Mary Madigan couldn't help but be 'grumpy' when she read that the Pill can dent female ambition. Why? Because there's no better option for contraception for her body, and so, she must simply take this news on the chin and get on with it. She writes why 'good enough' should be seen as 'not good enough' when it comes to contraceptive options.
According to the Centers for Disease Control and Prevention (CDC), nearly one-half — 47% — of Americans have high blood pressure (hypertension).1 Hypertension carries a high cost to your health. It is a major risk factor for cardiovascular disease and stroke,2 which are in the first and fifth position for leading causes of death in the U.S.3
The financial burden is over $131 billion each year in direct medical costs and lost work days, but does not include a number of other health conditions worsened by hypertension, including kidney disease and cognitive decline.
Only 1 in 4 of those with hypertension have their blood pressure under control.4 Unfortunately, while blood pressure monitoring has become commonplace at dentists' and eye doctors' offices, the CDC estimates 1 in 3 people are not aware they have hypertension.5
There are several ways to reduce your blood pressure without drugs, which I discuss below. Among them is balancing your potassium level, as this electrolyte has a significant effect on muscle contraction and arterial wall relaxation, but most Americans barely get half of the recommended daily allowance.6
What Is High Blood Pressure?
When your physician takes your blood pressure, he uses a sphygmomanometer to measure the amount of pressure your heart exerts to push blood through your arterial system. The top number represents the highest pressure and the bottom number is the lowest pressure needed. These numbers are related to the elasticity and diameter of your arterial walls.
When the pressure required to circulate your blood is high, it places an abnormal amount of stress on your heart muscle and smaller arteries, and reduces the amount of oxygen delivered to the smallest blood vessels in your body. Both of these consequences account for many of the secondary effects of hypertension.
Your blood pressure reading can vary throughout the day, so one high reading is not a concern. It is only when your blood pressure is consistently or chronically higher than normal that significant health conditions may occur.
The validity of your blood pressure reading will be affected by the size of the blood pressure cuff, the position of the cuff on your arm and whether you're nervous. Measuring your blood pressure in both arms at the same office visit may also give your vital information about your circulatory health.
A number of studies have revealed that a significant difference between your right and left arm pressure may indicate circulatory problems that raise your risk for stroke, peripheral artery disease or other cardiovascular problems.
While small differences between your arms is normal, researchers found when there is a difference of 5 points in the systolic reading (top number) it doubled the risk of dying from heart disease in the following eight years.7 The difference suggests the presence of plaque in the artery supplying the arm with the higher pressure.8
In a meta-analysis evaluating mortality rates of over 17,000 participants with inter-arm systolic blood pressure differences, researchers found participants with less than 10 points difference compared to those with greater than 10 point difference between arms suffered a 58% increased risk of death from cardiovascular disease.9 However, when the difference increased to 15 points, the risk increased to 88%.
Potassium Level Impacts High Blood Pressure
Potassium is a naturally occurring mineral that your body uses as an electrolyte, or substance in solution that will conduct electricity, and is vital for normal functioning.
Diarrhea, vomiting, excessive sweating (such as when using a sauna) and some drugs may deplete or disrupt your potassium balance. But, the most common reason your potassium levels are not within normal limits is due to poor dietary choices.
The average reported intake of potassium from food is about half of the 4,700 milligrams (mg) recommended.10 Research demonstrates that these low levels of potassium may have a significant impact on blood pressure, especially as it relates to the amount of salt normally found in a Western diet.
Dr. Paul Whelton, professor of epidemiology at Tulane School of Public Health and Tropical Medicine, did an analysis in 1997 of over 29 trials that demonstrated low levels of potassium resulted in higher systolic blood pressure readings.11 Studies performed since then have found similar results.12,13 According to Whelton's research:14
"The results support the premise that low potassium intake may play an important part in the genesis of high BP. Increased potassium intake should be considered as a recommendation for prevention and treatment of hypertension, especially in those who are unable to reduce their intake of sodium."
Potassium works in your body to relax the walls of your arteries, keep your muscles from cramping, and lowers your blood pressure.15 The reduction in blood pressure with added potassium has also been associated in studies with a reduced risk of stroke.16
The Many Benefits of Potassium
Research has found that women without hypertension who consumed the most potassium (nearly 3,200 mg/day) had a 21% reduced risk of stroke. Further, women who consumed the most potassium were 12% less likely to die during the study period than those who consumed the least.17 According to the study's lead researcher:18
"Potassium may play a role in improving blood vessel function in our brains. This could allow better oxygenation of our brain tissue, and prevent tissue death that occurs from lack of oxygen to the brain …
The effect of potassium consumption on reduced stroke risk could also be due to a better diet overall, though we did not investigate this in our study."
Potassium should be the third most abundant mineral in the human body. Adequate amounts of potassium are also associated with quicker recovery from exercise and improved muscle strength.19,20 As an electrolyte, potassium helps to regulate the fluid balance in your cells and throughout your body.21
Fluid balance is essential to maintaining life, preventing dehydration at the cellular level and maintaining brain function.22 Potassium is important in the transmission of nerve impulses in your brain, spinal cord and peripheral nervous system.23
Nerve impulses transmitting information from one nerve to the next happens as the result of electrical activity. This activity is what an electrocardiogram measures as it tracks heart activity.
Low levels of potassium have been linked with high levels of insulin and glucose, associated with metabolic syndrome and Type 2 diabetes.24 These results have been found in several studies,25 leading researchers to recommend dietary choices that boost potassium levels and reduce the risk of type 2 diabetes.
