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FDA Acknowledged That Vaccine Technology Outpacing Ability to Predict Adverse Events

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 Lyn Redwood, R.N., M.S.N., Executive Director, World Mercury Project

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Recently, top-tier autoimmunity researchers described vaccine safety science as a “hazardous occupation.” In their view, this is because uncompromising vaccine proponents are instantly ready to mount vociferous personal attacks on anyone who raises questions about any aspect of vaccine safety, even if the questions are buttressed by impeccable, high-quality science. Vaccine safety was not always such a taboo topic. In 1961, a leading polio researcher put forth the view in Science that “even after licensing, a new vaccine product must be considered to be on trial” because of the many “new variables” that accompany large-scale vaccine production and rollout.

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uncertainties about new vaccine technologies could easily result in a “black box” situation of unforeseen and unpredictable vaccine outcomes.

A leading Food and Drug Administration (FDA) official contended in 1999  that modern advances in vaccine technology were rapidly “outpacing researchers” ability to predict potential vaccine-related adverse events” and argued for closer attention to safety issues from the earliest stages of vaccine development. “One of the important things is that the technology used to make these vaccines actually exceeds the science and technology to understand how these vaccines work and to predict how they will work,” stated Dr. Peter Patriarca, MD, Director of the Viral Products Division of the FDA Center for Biological Evaluation and Research (CBER). “So this has the potential for ending up in a situation which I call a “black box” vaccine” referring to a situation of unforeseen and unpredictable vaccine outcomes.”

Dr. Patriarca also voiced concerns that with live attenuated vaccines “there is the potential for these vaccines, many of which have been poorly characterized to recombine with viruses that may be present in the vaccine.  Some of these viruses are latent and persist for a while, so it is very important to assure that these things are safe before they are given to people.”

In the two decades since the FDA official’s prescient words of warning, numerous published studies have highlighted vaccine safety concerns that were either unexplored or neglected prior to the introduction of the vaccines in question. Troubling issues have included the presence of adventitious agents and contaminants in vaccines and the rise of new allergies associated with synthetic vaccines. Studies also highlight major gaps in the methods, protocols and timelines used to assess vaccine safety.

First rotavirus vaccine debacle

The checkered history of rotavirus vaccines in the U.S. confirms the vital need for new vaccines to remain “on trial” after their launch in the general population. In 1998, the U.S. government licensed the first rotavirus vaccine, RotaShield, a tetravalent live-attenuated vaccine that used a genetically engineered rhesus monkey rotavirus along with three rhesus-human reassortant viruses. Other rhesus-based rotavirus vaccines previously had “failed to prove safe for administration in infants.” According to a detailed account of RotaShield in the Milbank Quarterly, the vaccine’s manufacturer, Wyeth, bragged about the vaccine as one of its “new, breakthrough therapies” and expressed the hope of establishing a large, profitable market in the U.S. as a prelude to marketing RotaShield in developing countries.

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…reports to the Vaccine Adverse Events Reporting System (VAERS) pointed to a substantially increased risk of bowel intussusception, a potentially fatal (though usually rare) condition involving intestinal enfolding and obstruction.

Despite the initial optimism, Wyeth had to commercially withdraw RotaShield one year later, when reports to the Vaccine Adverse Events Reporting System (VAERS) pointed to a substantially increased risk of bowel intussusception, a potentially fatal (though usually rare) condition involving intestinal enfolding and obstruction. For infants in their first year of life, intussusception risks increased 20 to 30 times within two weeks of receiving the first dose of RotaShield.

