COVID jab safety studies completely undermined by plans to remove control group
Apparently, concern about risk to the individual only matters when vaccine makers have everything to gain. By eliminating control groups, we'll have no way of really proving the harm that these 'vaccines' might impart over time, as all participants will be in the same proverbial boat.
COVID-19 “vaccines,” as the shots do not make you immune; you can still get infected, and they do not prevent you from spreading the virus if you’re infected
By Dr. Joseph Mercola
Makers of COVID-19 vaccines are now destroying long-term safety studies by unblinding their trials and giving the control groups the active vaccine, claiming it is “unethical” to withhold an effective vaccine
In so doing, they make it virtually impossible to assess any long-term safety and effectiveness, and the true benefit versus cost
It’s ironic, because vaccine mandates are being justified on the premise that the benefit to the community is more important than an individual’s risk of harm. Yet vaccine manufacturers are saying that participants in the control groups are harmed by not getting the vaccine, and saving the individual is more important than securing the data needed to make public health decisions
Getting the active vaccine comes with risk, not merely benefit. This is particularly true for the novel mRNA technology used in COVID-19 vaccines
As of April 1, 2021, VAERS had received 56,869 adverse events following COVID-19 vaccination, including 7,971 serious injuries and 2,342 deaths. Of those deaths, 28% occurred within 48 hours of vaccination. The youngest person to die was 18 years old
April 20, 2021 (LifeSiteNews) – While reports of side effects from COVID-19 gene therapies, including life-threatening effects and deaths, continue to climb at breakneck speed, (1) a one-sided narrative of safety and effectiveness permeates mainstream media and medical news. These “vaccines” are so safe and so effective, according to this narrative, that keeping control groups intact for long-term study and comparison of outcomes is now being derided as "unethical," despite the fact that there is absolutely no non-fraudulent data to support their perverse assertions. Truly, what we’re watching is the active destruction of basic medical science in a surreal dystopian nightmare. Vaccine makers to ditch control groups Consider this report in JAMA by Rita Rubin, senior writer for JAMA medical news and perspectives, for example. (2) According to Rubin, the launch of “two highly efficacious” COVID-19 vaccines has “spurred debate about the ethics, let alone the feasibility, of continuing or launching blinded, placebo-controlled trials …” Rubin recounts how Moderna representatives told a Food and Drug Administration advisory panel that rather than letting thousands of vaccine doses to go to waste, they planned to offer them to trial participants who had received placebo. SUBSCRIBE to LifeSite's daily headlines SUBSCRIBE U.S. Canada World Catholic Pfizer representatives made a similar announcement to the advisory panel. According to a news analysis published in The BMJ, (3) the FDA and U.S. Centers for Disease Control and Prevention are both onboard with this plan, as is the World Health Organization. (4) In the JAMA report by Rubin, Moncref Slaoui, Ph.D., chief scientific adviser for Operation Warp Speed, is quoted saying he thinks “it’s very important that we unblind the trial at once and offer the placebo group vaccines” because trial participants “should be rewarded” for their participation. All of these statements violate the very basics of what a safety trial needs, which is a control group against which you can compare the effects of the drug or vaccine in question over the long term. I find it inconceivable that unblinding is even a consideration at this point, seeing how the core studies have not even concluded yet. The only purpose of this unblinding is to conceal the fraud that these vaccines are safe. None of the COVID-19 vaccines currently on the market are actually licensed. They only have emergency use authorization — which, incidentally, also forbids them from being mandated, although this is being widely and conveniently ignored — as trials are still ongoing. At the earliest, they may be licensed two years from now, at the completion of the follow-up studies. (5) This is why those in the military are allowed to refuse it, and refuse they have. Among Marines, the refusal rate is nearly 40%. (6) So, before the initial studies are even completed, vaccine makers and regulatory agencies are now deciding to forgo long-term safety evaluations altogether by giving placebo recipients the real McCoy, and so-called bioethicists are actually supporting this madness. As reported in The BMJ: “Although the FDA has granted the vaccines emergency use authorization, to get full license approval two years of follow-up data are needed. The data are now likely to be scanty and less reliable given that the trials are effectively being unblinded.” (7) Hypocrisy abounds It’s ironic in the extreme, because vaccine mandates are being justified on the premise that the benefit to the community supersedes the risk of individual harm. In other words, it’s OK if some people are harmed by the vaccine because the overall benefit to society is more important. Yet