What Can Creatine Do for You?

what can creatine do for you

  • Creatine has been used by athletes to improve performance as it’s immediately used by the body to convert ADP to ATP and supply energy muscles need for contraction

  • Muscle mass is a significant key to longevity and while your body metabolizes creatine from high-protein foods, athletes can’t get enough to improve performance from only food

  • Creatine triggers incremental muscle growth by increasing proteins that create muscle fiber and raising insulin-like growth factors needed to increase muscle mass. But it also helps athletes perform longer and harder, which also improves muscle development

  • More strategies you can use to develop muscle include eating enough protein to build muscle mass, using resistance and aerobic training, and adding omega-3 fatty acids and leucine found in whey protein to your regimen

  • Data also show that creatine helps provide energy to the brain and may improve cognitive performance; early work also shows it demonstrates neuroprotective effects in an experimental model that mimicking mild traumatic brain injury

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There is no doubt — muscle mass is a significant key to longevity.1 If you’ve ever walked into a supplement store and asked about muscle mass, an employee has likely tried to sell you creatine. The promise is that you take it and suddenly you’re ripped. While the good news is that creatine is well studied and has benefits, it’s also accurate to say that if the promise sounds too good to be true, it likely isn’t true.

According to the National Institutes of Health,2 creatine is an amino acid your body produces in the muscle cells. It’s used to help store energy and serves as a phosphate donor in the conversion of ADP to ATP. In short, it helps supply the energy your muscles need for contraction.

Some people use it to boost their athletic performance since it helps the body produce energy rapidly. When you’re able to run faster or lift more weights, your muscle fibers rebuild stronger after your workout.

Creatine also helps pull more water into the body. One study published in 2003 found that there was a significant increase in total body water without a change in fluid distribution.3 Although the water gain increases your weight gain, it’s not muscle or fat gain.

Some people also find that creatine makes them feel bloated.4 Some people are sensitive to using creatine and feel bloated if they don’t drink enough water with the supplement. However, most of the time it goes away in just a few hours. Factors that affect bloating include how much water you drink, the intensity of your workout and your diet.

According to The New York Times,5 there are roughly 20 different formulations of creatine you can purchase as a nutritional supplement. However, it is creatine monohydrate that has been studied more frequently, with strong evidence of health benefits.

Your body metabolizes creatine from high-protein foods. But, to get enough creatine to produce a performance benefit, you’d need to eat pounds of protein. A creatine supplement is not a replacement for protein as it is not a complete protein and cannot help your body repair after a workout.

Although many people do experience performance benefits and muscle growth, it does not have the same effect in all populations. A 2022 study6 published in the journal Nutrients evaluated the results of 16 randomized control trials for benefits associated with creatine supplements and found it was an efficient way to promote muscle growth in young healthy individuals who were undergoing adequate training.

However, the results of using creatine in individuals with muscular diseases were less conclusive. Jose Antonio, an associate professor of health and human performance at Nova Southeastern University in Florida, has studied creatine. He spoke with a reporter from The New York Times, saying,7 “There’s probably more data on creatine monohydrate than any other supplement in existence.”

Researchers began studying creatinine in exercise performance in the early 1990s. A literature review8 published in 2022, looked at 35 randomized controlled studies that in total included 1,192 participants. They concluded that creatine supplementation, when added to a resistance training program, could increase lean body mass. The results also showed that creatine worked better in men than women.

Eric Rawson, Ph.D., is a health, nutrition and exercise science professor at Messiah University in Pennsylvania. He also spoke with The New York Times reporter, saying that vegetarians and vegans may have a greater response to creatine supplements since their diet does not include as much creatine. Additionally, he said that while creatine may give athletes a boost, “whether it’s a 2 or 3 or 4% gain, no dietary supplements compare to proper training and sleep and nutrition habits.”9

Creatine may work by increasing proteins that create muscle fibers10 and raising insulin-like growth factor,11 which is a hormone that increases muscle mass. Data also suggest that creatine may help lower blood sugar levels.