According to the Milbank Quarterly description, a 1997 pre-licensing regulatory review meeting led by the FDA’s Vaccines and Related Biological Products Advisory Committee had given Wyeth’s hired hand (a university professor) “a minute or two maximum” to discuss intussusception risks. There were “no follow-up questions…and no further discussion…during the remainder of the meeting,” despite the scientist’s expressed concern that “with larger numbers perhaps a causal relationship might emerge.” Nor did attendees consider intussusception at subsequent meetings of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), where, despite the professor sharing her intussusception data, vaccine cost-effectiveness was the focus of discussion. It was not until an estimated 500,000 children received at least one million doses of RotaShield that the FDA suspended the vaccine, at first temporarily and then permanently, without ever explaining the “precise mechanism” by which RotaShield caused intussusception. Ironically, the government subsequently trumpeted the RotaShield story as proof that “the systems established to detect and respond to vaccine safety concerns are effective.”

The second rotavirus vaccine debacle

Two new genetically engineered oral rotavirus vaccines entered the vaccine marketplace in 2006 and 2008, respectively: RotaTeq, a pentavalent (five-strain) bovine-human reassortant rotavirus vaccine made by Merck, and Rotarix, a live-attenuated single-human-strain rotavirus vaccine manufactured by GlaxoSmithKline (GSK). Although pre-licensure trials found no evidence of an association between the two vaccines and intussusception, post-licensure monitoring later indicated a statistically significant increased risk of intussusception events for all rotavirus vaccines. Unlike with RotaShield, FDA merely instructed Merck, in 2013, and GSK, in 2014, to update their labeling and prescribing information to include brief statements about increased intussusception risks but otherwise allowed the two vaccines to remain on the market.

…the researchers discovered that RotaTeq and Rotarix were contaminated with DNA from two porcine circoviruses—PCV1 (in Rotarix) and both PCV1 and PCV2 (in RotaTeq). Both GSK and Merck later confirmed these findings. The PCV2 pathogen is associated with severe wasting and immunodeficiency in pigs.

Meanwhile, the much-vaunted industry and governmental safety systems that ushered the two rotavirus vaccines to market failed to detect an additional and highly concerning problem, which an academic research team “unexpectedly” identified in 2010. While conducting “a novel, highly sensitive analysis not routinely used for adventitious agent screening,” the researchers discovered that RotaTeq and Rotarix were contaminated with DNA from two porcine circoviruses—PCV1 (in Rotarix) and both PCV1 and PCV2 (in RotaTeq). Both GSK and Merck later confirmed these findings. The PCV2 pathogen is associated with severe wasting and immunodeficiency in pigs.

Although the short- and long-term dangers from PCV1 and PCV2 are as yet unknown, the pioneers of genetic engineering foresaw horizontal gene transfer—the direct uptake and incorporation of genetic material from unrelated species—as a clear risk of genetically engineered vaccines. Unlike chemical pollutants, nucleic acids are infectious and can invade cells and genomes, multiplying, mutating and recombining indefinitely. Potential hazards of horizontal gene transfer include generation of new disease-causing viruses and bacteria (or reactivation of dormant viruses); spread of drug and antibiotic resistance genes among viral and bacterial pathogens; and random insertion into genomes of cells resulting in cancer.

If this contamination had been discovered prior to licensure of the rotavirus vaccines, FDA would not have licensed the vaccines—why should it be any different now?

At issue, in the example of RotaTeq and Rotarix, are the dangers of incorporation of adventitious PCV contaminants from live rotavirus vaccines into the human host or host-related bacteria (such as the gut flora)—dangers unrecognized and, therefore, unexplored before the two vaccines went to market. There is also additional cause for concern based on research demonstrating that the pathogenic potential of PCV2 to cause an AIDS-like disease in pigs is unleashed when there is simultaneous vaccine-induced immune system activation. In light of this research, the current recommendationto administer PCV2-contaminated rotavirus vaccine along with five other vaccines—hepatitis B (HepB), diphtheria-tetanus-acellular pertussis (DTaP), Haemophilus influenzaetype b (Hib), pneumococcal conjugate (PCV) and inactivated poliovirus (IPV)—represents a high-risk scenario for disease in humans. If the contamination had been discovered prior to licensure of the rotavirus vaccines, FDA would not have licensed the vaccines—why should it be any different now?