here they’re saying that participants in the control groups are being harmed by not getting the vaccine, so therefore vaccine makers have an obligation to give it to them before the long-term studies are completed. This is the complete opposite argument used for mandatory vaccination. If we are to accept the “greater good” justification for vaccination, then people who agree to participate in a study, and end up getting a placebo, need to roll the dice and potentially sacrifice their health “for the greater good.” Here, the greater good is the study itself, the results of which are of crucial importance for public health decisions. Without this data, we will never know whether the vaccines work in the long term and/or what their side effects are. If an individual in the control group gets COVID-19, then that’s the price of scientific participation for the greater good of society, just as when a vaccinated person gets harmed, that’s considered an acceptable price for creating vaccine-induced herd immunity. Put another way, when it comes to mandating vaccines, harm to the individual is acceptable, but when it comes to doing proper safety studies, all of a sudden, harm to the individual is not acceptable, and protecting the controls is more important than protecting the integrity of the research. The fact that they’re this inconsistent in their “ethics” could be viewed as proof positive that public health isn’t even a remote concern. Scientific ethics are eroding Apparently, concern about risk to the individual only matters when vaccine makers have everything to gain. By eliminating control groups, we’ll have no way of really proving the harm that these “vaccines” might impart over time, as all participants will be in the same proverbial boat. I remain confident that we’ll continue to see many more health problems and deaths develop in time, but without control groups, these trends can more easily be written off as “normal” and/or blamed on something else. As noted by Dr. Steven Goodman, associate dean of clinical and translational research at Stanford University, who is quoted in Rubin’s JAMA article: “By unblinding trial participants, ‘you lose a valid comparison group,' Goodman said. 'There will be this sense, and it will be sort of true, that the study is over.' Unlike, say, a highly effective cancer drug, 'the vaccine is not literally a life-and-death issue today and tomorrow' for most trial participants, Goodman said. So, he noted, those running COVID-19 vaccine trials shouldn't feel obligated to unblind participants and vaccinate placebo recipients right away. Doing so implies 'you can just blow up the trial' on the basis of promising preliminary results, establishing 'an ethical model for future trials that we maybe don't want to set,' Goodman said.” (8) Indeed, this strategy will set a dangerous precedent that will probably lead to vaccine and drug studies being conducted without control groups in the future, which could spell the end of medical science as we know it. At bare minimum, future variations of the current COVID-19 vaccine trials are likely to be conducted without control groups. Trial participants told not to unblind themselves Goodman is also quoted in another article, (9) this one in MedPage Today, discussing the problems with trial participants unblinding themselves by taking an antibody test: “ ‘There is no good scientific reason for someone to do this,' he told MedPage Today. 'I can understand why they want that information, but it can only serve to diminish the value of the trial. Getting tested is not right unless there is a pressing need for unblinding for health reasons’.” Here, yet another hypocritical irony arises, as the reason they don’t want trial participants to unblind themselves is because if they know they got the vaccine, they’re statistically more likely to take more risks that might expose them to the virus.
This, then, will skew the results and “could make the vaccine look less effective than it is,” Dr. Elizabeth McNally of Northwestern University explained to MedPage Today. (10) So, whether vaccine scientists agree with unblinding or not, unblinding really only has to do with whether it will skew results in their favor.
Trial participants unblinding themselves might make the vaccine appear less effective if they alter their behavior as a consequence, whereas vaccine makers unblinding the entire control group will allow them to hide side effects, even if participants alter their behavior.
Justification for elimination of controls is flimsy at best
While pro-vaccine advocates insist the elimination of control groups is justified on the “moral grounds” that it’s unethical to not provide volunteers with something of value, this argument completely ignores the undeniable fact that no vaccine is 100% safe.
As of April 1, 2021, VAERS had received 56,869 adverse events following COVID-19 vaccination, including 7,971 serious injuries and 2,342 deaths. Of those deaths, 28% occurred within 48 hours of vaccination.
Getting the active vaccine comes with risk, not merely benefit. This is particularly true for the novel mRNA technology used in COVID-19 vaccines. Historical data are troubling to say the least, and the U.S. Vaccine Adverse Event Reporting System (VAERS) is rapidly filling up with COVID-19 vaccine-related injury reports and deaths.