One 12-week study evaluated participants who combined creatine and exercise after a high-carb meal and found the combination offered better blood sugar control than exercise alone.12 Greater movement of blood sugar into the cells may contribute to other data13 that show creatine reduces fatigue and increases energy when participants are sleep deprived.

However, as researchers have demonstrated, taking creatine alone is not enough to build strong muscle. And, the gains from using creatine are usually incremental. Once you reach your forties, you can lose roughly 1% of muscle mass each year, which corresponds to a 1% to 3% drop in strength.14

This is a crucial loss, as it significantly impacts your ability to remain independent as you age. Loss of muscle is also linked with a downward decline in health and an increased risk of premature death.15

Stewart Phillips, Ph.D., is a professor of kinesiology at McMaster University in Canada. He’s an expert in growing and maintaining muscle mass as you age. In an interview with Rhonda Patrick, Ph.D.,16 he discussed the body’s need for protein reserves to survive serious disease.

He explained that the recommended dietary allowance is the amount of protein you need to replace the amino acids your body loses. He believes you need 0.8 grams of protein per kilogram (kg) of body weight initially and goes on to say there is data from other scientists who suggest a minimum maybe closer to 1.2 grams per kg of body weight per day.

“And, you know, athletes and even older people could probably benefit from going up from that level to about 1.6,” he said.17 As you consider your needs, it’s important to make your calculation based on grams of lean body mass and not total body weight. This is because you do not need protein to maintain fat mass, only to maintain lean muscle mass.

The second pillar of gaining muscle strength and mass is to include aerobic and resistance exercises. Philips notes that you will achieve the largest gains if you go from doing nothing to doing something. In fact, he goes so far as to say that regular resistance training is the key to building muscle, even more so than adequate protein.

Finally, you need to give your body time to recover and repair the damage from resistance training. As your body recovers from the stress, it reaches a point where you’re better than you were in the beginning, and nutrition supports this process.

Nutrition in combination with resistance and aerobic exercises is key to maintaining and developing muscle. The amino acids from proteins are particularly important as they are building blocks and play a vital role in new muscle growth. Leucine is another amino acid with anabolic properties.

Older people not only experience accelerated muscle loss but also require more protein to stimulate muscle synthesis as compared to younger people. The richest source of leucine is whey protein.18 Without whey, it can be difficult to consume enough leucine from diet alone.

A second addition to your nutritional intake that is often associated with heart health, is omega-3 fats. Phillips discussed19 a trial he designed of young women who used one leg brace for 2 weeks to trigger local disuse atrophy. Half the women in the trial took a high-dose omega-3 fat supplement and the other half received a placebo.

The group that took the omega-3 fats experienced less atrophy and returned to normal far quicker than the placebo group. Although not a nutritional supplement, integrating heat into your weekly workouts can also help protein synthesis20 and allow the proteins to function normally.

In the interview, Phillips commented on using creatine regularly, “You know, the stuff now with creatine that they’re uncovering that makes me think, “Maybe this should be part of my regular routine.” Actually [it] has less to do with the muscle and more to do with the brain and cognitive performance.”21

Research has also demonstrated that creatine plays a critical role in brain function and in other tissues that have high energy demand.22 Children who have genetic errors of creatine synthesis present with severe neurological symptoms and patients with other neurodegenerative diseases benefit from creatine supplements.

For example, creatine has demonstrated beneficial effects in mice23 that have Parkinson’s-like disease. It prevented 90% of the typical drop in dopamine levels that are associated with several of the serious symptoms, including loss of muscle function and speech impairment.

Although early research suggested that creatine may help delay the progression of Huntington’s disease,24 a more recent study published in 2017 found data from 553 participants did not support the use of creatine to delay functional decline.25

Data does show that creatine plays a significant role in brain health and function as the brain requires a large amount of ATP to function.26 Although biological evidence27 and animal models28 demonstrate a positive effect after traumatic brain injuries, the data in humans is scarce.