At a 2010 meeting convened by FDA to discuss the PCV contamination, a GSK executive went so far as to concede that “evolving technologies can lead to new findings that were not known at the time of licensure.” Nonetheless, the GSK researchers expressed little worry, having framed the presence of the PCV DNA in their vaccine as a simple “manufacturing quality issue” rather than a safety risk. GSK even put a positive spin on the matter, suggesting that the PCV investigation “could serve as a model for risk assessment in the event of new technologies identifying adventitious agents in the manufacturing of other vaccines.”

Are unforeseen outcomes inevitable?

Shortly after the GSK discovery, FDA recommended that physicians temporarily suspend use of Rotarix and switch to RotaTeq, but when Merck’s vaccine was found to contain similar contaminants, FDA reversed course and allowed continued use of both. Instead of calling for new safety studies and completing a new risk-benefit analysis (taking into consideration that mortality from rotavirus disease in the U.S. is very low), the FDA once again reassured the public that the benefits of rotavirus vaccination outweighed any “hypothetical” health risks of PCV contamination. The agency’s sole follow-up action was to rubber-stamp updates to the Merck and GSK package inserts to “reflect the presence of Porcine Circovirus Type-1 and -2 DNA in the vaccine[s].”

Can the assertion that the benefits outweigh the risks be taken at face value? Consider the history of the oral polio vaccine, which has used seed stocks contaminated with multiple strains of simian virus 40 (SV40) for over four decades. SV40 has been detected in the brains of deceased cancer patients who received the oral polio vaccine, and a 2002 Institute of Medicine report cited strong biological evidence that SV40 can transform normal cells into malignant cells. Whether the porcine circovirus contamination that afflicts the two current—and highly engineered—rotavirus vaccines will turn out to have insidious long-term health effects remains an unanswered question. Nonetheless, history indicates that we should not be surprised when novel and difficult-to-control vaccine technologies generate unforeseen outcomes.

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Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

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Study: Weekly Use of Disinfectants Greatly Increases Your Risk of Fatal Lung Disease

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In Brief

  • The Facts:

    A 30-year study conducted by Harvard researchers and the French National Institute of Health and Medical Research found that people who use disinfectants once a week have a 22-32% increased chance of developing lung disease.

  • Reflect On:

    How reliable are regulatory agencies when it comes determining how safe the products we use for cleaning are for our health and environment? Did you know that there are a number of effective alternatives and products available out there?

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What Happened: A 30-year study conducted by researchers at Harvard University alongside researchers at the French National Institute of Health and Medical Research (Inserm) found that regular use of bleach and other commonly used disinfectants can increase your chances of developing fatal lung disease. The study found that those who used these types of products just once a week had up to a 32% increased chance of developing the condition.

It’s called chronic obstructive pulmonary disease (COPD). Researchers looked at the incidence of the disease for the study in more than 55,000 nurses in the United States. Nurses were used for the study because they use disinfectants to clean surfaces on a regular basis. In this study population, 37 percent of nurses used disinfectants to clean surfaces on a weekly basis and 19 percent used them to clean medical instruments on a weekly basis.

In the UK alone, COPD is present approximately 1.2 million people. It includes various lung conditions like chronic bronchitis and emphysema. Obviously there are multiple factors that play a role, but according to this study, disinfectants are definitely one of them or at the very least, can’t be ruled out. Correlation may not mean causation but it’s safe to assume that breathing in these substances is not really safe, in my opinion, and can be detrimental to our health.

As far as deaths go, 25,000 people a year die from COPD in England. This number represents the third highest death rate from the disease. This study is thought to be the very first to identify such a link between COPD and specific cleaning products/chemicals known as “quaternary ammonium compounds (quats).”

To the best of our knowledge we are the first to report a link between disinfectants and COPD among healthcare workers, and to investigate specific chemicals that may underlie this association…Some of these disinfectants, such as bleach and quats, are frequently used in ordinary households, and the potential impact of domestic use of disinfectants on COPD development is unknown…Earlier studies have found a link between asthma and exposure to cleaning products and disinfectants at home, such as bleach and sprays, so it is important to investigate this further.- Inserm researcher Orianne Dumas (source)

The researchers analysed data from a mass study on female US nurses commenced by Harvard in 1989. In 2009, they looked at those who were still working as nurses who had no history of COPD and tracked them until May this year. During that period, 663 were diagnosed with the condition.

