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The disagreements around whether COVID-19 vaccinations are “safe and effective” stem not only from the subjective nature of such descriptors but also from the lack of consensus around the data used to substantiate or refute such a claim.
The Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Reports (MMWR) often draw from limited observations, and their assessment of vaccine effectiveness is based on relatively small subsets of our population.
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Their conclusions are sometimes reflective of outdated data and conflict with their own recommendations.
For example, here the CDC’s latest estimation of vaccine effectiveness is upwards of 80% in preventing COVID-19 (i.e. the risk of becoming infected is 5 times less if vaccinated). Why then the recommendation for boosters?
Note that this latest metric is based on the CDC’s most recent data from more than one month ago and represents data drawn only from 27 jurisdictions.
Eric Topol, a professor of molecular medicine at Scripps Research, is a former advisory board member of the Covid Tracking Project, a team that worked to collect and synthesize local COVID-19 during the peak of the pandemic.
Politico recently quoted Topol:
“I think we’ve done a horrible job from day one in data tracking for the pandemic. We’re not tracking all the things that we need to to get a handle on what’s going on. It is embarrassing.”
Meanwhile, vaccine injuries continue to accumulate in the Vaccine Adverse Event Reporting System (VAERS) and go unacknowledged, making any constructive discussion around risk impossible.
In order to find common ground, it is perhaps most appropriate to focus on published data from the vaccine trials themselves.
Was Emergency Use Authorization justified? Was the current confusion around vaccine effectiveness and safety predictable from the beginning?
A presentation by the Canadian COVID Care Alliance
Canadian COVID Care Alliance (CCCA) is a group of “Independent Canadian doctors, scientists and healthcare professionals committed to providing top quality and balanced evidence-based information to the Canadian public about COVID-19 so that hospitalizations can be reduced, lives saved and our country restored as safely as possible.”
CCCA assembled a presentation that comprehensively demonstrates how Pfizer’s purported randomized placebo-controlled, double-blinded study veered away from methodologies that would have answered the safety and efficacy questions definitively.
In this concise slide deck with an explanatory video, CCCA powerfully summarized why Pfizer’s trial was not designed to adequately demonstrate its product’s safety and efficacy.
Here are a few key points from the CCCA presentation:
- Initial data demonstrated a high relative risk reduction of infection yet this amounted to an absolute risk reduction of only 0.84%. It is the absolute risk reduction that determines the risk-benefit ratio required to make informed decisions around inoculation.
- Early unblinding: Several months before publishing six-month observational results Pfizer opted to offer its product to those participants who received the placebo. By eliminating nearly all participants in the placebo wing Pfizer effectively closed the curtain on its experiment because long-term comparisons can no longer be made.
- All-cause mortality and morbidity, the only sensible outcomes to use in determining efficacy and risk, were not considered. Indeed, all-cause mortality was higher in the vaccinated group after six months.
- Severe adverse events outnumbered cases of severe COVID prevented after six months of observation.
- Trial participants were not reflective of the most vulnerable members of our population — more than 50% of people dying from COVID are 75 years of age or older. This age group made up only 4.4% of trial participants. Also, 95% of those who have died from COVID had one or more comorbidities. Nearly 80% of trial participants had none.
- Not every trial participant was tested for COVID. Asymptomatic or paucisymptomatic (presenting few symptoms) cases were missed.
Questions regarding unblinding and data integrity
The CCCA presentation also resurrects a puzzling observation mentioned in a briefing document Pfizer submitted only to the FDA’s Vaccine and Related Biologic Products Advisory Committee (VRBPAC) of the FDA, but nowhere else — including the widely cited summary of the trial reported in New England Journal of Medicine.
According to the document, 3,410 participants were suspected from their clinical presentation of having COVID but they were excluded from efficacy calculations because a diagnosis could not be confirmed through PCR testing.
The CCCA presentation presumes this large group of participants was never tested. The wording in the VRBPAC briefing document is indeed vague, stating the participants were “not PCR-confirmed” in one sentence and “unconfirmed” in another.
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Assuming Pfizer’s investigators followed their study protocol, these participants were in fact tested. Yet that forces us to accept that more than 3,400 participants who had symptoms of COVID were suffering from other illnesses, not COVID.
In other words, there were 3,580 participants who clinically presented with COVID (3,410 suspected and 170 confirmed). Of these, more than 95% tested negative. This is difficult to accept in a group where clinical suspicion is high.
However, with no further testing by the investigators, we are left to accept these numbers as reported.
Peter Doshi, Ph.D., senior editor at The BMJ, explained the implications of this result in detail, in an opinion piece published nearly one year ago.