In an experimental model29 mimicking the effects of a mild traumatic brain injury, one research team found supplementing with creatine helped cognitive processing during oxygen deprivation. They concluded, “This is the first demonstration of creatine’s utility as a neuroprotective supplement when cellular energy provision is compromised.”

It is important to choose creatine from a reputable manufacturer. Clinical trials that have lasted up to five years have reported no adverse effects in healthy individuals.30 However, it is important to stay within the recommended dose. More of a good thing does not make it a better thing.

Keep in mind that it’s not guaranteed that you will build muscle from using creatine. Consider creating specific goals for using the supplement so you are not disappointed. If you’re a vegan or a vegetarian, you might consider using creatine to help protect brain health.

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Disclaimer: The entire contents of this website are based upon the opinions of Dr. Mercola, unless otherwise noted. Individual articles are based upon the opinions of the respective author, who retains copyright as marked.

The information on this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Mercola and his community. Dr. Mercola encourages you to make your own health care decisions based upon your research and in partnership with a qualified health care professional. The subscription fee being requested is for access to the articles and information posted on this site, and is not being paid for any individual medical advice.

If you are pregnant, nursing, taking medication, or have a medical condition, consult your health care professional before using products based on this content.

More Health Benefits of Quercetin Revealed

quercetin benefits

  • Quercetin has been shown to combat inflammation and acts as a natural antihistamine. Several studies have highlighted quercetin’s ability to prevent and treat both the common cold and influenza

  • Another, less known benefit and use for quercetin includes the prevention and/or treatment of high blood pressure, cardiovascular disease, metabolic syndrome, certain cancers, gout, arthritis and mood disorders

  • A review of quercetin’s effect on metabolic syndrome found it significantly reduced fasting plasma glucose when taken for at least eight weeks at a dosage of 500 milligrams per day or more

  • Other recent research found quercetin has a beneficial impact on nonalcoholic fatty liver disease by ameliorating inflammation, oxidative stress and lipid metabolism

  • Quercetin also has the ability to trigger tumor regression by interacting with your DNA and activating the mitochondrial pathway of apoptosis (the programmed cell death of damaged cells)

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Quercetin1 is an antioxidant flavonol found naturally in foods such as apples, plums, red grapes, green tea, elder flower and onions, just to name a few.2 According to a 2022 LinkedIn report,3 the quercetin market is growing rapidly as its health benefits are becoming more widely known, with a projected global market of $406 million by 2027.

Quercetin has been shown to combat inflammation and acts as a natural antihistamine. In fact, its antiviral capacity appears to be the primary focus of many studies looking at quercetin’s benefits, and a number of studies have highlighted quercetin’s ability to prevent and treat both the common cold and influenza.4 5 6

But there are also other, less known benefits and uses for this supplement, including the prevention and/or treatment of:7

  • High blood pressure8

  • Cardiovascular disease9

  • Metabolic syndrome10

  • Certain kinds of cancer11

  • Nonalcoholic fatty liver disease (NAFLD)12

  • Gout13

  • Arthritis14

  • Mood disorders15

  • Longevity, thanks to its senolytic benefits (clearing out damaged and worn-out cells)16 17

Additionally, quercetin is also helpful for aluminum-induced neurodegenerative changes, such as those seen in Alzheimer’s, Parkinson’s and amyotrophic lateral sclerosis (ALS). As noted in a 2016 study:18

“Administration of quercetin (10 mg/kg body wt/day) reduced aluminum (10 mg/kg body wt/day)-induced oxidative stress (decreased ROS production, increased mitochondrial superoxide dismutase (MnSOD) activity).