A follow up study published in 2019 examining more than 70,000 nurses came to the same conclusions.

We found that use of several specific disinfectants was associated with higher risk of COPD development; these included hypochlorite bleach (chlorine), hydrogen peroxide, alcohol, and quaternary ammonium compounds (commonly used for low-level disinfection of noncritical items, such as environmental surfaces) and glutaraldehyde (used for high-level disinfection). Several of these exposures often occurred concurrently, and disentangling the role of each product was challenging. When studying combinations of exposure to specific disinfectants, we found the highest risks of COPD incidence among nurses exposed to hypochlorite bleach or hydrogen peroxide and in those combining these exposures with exposure to aldehydes. Both the chemical properties of specific products and the greater number of products used could explain these elevated risks. Moreover, all of the agents that were associated with COPD incidence when evaluated separately have been described as airway irritants.

Why This Is Important: 

The everyday use of bleach currently has no specific health guidelines, and that’s very true with many other products as well. Cosmetics is a great example, that particular industry is not quite regulated as it should be, and products that do pass through federal health regulatory regulation and inspection are not always safe. Glyphosate is a great example, and there is a growing concern today among academics, journalists and everyday people regarding the close relationship between these regulatory agencies and the companies that manufacture these products. Sure they may work, but the case with many of these products is that there are alternatives that are just as effective and much more safer.

Whether it’s banking soda and vinegar, tea tree oil and lemons, or something else, the market and natural health stores are now filled with cleaning products that do not pose the same threat as mainstream conventional cleaning products. They’re not hard to find, all it takes is a simple internet search, or a trip to your local natural health food store. Many regular chains are also starting to carry more health and environmentally sound cleaning/disinfectant products as well. If you’re truly concerned and put effort into searching, you’ll have no problem finding these products.

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

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Health

How Effective is The Covid-19 Vaccine?

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In Brief

  • The Facts:

    The 95% efficacy of the Pfizer vaccine is widely touted by the media and the medical establishment, but there are important questions to be asked about this claim.

  • Reflect On:

    Are we being given all information available from covid vaccine study to make informed decisions? Are the studies even being done in a way that represents what effects the vaccine may have on the whole population?

Are you going to decline the Covid-19 vaccine if it is offered to you? Why or why not? No matter how certain you are in your reasoning there will no doubt be someone else who feels exactly the opposite to you and will be just as certain of their position. We trust different sources of information, we have had different experiences with vaccines and we have different impressions of the threat of SARS-COV2 to us and our species.

I would suggest that those in the “vaccine cautionary” community would decline the vaccine based on their ideas around its potential risks. On the other hand, supporters of the vaccine are more likely to focus on its potential benefits. The debate has largely been centered around the disagreement people have about the risks. In this essay I will consider the uncertainty I and others have about its benefits.

Is the Medical Community biased about the Vaccine?

As a contributor to Collective Evolution I am well aware of the “cautionary” perspective on vaccinations and CDC directives. As a physician, I have a reasonable understanding of how those in the medical community regard the “best of what modern science has to offer”. I am part of a Physician group on social media where doctors can seek advice from each other around all matters Covid-19, from interesting cases to rare side effects to how to address special concerns raised by patients. It has been alarming to realize how unilateral the support of vaccination is in this community. 

I mean no disrespect to my medical colleagues. Many of those in this community have seen their patients die from this very real virus. They have had to struggle with the divergent directives coming from the CDC. They have had to work through many weeks where Personal Protective Equipment (PPE) was in short supply as their hospital wards rapidly reached capacity and overflowed. Now that the Pfizer and Moderna vaccines have met minimum requirements for efficacy under the Emergency Use Authorization (EUA), they are faced with yet another impediment to getting themselves and their patients through this pandemic: growing skepticism around the vaccine coming from the very same people they are endeavoring to help. Their frustration around the situation is understandable, but is it biasing them?

