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That Was Then, This Is Now: Open Season on Vaccinating Pregnant Women

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By the World Mercury Project team

Instinctively, most of us know that pregnancy is a time when it makes sense to be cautious. After all, as even popular culture attests, “precious cargo” is involved. With medications, focus group research indicates that when the risks of a given medication are unknown, most women are not willing to take the medication during pregnancy.

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To help pregnant women navigate potential risks to themselves and their “cargo,” WebMD furnishes a long checklist of substances known to cause birth defects, including acne drugs, some antidepressants and heavy metals such as lead and organic mercury. However, when it comes to flu shots (some of which contain organic mercury), the website tells women that the vaccines are completely safe any time during pregnancy. The website’s certitude in this regard rests on the assurances of entities like the Centers for Disease Control and Prevention (CDC), which has long recommended influenza vaccines for pregnant women. CDC’s rationale is that the vaccines are needed to help pregnant women avoid the “excess” influenza-related deaths that apparently occurred during early-20th-century influenza pandemics.

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Published reports point to an increased risk of miscarriages and elevated risks of birth defects and autism in the offspring of mothers who received influenza vaccines during pregnancy—

Changing recommendations

Around 2006, CDC took stock of the persistently low compliance with its influenza recommendations, largely ignored by both doctors and pregnant women, and began more aggressively promoting flu shots for pregnant women. In an update in the Morbidity and Mortality Weekly Report, CDC cited as evidence of the vaccines’ safety during pregnancy a grand total of two retrospective epidemiological studies of medical records—one of which was published in 1973.

In 2011, CDC and other medical trade organizations also began recommending that all pregnant women get the Tdap vaccine (tetanus-diphtheria-acellular pertussis), which, among other ingredients, contains neurotoxic aluminum. Tdap coverage in pregnancy increased substantially following this recommendation, particularly in women who also received other vaccines during pregnancy. The FDA’s original approval of the two Tdap brands (Boostrix and Adacel) in the mid-2000s was as a booster for teens and adults, and the product inserts state that Tdap should be given during pregnancy only “when benefit outweighs risk.” At the time of the 2011 recommendation, no prelicensure studies of Tdap safety during pregnancy were available, so most of the (largely unpublished) data used to justify the recommendation came from post-licensure pregnancy pharmacovigilance conducted by vaccine manufacturers. To this day, online information for Boostrix states that “it is not known whether Tdap vaccine will harm an unborn baby.”

How have these vaccine recommendations worked out for pregnant women and their babies? Published reports point to an increased risk of miscarriages and elevated risks of birth defects and autism in the offspring of mothers who received influenza vaccines during pregnancy—described by World Mercury Project on multiple occasions. Although evidence about Tdap is still emerging, the global VigiBase database (launched in 1978 to collect reports of vaccine-related adverse events from heterogeneous systems in 110 countries) indicates that three-fifths (58%) of all the Tdap-related adverse events reported to VigiBase have occurred since 2010, half (49%) have been in females and 7% have been in the 18-44-year age group. Admittedly, the non-systematic nature of the VigiBase data makes it difficult to interpret these trends, but it still seems surprising that the default official position shared by academics and regulators is that “there is no documented causal evidence of developmental or reproductive toxic effects in humans following the use of [any] approved vaccine.”

…experts emphasize that toxicity is both dose and time-dependent, and that toxicity testing must investigate time-dependent effects. The vaccines destined for pregnant women have not been subjected to this type of nuanced scrutiny.

Looking back

Prevailing notions of what is “ethically permissible or necessary” with regard to the medical protection of pregnant women appear to be somewhat malleable. There was, in fact, a time when regulators did not display the same levels of insouciance about vaccine and drug administration during pregnancy. Formerly, federal policy (at least on paper) deemed it prudent to exclude women of childbearing age and pregnant women from taking part in clinical trials to test new drugs. This precautionary stance—grounded in established toxicological principles—aimed to forestall developmental toxicity disasters such as the one that occurred with thalidomide. In 1993, however, mounting pressure from various sectors persuaded the Food and Drug Administration (FDA) to abolish the perceived “medical research gender gap.” The FDA’s Center for Drug Evaluation and Research (CDER) reversed course and began encouraging routine inclusion of reproductive-age women in clinical trials—but it continued to note the special circumstances of pregnant women (and is just now getting around to formalizing scientific and ethical guidance pertaining to pregnant women’s participation in drug trials).