In addition, quercetin also prevents aluminum-induced translocation of cyt-c, and up-regulates Bcl-2, down-regulates Bax, p53, caspase-3 activation and reduces DNA fragmentation …

Further electron microscopic studies revealed that quercetin attenuates aluminum-induced mitochondrial swelling, loss of cristae and chromatin condensation. These results indicate that treatment with quercetin may represent a therapeutic strategy to attenuate the neuronal death against aluminum-induced neurodegeneration.”

Among the most recent papers on this powerful antioxidant is a review19 published in the March 2019 issue of Phytotherapy Research, which looked at nine randomized controlled trials investigating quercetin’s effect on metabolic syndrome.

Metabolic syndrome refers to a cluster of conditions (including high blood pressure, high blood sugar, high triglyceride levels and fat accumulation around the waist) that raise your risk for Type 2 diabetes, heart disease and stroke.

While pooled findings found no effect on fasting plasma glucose, insulin resistance or hemoglobin A1c levels, further subgroup analyses revealed quercetin supplementation “significantly reduced” fasting plasma glucose in studies lasting at least eight weeks and in which dosages of at least 500 milligrams (mg) per day were used.

In studies that included people over the age of 45, “significant” reductions in insulin were also found when using a dosage of 500 mg per day or more. An earlier study,20 published in 2011, looked at quercetin’s effects on certain traits of metabolic syndrome.

This study focused specifically atherosclerosis and inflammation in men with the APOE genotype 3/3, 3/4 and 4/4, and found quercetin significantly decreased waist circumference, postprandial systolic blood pressure, postprandial triacylglycerol, and increased HDL-cholesterol compared to placebo. Here, participants were given 150 mg of quercetin per day for eight weeks.

Research21 on obese rats published in 2008 also found that quercetin supplementation at doses of 2 mg per kilo or 10 mg/kg of body weight for 10 weeks improved systolic blood pressure, triglyceride, total cholesterol and free fatty acid levels. The 10 mg/kg dose also improved the animals’ inflammation status. As noted by the authors:

“In conclusion, both doses of quercetin improved dyslipidemia, hypertension, and hyperinsulinemia in obese Zucker rats, but only the high dose produced antiinflammatory effects in VAT together with a reduction in body weight gain.”

One of the first studies22 to demonstrate quercetin’s beneficial effects on blood pressure was published in 2007. As reported by the authors:

“Epidemiological studies report that quercetin … is associated with reduced risk of coronary heart disease and stroke … Men and women with prehypertension and stage 1 hypertension were enrolled in a randomized, double-blind, placebo-controlled, crossover study to test the efficacy of 730 mg quercetin/d for 28 d[ays] vs. placebo.

Blood pressure at enrollment was … 148 +/- 2/96 +/- 1 in stage 1 hypertensive subjects … Reductions in systolic (-7 +/- 2 mm Hg), diastolic (-5 +/- 2 mm Hg), and mean arterial pressures (-5 +/- 2 mm Hg) were observed in stage 1 hypertensive patients after quercetin treatment … These data are the first to our knowledge to show that quercetin supplementation reduces blood pressure in hypertensive subjects.”

Similarly, a January 2020 systematic review23 of 17 studies concluded quercetin “significantly decreased” blood pressure in human subjects. Those who took it for eight weeks or more also had “significantly” improved high-density lipoprotein cholesterol and triglycerides.

Other recent research24 published in the August 2019 issue of Phytotherapy Research concluded quercetin has a beneficial impact on NAFLD “by ameliorating inflammation, oxidative stress and lipid metabolism.”

Diabetes can play a role in NAFLD as well, showing just how influential insulin resistance is in the development of chronic diseases of all kinds. As explained in the abstract:

“Multiphase pathological processes involve in Type 2 diabetes (T2DM)‐induced nonalcoholic fatty liver disease (NAFLD). However, the therapies are quite limited. In the present study, the hepatoprotective effects and underlying mechanisms of quercetin in T2DM‐induced NAFLD were investigated …

The results revealed that quercetin alleviated serum transaminase levels and markedly reduced T2DM‐induced histological alterations of livers. Additionally, quercetin restored superoxide dismutase, catalase, and glutathione content in livers.