Before consenting to any intervention it is important to understand its relative risks and benefits. As I mentioned earlier, there has been much concern in the “vaccine cautionary” sphere about side-effects and deaths. Here I will take a closer look at what we know about the benefits of the vaccine based on Pfizer-Biontech’s  briefing document to the FDA’s Vaccines and Related Biological Products Advisory Committee. How confident can we be in the efficacy of the vaccine? Has the manufacturer done its due diligence in its analysis and in being transparent? These are the central questions that need to be answered.

Understanding False Positives and Negatives

There has been a lot of discussion about the rate of “false-positives” with regard to the Polymerase Chain Reaction (PCR) test for confirming infection with SARS-COV2. The PCR test can return a positive result even if only trace fragments of the virus are present. Fragments of the virus on a nasal swab is not necessarily representative of an active infection or transmissibility. Moreover the sensitivity of this test is dependent on the number of amplification cycles, or the cycle threshold (Ct), used.  The Ct is not standardized. It is not unreasonable to say that there will be a percentage of people who test positive that do not have the disease. Nevertheless, without a better test we as the public must treat all positive PCR tests as an indication of an infection. We must assume the test is right. The rate of false positives, whatever it is, is directly proportional to the overestimation of the prevalence of the disease. 

Here I would like to discuss the significance of “false-negatives”. These are people who get a negative PCR result but may still be infected. The rate of false negatives is directly proportional to the underestimation of disease prevalence. This aspect of the inaccuracy of our primary diagnostic test gets relatively little attention for practical reasons. If you are suffering symptoms consistent with Covid-19 but have a negative PCR test we assume that you have Covid-19 anyway. In other words, if someone is symptomatic we assume that the test is wrong, i.e. that it is a false-negative, and necessary measures are taken. We quarantine and isolate until we feel healthy again whether we have Covid-19 or not. 

Because we are in the midst of a pandemic we have no choice but to make these assumptions. We are responding appropriately given the limitations of the test. Because of the assumptions we are forced to make, we are exaggerating the prevalence of the disease and our response to it to some extent. It is the nature of the situation we are in.

How do we know that the Vaccine is 95% effective?

With this in mind I would like to discuss a post in the opinion blog of the British Medical Journal (BMJ) that appeared earlier this month. The author, Peter Doshi (PhD and Associate Editor at the BMJ), takes a rigorous look at the results reported by Pfizer regarding the efficacy of their mRNA vaccine. The success of their vaccine has been widely publicized to be 95%. Where exactly does this figure come from?

During the four weeks of observation (three weeks between 1st and 2nd dose followed by 7 days), 162 participants who received the placebo expressed symptoms of Covid-19 and tested positive by PCR. Compare that with only 8 in the group that received their experimental vaccine. The chance of getting Covid 19 after receiving the vaccine was about 20 times lower than if you got the placebo. This is the basis of the claim that their vaccine was 95% effective, well over the 50% threshold required for Emergency Use Authorization that allows their product to be deployed despite the fact that the two-year Phase III trial is still 20 months from completion.

How did Pfizer handle study participants in the “Suspected Covid-19” group?

It is less commonly known that of the nearly 38,000 participants in the Pfizer study, 3,410 fell into a group labeled “suspected Covid-19”. These are people who developed symptoms consistent with disease but tested negative by PCR. 1,594 of those in this group received the vaccine and 1,816 received the placebo. It should be quite clear that how we regard this much bigger group of symptomatic participants will have an enormous impact on the true efficacy of the vaccine. In other words, if we assume that the PCR test was accurate in all of these people and that they didn’t have Covid-19 and developed symptoms from another virus, the flu for example, then the vaccine would in fact be 95% effective as reported. On the other hand, if the PCR test was wrong every time and they all in fact had Covid-19, the efficacy of the vaccine would be much different: 1602 (1594 + 8) in the vaccine wing vs. 1978 (1816 + 162) in the placebo wing results in a vaccine efficacy of only 19%. 