Effects of High Blood Pressure on Your Body
Unfortunately, 20% of people who suffer with high blood pressure are unaware of the condition, significantly increasing their potential risk of health problems. With uncontrolled or poorly controlled hypertension, you increase the risk of significant health effects that reduce your quality of life and have a negative effect on the length of your life.
Hypertension increases your risk of stroke as it can cause blood vessels in your brain to rupture or clog more easily. In both instances, oxygen supply to a portion of the brain ceases and a stroke results.26 The increased workload on the heart muscle may result in heart failure, and damage to the arteries supplying the heart muscle with oxygen may result in a heart attack.
Hypertension may damage the smaller arteries, reducing the amount of oxygen delivered and severely impacting the ability of organs to function, such as your kidneys and eyes. This may result in kidney failure and vision loss. The damage to smaller blood vessels is called microvascular disease and may lead to angina, or chest pain when the heart muscle doesn't get enough oxygen, and sexual dysfunction.
Atherosclerosis is another form of damage to the arterial system from hypertension that may result in peripheral vascular disease. The narrowing of the arteries may occur in the legs, arms, stomach and head, triggering pain and fatigue.
Sodium/Potassium Ratio Is Key
The key to relaxing your arterial walls and reducing your blood pressure is the sodium to potassium ratio. In the United States and many other developed countries, salt has been vilified as a primary cause of high blood pressure and heart disease. According to research presented at last year's American Heart Association meeting,27 excessive salt consumption contributed to 2.3 million heart-related deaths worldwide in 2010.
However, it's important to realize that most Americans and other Westerners get the majority of their sodium from commercially available table salt and processed foods — not from natural unprocessed salt. So, not only is the ratio between potassium and sodium important, so is the type of sodium consumed.
If you eat a lot of processed foods and not many vegetables, there's a good chance your sodium-to-potassium ratio is unbalanced. If you're not sure, try using cronometer.com/mercola, which allows you to enter the foods you eat and then calculates the ratio automatically. It's generally recommended that you consume five times more potassium than sodium, but most Americans get the opposite ratio, eating two times more sodium than potassium.
This ratio is more important than your overall salt intake. A better strategy to promote public health would be to forgo the strict sodium reduction element and focus recommendations instead on a high-quality diet rich in potassium, as this nutrient helps offset the hypertensive effects of sodium. Imbalance in this ratio can not only lead to hypertension (high blood pressure) but also contribute to a number of other diseases, including:
Kidney stones
Memory decline
Cataracts
Osteoporosis
Erectile dysfunction
Stomach ulcers
Rheumatoid arthritis
Stomach cancer
Why a Balanced Diet Is Your Best Option
Getting nutrients from your food instead of supplements is preferable as your food contains more than a single nutrient and in different forms. For instance, potassium found in fruits and vegetables is potassium citrate or potassium malate, while supplements are often potassium chloride. The citrate and malate forms help produce alkali, which may promote bone health28 and preserve lean muscle mass as you age.29
Bone loss may lead to brittle bones or even osteoporosis. While potassium in fruits and vegetables may help build bone health, potassium chloride may not. As researcher Dr. Bess Dawson-Hughes from Tufts University explains:30
"If you don't have adequate alkali to balance the acid load from the grains and protein in a typical American diet, you lose calcium in the urine and you have bone loss … When the body has more acid than it is easily able to excrete, bone cells get a signal that the body needs to neutralize the acid with alkali … And bone is a big alkali reservoir, so the body breaks down some bone to add alkali to the system."
Research by Dawson-Hughes found that people who were in the neutral range for net acid excretion, meaning they had a fairly healthy balance for bone and muscle health, were eating just over eight servings of fruits and vegetables a day along with 5.5 servings of grains.
When they rounded this out, it came to about half as many grains as fruits and vegetables. For many Americans a simple recommendation to increase your alkali (and potassium) while reducing acid is to eat more vegetables and fewer grains.31
Other Drug-Free Methods to Control Blood Pressure
Here are several suggestions to help keep your blood pressure under control and reduce your risk of organ damage.
Address insulin and leptin resistance to impact magnesium and nitric oxide — High blood pressure is associated with insulin resistance, which results from eating a diet too high in sugar. As your insulin level rises, so does your blood pressure. Insulin stores magnesium, but if your insulin receptors are blunted and your cells grow resistant to insulin, you can't store magnesium so it passes out of your body through urination.
Magnesium stored in your cells relaxes muscles. If your magnesium level is too low, your blood vessels will constrict rather than relax, and this constriction raises your blood pressure.
Fructose also elevates uric acid, which drives up your blood pressure by inhibiting the nitric oxide in your blood vessels. (Uric acid is a byproduct of fructose metabolism. In fact, fructose typically generates uric acid within minutes of ingestion.) Nitric oxide helps your vessels maintain their elasticity, so nitric oxide suppression leads to increases in blood pressure.
If you're healthy, and want to stay that way, the general rule is to keep your total fructose intake to 25 grams per day or less. If you're insulin resistant and/or have high blood pressure, keep your total fructose to 15 grams or less per day until your condition has resolved.
Eat real food — A processed food diet, loaded with net carbohydrates (non-fiber carbs like sugar, fructose and grains) and trans fat (margarines and vegetable oils) is a recipe for hypertension. Instead, make whole, ideally organic foods the focus of your diet.
Also remember to swap non-fiber carbs for healthy fats such as avocados, butter made from raw, grass-fed organic milk, organic pastured egg yolks, coconuts and coconut oil, raw nuts such as pecans and macadamia, grass-fed meats and pasture raised poultry. To learn more about healthy eating, please see my optimal nutrition plan.
