Vaccine Studies… “the science is settled” and the evidence cannot be denied

There is nothing more important than protecting our population, especially the most vulnerable, from risks. If there is a risk, there must be a choice. Vaccines (lab-created biologics) are not without their risks. The statement “Vaccines are safe and effective” is simply unfounded. Protection of informed consent is essential in a free society, but that is threatened today.

Independent bodies such as the Cochrane Collaboration, which is considered Level I hierarchy of medical evidence, are unable to determine if vaccination prevents primary disease and reports safety issues. This is a lot of information, so it is broken down by the vaccine. I have thoroughly covered measles and chickenpox, so they are not included in this post. You can find those here and here. Quotes below are directly obtained from studies.

 

COMBO VACCINES

In 2012, Bar-On, Goldberg, Hellman, & Leibovici evaluated DTP-HBV and HIB vaccines. Overall, they reported “Data for the primary outcome (prevention of disease) were lacking” and reported increased bias within performed studies. There was a reassessment of this in 2017, and those authors were unable to perform the study.

 

HEPATITIS B

Mathew, El Dib, Mathew, Boxall, & Brok evaluated Hepatitis B in 2009 and stated “Twelve trials were eligible. All had high risk of bias and reporting was inconsistent.” They went on further to state:

“In people not previously exposed to hepatitis B, vaccination has unclear effect on the risk of developing infection, as compared to no vaccination. The risk of lacking protective antibody levels as well as serious and non-serious adverse events appear comparable among recipients and non-recipients of hepatitis B vaccine.”

A review evaluating Hepatitis B booster vaccination conducted in 2016 reported, “There were no eligible randomised clinical trials fulfilling the inclusion criteria of this review.”

In 2017, Eke, Eleje, Eke, Xia, & Liu performed a study evaluating the Hepatitis B vaccine on newborns of seropositive women, and they stated:

“Due to very low to low quality evidence found in this review, we are uncertain of the effect of benefit of antenatal HBIG administration to the HBV-infected mothers on newborn outcomes, such as HBsAg, HBV-DNA, and HBeAg compared with no intervention. The results of the effects of HBIG on HBsAg and HBeAg are surrogate outcomes (raising risk of indirectness), and we need to be critical while interpreting the findings. We found no data on newborn mortality or maternal mortality or both, or other serious adverse events. Well-designed randomised clinical trials are needed to determine the benefits and harms of HBIG versus placebo in prevention of MTCT of HBV.”

 

TETANUS AND PERTUSSIS

In 2014, Zhang, Prietsch, Axelsson, & Halperin reported in a tetanus study that:

“Ethical barriers to the inclusion of a placebo group, combined with the evidence that whole-cell vaccines are not uniformly effective, will create problems for future efficacy studies. Such studies will need to include a self-selected, non-immunised and potentially biased control group, in order to provide an estimate of absolute vaccine efficacy. Further, analyses of the data from existing placebo-controlled studies, with the aim of determining characteristics of participants and their environment which affect vaccine efficacy, will permit future studies to improve these estimates of absolute efficacy by adjusting for such factors.

Finally, the lack of a laboratory correlate of efficacy means that the testing of new acellular pertussis vaccines currently requires prolonged and expensive clinical trials. Research into determining such a laboratory correlate should be a priority.”

In 2015, Demicheli, Barale, & Rivetti evaluated the studies on effects of TDaP vaccines in pregnant women concluding, “For our primary outcomes, there was no high-quality evidence according to GRADE assessments.” They went on to elaborate on two chosen trials and said:

“One study (1182 infants) assessed the effectiveness of tetanus toxoid in comparison with influenza vaccine in preventing neonatal tetanus deaths.

Another study, involving 8641 children, assessed the effectiveness of tetanus-diphtheria toxoid in comparison with cholera toxoid in preventing neonatal mortality after one or two doses.”

These two studies qualified to be evaluated, and both studies do not have true saline-placebo controls as the ‘placebo arm’ was administered a vaccine including adjuvanted components.

 

PNEUMOCOCCAL

In 2012, review by Moberley, Holden, Tatham, & Andrews on a Pneumococcal Pneumonia Vaccine (PPV) they report:

“PPV was not associated with substantial reductions in all-cause mortality (OR 0.90, 95% CI 0.74 to 1.09; random-effects model, I2 statistic = 69%). Vaccine efficacy against primary outcomes appeared poorer in adults with chronic illness. Non-RCTs provided evidence for protection against IPD in populations for whom the vaccine is currently utilised (OR 0.48, 95% CI 0.37 to 0.61; random-effects model, I2 statistic = 31%). This review did not consider adverse events as it was outside the scope of the review.”

In a 2015 review of evidence for the use of pneumococcal vaccines in pregnancy, Chaithongwongwatthana, Yamasmit, Limpongsanurak, Lumbiganon, & Tolosa reports:

“The overall quality of evidence is low for primary outcomes. Most outcomes had wide confidence intervals crossing the line of no effect, and most of the included trials had small numbers of participants and few events which led to downgrading evidence for imprecision of findings.

