December 10, 2020 | Written By: Dr. Joseph Mercola | GreenMedInfo.com |
Originally published on www.mercola.com
- Early November 2020, Pfizer announced its vaccine is more than 90% effective. One week later, Moderna — which designed its vaccine candidate in just two days — boasted a 94.5% effectiveness rating
- Clinical trial data leave out crucial information, such as the cycle threshold used for the PCR testing, whether “cases” had symptoms or not, and how long the vaccine lasts if protective
- None of the COVID-19 trials for which we have data are designed to find out whether the vaccine reduces hospitalization rates or deaths. They only look at whether it reduces symptoms if you do get infected
- The estimated number needed to vaccinate (NNTV) for Moderna’s vaccine is 167, meaning 167 people must receive the vaccine in order to prevent one case of COVID-19
- The estimated NNTV for Pfizer’s vaccine candidate is 256
With COVID-19 vaccines on the precipice of mass distribution, news media are on fire as they talk about who will get the vaccine first and how it will be distributed. The one thing they aren’t discussing, however, is the definition of “effective” when it comes to these vaccines.
Early November 2020, Pfizer sent the stock market soaring1 when it announced its vaccine is more than 90% effective.2 One week later, Moderna — which designed its vaccine candidate in just two days3 — boasted a 94.5% effectiveness rating.4
However, if you read Pfizer’s and Moderna’s press releases and other clinical trial information, you’ll see that they have left out some really crucial information. For example:5
- They don’t say how many cycles they used for the PCR tests they gave to count COVID-19 cases, which is crucial for determining the accuracy of those tests
- They don’t say whether the “cases” had symptoms or not
- They don’t mention anything about hospitalizations or deaths, meaning there is no indication it prevents either
- There is no indication about how long the vaccine lasts if it truly is effective and protective. Some indications suggest you might need to take this vaccine every three to six months in order for it to be effective
Odds Ratios Can Be Misleading
In an article published by the Mises Institute, Dr. Gilbert Berdine, associate professor of medicine at Texas Tech University Health Sciences Center, writes:6
“The Pfizer study had 43,538 participants and was analyzed after 164 cases. So, roughly 150 out 21,750 participants (less than 0.7%) became PCR positive in the control group and about one-tenth that number in the vaccine group became PCR positive.
The Moderna trial had 30,000 participants. There were 95 ‘cases’ in the 15,000 control participants (about 0.6%) and five ‘cases’ in the 15,000 vaccine participants (about one-twentieth of 0.6%). The ‘efficacy’ figures quoted in these announcements are odds ratios …
When the risks of an event are small, odds ratios can be misleading about absolute risk. A more meaningful measure of efficacy would be the number [needed] to vaccinate to prevent one hospitalization or one death. Those numbers are not available.
An estimate of the number [needed] to treat from the Moderna trial to prevent a single ‘case’ would be 15,000 vaccinations to prevent 90 ‘cases’ or 167 vaccinations per ‘case’ prevented, which does not sound nearly as good as 94.5% effective.”
Pfizer’s Number Needed to Vaccinate = 256
In a letter to the editor, Dr. Allan Cunningham, a retired pediatrician in New York, also points out that Pfizer’s 90% effectiveness rating fails to tell the story in a way that people can understand, and goes on to estimate the number needed to vaccinate for Pfizer’s vaccine. He writes:7
“Specific data are not given but it is easy enough to approximate the numbers involved, based on the 94 cases in a trial that has enrolled about 40,000 subjects: 8 cases in a vaccine group of 20,000 and 86 cases in a placebo group of 20,000.
This yields a COVID-19 attack rate of 0.0004 in the vaccine group and 0.0043 in the placebo group. Relative risk (RR) for vaccination = 0.093, which translates into a ‘vaccine effectiveness’ of 90.7% [100(1-0.093)]. This sounds impressive, but the absolute risk reduction for an individual is only about 0.4% (0.0043-0.0004=0.0039).
The Number Needed to Vaccinate (NNTV) = 256 (1/0.0039), which means that to prevent just one COVID-19 case 256 individuals must get the vaccine; the other 255 individuals derive no benefit, but are subject to vaccine adverse effects, whatever they may be and whenever we learn about them.”