Mind your sodium to potassium ratio — According to Lawrence Appel, lead researcher on the DASH diet and director of the Welch Center for Prevention, Epidemiology and Clinical Research at Johns Hopkins, your diet as a whole is the key to controlling hypertension — not salt reduction alone.
He believes a major part of the equation is this balance of minerals, i.e., most people need less sodium and more potassium, calcium and magnesium. According to Appel,32 "Higher levels of potassium blunt the effects of sodium. If you can't reduce or won't reduce sodium, adding potassium may help. But doing both is better."
Indeed, maintaining a proper potassium to sodium ratio in your diet is very important, and hypertension is but one of many side effects of an imbalance. A processed food diet virtually guarantees you'll have a lopsided ratio of too much sodium to potassium.
Making the switch from processed foods to whole foods will automatically improve your ratios. Include foods high in potassium such as sweet potatoes, tomatoes, spinach, beets, black beans, wild caught salmon, edamame, butternut squash, Swiss chard, apricots, cantaloupe, mushrooms and tuna.33
Load up on veggies — Juicing is a simple way to increase the amount of vegetables in your diet, and many NO3-rich veggies (which raise your nitric oxide level) are suitable for juicing, such as beets, kale, celery, spinach, carrots and more. Allicin-rich garlic, leeks, shallots and chives also help improve your blood pressure, and are easy to add to salads and various dishes.
Optimize your vitamin D level
Boost your animal-based omega-3 intake — The best way to boost your omega-3 is to eat plenty of oily fish that are low in mercury and other pollutants. Good options include wild caught Alaskan salmon, sardines and anchovies. Alternatively, take a high-quality krill oil or fish oil supplement. Krill oil has advantages over fish oil, which is why I prefer it.
Consider intermittent fasting —Intermittent fasting is one of the most effective ways I've found to normalize your insulin/leptin sensitivity. It's not a diet in conventional terms, but rather a way of scheduling eating in such a way as to promote efficient energy use.
Essentially, intermittent fasting means eating your calories during a specific window of the day, and choosing not to eat food during the rest. When you eat, your body reacts by elevating insulin and leptin.
Exercise regularly — A comprehensive fitness program can go a long way toward regaining your insulin sensitivity and normalizing your blood pressure. To reap the greatest rewards, I recommend including high intensity interval exercises in your routine.
I also recommend training yourself to breathe through your nose when exercising, as mouth breathing during exercise can raise your heart rate and blood pressure, sometimes resulting in fatigue and dizziness.
Avoid smoking and other forms of pollution — Smoking is known to contribute to high blood pressure, as are other forms of air pollution, even noise pollution. To address these, avoid smoking, consider using ear plugs during sleep if you live in a noisy neighborhood (provided you cannot move), and take steps to improve your indoor air quality.
Walk barefoot — Going barefoot will help you ground to the earth. Experiments show that walking barefoot outside (also referred to as Earthing or grounding) improves blood viscosity and blood flow, which help regulate blood pressure. So, do yourself a favor and ditch your shoes now and then.
Grounding also calms your sympathetic nervous system, which supports your heart rate variability. This in turn promotes homeostasis, or balance, in your autonomic nervous system. In essence, anytime you improve heart rate variability, you're improving your entire body and all of its functions.
Address your stress — The connection between stress and hypertension is well documented, yet still does not receive the emphasis it deserves. In fact, it has been shown that people with heart disease can lower their risk of subsequent cardiac events by over 70% simply by learning to manage their stress.
Suppressed negative emotions such as fear, anger and sadness can severely limit your ability to cope with the unavoidable every day stresses of life. It's not the stressful events themselves that are harmful, but your lack of ability to cope.
The good news is, strategies exist that quickly and effectively transform your suppressed, negative emotions, and relieve stress. My preferred method is the Emotional Freedom Techniques (EFT), an easy to learn, easy to use technique for releasing negative emotions.
EFT combines visualization with calm, relaxed breathing, while employing gentle tapping to "reprogram" deeply seated emotional patterns.
It might be a topic you’d rather avoid but, as a growing number of Australians are discovering, organising your last goodbye can be an empowering experience. Not only can you ensure your funeral is a true celebration of your life, but you can also help to ease the grieving process for the ones you leave behind. Here’s how to make your final farewell one to remember.
Children’s Health Defense (CHD)1 produced and published a comprehensive and interesting resource for parents and families about childhood vaccines. While many people are currently focused on an experimental jab using genetic material, the CHD presents documented evidence in “Vaccine Secrets,” some of it from the federal government, that our children have been vaccine guinea pigs for decades.
They present the data in short “chapter” videos that are less than two minutes each — or, if you prefer, you can watch the whole video in less than 25 minutes. In it, you’ll find answers to more than a dozen questions about the vaccines your child gets that may very well surprise, if not shock, you.
First, a Bit of Background
The first U.S. shots for COVID-19 were given in December 2020 to health care workers in New York.2 In the short 20 months that followed, a lot has been learned about the jabs and the adverse effects that have devastated those who have taken them.
The sheer number of adults and children affected is dramatically higher than in any year since the vaccine adverse event reporting system (VAERS) began recording events in 1990.3
As of August 12, 2022, there have been over 1.3 million adverse event reports after the COVID jab,4 including over 30,000 deaths and over 56,000 individuals who are now permanently disabled. The pandemic has demonstrated that many physicians were unaware of the existence of VAERS, which is comanaged by the CDC and FDA.5
In the past, the system’s intended use had been to detect “unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine.”6
However, it’s apparent as the FDA, CDC and other public health agencies ignore the number of reports following the COVD jab, that the system may be recording damage, but the public health officials are ignoring it.