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Over at the FDA’s sister office CBER (Center for Biologics Evaluation and Research), which oversees vaccines and other “biologics,” officials initially seemed to share CDER’s apparent restraint concerning pregnant women. In 1996, CBER’s Office of Vaccines Research and Review (OVRR) wrote up a detailed two-page memorandum on reproductive toxicity and vaccines. It then invited the public to submit written comments(in 2000) and eventually published “Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications” (in 2006).

The memo and subsequent guidance spelled out the critical need to conduct preclinical studies in animal models to assess reproductive and developmental toxicity “prior to licensure of vaccines intended for maternal immunization and/or women of childbearing age” (see table below). However, the documents admitted that “lack of adverse effects on embryo/fetal development in an animal study does not necessarily imply absence of risk for humans.” Moreover, given the FDA’s emphasis (in a header on every page) that all of the recommendations included in its guidance are non-binding, the extent to which vaccine manufacturers choose to abide by them is largely unknown.

…neither the FDA nor the WHO commented on the possible conflicts-of-interest inherent in having vaccine manufacturers conduct their own pharmacovigilance.

In 2013, when the World Health Organization’s (WHO’s) Global Advisory Committee on Vaccine Safety reviewed the safety of the growing number of vaccines intended for pregnant women, it noted “the limited amount of clinical trial data on pregnant women” and, like the FDA, emphasized the importance of “enhanced pharmacovigilance in the post-licensure phase.” However, neither the FDA nor the WHO commented on the possible conflicts-of-interest inherent in having vaccine manufacturers conduct their own pharmacovigilance.

 Numerous challenges

Even under the best of circumstances, vaccine development for pregnant women poses special challenges. As one researcher recently stated:

Not only do vaccines for pregnant women require evidence of immunogenicity, potency, stability, and limited reactogenicity, they must also provide efficacy in decreasing morbidity for the pregnant woman, her fetus, and the neonate, demonstrate safety or lack of evidence of harm, and offer benefit or potential benefit of vaccination during pregnancy.”

Conducting the types of preclinical developmental toxicity studies and after-the-fact monitoring activities described in the FDA documents comes with its own set of challenges. These include:

  • Identifying suitable animal models for preclinical studies, particularly because not all species (e.g., primates, rodents or rabbits) are appropriate for all research questions.
  • Assessing whether adverse effects on the developing embryo or fetus were caused by the vaccine antigen or by other vaccine constituents (such as adjuvants, preservatives and stabilizers).
  • Evaluating adverse influences of vaccine-induced antibodies on both fetal and postnatal
  • Determining whether maternal vaccination affects immune development in the offspring.

Toxicologists also continually call attention to the fact that even very small doses of substances such as mercury “may cause extensive adverse effects later in life.” These experts emphasize that toxicity is both dose and time-dependent, and that toxicity testing must investigate time-dependent effects. The vaccines destined for pregnant women have not been subjected to this type of nuanced scrutiny.

Where are the warnings?

A recent assessment of titanium dioxide nanoparticles—a modern product included in many cosmetics and drugs—warned of significant and potentially devastating effects on “millions of pregnant mothers and their offspring.” Vaccines contain an array of nanoparticulate ingredients (some intended and some not), but no comparable studies have emerged nor have warnings been issued. In general, published discussions of vaccine safety during pregnancy exhibit a linguistic slant toward describing risks to the fetus as “perceived” and “potential” rather than actual. Whether regulatory agencies’ former professed interest in protecting pregnant women from exposure to potential toxins was ever sincere or not, by and large, it appears to have become a historical footnote.

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Positive Association Found Amongst COVID Deaths & Flu Shot Rates Worldwide In Elderly

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In Brief

  • The Facts:

    A recently published paper has found a positive association between COVID-19 deaths and influenza vaccination rates in elderly people worldwide.

  • Reflect On:

    Why does vaccine hesitancy continue to grow worldwide? What's going on? What information/factors are contributing to this hesitancy?