Not only that, quercetin markedly attenuated T2DM‐induced production of interleukin 1 beta, interleukin 6, and TNF‐α. Accompanied by the restoration of the increased serum total bile acid and the decreased liver total bile acid, quercetin could reduce lipid accumulation in the liver … These findings suggested that quercetin might be a potentially effective drug for the treatment of T2DM‐induced NAFLD.”

According to research25 published in 2016, quercetin even has the ability to trigger tumor regression by interacting with your DNA and activating the mitochondrial pathway of apoptosis (the programmed cell death of damaged cells).

Quercetin was found to induce cytotoxicity in leukemic cells, and the effect was dose-dependent. Limited cytotoxic effects were also found in breast cancer cells. Overall, quercetin increased the life span in cancer-ridden mice fivefold compared to untreated controls.

The authors attributed these effects to quercetin’s direct interaction with DNA and its activation of the mitochondrial pathway of apoptosis, and suggested quercetin’s potential use as a cancer therapy adjunct deserves further exploration.

More recent research26 in the journal Molecules also highlights quercetin’s epigenetic influence and ability to:

  • Interact with cell-signaling pathways

  • Modulate gene expression

  • Influence the activity of transcription factors

  • Modulate microRNAs

MicroRNAs used to be considered “junk” DNA. Far from being useless, research has now revealed that “junk” DNA is actually microRNA and plays a crucial role in regulating genes that make the proteins that build your body.

The microRNA function as “on/off” switches for the genes. Depending on the microRNA input, a single gene can code for any of more than 200 protein products. Quercetin’s ability to module microRNA may also help explain its cytotoxic effects, and why it appears to improve cancer survival (at least in mice).

As mentioned, one of the most well-studied attributes of quercetin is its antiviral capacity, which have been attributed to three main mechanisms of action:

  1. Inhibiting the virus’ ability to infect cells

  2. Inhibiting replication of already infected cells

  3. Reducing infected cells’ resistance to treatment with antiviral medication

For example, research27 published in 2007 found it lowered cyclists’ risk of upper respiratory track infections following intensified exercise.

Here, cyclists who received a daily dose of 1,000 mg of quercetin in combination with vitamin C (which enhances plasma quercetin levels28 29) and niacin (to improve absorption) for five weeks were significantly less likely to contract a viral illness after bicycling three hours a day for three consecutive days, compared to untreated controls. While 45% of the placebo group got sick, only 5% of the treatment group did.

In another study30 funded by the U.S. Defense Advanced Research Projects Agency (DARPA), published in 2008, animals treated with quercetin were challenged with a highly pathogenic H1N1 influenza virus. Again, the treatment group had significantly lower morbidity and mortality than the placebo group. A number of other studies have also confirmed quercetin’s effectiveness against a variety of viruses, including the following:

A 1985 study found quercetin inhibits infectivity and replication of herpes simplex virus type 1, polio-virus type 1, parainfluenza virus type 3 and respiratory syncytial virus.31

A 2010 animal study found that quercetin inhibits both influenza A and B viruses. Two other important discoveries were made. Firstly, the viruses were unable to develop resistance to quercetin, and secondly, when used concomitant with antiviral drugs (amantadine or oseltamivir), the effect was significantly amplified — and it prevented drug-resistance from developing.32

A 2004 animal study investigating quercetin’s effect on influenza used a strain of the H3N2 virus. According to the authors:33

“During influenza virus infection, there is ‘oxidative stress.’ Because quercetin restored the concentrations of many antioxidants, it is proposed that it may be useful as a drug in protecting the lung from the deleterious effects of oxygen derived free radicals released during influenza virus infection.”