As you consider the documented evidence presented by the CHD, it begs the question — since the damage and devastation from the COVID shot is obviously being ignored by public health officials, how long have they been ignoring vaccine damage in our most vulnerable? According to CHD and the National Vaccine Information Center (NVIC), it’s been going on for decades.
Factors Involved in Vaccine Safety
There’s no question the number of vaccinations required for children just to enter school has jumped dramatically from the 1970s to the present time. According to the Children’s Hospital of Philadelphia,7 the number of vaccines increased from four in the 1940s, to seven in the 1970s and then to 14 by 2020.
But, according to CHD,8 that vaccine schedule includes 50 shots by age 6 and 69 shots by age 18. When you add all the antigens — the weakened or inactive microbes of the diseases that trigger an immune response9 — to the adjuvants — foreign substances added to a vaccine to help the antigens create a stronger immune response10 — you have a staggering amount of foreign substances being pumped into your child over a very relatively short period of time.
As CHD points out, some children appear able to handle this, but many do not, which leads to another factor: how vaccine safety is tested and proved. Unfortunately, while you may think that independent research tests and supports safety, this is not true. Actually that’s all done by the vaccine manufacturers themselves. According to the FDA:11
“Before the FDA licenses (approves) a vaccine, the vaccine is tested extensively by its manufacturer. FDA scientists and medical professionals carefully evaluate all the available information about the vaccine to determine its safety and effectiveness.”
When you read the last line, you’ll notice they evaluate “all available information.” As the CHD points out, this does not include all the information from testing. Let’s consider the current release of Pfizer documents that were used to approve Comirnaty, the Pfizer COVID-19 jab.12
Operation Rescue13 reported the data revealed that 270 pregnant women were vaccinated and a large percentage — 238 (88%) — of those were not followed up. This lack of follow-up is concerning since the data also showed that 124 of the 270 had some adverse reaction to the shot; 75 were serious and 49 were nonserious.
The outcome of only 34 pregnancies was recorded and 28 of those babies died in utero or at birth. Of the 34 pregnancies only one was recorded as normal and five were recorded in Pfizer data as "pending."14 This is the data that the FDA used to determine that the shot was “safe” for pregnant women. Yet, the data show that from 82% to 97% of the documented outcomes resulted in death.
This demonstrates that even when the FDA has the data, the results of the analysis that leads to the statement “safe and effective”15 are questionable. When the FDA approves shots based on this flawed data, you must ask yourself how bad are the data Big Pharma is hiding?
Vaccines Do Not Reliably Prevent Disease, but Do Spread It
Another point the CHD makes is that data demonstrate that vaccines do not reliably prevent disease. Not only that, vaccinated people can and do spread the diseases against which they’re vaccinated. If you need a current example, consider the COVID shot, which the CDC acknowledged is not effective for disease prevention:16
“CDC’s COVID-19 prevention recommendations no longer differentiate based on a person’s vaccination status because breakthrough infections occur, though they are generally mild, and persons who have had COVID-19 but are not vaccinated have some degree of protection against severe illness from their previous infection.”
The film goes on to show several examples of vaccinated people who got the disease they were vaccinated against, for example, measles. Statistics from the CDC17 showed up to 30% of measles cases in 2019 were in people who were vaccinated against measles. The CHD cites four more cases in which researchers documented measles in individuals who were vaccinated.18
Unfortunately, although vaccines are supposed to protect vulnerable people, those who receive certain vaccines can spread the diseases in a process called shedding. According to the CDC,19 individuals given a live attenuated influenza vaccine can shed the virus and spread the illness.
The CHD20 also notes other viruses that can shed or spread after vaccination include measles, rubella, chickenpox, rotavirus and shingles.
Disease Decline Not Related to Vaccines
Probably just as important as the fact that the vaccines are not always safe, do not always protect against the disease and may cause shedding and spreading of the illness, is that government data show the vaccine program does not deserve the credit for alleviating problems in the U.S. against contagious diseases.
In fact, when you look at the data, it’s apparent that public health experts have lied about the importance of the vaccine program. As demonstrated by CHD, data from the National Vital Statistics System (NVSS),21 which is overseen by the CDC, unequivocably show that improvements in hygiene and clean drinking water triggered the decline in mortality from these diseases before the vaccines were even introduced.
Vaccines Are Big Business
In 2009, the Globe and Mail22 looked at the growth of the vaccine industry and how the H5N1 bird flu contributed to the growth of the flu vaccine industry, which soared 32% every year between 2004 and 2007. At the time, experts estimated the global vaccine industry would top $40 billion by 2012.
In 2022, Fortune Business Insights23 released data from 2020 and estimated the global vaccine market at $55.44 billion before COVID-19 shots were introduced. They then projected the market would grow to $61.04 billion in 2021 and $125.49 billion by 2028 with an estimated compound annual growth rate of 10.8%, the largest contributor of which would be the COVID-19 shot. The market analysis called this “stellar growth.”
In March 202124 Pfizer reported they expected sales of the COVID jab to total $15 billion by the end of the year with a profit margin of 30%. However, by 2022 they had far exceeded expectations. According to Poynter,25 Moderna reported first quarter earnings in 2022 that were more than triple the same period the last year, earning $5.9 billion in just one quarter.
This was dwarfed by Pfizer's first quarter earnings in 2022 that grew 77% to more than $25 billion compared to the same period in the previous year. According to CNBC,26 this growth was driven by $13.2 billion in sales of the COVID shot in one quarter, compared to the $15 billion in annual sales they “estimated” for 2021.
