In Brief The Facts: A new study raises concerns and questions about the effectiveness of the HPV and if it really plays any role at all in preventing cervical cancer.

Reflect On: Are vaccines as effective as they're marketed to be?

A new study published in The Royal Society of Medicine is one of multiple studies over the years that has emerged questioning the efficacy of the HPV vaccine. The researchers conducted an appraisal of published phase 2 and 3 efficacy trials in relation to the prevention of cervical cancer and their analysis showed “the trials themselves generated significant uncertainties undermining claims of efficacy” in the data they used. The researchers emphasized that “it is still uncertain whether human papillomavirus (HPV) vaccination prevents cervical cancer as trials were not designed to detect this outcome, which takes decades to develop.” The researchers point out that the trials used to test the vaccine may have “overestimated” the efficacy of the vaccine.

A part of the problem, as the study points out, is that it’s unknown as to whether certain infections would clear, or would persist and lead to cervical changes. This is a big point. Every year around the world, approximately 13.1/100,000 women are diagnosed with cervical cancer, so the rate of incidence is quite low. Furthermore, the vaccination is offered to girls aged 9-13, as the study points out, “before sexual debut and naive to HPV infection.”

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The study reviewed 35 published papers relating to 12 randomized blinded non-HPV vaccine-controlled Phase 2 and 3 trials of Gardasil and Cervarix conducted from 2001 to 2016 assessing efficacy against cervical cancer and its precursors. Researchers also examined 39 meta-analyses and systematic reviews of HPV vaccine efficacy.

No Evidence HPV Vaccine Prevents Cervical Cancer

They emphasized after their examination that that none of the trials they examined were actually designed to determine efficacy or effectiveness of the HPV vaccine against cervical cancer. In fact, there were no reported cases of cervical cancer in any of the trials.

The time between first exposure to HPV and peak development of CIN3 is 7–10 years. It takes a further 10 years or so for cervical cancer to develop according to natural history studies. All trials had a mean length of follow-up of six or fewer years, apart from the HPV-023 extension with a mean follow-up of 8.9 years.

The authors point out that it was even questionable whether or not the vaccine prevents pre-cancerous lesions.

HPV Infections Often Clear On Their Own

One issue is that cervical cancer takes many years to develop. Out of all the women who get an HPV infection, approximately 70 percent of those are going to clear that infection all by themselves. The body will take care of it, and you don’t even have to detect it, within two years of the infection, approximately 90 percent of women will have cleared that HPV infection with no help. By three years, half of the remaining 10 percent will have progressed into a CIN 2 3 lesion, a pre-cancerous legion. So, approximately 5 percent of of the original 100 percent of women with an HPV infection will develop into a pre-cancerous lesion.

So now, you have that small group of women who now have pre-cancerous lesions, so now lets look at those moving into actual cancer. What we know is that amongst women with CIN 3 lesions, which is a little bit more severe than CIN 2 lesions, it takes five years for approximately 20 percent of those to develop into cancer, if they do. Furthermore, it takes about 30 years for 40 percent of them to become cancer.

The information above is why multiple studies have questioned the administration of the HPV vaccine. In a study published in Autoimmunity Reviews, the authors note that “The decision to vaccinate with HPV vaccine is a personal decision, not one that must be made for public health. HPV is not a lethal disease, in 95 percent of the infections; and the other 5 percent are detectable and treatable in the precancerous state.

So, one must ask themselves, What are the chances of a 9-13 year old girl getting an HPV infection? And what are the chances of that infection clearing itself? Furthermore, the vaccine only provides 5-10 years immunity, so when that 9 year old reaches the age of 19, or perhaps sooner, the immunity they’ve received from a few, out of many types of HPV infections, is no longer there. There are more than 100 HPV infections, and only 12 of them are carcinogenic to humans.

Furthermore, the idea that the HPV vaccine helps prevent cervical cancer, according to this recent study, is not a correct assumption, so one must ask themselves why is it marketed in that manner?

Corroboration From Other Studies

Again the main study of discussion in this article is complemented by many others that emphasize the same thing. For example, a study published in 2013 in Current Pharmaceutical Design carried out a review of HPV vaccine pre- and post-licensure trials to assess the evidence of their effectiveness and safety. They found that,

HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate. Additionally, we note evidence of selective reporting of results from clinical trials (i.e., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications). Given this, the widespread optimism regarding HPV vaccines long-term benefits appears to rest on a number of unproven assumptions (or such which are at odds with factual evidence) and significant misinterpretation of available data. For example, the claim that HPV vaccination will result in approximately 70% reduction of cervical cancers is made despite the fact that the clinical trials data have not demonstrated to date that the vaccines have actually prevented a single case of cervical cancer (let alone cervical cancer death), nor that the current overly optimistic surrogate marker-based extrapolations are justified. Likewise, the notion that HPV vaccines have an impressive safety profile is only supported by highly flawed design of safety trials and is contrary to accumulating evidence from vaccine safety surveillance databases and case reports which continue to link HPV vaccination to serious adverse outcomes (including death and permanent disabilities). We thus conclude that further reduction of cervical cancers might be best achieved by optimizing cervical screening (which carries no such risks) and targeting other factors of the disease rather than by the reliance on vaccines with questionable efficacy and safety profiles.