The PCR test (like any test) can be wrong some of the time and right some of the time. No test is 100% accurate, however in this situation the accuracy of the PCR test has a very large impact on how we interpret the results of the vaccine trial. The true efficacy of the Pfizer vaccine can be known only if we know how many symptomatic people in each wing had Covid-19 despite testing negative by PCR.

It is likely that the percentage of false negatives are different in each arm. As the FDA briefing document on the Pfizer study and the BMJ piece correctly note, there should be fewer false negatives in the vaccine group. Why? It is because there is a greater chance of developing Covid-19 symptoms after receiving the vaccine compared to getting a placebo. Reactogenicity, or the acute response of the body to the vaccine, is common. Most of the acute inflammatory reaction to the vaccine occurs in the first seven days after receiving the vaccine. Looking more closely at the data, 409 patients in the vaccine group developed symptoms in the first seven days after inoculation. Compare this to 287 in the placebo group. If we assume that any participant who expressed symptoms in the first seven days must be suffering from the side effects of the vaccine or the placebo and not a new Covid-19 infection, the efficacy of the vaccine would still only be 29% if everyone else in that group was a false negative. This is admittedly a very large assumption but it is not outside the realm of possibility.

There are other more extreme possibilities. If all of the vaccinated participants who were suspected of Covid-19 truly did not have the disease and all of the unvaccinated (placebo) participants who were suspect did have the disease we would have a true miracle vaccine. Why? It would mean that only 8 people got the disease in the vaccinated group compared to 1978 in the placebo group. This would mean that the vaccine was approximately 99.6% effective. On the other hand, if all those who got vaccinated in the suspected group got Covid-19 and those who got the placebo didn’t, the vaccine would be not just ineffective, it would be dangerous.

Putting aside extreme and unlikely possibilities, the matter of the 3,412 “suspected Covid-19” participants and our assumptions about them still has very large implications. Let us say hypothetically that we as a nation decide to vaccinate our entire population with the Pfizer vaccine assuming that it has a 95% efficacy in preventing the disease. In other words, we are assuming that none of those “suspected” of having Covid-19 actually have the disease. This is in fact the assumption that the FDA is making when approving the use of the vaccine under the EUA. We can predict that within a month about 6.3% people will develop Covid-like symptoms from something other than vaccine reactogenicity or the disease itself. This is based on the number of participants who became symptomatic (from something other than reactogenicity) despite getting the vaccine and testing negative (1,185) divided by the total number who got the vaccine (18,801) = 0.063. That’s what happened in the study.

In a population of 300 million, we would expect roughly 19 million people to develop symptoms of Covid from something other than SARS-COV2 within a month. We can agree that we must be extremely confident about whether these 19 million people have the disease or not. Why would we assume they all don’t have Covid-19 when the vaccine trial itself considered them to be “suspected” of having it? We won’t. We shouldn’t, and practically speaking, we will be in the same situation we are in right now.

Pfizer either did not do or report additional testing that would have helped

The real issue here is that we shouldn’t be guessing about such important numbers. What do you suppose Pfizer did, knowing that this larger pool of symptomatic participants could have an enormous impact on the estimation of their vaccine’s efficacy? In my opinion, they should have tested everyone who developed symptoms for antibodies to help quantify the percentage of false negative PCR tests. If a participant felt like they were coming down with Covid-19 but had a negative PCR test, it seems clear that performing an antibody test would have offered additional clarity. This was either not done or not reported.

We must be careful when interpreting the power of a vaccine study. Although tens of thousands of people were enrolled, the only meaningful numbers with regard to efficacy have to do with those who contracted the disease during the period of observation. This is the only way to assess the efficacy of the vaccine. When Pfizer only considers participants that became symptomatic and tested positive we only have a group of 170 cases to cross compare.