The CHD27 points out that in one year Merck sold $3.15 billion worth of Gardasil. Fierce Pharma28 reported sales of Gardasil increased by 31% in the first quarter of 2019 after launching the product in China. Merck executives called this “unprecedented.”
Note that Gardasil has yet to demonstrate that it’s prevented a single case of cancer. Why? To prove its effectiveness against cancer, Merck would have had to wait roughly 35 years — or more — between giving the shot to young females and age 50, when the average woman develops cervical cancer. But they didn’t do that because, they said, “studying cancer itself isn’t feasible, because it takes too long.”29
When you understand that Merck having to wait 35 years for a true efficacy finding would cost $3 billion a year in sales over that 35 years, or about $105 billion total, it becomes plain that it’s all about the money, not safety or efficacy. Who says vaccines aren’t big business?
The CHD also notes the revolving door between health authorities and Big Pharma. Dr. Julie Gerberding was the director of the CDC when Gardasil was approved. The CHD writes:30
“Her move from the CDC to Merck significantly increased her income. Apparently, she went from about $172,000 in salary to around $25 million in compensation from stock sales at Merck and CERN. Vaccines make billions of dollars for corporations and millions of dollars for some lucky insiders. If they weren’t such “gravy trains” do you really think they would be pushed so hard?”
Parents Must Make Health Decisions
These are just a few of the highlights from this incredibly informative video. You also discover what the pharmaceutical industry uses for their control in testing vaccines in children — and it isn’t a placebo. The CHD also discusses the many dangerous ingredients that are included in manufacturing vaccines, including bird virus and pig virus fragments.
Additionally, they discuss the pitiful compensation process and remuneration that victims receive after being injured — if they are among the lucky few whose injuries are compensated. What this all shows is how imperative it is for parents to do their due diligence before going along with a pediatrician's advice to inject their child with 69 shots before they are aged 18.
You can stay up to date with the latest legislative activities in your state when you sign up for the NVIC advocacy portal. You can also learn more about what's happening in children's health through The Defender, the free newsletter from the Children's Health Defense.
On Wednesday, August 31, the FDA issued emergency use authorizations for new Pfizer and Moderna mRNA booster vaccines for COVID. The next day, September 1, the CDC's advisory committee and CDC Director approved the immediate rollout of the new vaccines. They will be administered in the US starting this week.
Fastest Vaccine Rollout in World History
Surprisingly, more than a month before either agency had given its okay to the entirely new formulation, the federal government ordered 105 million doses from Pfizer and 66 million doses from Moderna.
The desired composition of the vaccine had only been formally determined by FDA after its advisory committee had met on June 24, 2022. The vaccines contain a mix of the old, original Wuhan strain vaccine mRNA (now also referred to as the ancestral vaccine) and a new omicron BA.4/5 mRNA coding for the omicron spike protein.
The total amount of mRNA for the Pfizer and Moderna booster vaccines is the same as before: 30 mcg for Pfizer and 50 mcg for Moderna. Each is composed of 50% omicron mRNA and 50% ancestral mRNA, and they are termed bivalent vaccines.
The new vials and their boxes do not list the dose, hinting that the decision regarding how much to use was made very recently. Even the members of the CDC's advisory committee did not know the dosage of the new bivalent vaccines until their September 1 meeting.
This is the fastest rollout of a new vaccine in world history. How did it happen? Instead of this being a tale of human grit and ingenuity, it is a tale of human weakness and recklessness. Let me ask again: how did such a rapid vaccine rollout occur?
It occurred the only way it could possibly occur: by bending the rules, creating a new regulatory playbook and failing to obtain any human data for the new vaccines. The manufacturers did not have to go through months-long trials, and FDA did not have to pore over any human trial data, because there weren't any. Let that sink in: the new BA.4/5 bivalent vaccines have only been tested in mice, not humans.
Unexpected International Coordination
Here is an amazing fact: On the same day that the CDC gave its approval to start the vaccine program, September 1, health agencies in Canada, Switzerland and the European Union's FDA (the European Medicines Association) also rolled out new, bivalent booster shot programs. Almost simultaneously, the UK authorized 2 different bivalent boosters on August 15 and September 3.
The UK has told people to expect the largest rollout in history for the new bivalent boosters. And it has started the program by promising large bonuses to doctors if they manage to vaccinate every single resident of a nursing home by October 23.
These other countries are using an earlier omicron mRNA as the template for their omicron-ancestral bivalent vaccines, while the US is using the mRNA code for the later omicron variant BA.4/5 spike.
How Can You Get Complete Information on These Boosters?
How are the mainstream media telling this story? With their usual spin, avoiding the sticky parts. Instead of helping you understand what just happened, the New York Times asks, "When should you get yours?" Not should you get it, just when should you get it. The Herald Tribune tells you why you should get it.
STAT News says it answers your questions, but it never asks the relevant questions about why such a rapid, unprecedented rollout occurred — especially when we are at practically historic lows for deaths and ICU stays due to COVID.
The Associated Press did slightly better, at least posing the question of whether you should get a new booster. But then its answers don't dig any deeper than its fellow media outlets.
It looks like you won't be getting the information you need to understand the boosters and the process by which they were ushered in from the major media.
So the Defender has reviewed FDA documents, attended the all day CDC advisory committee meeting on September 1, studied a review of the boosters published in the New England Journal of Medicine on August 31, and evaluated a study of omicron boosters that were tested in non-human primates by Dr. Fauci's Vaccine Research Center. We will provide you real science.