Another 2016 study found quercetin offered protection against influenza A virus H1N1 by modulating protein expression. More specifically, the regulation of heat shock proteins, fibronectin 1 and prohibitin was instrumental in reducing viral replication.34

A third study published in 2016 found quercetin inhibited a wide spectrum of influenza strains, including H1N1, H3N2 and H5N1. According to the authors, “This study indicates that quercetin showing inhibitory activity in the early stage of influenza infection provides a future therapeutic option to develop effective, safe and affordable natural products for the treatment and prophylaxis of [influenza A viruses] infections.”35

In 2014, researchers noted that quercetin appears to be “a promising treatment for the common cold,” caused by the rhinovirus, adding that “Quercetin has been shown to reduce viral internalization and replication in vitro, and viral load, lung inflammation and airways hyper-responsiveness in vivo.”36

By attenuating oxidative damage, it also lowers your risk of secondary bacterial infections, which is actually the primary cause of influenza-related deaths. Importantly, quercetin increases mitochondrial biogenesis in skeletal muscle, which suggests part of its antiviral effects are due to enhanced mitochondrial antiviral signaling.

A 2016 animal study37 found quercetin inhibited mouse dengue virus and hepatitis virus. Other studies have confirmed quercetin’s power to inhibit both hepatitis B38and C39 infection.

Most recently, a March 2020 study40 in the Microbial Pathogenesis journal found quercetin “provides comprehensive protection against Streptococcus pneumoniae infection,” both in vitro and in vivo, primarily by neutralizing pneumolysin (PLY),41 one of the toxins released from pneumococci that encourages S. pneumoniae infection to blossom in the first place. As reported by the authors in Microbial Pathogenesis:

“The results indicated that quercetin significantly reduced PLY-induced hemolytic activity and cytotoxicity via repressing the formation of oligomers.

In addition, treatment with quercetin can reduce PLY-mediated cell injury, improve the survival rate of mice infected with a lethal dose of S. pneumoniae, alleviate the pathological damage of lung tissue and inhibit the release of cytokines (IL-1β and TNF-α) in bronchoalveolar lavage fluid.

Considering the importance of these events in antimicrobial resistant S. pneumoniae pathogenesis, our results indicated that quercetin may be a novel potential drug candidate for the treatment of clinical pneumococcal infections.”

Aside from its antiviral activity, quercetin is also known for boosting immunity and combating inflammation. As noted in a 2016 study42 in the journal Nutrients, mechanisms of action include (but is not limited to) the inhibition of:43

  • Lipopolysaccharide (LPS)-induced tumor necrosis factor α (TNF-α) production in macrophages. TNF-α is a cytokine involved in systemic inflammation, secreted by activated macrophages, a type of immune cell that digests foreign substances, microbes and other harmful or damaged components

  • LPS-induced mRNA levels of TNF-α and interleukin (IL)-1α in glial cells, which results in “diminished apoptotic neuronal cell death”

  • The production of inflammation-producing enzymes

  • Calcium influx into the cell, which in turn inhibits:

    • Pro-inflammatory cytokine release

    • Histamine and serotonin release from intestinal mast cells release44

According to this paper, quercetin also stabilizes mast cells, has cytoprotective activity in the gastrointestinal tract, and “a direct regulatory effect on basic functional properties of immune cells,” which allows it to inhibit “a huge panoply of molecular targets in the micromolar concentration range, either by down-regulating or suppressing many inflammatory pathways and functions.”45

Considering its wide-ranging benefits, quercetin may be a useful supplement for many, either acutely or more long-term. It’s one of the supplements I recommend keeping in your medicine chest for times when you feel you’re “coming down” with something, be it the common cold or influenza.

If you’re prone to colds and flu, you could consider taking it for a couple of months before cold and flu season hits to boost your immune system. More long-term, it appears useful for those with metabolic syndrome, although it would be foolish to rely on any given supplement without also addressing more fundamental strategies such as diet and exercise.