The 3,410 people who became symptomatic but tested negative during the four weeks of observation would represent a much larger set of cohorts and would amplify the power of the study 20 fold if infection could be confirmed or ruled out through additional testing. In other words, the 3,410 symptomatic people should be the ones that Pfizer were hoping would emerge when they enrolled 37,000+ individuals in their study. I find this lapse in diligence suspicious and at the very least inexplicable, especially in light of the latitude they are granted under the EUA. The fact of the matter is that we do not know if this was done. Pfizer, per their own protocol, will not make this data available until the trial is completed 20 months from now. 

Why didn’t Pfizer look harder?

This forces us to ask some sobering questions. If Pfizer is required (or has agreed) to make all data available in two years, would they have conducted antibody tests on the “suspected Covid” group? If those results told a different story it would be quite damning, if not now, eventually. Their product would not be permitted for use under the EUA if a 50% efficacy requirement could not be met. On the other hand, if antibody tests were conducted and the results confirmed the impressive efficacy of the vaccine, why wouldn’t they have made the data available right now?

It should be clear that if Pfizer’s primary goal was to obtain approval under the EUA they would have had little incentive to do further testing to confirm their product’s efficacy. Why would they take the risk of seeking more information on 3,400 participants that could potentially overturn their results that were based on only 170 outcomes? This is where we must be very careful in our assessment of the situation. If you believe Pfizer and vaccine manufacturers are only out for profit, it would be easy to conclude that they are being manipulative. If you believe that these corporations are seeking to improve public health and safety you may grant them a lot of latitude here. To be truly objective we must ask if they have been scientific in their approach.

At the very least I feel that they have not been diligent, and their position hints at disingenuousness: Pfizer didn’t mention this group of participants in their 92 page report or in their publication in the New England Journal of Medicine. This group was only mentioned in two paragraphs of a 53 page briefing to the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA submitted December 10, 2020. The FDA, an agency of the department of Health and Human Services that ostensibly serves to protect the public by ensuring the safety of drugs, biological products and medical devices, continues to remain silent around this issue.

The Take Away

The 95% efficacy of the Pfizer vaccine is widely touted by the media and the medical establishment. Why didn’t Pfizer test or report the testing of an enormously important group of participants in their trial? We can predict that without these additional tests deploying the vaccine will not change our behavior nor our attitude to this pandemic.

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

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Alternative News

Norway Investigates 29 Deaths in Elderly Patients After Pfizer Covid-19 Vaccination

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In Brief

  • The Facts:

    Norway has registered a total of 29 deaths among people over the age of 75 who’ve had their first Covid-19 vaccination shot, raising questions over which groups to target in national inoculation programs.

  • Reflect On:

    Should freedom of choice always remain here? Should governments and private institutions not be allowed to mandate this vaccine in order to have access to certain rights and freedoms?

What Happened: 29 patients who were quite old and frail have died following their first dose of the Pfizer COVID-19 vaccination. As a result, Norwegian officials have since adjusted their advice on who should get the COVID-19 vaccine.

This doesn’t come as a surprise to many given the fact that the clinical trials were conducted with people who are healthy. Older and sick people with co-morbidities were not used in the trials, and people with severe allergies and other diseases that can make one more susceptible to vaccine injury were not used either. It can be confusing given the fact that vaccination is being encouraged for the elderly in nursing homes and those who are more vulnerable to COVID-19.

Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), told the British Medical Journal (BMJ) that “There is no certain connection between these deaths and the vaccine.”

On the 15th of January it was 23 deaths, Bloomberg is now reporting that a total of 29 deaths among people over the age of 75 who’ve had their first COVID-19 shot. They point out that “Until Friday, Pfizer/BioNTech was the only vaccine available in Norway”, stating that the Norwegian Medicines Agency told them that as a result “all deaths are thus linked to this vaccine.”

“There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed,” the agency said. All the reported deaths related to “elderly people with serious basic disorders,” it said. “Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition.”