What Did FDA Say About Its Emergency Use Authorization for the New Boosters?
FDA did not convene its advisory committee before issuing the authorizations, and it is not hard to guess why. Last year, its advisors voted against authorizing the ancestral boosters, because the data they were given indicated the old vaccines were continuing to work well. Two top officials at FDA who disagreed with the 2021 booster rollout resigned, hinting that the decision to issue boosters had been imposed on the FDA.
This year, FDA's VRBPAC (Vaccine and Related Biological Products Advisory Committee) members have been complaining about being given less and less data as they are asked to sign off on vaccine programs for younger and younger ages.
VRBPAC member Dr. Paul Offit, a professor of pediatric infectious diseases at the University of Pennsylvania and coinventor of a Rotavirus vaccine said last month that "the fix was in," implying that the committee's deliberations were a sham, because the White House announced it was purchasing the vaccine right after the meeting ended.
Dr. Offit was quoted last week as saying the mouse data were not sufficient to roll out the new boosters. So FDA chose not to give him and the other members a public venue where they would predictably complain about FDA's laxity — what some might call recklessness, insubordination or even gross malfeasance.
After all, according to the FDA's mission statement, FDA "is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices." Not rubberstamping untested vaccines.
The FDA justified its authorizations using language that was probably intended to confuse the public. Here are several examples.
1. Everyone knows the term "safe and effective," which is an official FDA stamp of approval for licensed drugs and vaccines. However, by law the term cannot be used by FDA to refer to unlicensed, experimental products, which is what all emergency use authorized drugs and vaccines are. So FDA tried to hint at the desired terminology without using it.
In its press release on the new boosters, FDA used almost, but not quite identical terminology, quoting Dr. Peter Marks, the director of FDA's vaccine center: "We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently."
2. Dr. Marks also said, "The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization." Again, 'safe and effective' is implied but not exactly stated.
3. What Dr. Marks expects the public to miss is the fact that there are no quality standards for emergency use authorizations (EUAs). The statute authorizing EUAs simply requires that the known and expected benefits outweigh the known and expected risks of the product. There are no quality requirements at all, and FDA is not even required to inspect the factories where EUA products are manufactured, as it must do for licensed products.
Nor is it required to inspect the final product. So the FDA is fooling us when it claims the standards are rigorous. Furthermore, Dr. Marks and the FDA know that all EUA products have been granted an extremely broad waiver of liability that covers Dr. Marks, the FDA, CDC, HHS, the manufacturers, distributors, doctors, pharmacists, and everyone involved in the vaccine program.
So they can tell us anything, because the public has no recourse to the courts to bring suit when an EUA product is involved.
4. FDA justifies its assessment that the untested vaccines are safe using the following argument: "The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process."
This is the same as claiming that almond butter is safe, so peanut butter is safe too because it is manufactured using the same process. Is that really the best excuse for failing to perform its regulatory functions that FDA can offer?
What Happened at the CDC ACIP (Advisory Committee on Immunization Practices) Meeting on September 1?
CDC knew that it would have a hard time convincing the public to take these vaccines, since almost everyone has already had COVID, the earlier vaccine benefits were overpromised, the disease has become milder, the vaccines do not prevent infection or transmission and the fearfulness around COVID is mostly gone. Therefore, CDC needed to employ new strategies.
One strategy was to invoke the 'bandwagon effect.' You try to convince the public that everyone else is getting the shot, so they too should jump on the bandwagon. A poll was presented at the ACIP meeting that claimed that 72% of people that were eligible planned to get the new boosters.
How likely is that to be true? Only 33% of the population has already gotten a first booster, while 65% have said, 'No thanks.' And the interest in COVID jabs is way down. Under 5% of preschoolers have received a COVID vaccine in the 3 months since they were authorized.
CDC implied to the ACIP that 49% of the public had been boosted, while its own statistics in the NY Times say the actual number is 33%. Here is how CDC performed the calculation to make it appear the boosters are more popular than they are: sixty-seven per cent of the public is 'fully vaccinated' according to the CDC. Forty-nine percent of those 67% (those who are fully vaccinated) is 33%.
The federal government allocated a billion dollars to buy advertising and guarantee positive news coverage (and suppress bad news) to push the earlier COVID vaccines. One wonders how much will be spent to push the new boosters.
CDC says that 224 million Americans are 'fully vaccinated.' The ACIP members were told that of this number, 210 million are already eligible for the new boosters. The government has bought 171 million bivalent booster doses so far (105 million from Pfizer and 66 million from Moderna) which can be used for those aged 12 and up.
FDA and CDC have yet to allow the rollout of new bivalent boosters for children under twelve, who have in the past received lower dose COVID vaccines than adults. But the agencies said they plan to do so within weeks.
Another testy issue for the ACIP committee was the question of how long these boosters will work, and how frequently they will be recommended. The ACIP members are responsible for giving advice on all vaccines, and they don't want the COVID vaccines to sour the public on other vaccines.
Although a recommendation to give the bivalent boosters 4 months after an earlier dose had once been floated, the ACIP committee was asked to approve the boosters when at least 2 months had passed since a prior dose. CDC's Dr. Twentyman said that CDC is no longer counting the total number of doses. She said that even if a person has received 4 or 5 prior COVID vaccinations, a new bivalent booster "should not be denied," as long as 2 months have passed since the last dose.
"increased neutralizing antibody titers, as well as clinical effectiveness, have been shown to wane by four months after a third messenger RNA immunization. After a fourth messenger RNA immunization, protection against infection with SARS-CoV-2 omicron has been reported to wane after just 4 weeks, although protection against severe disease lasts longer.