What Happened: A recently published study in PeerJ  by Christian Wehenkel, a Professor at Universidad Juárez del Estado de Durango in Mexico, has found a positive association between COVID-19 deaths and influenza vaccination rates in elderly people worldwide.

According to the study, “The results showed a positive association between COVID-19 deaths and IVR (influenza vaccination rate) of people ≥65 years-old. There is a significant increase in COVID-19 deaths from eastern to western regions in the world. Further exploration is needed to explain these findings, and additional work on this line of research may lead to prevention of deaths associated with COVID-19.”

To determine this association, data sets from 39 countries with more than half a million people were analyzed.

The study was published on October 1st, and two weeks later a note from the publisher appeared atop the paper emphasizing that correlation does not equal causation, and that this paper “should not be taken to suggest that receiving the influenza vaccination results in an increased risk of death for an individual with COVID-19 as there may be confounding factors at play.”

The paper provides evidence from others which have recently been published that ponder if the flu shot could increase ones chance of contracting and dying from COVID-19.

For example, this study published in April of 2020, reported a negative correlation between influenza vaccination rates (IVRs) and COVID-19 related mortality and morbidity. Marín-Hernández, Schwartz & Nixon (2020) also showed epidemiological evidence of an association between higher influenza vaccine uptake by elderly people and lower percentage of COVID-19 deaths in Italy, which directly contradicts the author’s own findings and suggests that the flu shot may help prevent COVID-19 related deaths.

He goes on to mention another study:

In a study analyzing 92,664 clinically and molecularly confirmed COVID-19 cases in Brazil, Fink et al. (2020) reported that patients who received a recent flu vaccine experienced on average 17% lower odds of death. Moreover, Pawlowski et al. (2020) analyzed the immunization records of 137,037 individuals who tested positive in a SARS-CoV-2 PCR. They found that polio, Hemophilus influenzae type-B, measles-mumps-rubella, varicella, pneumococcal conjugate (PCV13), geriatric flu, and hepatitis A/hepatitis B (HepA-HepB) vaccines, which had been administered in the past 1, 2, and 5 years, were associated with decreased SARS-CoV-2 infection rates.

So, its important to mention that correlations between the flu vaccine have also found that it may decrease ones chance of deaths from COVID-19.

But are there studies that have shown an increased chance of death or contracting other respiratory viruses as a result of getting the flu shot? Yes.

That’s also discussed in the paper. For example, he mentions a paper published in 2018:

In a study with 6,120 subjects, Wolff (2020) reported that influenza vaccination was significantly associated with a higher risk of some other respiratory diseases, due to virus interference. In a specific examination of non-influenza viruses, the odds of coronavirus infection (but not the COVID-19 virus) in vaccinated individuals were significantly higher, when compared to unvaccinated individuals (odds ratio = 1.36).

The study above found the flu shot to increase the risk of other coronaviruses among those who had been vaccinated for influenza by 36 percent. The study was conducted prior to COVID-19, so it’s not included and only applies to pre-existing coronaviruses. The study also found an even higher chance of contracting human metapneumovirus amongst those who had received the flu shot.

Below are some more studies regarding the flu shot and viral infections that hint to the same idea.

  • 2018 CDC study (Rikin et al 2018) found that flu shots increase the risk of non-flu acute respiratory illnesses (ARIs), including coronavirus, in children.
  • A 2011 Australian study (Kelly et al 2011) found that flu shots doubled the risk for non-flu viral lung infections.
  • 2012 Hong Kong study (Cowling et al 2012) found that flu shots increase the risk for non-flu respiratory infections by 4.4 times.
  • 2017 study (Mawson et al 2017) found vaccinated children were 5.9 times more likely to suffer pneumonia than their unvaccinated peers.

Why This Is Important: We live in an age where vaccinations are heavily marketed. We’ve seen this with the flu shot time and time again and we are also living in an age where a push for more mandated vaccines seems to be growing.

Dr. Peter Doshi is an associate editor at The BMJ (British Medical Journal) and also an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. He published a paper in The BMJ titled “Influenza: Marketing Vaccines By Marketing Disease.”  In it,  he points out that the CDC pledges “to base all public health decisions on the highest quality of scientific data, openly and objectively derived,” and how this isn’t the case when it comes to the flu vaccine and its marketing. He stresses that “the vaccine may be less beneficial and less safe than has been claimed, and that “the threat of influenza seems to be overstated.”