Major Safety Questions Still Remain
Indeed, when it comes to safety, it’s important to realize that since only a few thousand verified healthy volunteers have been exposed to the actual vaccine, the real beta testers will be the masses of people who line up first to take the vaccines when they come to market.
In his article, Berdine stresses he has yet to find a medical colleague who is willing to be among the first to take the experimental vaccine. Most say they want to review the safety data after a year or so of use before they’ll consider getting it.
“These colleagues are concerned about possible autoimmune side effects that may not appear for months after vaccination,” Berdine writes. It’s worth noting that none of the trials currently underway include immunocompromised volunteers, so the effects of these vaccines on people with suppressed immune function is wholly unknown.
This is a significant problem, seeing how an estimated 14.7 million to 23.5 million Americans suffer from some form of autoimmune disease,8 and these people are also at increased risk for COVID-19 complications and death.
If the vaccine exacerbates autoimmune problems, the outcome could be devastating for an extraordinary number of people. The volunteers currently enrolled in trials are all healthier than the average American, yet side effects appear commonplace even among this “elite” group.
What You Can Expect From the COVID-19 Vaccine
An October 20, 2020, article9 in the Observer lists the known side effects that have emerged in the various trials. Chills, fever, body aches and headache are the most commonplace, but at least two cases of transverse myelitis — inflammation of the spinal cord — have also occurred.
Even the U.S. Centers for Disease Control and Prevention warns that the vaccine’s side effects are “no walk in the park,”10 and Saad Omer, director of the Yale Institute for Global Health, has stressed the need for a broad-based outreach campaign to discuss the reality of side effects, as patients might not come back for the required second dose if the side effects take them by surprise.11
Dr. Eli Perencevich, a professor of internal medicine and epidemiology at the University of Iowa Health Care, has suggested essential workers should be granted three days of paid leave after they’re vaccinated, as many will feel too sick to work.12
A December 1, 2020, CNBC article,13 which looked at the frequency of adverse reactions, noted that 10% to 15% of participants in the Pfizer and Moderna trials reported “significantly noticeable” side effects.
Buried way down at the bottom of the article is a suggestion from a past advisory committee member, who proposes the nomenclature of “serious adverse reaction” be changed to “immune response,” so they can reprogram how people think about these side effects, even if they end up having to stay home from work because of them.
The article also admits they have no idea what, if any, long-term reactions there might be, which means (as we already knew) that this is a great big public health experiment and, of course, anything that happens post-marketing will be labeled a “coincidence.”
In related news, a participant in India’s AstraZeneca trial is now suing the company claiming the vaccine caused “serious neurological damage,”14 and a group of researchers warn the COVID-19 vaccines could potentially increase your risk of HIV infection.15 Then there are the concerns about the COVID-19 vaccine permanently altering your DNA, effectively turning you into a transhuman.16 As you can see, there’s a lot to consider before taking this vaccine.
Do We Really Need a COVID-19 Vaccine?
Berdine also points out that most of his colleagues believe “the uncertainties about safety exceed what they perceive to be a small benefit.”17 Indeed, at this point, a range of data suggest the COVID-19 vaccine may be completely unnecessary. For example:
- COVID-19 mortality is extremely low outside of nursing homes — 99.7% of people recover from COVID-19.18 If you’re under 60 years of age, your chance of dying from seasonal influenza is greater than your chance of dying from COVID-19.19
- Data clearly show that COVID-19 has not resulted in excess mortality, meaning the same number of people who die in any given year, on average, have died in this year of the pandemic.20,21 This is true even among the elderly, as evidenced in a Johns Hopkins University article published just before Thanksgiving. According to the article:22
“The deaths of older people stayed the same before and after COVID-19. Since COVID-19 mainly affects the elderly, experts expected an increase in the percentage of deaths in older age groups. However, this increase is not seen from the CDC data. In fact, the percentages of deaths among all age groups remain relatively the same.”
As soon as the article started trending on Twitter, Johns Hopkins deleted it saying it “was being used to support false and dangerous inaccuracies about the impact of the pandemic.”23
- Studies24,25,26,27,28,29,30,31 suggest immunity against SARS-CoV-2 infection is more widespread than suspected, thanks to cross-reactivity with other coronaviruses that cause the common cold.