Hybrid immunity from both vaccination and infection provides greater and more durable protection than either alone."
Four weeks! Antibody titers sink 4 weeks after the 4th dose. No wonder CDC is allowing, and may encourage, such frequent boosters.
The COVID vaccinators have coined a new term, hybrid immunity, riffing off hybrid electric cars. It refers to the improved immunity a vaccinated person has if they also got the disease! As if being vaccinated but getting the disease anyway is to be normalized as desirable. After CDC spent two years denying that natural immunity — the kind people get after infection — even exists, CDC is now trying to take a lemon vaccine, add natural immunity, call it hybrid immunity and make lemonade!
How Was This Rollout Justified?
Omicron variants have been present since last November, and it was soon discovered that both vaccine-induced and natural immunity due to earlier variants were very limited for omicron variants, because they are so different from the ancestral strain. The health agencies and manufacturers have been testing omicron vaccine prototypes for up to 9 months.
Most of those tests involved BA.1 and BA.2 omicron strains. However, 90% of current cases are caused by omicron BA.5, which is genetically far from BA.1 and BA.2.
But there was some human data (involving a few hundred subjects each) for several of the earlier omicron vaccine prototypes, so the health agencies decided to simply pretend that mRNA designed for BA.1 and BA.2 was close enough to BA.5 that the data were comparable.
Since 50% of the vaccine contents would be the old vaccine, FDA claimed it had already established the safety and efficacy of that half. Then, to round things out, there were data from mice, which generated comparable antibody levels to the new vaccines as they had to older vaccines. And of course, we can rely on mice to behave exactly like people, right? After all, they have been 'humanized' to contain a human ACE-2 receptor.
No, we cannot rely on mice. We cannot even rely on nonhuman primates as a model for vaccines, as every species reacts uniquely and unpredictably to infections and to vaccinations. But mice data do bulk up FDA's authorization 'package' so it looks like FDA did a more thorough review.
Having Discussed How Long This Booster Might Last, One Needs to Ask How Well It Might Work
Predictions from Nature magazine and Dr. Fauci's NIAID Vaccine Research Center (VRC) at the NIH are that the new vaccines will not improve on the old vaccines.
According to the VRC, "a study in nonhuman primates showed that an omicron specific messenger RNA vaccine was not better than the original messenger RNA-1273 [ancestral Moderna] vaccine for protection against omicron challenge."
Nature notes, "an analysis [posted August 26] suggests that updated boosters seem to offer much the same protection as an extra dose of the older vaccines — particularly when it comes to keeping people out of hospital."
Neither of these studies was discussed at the ACIP meeting. No discussion was provided regarding why and how the bivalent vaccines were chosen.
The reason why the omicron vaccines won't stimulate a good omicron response is attributed by the NIAID VRC authors to antigenic priming, also known as original antigenic sin. This means that the immune system has been programmed to respond over and over again to the first coronavirus infection or vaccine it encountered, even when it encounters different coronavirus antigens later.
How well did the old vaccine work? The CDC slide below, presented by CDC's Dr. Link-Gelles, is not well labeled, but it shows that whether you got two or three doses of the old vaccine, during the omicron period efficacy in all age groups was under 40% at three months. By six months it hovered around zero efficacy (no benefit), and after that it was negative (harmful) for most ages.
Negative efficacy means that the vaccinated are more prone to being infected with COVID than the unvaccinated. This is consistent with what we are seeing from the UK and some other countries: the vaccinated become more likely to get COVID. And it is this effect that the public health agencies are probably trying to stave off, or hide, with perpetual boosters.
It appears the public here and in many other countries is being misled to receive an untested (or in other countries a BA. 1 or 2 minimally tested) shot on the false promise it will be so much better than the older vaccine. The regulators know it is unlikely to be better, but their public relations engines are revved up to convince us otherwise.
How Safe Are the New Vaccines?
That is anybody's guess, because you cannot assess human safety from animal models, since they don't predict the human response. What was done to evaluate the safety of the bivalent vaccines?
Reactogenicity
Reactogenicity is a word that refers to short term vaccine adverse reactions, like fever, redness, fatigue or muscle aches. According to the CDC briefers, the degree of reactogenicity from the omicron prototype vaccines was comparable to that from the older, 'ancestral' COVID vaccines.
There were no data on more serious side effects, and Dr. Shimabukuro of CDC said there was no way to assess the risk of myocarditis due to the small number of subjects who received the prototype vaccines.
However, if you look at Pfizer's chart prepared for the ACIP members below, you will notice that there was greater reactogenicity (more acute side effects) seen after the omicron prototype vaccines than seen after the older vaccines. This may be a signal that more severe reactions will result from the newer vaccines, but there is no way to be sure.
Myocarditis
Presenters to the ACIP claimed that myocarditis was less common after booster shots of the old vaccine than after the second dose of the initial series. However, slide 39 shown by Dr. Shimabukuro, which was quickly passed over, showed the opposite. For 16-17 year-old boys and girls, and for men aged 30-39, the chance of myocarditis was increased after a booster. (See below.)
So there is no reason to think the boosters will be any safer than the second dose, in terms of myocarditis. That risk, by the way, was about 1 in 2,000 young men aged 18-24 after their second dose in one Kaiser study.
Dr. Shimabukuro also said that if you get vaccinated soon after recovering from COVID, increased side effects, at least short-term, are to be expected — but "there is a lack of evidence that it places you at increased risk of myocarditis." I am not reassured by the lack of evidence. In fact, pediatric cardiologist Dr. Kirk Milhoan last week reviewed all the evidence that Dr. Shimabukuro couldn't find.