This is a touchy subject that dives into medical ethics and the connections that big pharmaceutical companies have with our federal health regulatory agencies and health associations. Vaccines are a multi billion dollar industry.

At a recent World Health Organization conference on vaccine safety, it was expressed that vaccine hesitancy is growing at quite a fast pace, especially among doctors who are now becoming hesitant to recommend certain vaccines on the schedule. You can read more about that and find links to the conference here.

We have to ask ourselves, why is this happening? Is it because people and professionals are becoming aware of certain information that warrants the freedom of choice? Should freedom of choice with regards to what we put in our body always remain? Are we really protecting the “herd” by taking these actions?

In a 2014 analysis in the Oregon Law Review by New York University (NYU) legal scholars Mary Holland and Chase E. Zachary (who also has a Princeton-conferred doctorate in chemistry), the authors show that 60 years of compulsory vaccine policies “have not attained herd immunity for any childhood disease.” It is time, they suggest, to cast aside coercion in favor of voluntary choice.

When it comes to the flu shot, I put more information and science as to why so many people seem to refuse it, in this article if interested.

The University of California is currently being sued for mandating the flu shot for all staff, faculty and students. A judge has prevented them from doing so as a result until a decision has been made. You can read more about that here.

In South Korea, 48 people have now died after receiving the flu shot this season causing a lot of controversy. You can read more about that here.

The Takeaway: There are many concerns with vaccines, and vaccine injury is one of them. The National Childhood Vaccine Injury Act has paid more than $4 billion to families of vaccine injured children. A 2010 HHS pilot study by the Federal Agency for Health Care Research (AHCR) found that 1 in every 39 vaccines causes injury, a shocking comparison to the claims from the CDC of 1 in every million.

Should these statistics alone warrant the freedom of choice? Should the government have the ability to force us into measures, or would it simply be better for them to present the science, make recommendations and urge people to follow them? When the citizenry is forced and coerced into certain actions, sometimes under the guise of good-will, there always seems to be a tremendous amount of uproar and people who disagree. Why are these people silenced? Why are they censored? Why are they ridiculed? Why don’t independent health organizations receive the same voice and reach that government and state “owned” or organizations do? What’s going on here? Do we really live in a free, open and transparent world or are we simply subjected to massive amounts of perception manipulation?

When it come to the flu shot there is plenty of information on both sides of the coin that point to its effectiveness, and on the other hand there is information that points to the complete opposite. When something is not 100 percent clear, freedom of choice in all places should always remain, in my opinion.

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Some South Korean Doctors & Politicians Call To Stop Flu Shots After 48 People Die

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In Brief

  • The Facts:

    The number of South Koreans who have died after getting flu shots has risen to 48, but health authorities in South Korea have found no link between the vaccine and the deaths.

  • Reflect On:

    Is the flu shot as safe as it's marketed to be?

What Happened: It’s that time of year and flu shot programs are rolling out across the globe. The number of South Koreans who have died after getting the flu shot has now risen to 48 and some South Korean doctors and politicians have called to stop flu shots as a result, according to Reuters. The Korea Disease Control and Prevention Agency (KDCA) has decided not to stop the program, and that flu vaccines would continue to be given and will reduce the chance of having simultaneous epidemics in the era of COVID-19.

Health authorities in South Korea have explained that they’ve found no direct link between these deaths and the shots. KDCA Director Jeong Eun-kyung said, “After reviewing death cases so far, it is not the time to suspend a flu vaccination programme since vaccination is very crucial this year, considering…the COVID-19 outbreaks.”

According to Reuters, “Some initial autopsy results from the police and the National Forensic Service showed that 13 people died of cardiovascular, cerebrovascular and other disorders not caused by the vaccination.”

The South Korean government is hopeful to vaccinate approximately 30 million of the country’s 54 million people.

Concerns Some People Have With The Flu Shot: One concern many people seem to have is the worry of a severe adverse reaction.