As explained in my 2015 interview with Dr. Robert Lustig, sugar has been shown to be a causative factor in insulin resistance, which is a hallmark of metabolic syndrome and a risk factor for virtually all chronic disease.

If you have one or more of the conditions that make up metabolic syndrome, you’d be wise to limit your total sugar consumption to 15 grams per day. If you’re healthy, and want to stay that way, your daily sugar limit would be around 25 grams.

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Disclaimer: The entire contents of this website are based upon the opinions of Dr. Mercola, unless otherwise noted. Individual articles are based upon the opinions of the respective author, who retains copyright as marked.

The information on this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Mercola and his community. Dr. Mercola encourages you to make your own health care decisions based upon your research and in partnership with a qualified health care professional. The subscription fee being requested is for access to the articles and information posted on this site, and is not being paid for any individual medical advice.

If you are pregnant, nursing, taking medication, or have a medical condition, consult your health care professional before using products based on this content.

Weekly Recap: Midterms Update – Tabulation Issues Everywhere!, Trump's Announcement, New Q Posts, & A Rothschild Dies


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A Drug Safety Physician’s Correspondence with the FDA: A Quest for Accuracy in Investigational Bivalent mRNA COVID-19 ‘Vaccine’ Adverse Event Reporting



On November 4, 2022, the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) concluded that, based on Vaccine Adverse Events Reporting System (VAERS) and v-safe data received between August 31, 2022, and October 23, 2022, “Health care providers and patients can be reassured that adverse events reported after a bivalent booster dose [COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)] are consistent with those reported after monovalent doses.” (https://www.cdc.gov/mmwr/volumes/71/wr/mm7144a3.htm?s_cid=mm7144a3_w)


Unlike the flu vaccine you may receive this fall, the bivalent COVID-19 ‘vaccines’ are:

  • Unapproved, investigational products still under Emergency Use Authorization (EUA) only
  • Currently being tested in clinical (human) trials
  • Authorized based on “the totality of the scientific evidence available:” zero data from the actual vaccine product in human







In my professional medical opinion, the bivalent ‘vaccines’ should never have been released to the public at their stage of development. Also, I consider passive surveillance systems such as VAERS and v-safe to be vastly inappropriate as standalone safety evaluations for these investigational biologics. But, in an attempt to help make the evolving safety profiles of the bivalent ‘vaccines’ more accurate, transparent and evaluable, I reached out to the FDA with my concerns regarding adverse event reporting.


My letter below summarizes the current status of my requests of the FDA, with an additional request for a status update.


The FDA responded back to me on November 3, 2022: “We will review the letter and respond when we are able.” My hope is that they reanalyze their “early safety findings” (August 31, 2022, to October 23, 2022) in light of the safety concerns I raised. (https://www.cdc.gov/mmwr/volumes/71/wr/mm7144a3.htm?s_cid=mm7144a3_w)

Letter to the FDA


November 2, 2022


Dear Dr. Marks,


Below is a table reflecting the current status of my recent requests of the FDA regarding accurate and comprehensive reporting of adverse events to the Vaccine Adverse Event Reporting System (VAERS) in association with the investigational bivalent Covid-19 ‘vaccines.’ I appreciate the FDA’s action taken on two of four of the items. I would greatly appreciate your response as to the status of the remaining two items.


My Request to FDADate of My RequestFDA Response Back to Me (date)Status
“On one of the manufacturer’s websites, Pfizer’s in this case, directed by the EUA Fact Sheet for reporting, there is NO drop-down or specification for the bivalent vaccine product — the closest match is a static “COVID 19” vaccine option. Also, there is NO instruction to the Reporter to even write in the bivalent vaccine suspect product in any field, such as adverse event description”



09SEP2022“We will review and get back to you when we’re able.” (12SEP2022)


“For the concern about the Pfizer Safety Reporting Website, we have contacted the manufacturer to address this issue.” (15SEP2022)

Done (bivalent checkbox added to Pfizer’s online AE reporting form).
“In the online VAERS reporting instructions [Item 17], the Reporter is asked to “Select a U.S.-licensed vaccine if applicable; otherwise scroll down…and select “Other”:

Despite the bivalent drop-downs, this might present a conflict to some of the more conscientious reporters, resulting in “Other” being chosen over the bivalent option—data would be lost. It is also misleading in that it implies the bivalent vaccine is licensed.”