Getting vaccinated soon after recovering from COVID is foolhardy, and any officials mandating the shots after recovery are putting those in their charge at even greater risk of adverse reactions, including myocarditis.
Some scientists, including Dr. Barouch in last week's NEJM, assert that myocarditis is "far more frequent" after a case of COVID than it is after vaccination. But he cited not a single source for this claim.
Pediatric cardiologist Kirk Milhoan reviewed all the recent literature on the question of myocarditis rates after infection versus after vaccination. It appears that the vaccine puts you at more risk of myocarditis than a COVID infection does, but there are many different factors that influence risk, including age, gender, whether you already had COVID and how recently, and the type of vaccines received.
Moderna vaccines are more likely to cause myocarditis than Pfizer. Receiving a Moderna vaccine after an initial Pfizer vaccine raises the risk even more than getting 2 Moderna vaccines. See Table 2 from an important study of myocarditis in 4 Nordic countries.
An ACIP member asked whether the Jynneos monkeypox vaccine, which can also induce myocarditis, could be given together with the new bivalent vaccines? Would this increase the myocarditis risk? The surprising response was, "Read the briefing book," which may have meant that this was not to be discussed in public.
Speaking of what could be discussed in public, any discussion of pregnancy and COVID vaccination was forbidden at the ACIP meeting. Multiple committee members asked for information on pregnancy, but the briefers steadfastly refused to provide any. Nothing on hospitalizations, deaths, fetal outcomes.
The ACIP members were told they would be briefed on this at a future meeting. Dr. Miller, representing Moderna, said they were in the process of enrolling a total of 800 pregnant women in a study. Which would someday be completed. The only conclusion I can draw is that the CDC doesn't like the results they have now. And they plan to delay providing them to the public for as long as possible.
Yet CDC established a pregnancy registry for the COVID vaccines nearly 18 months ago. CDC and FDA must have data on many thousands of pregnancies. Every woman who receives a COVID vaccine dose must provide information on whether she is pregnant before she can be vaccinated, and CDC collects all this information. Furthermore, there are thousands of VAERS reports on adverse pregnancy outcomes.
FDA required Pfizer/BioNTech to study the effect of the vaccine in pregnancy when it issued a license for Comirnaty on August 23, 2021. FDA also required additional vaccine safety studies in children and additional studies of myocarditis at the same time. The problem is that these studies won't be completed for up to five years, long after billions of doses have been given and the vaccines will be long out of date.
It is difficult to justify why FDA would ask for these studies to take so long. Was FDA requesting such long study durations in order to delay its vaccine safety assessment until after the vaccines are no longer in use?
The only conclusion I can draw is that FDA and CDC don't like the safety results they already have. And they plan to withhold the bad news for as long as possible.
Long COVID
The committee was also interested in long COVID. Might the vaccines prevent this dread complication? CDC was mum. The CDC briefer claimed that CDC does not have "systematic data" on long COVID. Nor has CDC developed a case definition for long COVID. Why has CDC delayed investigating this critically important complication?
The NY Times revealed in February 2022 that CDC conceals the bulk of the public health data it collects. According to the Times, "Much of the withheld information could help state and local health officials better target their efforts to bring the virus under control."
You are not going to find a more public indictment from the NY Times of our Centers for Disease Control than that.
Does vaccination fail to prevent long covid? Does it cause long covid? FLCCC founder and esteemed intensive care physician Dr. Paul Marik has postulated that both long COVID and many COVID vaccine injuries are due to the same thing: the prolonged presence of spike proteins in the circulation.
If true, there may be considerable overlap between the symptoms and pathology of long COVID and vaccine injuries, and CDC may be trying to conceal this, or perhaps be seeking a way to claim that all the vaccine injuries are due to COVID.
FDA Revoked All Pfizer and Moderna Emergency Use Authorizations for the Old Boosters on August 31
This was sudden and unexpected. Appointments had to be cancelled, because starting on August 31 the old vaccines were limited to use in only young children or for the initial series. The FDA did not withdraw or recall the licensed Comirnaty and Spikevax vaccines, which have also been approved as a booster dose. Is this a tacit acknowledgement that there is no licensed Comirnaty or Spikevax available in the US?
Might the FDA have rolled out the new vaccines so quickly to justify removing most of the old vaccines from use, soon after reports began circulating about their contents containing undisclosed and possibly harmful materials?
Conclusions
The FDA and CDC have cooperated to issue emergency use authorizations and rollout new, bivalent Pfizer and Moderna COVID vaccines this week, without any human trials, which is unprecedented.
These vaccines continue to enjoy extraordinary protection from liability, while the recipient has no access to the legal system in the case of injury.
There is no evidence that the new vaccines are safe, while there is limited evidence that they may be more harmful than earlier COVID vaccines — but in the absence of human testing, there is no way to truly predict their safety. Safety data are being concealed by the federal health agencies. Messaging by them is misleading.
There is no evidence the new bivalent vaccines will be more effective than the older vaccines, and existing evidence suggests that any efficacy they provide will persist no longer than 1 to several months.
COVID vaccines appear to increase susceptibility to COVID infections, on average starting 6 months after an inoculation.
Perpetual boosters briefly stave off the negative efficacy that develops a few months after a COVID vaccination. This may be why frequent boosters are being pushed. But frequent boosters may also weaken overall immunity and may even contribute to rising mortality rates in the US and UK.
There is international coordination regarding bivalent boosters, and a major effort will be undertaken to get them into arms, despite historically low levels of severe COVID. Why?
