist, infectiologist, a professor of paediatrics at Johns Hopkins university of Baltimore Maryland, US, noticed that patients who had received horse serum or smallpox vaccine usually had quicker, more severe reactions to the second injection. He called it serum sickness and correctly attributed this disease to the formation of antibodies and their interaction with antigens contained in the serum. He coined the term allergy to these antibody-antigen reactions. This comprised both “hyper- and hypo-sensitivity reactions. He also studied vaccination and vaccinal allergy.

He recognised the secondary and delayed toxic effects of the foreign antigens in horse serum and contrasted them with the familiar primary toxic effects of various substances and their recurrence was interpreted as the result of counter-effects.

In my rapid response (10 December 2008) I quote a number of authors, such as Levine et al’s article (1966. Hyperacute allergic encephalomyelitis: adjuvant effect of pertussis vaccines and extracts. J Immunology; 97(3): 363-368) and Selye (1937. Studies on adaptation. Endocrinology; 21 (1): 169-178) documenting the characteristic but non-specific nature of responses and reactions to all and any vaccines and the reasons why they do not and cannot prevent any diseases.

HPV vaccine appears as no exception. Outbreaks of genital warts after HPV vaccination occurred in many countries, perhaps best publicised in Fiji (Matelita Ragogo, “Are our girls guinea pigs? – The FIJI Times ONLINE 26 March 2014; Joanne Waldron. Gardasil linked to seventy-eight outbreaks of genital warts. Natural News; 11 November 2008).

A great number of articles has demonstrated that naturally-acquired infectious diseases are beneficial.

The latest of such articles, showing that natural HPV infection is beneficial, appeared in Journal of Infectious Diseases Advance Access (Castellsague et al.) published on 8 March 2014. It is a major study with international participation, titled “Risk of newly detected infections and cervical abnormalities in women seropositive for naturally-acquired HPV-16/18 antibodies: analysis of the control arm of PATRICIA”.

The study was supported/funded by GlaxoSmithKline Biologicals SA (NCT00122681).

The main results of this important study were as follows:

“This study is the first to demonstrate a statistically significant quantitative relationship between titers of naturally-acquired antibodies to HPV-16 and the incidence of newly detected and 6-months persistent infection and HPV-16-associated ASC-US +. Antibody titers of approximately 370, 204, and 480 EU/mL were associated with a 90% risk reduction of incident infection, 6-months persistent infection, and ASC-US+, respectively. However, these values do not represent correlates of protection with regard to antibody levels induced by vaccination, because there are certainly some differences between naturally-acquired versus vaccine-induced antibody production. Antibody properties such as affinity, avidity, and specificity may also be different, In addition, naturally-acquired HPV infections potentially enable broad exposure to many HPV-specific proteins during the virus life cycle, unlike HPV vaccine-based on L1 VLPs. Thus, natural infections are likely not restricted to the generation of L1 antibody responses but would be expected to include a spectrum of HPV-specific cell-mediated and humoral immune responses that could contribute to reduction in new infections.”

And,

“We compared risk of newly detected infection and cervical abnormalities associated with HPV-16/18 between seronegative versus seropositive women (15-25 years) in the control arm DNA-negative at baseline for the corresponding HPV type [HPV-16 – n=8193; HPV-18 n=8463].”

The results showed that “High titers of naturally-acquired HPV-16 antibodies and/or linear trend for increasing antibody levels were significantly associated with lower risk of incident and persistent infection, atypical squamous cells of undetermined significance or greater ASC-US+, and cervical intraepithelial neoplasia grade 1, 2 or greater (C1N1+ and C1N2+). For HPV-18, while seropositivity was associated with lower risk of ASC-US+ and C1N1+, no association between naturally-acquired antibodies and infection was demonstrated.” The reason for this discrepancy in observations, given by the above authors, was ‘underpowering of studies’ and ‘differences in methodology’, which opens the way to further research and better results.

The authors of the above study concluded, “Naturally-acquired antibody to HPV-16 and to a lesser extent HPV-18, are associated with some reduced risk of subsequent infection and cervical abnormalities associated with the same HPV type.”

None of the industry-supported studies are without some value. Indeed, I have found many such studies of great value in understanding the ineffectiveness and real dangers of all vaccines, revealed intentionally or unintentionally by such studies.

Competing interests: No competing interests

26 March 2014
Dr Viera Scheibner (PhD)
scientist/author retired
n/a
Blackheath, Australia