There is insufficient evidence to assess whether pneumococcal vaccination during pregnancy could reduce infant infections.”

 

ROTAVIRUS

In the 2010 review by Soares-Weiser, Goldberg, Tamimi, Leibovici, & Pitan on rotavirus in preventing diarrhea, the study reported:

“Evidence about safety, and about mortality or prevention of severe outcomes, is scarce and inconclusive… Rotavirus vaccines can prevent diarrhoea caused by rotavirus, but we are still not clear about safety and whether they prevent deaths.”

Because the vaccine evaluated in the above study was taken off the market due to intussusception, there was an updated review conducted in 2012. Soares-Weiser, MacLehose, Bergman, Ben-Aharon, Nagpal, Goldberg, Pitan, & Cunliffe conclude:

“Serious adverse events were reported in 4565 out of 99,438 children vaccinated with RV1 and in 1884 out of 78,226 children vaccinated with RV5. Fifty-eight cases of intussusception were reported in 97,246 children after RV1 vaccination, and 34 cases in 81,459 children after RV5 vaccination.

The vaccine efficacy is lower in high-mortality countries; however, due to the higher burden of disease, the absolute benefit is higher in these settings. No increased risk of serious adverse events including intussusception was detected, but post-introduction surveillance studies are required to detect rare events associated with vaccination.

Of the 41 RCTs analysed in this review, 25 (61%) reported an adequate generation of allocation sequence, while the method of assignment was unclear in the remaining studies. The methods used to conceal allocation were considered adequate in 19 trials (46%), and unclear in the remaining studies.

Incomplete outcome data was adequately addressed in 28 studies (68%), unclear in 12 studies, and was not addressed adequately in one study. Sixteen trials were free from selective reporting bias, eight were not, and the remaining trials were unclear. Most trials were sponsored by the industry and it was not possible to assess if they were free of other biases; two recent trials performed in Africa were considered free from other biases.”

 

INFLUENZA

In 2018, Jefferson, Rivetti, Di Pietrantonj, and Demicheli reported in an influenza vaccine study in healthy children that, “Only a few studies were well designed and conducted, and the impact of studies at high risk of bias varied across the outcomes evaluated.”

The 2018 study on influenza vaccination in adults conducted by Demicheli, Jefferson, Ferroni, Rivetti, & Di Pietrantonj, they report:

“We found 52 clinical trials of over 80,000 adults. We were unable to determine the impact of bias on about 70% of the included studies due to insufficient reporting of details. Around 15% of the included studies were well designed and conducted. We focused on reporting of results from 25 studies that looked at inactivated vaccines. Injected influenza vaccines probably have a small protective effect against influenza and ILI (moderate-certainty evidence), as 71 people would need to be vaccinated to avoid one influenza case, and 29 would need to be vaccinated to avoid one case of ILI. Vaccination may have little or no appreciable effect on hospitalisations (low-certainty evidence) or number of working days lost.

Fifteen included RCTs were industry funded (29%).”

In the 2018 study performed by Demicheli, Jefferson, Di Pietrantonj, Ferroni, Thorning, Thomas, & Rivetti regarding influenza vaccination in older adults, they concluded:

“The evidence for a lower risk of influenza and ILI with vaccination is limited by biases in the design or conduct of the studies. Lack of detail regarding the methods used to confirm the diagnosis of influenza limits the applicability of this result. The available evidence relating to complications is of poor quality, insufficient, or old and provides no clear guidance for public health regarding the safety, efficacy, or effectiveness of influenza vaccines for people aged 65years or older. Society should invest in research on a new generation of influenza vaccines for the elderly.”

 

There you have it! Of the available studies about vaccines, this is the available analysis…

  • Lack of
  • Limited by bias
  • Low-quality
  • Low-certainty
  • Uncertain
  • High-risk of bias
  • Inconclusive
  • Insufficient

Don’t believe me? Go have a look for yourself. These evaluations were made by medical doctors of an independent, non-profit organization that are free from conflicts of interest. This demonstrates that there is no evidence of safety, nor efficacy, of these vaccines. Further, evaluating the use of several vaccines at the same time is absent from the literature. We need to create an independent council that can evaluate the overall safety of the childhood vaccine schedule. We also need the ability to evaluate vaccines for all ages, as mandatory vaccine laws are entertained in legislative houses today.

The good news is that the Cochrane Hepato-Biliary Group has proposed a systematic review on the use of aluminum adjuvants in vaccines this year (2019). This is going to be a monumental study that has implications for the entire vaccine schedule as most vaccines contain aluminum adjuvants. I eagerly await the results.

HEAR THIS WELL: Your rights to medical freedom and informed consent are being threatened TODAY. These are current vaccinations that are being tested.