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In his widely discussed commentary, Doshi noted another baffling finding in the Pfizer data. Within 7 days of administration of the second of two doses, 371 (310 in the vaccinated group and 61 in the placebo group) trial participants were withdrawn from the study due to “important protocol deviations.”
Of course, protocol deviations occur, but why were five times more vaccine recipients excluded than placebo recipients at that point in the study?
Although there were nearly 40,000 participants in the evaluable population, only 170 contributed to the efficacy calculation with regard to protection from infection, and only 10 with regard to protection from severe infection.
In other words, just a handful of incorrectly diagnosed and categorized participants could easily result in a substantially different estimation of the vaccine’s efficacy and safety.
Statistician and educator Mathew Crawford pointed out the likelihood of such a disparity between groups is exceedingly unlikely. However, because the investigators should have been blinded, we must accept this as an extraordinary coincidence.
Incredibly, the very same disparity occurred in the pediatric trials (ages 5 to 11). Table 12 from the corresponding summary to the FDA’s VRBPAC indicated 3.1% of children were removed from the trial if they received the vaccine compared to 0.5% if they received the placebo.
Once again, there is a factor of 5 difference at exactly the same point in the trial (within 7 days of dose 2). It is true that the vaccine formulation requires steps prior to administration that are not required with the placebo, but why didn’t these protocol deviations happen with the first dose as well? What happened to these vaccine recipients soon after they received their second dose?
These remarkable “coincidences” can be best explained if we are willing to consider the possibility that the investigators were not, in fact, blinded. This is precisely the most damning allegation by whistleblower Brook Jackson, formerly a regional director at Ventavia, one of several clinical research organizations conducting Pfizer’s vaccine trials in 2020.
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In addition to the unblinding of investigators, Jackson also accused Ventavia of falsifying data.
These are weighty accusations. Why should we believe her? Because her story is corroborated by the trial data themselves.
She was fired within a day of reporting her concerns directly to the FDA. Her story was covered in The BMJ Nov. 2. Mainstream media has yet to report on it.
Conclusion
Though public health authorities continue to proclaim these products are safe and effective, every week brings more and more evidence to the contrary.
A thorough analysis of data from Pfizer’s vaccine trials reveals more questions than answers. Claims the vaccine maker’s product is performing “as expected” may not be so far from the truth.
© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
Image by Marco Verch Professional Photographer via Flickr, CC BY 2.0.
Five Things New “Preppers” Forget When Getting Ready for Bad Times Ahead
The preparedness community is growing faster than it has in decades. Even during peak times such as Y2K, the economic downturn of 2008, and Covid, the vast majority of Americans made sure they had plenty of toilet paper but didn’t really stockpile anything else.
Things have changed. There’s a growing anxiety in this presidential election year that has prompted more Americans to get prepared for crazy events in the future. Some of it is being driven by fearmongers, but there are valid concerns with the economy, food supply, pharmaceuticals, the energy grid, and mass rioting that have pushed average Americans into “prepper” mode.
There are degrees of preparedness. One does not have to be a full-blown “doomsday prepper” living off-grid in a secure Montana bunker in order to be ahead of the curve. In many ways, preparedness isn’t about being able to perfectly handle every conceivable situation. It’s about being less dependent on government for as long as possible. Those who have proper “preps” will not be waiting for FEMA to distribute emergency supplies to the desperate masses.
Below are five things people new to preparedness (and sometimes even those with experience) often forget as they get ready. All five are common sense notions that do not rely on doomsday in order to be useful. It may be nice to own a tank during the apocalypse but there’s not much you can do with it until things get really crazy. The recommendations below can have places in the lives of average Americans whether doomsday comes or not.
Note: The information provided by this publication or any related communications is for informational purposes only and should not be considered as financial advice. We do not provide personalized investment, financial, or legal advice.
Secured Wealth
Whether in the bank or held in a retirement account, most Americans feel that their life’s savings is relatively secure. At least they did until the last couple of years when de-banking, geopolitical turmoil, and the threat of Central Bank Digital Currencies reared their ugly heads.
It behooves Americans to diversify their holdings. If there’s a triggering event or series of events that cripple the financial systems or devalue the U.S. Dollar, wealth can evaporate quickly. To hedge against potential turmoil, many Americans are looking in two directions: Crypto and physical precious metals.
There are huge advantages to cryptocurrencies, but there are also inherent risks because “virtual” money can become challenging to spend. Add in the push by central banks and governments to regulate or even replace cryptocurrencies with their own versions they control and the risks amplify. There’s nothing wrong with cryptocurrencies today but things can change rapidly.