Reports of side effects and deaths are piling up
As reported by The Defender, (11) as of April 1, 2021, VAERS had received 56,869 adverse events following COVID-19 vaccination, including 7,971 serious injuries and 2,342 deaths. Of those deaths, 28% occurred within 48 hours of vaccination! The youngest person to die was 18 years old. There were also 110 reports of miscarriage or premature birth among pregnant women.
As reported in “COVID-19 Vaccine To Be Tested on 6-Year-Olds,” between January 2020 and January 2021, COVID-19 vaccines accounted for 70% of the annual vaccine deaths, even though these vaccines had only been available for less than two months!
In my view, it’s unconscionable and morally reprehensible to not take these data into account. Clearly, these “vaccines” have risks. Pretending like they don't, and that all placebo recipients in vaccine trials are at a distinct disadvantage simply isn't true.
If only 10% are reported, we may be looking at 23,420 deaths, but if it is as low as 1%, it jumps to more than 230,000 deaths. We will never know because there are major attempts to suppress this information, as we have already witnessed with the deaths of sport celebrities Hank Aaron and Marvin Hagler, both of whom died shortly after COVID vaccinations.
Regardless, it’s hard to justify even a single death of an otherwise healthy individual, seeing how the survival rate for COVID-19 across all age groups is 99.74%. If you’re younger than 40, your survival rate is 99.99%. (14)
There's every reason to suspect that these reports account for just a small percentage of actual side effects. Just think of all those who get the vaccine at grocery stores or temporary vaccination sites, for example. First of all, are all Americans even aware that VAERS exists and that they need to file a report if they suffer an adverse reaction post-COVID vaccination?
Who is going to file the adverse report if you get vaccinated in a grocery or convenience store? Will they return to the pharmacist and report their side effects? Will the pharmacist file the report? Who’s responsible for filing the report if you go to a temporary vaccination site?
CDC stays mum on how it’s ensuring reporting compliance
According to the CDC, deaths from COVID-19 vaccines are required to be reported to VAERS. (15) It's not supposed to be voluntary, as with other vaccines. However, it is not being transparent about how it is ensuring this “requirement” is being followed, so it’s impossible to confirm that all related deaths are in fact being reported. As reported by The Defender: (16)
"We … inquired about whether healthcare providers are reporting all injuries and deaths that might be connected to the COVID vaccine, and what education initiatives are in place to encourage and facilitate proper and accurate reporting.
Twenty-two days later a representative from the CDC's Vaccine Task Force responded by saying the agency had never received our questions — even though the employees we talked to several times said their press officers were working through the questions we sent. We provided the questions again and requested a response by April 7. To date, the CDC has not responded despite our repeated follow-up attempts.”
Absolute versus relative risk reduction
Vaccine makers are also very careful about only referencing relative risk, not absolute risk. By doing so, the vaccines appear far more protective than they actually are. It's a commonly used statistical trick that I encourage you to familiarize yourself with. For example, in his November 26, 2020, BMJ article, (17) Peter Doshi, associate editor of The BMJ, pointed out that while Pfizer claims its vaccine is 95% effective, this is the relative risk reduction. The absolute risk reduction — which is far more relevant for public health measures — is actually less than 1%! I recommend listening to the interview with Dr. Ron Brown above, in which he explains the ins and outs of relative and absolute risks, and the differences between them. He’s also written two papers detailing the problems with this kind of reporting bias: “Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials” (18) and “Public Health Lessons Learned From Biases in Coronavirus Mortality Overestimation.” (19) You likely don’t need a vaccine If you're concerned about vaccine side effects, please understand there are several prevention strategies and treatments readily available that have been shown to be highly effective, which means the need for a vaccine in the first place is nearly moot. For example, nebulized hydrogen peroxide with iodine, which I've written about in previous articles, works very well. For a refresher, see “How Nebulized Peroxide Helps Against Respiratory Infections.”Other treatments include hydroxychloroquine with zinc, ivermectin and the iMASK and MATH+ protocols, which you can learn more about in the linked articles. What to do if you got the vaccine and are having problems In closing, if you got the vaccine and now regret it, you