Madsen also told the BMJ that,

There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly. We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease. We are not asking for doctors to continue with vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it. This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.

The BMJ article goes on to point out that the Paul Ehrlich Institute in Germany is also investigating 10 deaths shortly after COVID-19 vaccination, and closes with the following information:

In a statement, Pfizer said, “Pfizer and BioNTech are aware of reported deaths following administration of BNT162b2. We are working with NOMA to gather all the relevant information.

“Norwegian authorities have prioritised the immunisation of residents in nursing homes, most of whom are very elderly with underlying medical conditions and some of whom are terminally ill. NOMA confirm the number of incidents so far is not alarming, and in line with expectations. All reported deaths will be thoroughly evaluated by NOMA to determine if these incidents are related to the vaccine. The Norwegian government will also consider adjusting their vaccination instructions to take the patients’ health into more consideration.

“Our immediate thoughts are with the bereaved families.”

Vaccine Hesitancy is Growing Among Healthcare Workers: Vaccine hesitancy is growing all over the globe, one of the latest examples comes from Riverside County, California. It has a population of approximately 2.4 million, and about 50 percent of healthcare workers in the county are refusing to take the COVID-19 vaccine despite the fact that they have top priority and access to it.  At Providence Holy Cross Medical Center in Mission Hills, one in five frontline nurses and doctors have declined the shot. Roughly 20% to 40% of L.A. County’s frontline workers who were offered the vaccine did the same, according to county public health officials. You can read more about that story here.

Vaccine hesitancy among physicians and academics is nothing new. To illustrate this I often point to a conference held at the end of 2019 put on by the World Health Organization (WHO). At the conference, Dr. Heidi Larson a Professor of Anthropology and the Risk and Decision Scientist Director at the Vaccine Confidence Project Emphasized this point, having  stated,

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.

A study published in the journal EbioMedicine  as far back as 2013 outlines this point, among many others.

Pfizer’s Questionable History:  Losing faith in “big pharma” does not come without good reason. For example, in 2010 Robert G. Evans, PhD, Centre for Health Services and Policy Research Emeritus Professor, Vancouver School of Economics, UBC, published a paper that’s accessible in PubMed titled “Tough on Crime? Pfizer and the CIHR.”

In it, he outlines the fact that,

Pfizer has been a “habitual offender,” persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results. Since 2002 the company and its subsidiaries have been assessed $3 billion in criminal convictions, civil penalties and jury awards. The 2.3-billion settlement…set a new record for both criminal fines and total penalties. A link with Pfizer might well advance the commercialization of Canadian research.

Suppressing clinical trial results is something I’ve come across multiple times with several different medicines. Five years ago I wrote about how big pharma did not share adverse reactions people had and harmful results from their clinical trials for commonly used antidepressant drugs.

Even scientists from within federal these health regulatory agencies have been sounding the alarm. For example, a few years ago more than a dozen scientists from within the CDC put out an anonymous public statement detailing the influence corporations have on government policies. They were referred to as the  Spider Papers.

The Takeaway: Given the fact that everything is not black and white, especially when it comes to vaccine safety, do we really want to give government health agencies and/or private institutions the right to enforce mandatory vaccination requirements when their efficacy have been called into question? Should people have the freedom of choice? It’s a subject that has many people polarized in their beliefs, but at the end of the day the sharing of information, opinion and evidence should not be shut down, discouraged, ridiculed or censored.

In a day and age where more people are starting to see our planet in a completely different light, one which has more and more questioning the human experience and why we live the way we do it seems the ‘crack down’ on free thought gets tighter and tighter. Do we really want to live in a world where we lose the right to choose what we do with our own body, or one where certain rights and freedoms are taken away if we don’t comply? The next question is, what do we do about it? Those who are in a position to enforce these measures must, it seems, have a shift in consciousness and refuse to implement them. There doesn’t seem to be a clear cut answer, but there is no doubt that we are currently going through that possible process, we are living in it.

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

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