Dr. Alvin Moss, MD and professor at the West Virginia University School of Medicine emphasizes in this video:

The flu vaccine happens to be the vaccine that causes the most injury in this country. The vaccine injury compensation program, 40 percent of all vaccinations in this country are flu shots, but 60 percent of all the compensations are for the flu vaccine. So a disproportionate number of  vaccine related injuries are the flu shot.

Moss is one of many who believe that the flu vaccine is not as effective as it’s been marketed to be. For example,  A study recently published in Global Advances In Health & Medicine titled “Ascorbate as Prophylaxis and Therapy for COVID-19—Update From Shanghai and U.S. Medical Institutions outlines the following:

Recently outlined A recent consensus statement from a group of renowned infectious disease clinicians observed that vaccine programs have proven ill-suited to the fast-changing viruses underlying these illnesses, with efficacy ranging from 19% to 54% in the past few years.

Dr. Peter Doshi is an associate editor at The BMJ (British Medical Journal)  published a paper in The BMJ titled “Influenza: Marketing Vaccines By Marketing Disease.”  In it,  he points out that the CDC pledges “to base all public health decisions on the highest quality of scientific data, openly and objectively derived,” and how this isn’t the case when it comes to the flu vaccine and its marketing. He stresses that “the vaccine may be less beneficial and less safe than has been claimed, and that “the threat of influenza seems to be overstated.”

These are just a few examples out of many claiming that the flu shot has not really been effective, opposing others that claim it is.  Mercury that’s still present in some flu shots also seems to be a concern.

The National Childhood Vaccine Injury Act has paid more than $4 billion to families of vaccine injured children. A 2010 HHS pilot study by the Federal Agency for Health Care Research (AHCR) found that 1 in every 39 vaccines causes injury, a shocking comparison to the claims from the CDC of 1 in every million.

Professor Heidi Larson, a Professor of Anthropology and the Risk and Decision Scientist Director at the Vaccine Confidence Project stated at a World Health Organization (WHO) conference that more doctors are starting to be hesitant when it comes to recommending vaccines.

The other thing that’s a trend, and an issue, is not just confidence in providers but confidence of health care providers, we have a very wobbly health professional frontline that is starting to question vaccines and the safety of vaccines. That’s a huge problem, because to this day any study I’ve seen… still, the most trusted person on any study I’ve seen globally is the health care provider…

This is no secret, and actions against mandates are being taken. The University of California was recently sued for making the flu shot mandatory. That trial will begin soon, and you can read more about it here, and find information regarding the claim that the flu shot can help in the times of COVID-19.

The Takeaway: We are living in an age of extreme censorship of information, no matter how credible or how much evidence is provided, information that goes against the grain always seems to receive a harsh backlash from mainstream media as well as social media outlets. Why is there a digital fact checker patrolling the internet? Should people not have the right to examine information openly and freely and determine for themselves what is and what isn’t?

As far as vaccines are concerned, despite the fact that there are many safety issues the scientific community  is bringing up, a push for vaccine mandates continues and the idea that we are protecting other people is usually the narrative that’s pushed hard. Vaccine skepticism is growing at a fast pace among people of all professions, and people aren’t stupid. There’s a reason why more and more people are starting to question what we’ve been told for years, and those reasons should be acknowledged and openly discussed amongst people on both sides of the coin.

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University of California Sued For Making Flu Shot Mandatory: Latest Updates

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In Brief

  • The Facts:

    A hearing will take on November 4th as to whether or not the University of California will be allowed to mandate the flu vaccine for all staff, faculty and students. This comes after they were sued after announcing the mandate this past summer.

  • Reflect On:

    Why has vaccine hesitancy grown so much amongst scientists and doctors?

The University of California is one of many in the United States that have made the flu shot mandatory for all students, staff and faculty. Originally, Flu shots were required to be taken by November 1st of this year, according to UC, but Judge Richard Seabolt has halted their ability to do that until November 4th, when he will determine whether or not UC can or cannot mandate the flu vaccine.

Due to the growing amount of evidence that vaccines are not completely safe for everyone, let alone completely safe, attorney’s Rick Jaffe  Robert F. Kennedy Jr, renowned attorney and Chair of Children’s Health Defense are sued the University of California for mandating the flu shot. You can read a bit of their reasoning here.