As for physical precious metals, many Americans pay cash to keep plenty on hand in their safe. Rolling over or transferring retirement accounts into self-directed IRAs is also a popular option, but there are caveats. It can often take weeks or even months to get the gold and silver shipped if the owner chooses to close their account. This is why Genesis Gold Group stands out. Their relationship with the depositories allows for rapid closure and shipping, often in less than 10 days from the time the account holder makes their move. This can come in handy if things appear to be heading south.
Lots of Potable Water
One of the biggest shocks that hit new preppers is understanding how much potable water they need in order to survive. Experts claim one gallon of water per person per day is necessary. Even the most conservative estimates put it at over half-a-gallon. That means that for a family of four, they’ll need around 120 gallons of water to survive for a month if the taps turn off and the stores empty out.
Being near a fresh water source, whether it’s a river, lake, or well, is a best practice among experienced preppers. It’s necessary to have a water filter as well, even if the taps are still working. Many refuse to drink tap water even when there is no emergency. Berkey was our previous favorite but they’re under attack from regulators so the Alexapure systems are solid replacements.
For those in the city or away from fresh water sources, storage is the best option. This can be challenging because proper water storage containers take up a lot of room and are difficult to move if the need arises. For “bug in” situations, having a larger container that stores hundreds or even thousands of gallons is better than stacking 1-5 gallon containers. Unfortunately, they won’t be easily transportable and they can cost a lot to install.
Water is critical. If chaos erupts and water infrastructure is compromised, having a large backup supply can be lifesaving.
Pharmaceuticals and Medical Supplies
There are multiple threats specific to the medical supply chain. With Chinese and Indian imports accounting for over 90% of pharmaceutical ingredients in the United States, deteriorating relations could make it impossible to get the medicines and antibiotics many of us need.
Stocking up many prescription medications can be hard. Doctors generally do not like to prescribe large batches of drugs even if they are shelf-stable for extended periods of time. It is a best practice to ask your doctor if they can prescribe a larger amount. Today, some are sympathetic to concerns about pharmacies running out or becoming inaccessible. Tell them your concerns. It’s worth a shot. The worst they can do is say no.
If your doctor is unwilling to help you stock up on medicines, then Jase Medical is a good alternative. Through telehealth, they can prescribe daily meds or antibiotics that are shipped to your door. As proponents of medical freedom, they empathize with those who want to have enough medical supplies on hand in case things go wrong.
Energy Sources
The vast majority of Americans are locked into the grid. This has proven to be a massive liability when the grid goes down. Unfortunately, there are no inexpensive remedies.
Those living off-grid had to either spend a lot of money or effort (or both) to get their alternative energy sources like solar set up. For those who do not want to go so far, it’s still a best practice to have backup power sources. Diesel generators and portable solar panels are the two most popular, and while they’re not inexpensive they are not out of reach of most Americans who are concerned about being without power for extended periods of time.
Natural gas is another necessity for many, but that’s far more challenging to replace. Having alternatives for heating and cooking that can be powered if gas and electric grids go down is important. Have a backup for items that require power such as manual can openers. If you’re stuck eating canned foods for a while and all you have is an electric opener, you’ll have problems.
Don’t Forget the Protein
When most think about “prepping,” they think about their food supply. More Americans are turning to gardening and homesteading as ways to produce their own food. Others are working with local farmers and ranchers to purchase directly from the sources. This is a good idea whether doomsday comes or not, but it’s particularly important if the food supply chain is broken.
Most grocery stores have about one to two weeks worth of food, as do most American households. Grocers rely heavily on truckers to receive their ongoing shipments. In a crisis, the current process can fail. It behooves Americans for multiple reasons to localize their food purchases as much as possible.
Long-term storage is another popular option. Canned foods, MREs, and freeze dried meals are selling out quickly even as prices rise. But one component that is conspicuously absent in shelf-stable food is high-quality protein. Most survival food companies offer low quality “protein buckets” or cans of meat, but they are often barely edible.
Prepper All-Naturals offers premium cuts of steak that have been cooked sous vide and freeze dried to give them a 25-year shelf life. They offer Ribeye, NY Strip, and Tenderloin among others.
Having buckets of beans and rice is a good start, but keeping a solid supply of high-quality protein isn’t just healthier. It can help a family maintain normalcy through crises.
Prepare Without Fear
With all the challenges we face as Americans today, it can be emotionally draining. Citizens are scared and there’s nothing irrational about their concerns. Being prepared and making lifestyle changes to secure necessities can go a long way toward overcoming the fears that plague us. We should hope and pray for the best but prepare for the worst. And if the worst does come, then knowing we did what we could to be ready for it will help us face those challenges with confidence.
See all the latest videos and articles patriots need to watch and read at Discern.tv.
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