HPV vaccination: benefit-risk ratio unclear

A large review deals with the benefits and risks of HPV vaccination (Jørgensen L: Benefits and Harms of the HPV Vaccines). The main author Lars Jørgensen was supported by the internationally recognized evidence physicians and epidemiologists Peter C. Gøtzsche and Thomas Jefferson. It is to date the most complete and detailed independent study on this topic, because the authors have partially managed to get the raw data from manufacturer studies (most published studies report less than half of the side effects that are recorded in the raw data).

The authors summarize:
„Ultimately, it is unclear whether the benefits of HPV vaccines outweigh their risks.“

The systematic review of 24 clinical trials with almost 100,000 participants showed that the HPV vaccines reduce the HPV-related precursors of cancer and corresponding treatments within four years, but increase the risk of serious disorders of the nervous system.

Benefits: The HPV vaccines led to a comparison with the aluminum potentiator or a hepatitis vaccine:

– Reduction of moderate and higher grade dysplasia (CIN 2+): 952 cases in HPV vaccinated vs. 1239 in the control group. 190 girls or women must be vaccinated to prevent one case.

– Reduction of abnormal cells at a pre-invasive stage („carcinoma in situ“): 367 vs. 490. 387 girls or women must be vaccinated to prevent one case.

– Accordingly, fewer conisation treatments were carried out on the HPV vaccine: 1081 vs. 1416

Risks: HPV vaccines had compared to the aluminum potentiator or a hepatitis vaccine:

a higher risk of general complaints such as tiredness, headache and / or muscle pain (risk 1:50),
a higher risk of serious nervous system disorders (risk 1: 1325), e.g. impaired consciousness, nerve inflammation, migraine or multiple sclerosis (less than 6 cases each among 50,000 vaccinated),
a higher risk (“risk signal”) for chronic regional pain syndrome CRPS1) and postural orthostatic tachycardia syndrome POTS2) (risk about 1: 1000 each) – in the studies these two serious disorders were not listed as independent diagnosis.

Already known side effects of HPV vaccines are anaphylactic reactions and fainting. Case series also point to a possible connection with chronic fatigue syndrome, Guillain-Barré syndrome, and premature ovarian failure. Gardasil 9 vaccine causes 8% more general reactions and 30% more serious side effects (3.2% vs. 2.5%) than the previous Gardasil vaccine.

In the HPV vaccination studies, the authors find the following deficiencies that make assessment difficult:

The results were not published in half of the registered HPV vaccination studies, and more than a third of the studies were not published in medical journals.
It was very difficult and sometimes impossible to get the raw data from the studies; especially the European Medical Agency EMA was not very cooperative.
All published studies show a high risk of bias in the study design. They are designed to demonstrate the benefits of vaccines and not to uncover risks. Serious harms were incompletely reported for 72% of the participants. The study material contains contained redactions and lacked significant parts.
In the control groups, 99% of the study participants did not receive a real placebo, but an active comparison drug – either the aluminum-containing potentiator of the HPV vaccine or hepatitis vaccines with the same potentiator. This discounts side effects caused by the potentiator. Half of the study participants were only admitted if they had never received the aluminum-containing effect amplifier – although the manufacturers claim that the aluminum compound is safe.

An interview with Peter Gøtzsche in the SWR is worth listening to and worth seeing.

The benefit-risk ratio of vaccination raises even more questions if one takes into account that non-smoking and participation in the screening test (and, if necessary, treatment of cancer precursors) greatly reduces the risk of developing cervical cancer, while for serious ones vaccine side effects such as CRPS or POTS therapy options are missing.

1) CRPS (chronic regional pain syndrome): Chronic neurological disease with localized or diffuse pain, muscle weakness and restricted movement up to joint stiffness and osteoporosis

2) POTS (Postural Orthostatic Tachycardia Syndrome): Chronic standing circulatory weakness, with pulsation

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