According to Greg Glaser., general counsel at the Physicians For Informed Consent (PIC), “In this lawsuit against the UC Board of Regents over their new flu vaccine mandate, some of the world’s top experts have provided declarations opposing the flu shot mandate…Their declarations will have a s significant impact on decisions made regarding public health.”

Dr. Shira Miller, founder and president of PIC says “there’s data showing that the flu shot increases one’s chances of non-flu illness by 65% – meaning that not only does this mandate lack scientific justification, but it puts UC students, faculty and staff at a greater risk of other respiratory illnesses…The studies referenced in the UC Regents’ flu vaccine mandate suggest positive effects of the flu vaccine on the incidence of illness caused by flu viruses; however, that benefit may be outweighed by an increase in non-flu respiratory illnesses. And although the possibility has been studied, there is no evidence that the vaccine prevents the spread of influenza.”

UC will not take adverse action against any employee or student who comes to campus who has not had a flu shot. We will see what happens during the trial.

Jaffe states: The judge is obviously taking this motion very seriously, and that is a very good thing. He wanted more time to consider all the papers and write an opinion that will have enormous implications. Judge Seabolt gets to be the first judge in the country to weigh in on whether the state can mandate a vaccine during a pandemic where the vaccine doesn’t treat the pandemic disease and where there is reason to believe that the flu shot could actually increase COVID cases, hospitalizations and deaths. That’s alot to think about. It seems like he’s trying to get it right, and that is certainly extremely encouraging, since in my view, the more anyone reasonable thinks about it, the worse the mandate looks because of the lack of proper procedure in its issuance, and the lack of proof that the vaccine won’t cause much more harm than good. So I am all for the judge taking all the time he needs on this.

There are many concerns with vaccines, and vaccine injury is one of them. The National Childhood Vaccine Injury Act has paid more than $4 billion to families of vaccine injured children. A 2010 HHS pilot study by the Federal Agency for Health Care Research (AHCR) found that 1 in every 39 vaccines causes injury, a shocking comparison to the claims from the CDC of 1 in every million.

Professor Heidi Larson, a Professor of Anthropology and the Risk and Decision Scientist Director at the Vaccine Confidence Project stated at a World Health Organization (WHO) conference statesd that:

The other thing that’s a trend, and an issue, is not just confidence in providers but confidence of health care providers, we have a very wobbly health professional frontline that is starting to question vaccines and the safety of vaccines. That’s a huge problem, because to this day any study I’ve seen… still, the most trusted person on any study I’ve seen globally is the health care provider…

Some Science:

A study published in the journal Vaccine found a greater risk of contracting coronavirus among individuals in the study who received the influenza vaccine. These studies were conducted prior to COVID 19, and apply to already circulating coronaviruses prior to the novel coronavirus.

  • 2018 CDC study (Rikin et al 2018) found that flu shots increase the risk of non-flu acute respiratory illnesses (ARIs), including coronavirus, in children.
  • A 2011 Australian study (Kelly et al 2011) found that flu shots doubled the risk for non-flu viral lung infections.
  • 2012 Hong Kong study (Cowling et al 2012) found that flu shots increase the risk for non-flu respiratory infections by 4.4 times.
  • 2017 study (Mawson et al 2017) found vaccinated children were 5.9 times more likely to suffer pneumonia than their unvaccinated peers.

A study recently published in Global Advances In Health & Medicine titled “Ascorbate as Prophylaxis and Therapy for COVID-19—Update From Shanghai and U.S. Medical Institutions outlines the following:

“Recently outlined A recent consensus statement from a group of renowned infectious disease clinicians observed that vaccine programs have proven ill-suited to the fast-changing viruses underlying these illnesses, with efficacy ranging from 19% to 54% in the past few years.”

I’ve put more information and science about the flu shot that goes more in depth and provides more sources in an article I published last year: “Reasons Why People Refuse The Flu Shot”

The Takeaway: Why do federal health authorities and state health affiliated organizations and institutions have a right to mandate a vaccine. What about the opinions of independent health organizations? Why do their voices constantly go unacknowledged and in some cases, ridiculed?

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