Vaccine Trial Tracker

Maybe you don’t care about the childhood vaccine schedule. Maybe you don’t have children and never plan to do so. Maybe you believe in your heart of hearts that vaccines are for the greater good. That is fine. That is YOUR choice (for now). However, if a mandatory vaccination law is passed, there is NO LIMIT to the number of vaccines that are authorized to be injected into YOU, an adult.

What happens if it is no longer your choice? What happens when Stage 4 of the clinical trial (use in populations and post-marketing studies) determines that a new vaccine causes harm and you did not have a choice? Well, by that point it does not matter. You have NO CONTROL over your health. You have NO CONTROL over what goes into your body at the discretion of pharmaceutical companies and government agencies. Then what? Public health officials can essentially go door-to-door to mass vaccinate communities. Is this what you want? Because if you do not stand up now, this is what you will get. It has been done before and it can be done again.

Your voice must be heard. Informed consent must be protected. A law mandating a medical intervention eliminates informed consent, as you no longer have the choice and therefore do not need to know the risks. Last year (2018), HEPLISAV-B was approved for the adult vaccination schedule. Just look up ACIP vote last year on this issue and how exactly they voted this vaccine through, here is one link. Certainly, that brings you to pause. Still feel like lining up for the future HIV vaccine?

Above all, we need to focus on safety. Even if you are a proponent for mandatory vaccines, you should be able to prove their safety and efficacy. You should be 100% confident in what an unbiased safety council will find when evaluating these biologics. So why not prove it? This easily accessed petition will help squander this debate.

You can find state-specific information on vaccine laws here. But in the meantime, #IDoNotConsent. A society that touts personal liberty should be free from coercion. Informed consent, body autonomy, individualized care, and evidence-based practice are cornerstones to today’s medical practice; without these things, we can expect higher profits for pharmaceutical/medical technology and insurance companies, higher risks, and worsening health outcomes. Stand up for yourself (and future generations), before you’re forced to sit down and blindly accept medical interventions.

Shalom, Light, and Love.

 

Sites To Consider:
https://www.cochranelibrary.com/cdsr/about-cdsr
https://physiciansforinformedconsent.org/
https://nvicadvocacy.org/members/Home.aspx
https://www.nvic.org/
https://www.learntherisk.org/
https://www.who.int/immunization/research/vaccine_pipeline_tracker_spreadsheet/en/
https://petitions.whitehouse.gov/petition/presidential-appointment-independent-vaccine-safety-commission

Eke, A. C., Eleje G.U., Eke, U.A., Xia Y., & Liu J. (2017). Hepatitis B immunoglobulin during pregnancy for prevention of mother-to-child transmission of hepatitis B virus. Cochrane Database of Systematic Reviews, (2).

Bar-On, E. S., Goldberg, E., Hellman, S., & Leibovici, L. (2012). Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae B (HIB). Cochrane Database of Systematic Reviews, (4).

Chaithongwongwatthana, S., Yamasmit, W., Limpongsanurak, S., Lumbiganon, P., Tolosa, J. E. (2015). Pneumococcal vaccination during pregnancy for preventing infant infection. Cochrane Database of Systematic Reviews, (1).

Demicheli, V., Barale, A., & Rivetti, A. (2015). Vaccines for women for preventing neonatal tetanus. Cochrane Database of Systematic Reviews, (7).

Demicheli, V., Jefferson, T., Ferroni, E., Rivetti, A., & Di Pietrantonj, C. (2018). Vaccines for preventing influenza in healthy adults. Cochrane Database of Systematic Reviews, (2).

Demicheli, V., Jefferson, T., Di Pietrantonj, C., Ferroni, E., Thorning, S., Thomas, R. E., & Rivetti, A. (2018). Vaccines for preventing influenza in the elderly. Cochrane Database of Systematic Reviews, (2).

Jefferson, T., Rivetti, A., Di Pietrantonj, C., & Demicheli, V. (2018). Vaccines for preventing influenza in healthy children. Cochrane Database of Systematic Reviews, (2).

Mathew, J. L., El Dib, R., Mathew, P.J., Boxall, E.H., & Brok, J. (2009). Hepatitis B immunisation in persons not previously exposed to hepatitis B or with unknown exposure status. Cochrane Database of Systematic Reviews, (1).

Moberley, S., Holden, J., Tatham, D. P., Andrews, R.M. (2012). Vaccines for preventing pneumococcal infection in adults. Cochrane Database of Systematic Reviews, (1).

Soares-Weiser, K., Goldberg, E., Tamimi, G., Leibovici, L., & Pitan, F. (2010). Rotavirus vaccine for preventing diarrhoea. Cochrane Database of Systematic Reviews, (9).

Soares-Weiser, K., MacLehose, H., Bergman, H., Ben-Aharon, I., Nagpal, S., Goldberg, E., Pitan, F., & Cunliffe, N. (2012). Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database of Systematic Reviews, (11).

Zhang, L., Prietsch, S. O. M., Axelsson, I., & Halperin, S. A. (2014). Acellular vaccines for preventing whooping cough in children. Cochrane Database of Systematic Reviews, (9).