may be able to address your symptoms using the same strategies you'd use to treat actual SARS-CoV-2 infection. I’ve written many articles over the past year detailing simple strategies to improve your immune system, and with a healthy immune system, you'll get through COVID-19 without incident. Below, I'll summarize some of the strategies you can use both to prevent COVID-19 and address any side effects you may encounter from the vaccine. • Eat a “clean,” ideally organic diet. Avoid processed foods of all kinds, especially vegetable oils, as they are loaded with damaging omega-6 linoleic acid that wrecks your mitochondrial function. Linoleic acid has been shown to increase mortality from COVID-19. • Consider nutritional ketosis and a time-restricted eating window of six to eight hours with no food at least three hours before bed. These strategies will help you optimize your metabolic machinery and mitochondrial function. • Implement a detoxification program to get rid of heavy metals and glyphosate. This is important as these toxins contribute to inflammation. To improve detoxification, I recommend activating your natural glutathione production with molecular hydrogen tablets. A simple way to block glyphosate uptake is to take glycine. Approximately 3 grams, about half a teaspoon, a few times a day should be sufficient, along with an organic diet, so that you're not adding more glyphosate with each meal. • Maintain a neutral pH to improve the resiliency of your immune system. You want your pH to be right around 7, which you can measure with an inexpensive urine strip. The lower your pH, the more acidic you are. A simple way to raise your pH if it’s too acidic (and most people are) is to take one-fourth teaspoon of sodium bicarbonate (baking soda) or potassium bicarbonate in water a few times a day. Nutritional supplementation can also be helpful. Among the most important are: Vitamin D — Vitamin D supplements are readily available and one of the least expensive supplements on the market. All things considered, vitamin D optimization is likely the easiest and most beneficial strategy that anyone can do to minimize their risk of COVID-19 and other infections, and can strengthen your immune system in a matter of a few weeks. N-acetylcysteine (NAC) — NAC is a precursor to reduced glutathione, which appears to play a crucial role in COVID-19. According to one literature analysis, (20) glutathione deficiency may actually be associated with COVID-19 severity, leading the author to conclude that NAC may be useful both for its prevention and treatment. Zinc — Zinc plays a very important role in your immune system's ability to ward off viral infections. Like vitamin D, zinc helps regulate your immune function (21) — and a combination of zinc with a zinc ionophore, like hydroxychloroquine or quercetin, was in 2010 shown to inhibit SARS coronavirus in vitro. In cell culture, it also blocked viral replication within minutes. (22) Importantly, zinc deficiency has been shown to impair immune function. (23) Melatonin — This boosts immune function in a variety of ways and helps quell inflammation. Melatonin may also prevent SARS-CoV-2 infection by recharging glutathione (24) and enhancing vitamin D synthesis, among other things. Vitamin C — A number of studies have shown vitamin C can be very helpful in the treatment of viral illnesses, sepsis and ARDS, (25) all of which are applicable to COVID-19. Its basic properties include anti-inflammatory, immunomodulatory, antioxidant, antithrombotic and antiviral activities. At high doses, it actually acts as an antiviral drug, actively inactivating viruses. Vitamin C also works synergistically with quercetin. (26) Quercetin — A powerful immune booster and broad-spectrum antiviral, quercetin was initially found to provide broad-spectrum protection against SARS coronavirus in the aftermath of the 2003 SARS epidemic, (27), (28), (29) and evidence suggests it may be useful for the prevention and treatment of SARS-CoV-2 as well. B vitamins — B vitamins can also influence several COVID-19-specific disease processes, including (30) viral replication and invasion, cytokine storm induction, adaptive immunity and hypercoagulability. Type 1 interferon — Type 1 interferon prevents viral replication and helps degrade the RNA. It's available in spray form that you can spray directly into your throat or nose. You can try taking a couple of sprays per day prophylactically, and more if you have a cough, fever or headache. Report all COVID-19 vaccine side effects Last but not least, if you or someone you love have received a COVID-19 vaccine and are experiencing side effects, report it. The Children’s Health Defense is calling on all who have suffered a side effect from a COVID-19 vaccine to do three things: (31)
If you live in the U.S., file a report on VAERS
Report the injury on VaxxTracker.com, which is a nongovernmental adverse event tracker (you can file anonymously if you like)
Report the injury on the CHD website