- Asymptomatic people are highly unlikely to spread SARS-CoV-2 — A study32 looking at PCR test data from nearly 10 million residents in Wuhan city found that not a single one of those who had been in close contact with an asymptomatic individual (someone who tested positive but had no symptoms) had been infected with the virus. In all instances, virus cultures from people who tested positive but had no symptoms also came up negative for live virus.
Will COVID-19 Vaccine Save Lives?
Peter Doshi, associate editor of The BMJ, also questions the effectiveness of the COVID-19 vaccines, pointing out that current trials are not designed to tell us whether the vaccines will actually save lives. And, if they don’t, are they really worth the risks involved? Doshi writes:33
“What will it mean exactly when a vaccine is declared ‘effective’? To the public this seems fairly obvious. ‘The primary goal of a COVID-19 vaccine is to keep people from getting very sick and dying,’ a National Public Radio broadcast said bluntly …
Yet the current phase III trials are not actually set up to prove either. None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.”
Doshi points out that when Dr. Paul Offit was asked in an interview whether a recorded “event” in these trials meant moderate to severe illness, he replied yes, “that’s right.” But that’s not, in fact, correct. All Phase 3 trials count mild symptoms, such as a cough, as a “COVID-19 event,” and all will finalize their analyses after a mere 150 or 160 of the volunteers develop symptomatic COVID-19 — regardless of severity.
“Part of the reason may be numbers. Severe illness requiring hospital admission, which happens in only a small fraction of symptomatic COVID-19 cases, would be unlikely to occur in significant numbers in trials.
Data published by the U.S. Centers for Disease Control and Prevention in late April reported a symptomatic case hospitalization ratio of 3.4% overall, varying from 1.7% in 0-49 year olds and 4.5% in 50-64 year olds to 7.4% in those 65 and over.
Because most people with symptomatic COVID-19 experience only mild symptoms even trials involving 30,000 or more patients would turn up relatively few cases of severe disease,” Doshi writes.34
“Hospital admissions and deaths from COVID-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30,000 people.”
These trials also do not tell us anything about the vaccine’s ability to prevent transmission, as this would require testing volunteers twice a week for long periods of time — a strategy that is “operationally untenable,” according to Tal Zaks, chief medical officer at Moderna.35
COVID-19 Vaccine Poses Rare Distribution Challenges
Questions have also been raised about the potential for the COVID-19 vaccines to “go bad” due to improper storage. Pfizer’s COVID-19 vaccine has to be stored at an unheard of cold temperature even for Antarctica — minus 70 degrees Celsius, or 94 degrees below zero, Fahrenheit. Moderna’s can be kept a bit warmer, at “just” minus 20 degrees C, or 4 below zero F. Both pose a problem for providers who will be administering the shots.
To get an idea of why the vaccines have to be frozen, NPR compares them to chocolates that melt easily.36 The reason the vaccines are so fragile is because they’re made with messenger RNA (mRNA), which turn your own cells into little factories that produce SARS-CoV-2 protein that in turn trigger antibody production.
The problem is that mRNA is easily broken down, so it needs the freezing temperatures to keep stable. Pfizer said its special packaging keeps the vaccines frozen with the help of dry ice. Even so, providers will still have to abide by strict guidelines, one of which says the freezer compartment storing the vaccines cannot be opened more than twice a day, and when opened, must be closed within one minute. Once thawed, the vaccine can be kept refrigerated for five days.
The whole situation makes distribution a challenge, too since the smallest amount you can order is 975 doses. That means the vaccines most likely will have to go to places capable of administering large numbers of vaccines in a short period of time to avoid spoilage. What happens if the vaccine is mishandled and spoils? No one knows. At best, it may be ineffective. At worst, it may cause completely unexpected side effects.
The Gold Rush of Vaccines and Indemnity
The risk of side effects is particularly troubling in light of the fact that vaccine manufacturers are indemnified against any harm that occurs from the use of their vaccines. In the video above, Children’s Health Defense (CHD), founded by Robert F. Kennedy Jr., highlights the gold rush that occurred for pharmaceutical companies when the World Health Organization declared swine flu a pandemic in 2009.