Is The HPV Vaccine 100% Safe?

Given the information above, I would personally have a hard time justifying giving my daughter the HPV vaccine. The risk is very low for a young girl to develop cervical cancer, as you can see from the information provided above. Furthermore, the HPV vaccine is not completely safe for everybody. For example, after the HPV vaccine, a disabling syndrome of chronic neuropathic pain, fatigue, and autonomic dysfunction may manifest. In questionnaires from 45 individuals who experienced issues after HPV vaccination,

Twenty-nine percent of the cases had immediate (within 24 h) post-vaccination illness onset. The most common presenting complaints were musculoskeletal pain (66%), fatigue (57%), headache (57%), dizziness/vertigo (43%), and paresthesias/allodynia (36%). Fifty-three percent of affected individuals fulfill the fibromyalgia criteria…After a mean period of 4.2 ± 2.5 years post-vaccination, 93% of patients continue to have incapacitating symptoms and remain unable to attend school or work.

A Study published in Clinical Rheumatology entitled “Serious adverse events after HPV vaccination: a critical review of randomized and post-marketing case series” also brings up concerns:

HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study.Is The Aluminum In HPV Vaccines The Issue?

A study published in Current Medical Chemistry states,

Aluminum is an experimentally demonstrated neurotoxin and the most commonly used vaccine adjuvant. Despite almost 90 years of widespread use of aluminum adjuvants, medical science’s understanding about their mechanisms of action is still remarkably poor. There is also a concerning scarcity of data on toxicology and pharmacokinetics of these compounds. In spite of this, the notion that aluminum in vaccines is safe appears to be widely accepted. Experimental research, however, clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans. (source)

Many scientists presented facts about vaccines and vaccine safety at the recent Global Health Vaccine Safety summit hosted by the World Health Organization in Geneva, Switzerland.

An interesting point that caught my attention was made by Dr. Martin Howell Friede, Coordinator of Initiative For Vaccine Research at the World Health Organization. He brought up the topic of vaccine adjuvants like aluminum. In certain vaccines, without these adjuvants the vaccine simply doesn’t work. Dr. Friede mentioned that there are clinical studies that blame adjuvants for adverse events seen as a result of administering vaccines, and how people in general often blame adverse reactions to vaccines being the result of the vaccine adjuvant. He mentioned aluminum specifically.

He showed concern given the fact that “without adjuvants, we are not going to have the next generation of vaccines.” He also stated that,

When we add an adjuvant, it’s because it is essential. We do not add adjuvants to vaccines because we want to do so, but when we add them it adds to the complexity. And I give courses every year on ‘how do you develop vaccines’ and ‘how do you make vaccines’ and the first lesson is, while you are making your vaccine, if you can avoid using an adjuvant, please do so. Lesson two is, if you’re going to use an adjuvant, use one that has a history of safety, and lesson three is, if you’re not going to do that, think very carefully.

You can read more about that, and find links to the conference and it’s full coverage in this article I published about it a few weeks ago.

In 2018, a paper published in The Journal of Inorganic Biochemistry found that almost 100 percent of the intramuscularly injected aluminum in mice as vaccine adjuvants was absorbed into the systemic circulation and traveled to different sites in the body such as the brain, the joints, and the spleen, where it accumulated and was retained post-vaccination. The researchers also found massive damage to motor neurons and behaviour abnormalities after injection. This study complimented and earlier study published in in 2015 that found the following:

Evidence that aluminum-coated particles phagocytozed in the injected muscle and its draining lymph nodes can disseminate within phagocytes throughout the body and slowly accumulate in the brain further suggests that alum safety should be evaluated in the long term.

When it comes to the HPV vaccine, there are multiple examples of injury. Here is one specific examples out of many you can read about more in depth.

The Takeaway

It’s no secret that vaccines are not completely safe for everyone, it’s clearly not a ‘one size fits all’ product, and that’s evident by the fact that nearly $4 billion has been paid out to families of vaccine injured children via the National Childhood Vaccine Injury Act (NCVIA). As astronomical as the monetary awards are, they’re even more alarming considering that only an estimated 1% of vaccine injuries are even reported to the Vaccine Adverse Events Reporting System (VAERS).

If the numbers from VAERS are correct – only 1% of vaccine injuries are reported and only 1/3 of the petitions are compensated – then up to 99% of vaccine injuries go unreported. Furthermore, vaccines are a liability-free product, that’s part of the NCVIA. There is no incentive to make a safe product.

Ask yourself, with all of this information out there, is it right to make vaccines mandatory? It’s no secret that vaccine hesitancy is on the rise, not because people are lacking education, but the complete opposite. It’s on the rise because more and more people are coming across information that does not resonate with them, and they are looking for answers.

The community at large should not use terms like ‘anti-vax’ or ‘pro-vax.’ Neither should the word ‘conspiracy’ be tossed around. This simply separates people when, at the end of the day, we all want the same thing and that’s healthy children. Accordingly. the concerns of vaccine safety advocates should be addressed, acknowledged, and not ignored.