Several experimental vaccines were hastily rushed to market following the WHO’s pandemic declaration, one of which resulted in thousands of European children and teens developing chronic narcolepsy and cataplexy (the sudden collapse due to loss of voluntary muscle control triggered by strong emotions or laughter).
In 2011, the ASO3-adjuvanted swine flu vaccine Pandemrix (used in Europe but not in the U.S. during 2009-2010) was causally linked37 to childhood narcolepsy, which had abruptly skyrocketed in several countries.38,39 Children and teens in Finland,40 the U.K.41 and Sweden42 were among the hardest hit.
Further analyses also discerned a rise in narcolepsy among adults who received the vaccine, although the link wasn’t as obvious as that in children and adolescents.43
A 2019 study44 reported finding a “novel association between Pandemrix-associated narcolepsy and the non-coding RNA gene GDNF-AS1” — a gene thought to regulate the production of glial cell line-derived neurotrophic factor or GDNF, a protein that plays an important role in neuronal survival.
They also confirmed a strong association between vaccine-induced narcolepsy and a certain haplotype, suggesting “variation in genes related to immunity and neuronal survival may interact to increase the susceptibility to Pandemrix-induced narcolepsy in certain individuals.”
Now, in the midst of another controversial pandemic, we’re facing an eerily similar playbook — with pharmaceutical companies eager to cash in on the first COVID-19 vaccine, which begs the question, “Are we are being played — again?”
Not the First Hoax — Practice Makes Perfect
Pandemics have come and gone around the globe for centuries, but in recent history they’ve been used as points of manipulation that have profited corporations, particularly pharmaceutical companies.
The 2005 bird flu epidemic, for example, was predicted to kill from 2 million to 150 million people. It killed just 98 people, globally, in 2005, 115 in 2006 and 86 in 2007.45 No one in the U.S. died from this infection. The brazenness of the hoax prompted me to write my New York Times best seller book “The Great Bird Flu Hoax.”
In 2006, 2007 and again in 2008, hyped warnings over the bird flu were repeatedly exposed as little more than a cruel hoax, designed to instill fear and line the pocketbooks of industry and various vested individuals. In 2009, there was the swine flu hoax, the vaccination campaign for which, as mentioned, turned into a disaster.
The summer of 2012 was again filled with dire predictions of bird flu sufficiently mutating to cause a human pandemic, immediately followed by urgent calls for fast-tracked vaccines. None of these pandemics ever turned into global killers, and COVID-19 is no different. As mentioned earlier, there’s no evidence of excess deaths due to this novel virus.
The COVID-19 pandemic differs from previous ones, however, in that it’s being used not just to enrich drug companies and justify the existence of gain-of-function research, but also to usher in a “reset” of the entire global economy by the technocrats. While failing economies around the world are blamed on the pandemic, the central bank system has been faltering for some time and is now on its last leg.
The global debt load is now so high, countries cannot even pay off the interest, and thus the system no longer works. It needs to be “reset,” but rather than ditching the central bank system and resetting it to something stable (such as returning to a gold-backed system), the technocrats in charge are ushering in an all-digital centralized currency that will give them total control over the finances of every human on earth.
What’s more, the economic reset is only one part of this all-encompassing totalitarian takeover. The COVID-19 vaccine fits into the scheme by providing an excuse to track and trace everyone’s whereabouts, and connect this medical surveillance together with the digital economy. You can learn more about this in “What You Need to Know About the Great Reset.”
No Accountability for Vaccine Harms
As noted by Barbara Loe Fisher, co-founder of the National Vaccine Information Center (NVIC), based on the historical failures of past coronavirus vaccines, a fast-tracked COVID-19 vaccine could become one of the biggest public health disasters in history.
And, no one involved will be held accountable or face any repercussions, just as GlaxoSmithKline was not held accountable for the narcolepsy cases caused by Pandemrix. Instead, they will all continue to profit while an unsuspecting public will beta test yet another potentially dangerous vaccine.
Even if severe side effects are rare, when you’re talking about vaccinating some 7 billion people, even a tiny percentage will translate into millions of people affected.”
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