09SEP2022“We will review and get back to you when we’re able.” (12SEP2022)


“…we are working with our colleagues at CDC to modify the VAERS instructions to clarify that individuals should chose the specific vaccine name whether it be fully licensed or available under Emergency Use Authorization. “ (15SEP2022)

Done. Item 17 now reads: “Select a U.S.-licensed or authorized vaccine if applicable…”


“The VAERS online reporting form does not capture all prior covid-19 vaccine injections in the series (primary or booster) since the December 2020 deployment: only “Date of vaccination [Item 4]” and “Any other vaccines received within one month prior to the date of vaccination [Item 22]” are captured.”

“There is no way to collect product information to detect cumulative toxicity data from exposure of the various covid-19 vaccines since initiation in December 2020. Adverse events found to be dose-dependent and/or temporally related (such as myocarditis, vaccine-induced-immune thrombotic thrombocytopenia, etc…), may only be observed with a complete vaccination history (beyond one month).”

“As a solution, VAERS form “Item 22” might be edited to also include all prior covid-19 vaccinations, not just those within one month of item 4 (vaccination date associated with currently reported AE). Although the VAERS form is intended to be generic across all vaccines, due to the unique investigational phase of some of the covid-19 vaccines, as well as the requirement for ongoing safety studies even for the “original” products, it is imperative to immediately modify the VAERS form to include a special section, or special instructions, to capture vaccination history for a recipient’s entire covid-19 vaccine series.” https://vaers.hhs.gov/esub/EsubController

19SEP2022“We appreciate your comments and suggestions below, and have shared with the appropriate staff for consideration.” (21SEP2022)I don’t see evidence that this has been addressed.
“I have checked VAERS for the month of September to see if suspect bivalent Covid-19 vaccines were erroneously being reported [to VAERS by Moderna or Pfizer] under the monovalent (‘original’) “Vaccine Product” category.” “I found [… ] reports with “bivalent” in the AE Description that were categorized under the ‘original’ monovalent vaccine.” “[I]t’s critical to accurately capture the safety profile of the bivalent vaccine as compared to the ‘original’ monovalent vaccine.”


02OCT2022“Thank you for your message. We will look into this further.” (02OCT2022)I don’t see evidence that this has been addressed. As seen with the examples below, this appears to still be occurring.*


*VAERS ID: 2481257-1:


*VAERS ID: 2481090-1:




Carol Taccetta, MD, FCAP

The post A Drug Safety Physician’s Correspondence with the FDA: A Quest for Accuracy in Investigational Bivalent mRNA COVID-19 ‘Vaccine’ Adverse Event Reporting appeared first on DailyClout.

Polling Recap for Midterms

Voters See 2022 Midterm Election as Reckoning for Biden and Democrats

  • Two-Thirds of Americans Say Democrats Have Not Made a Case to Earn Votes in Midterms
  • Over 80 Percent of Voters Say Republicans Will Win Control of One or Both Chambers in Congress
  • 60 Percent of Independents Believe Their Friends and Family are Voting Republican in Midterms
  • 54.4 Percent of Voters Say Rising Gas Prices Will Make Them More Likely to Vote for Republicans in Midterm Elections
  • Nearly 70 Percent Say Skyrocketing Food Prices Motivating Them to Vote In Midterms

Large Majorities of Americans Openly Opposed to Progressive Policies from Democrats

  • Over 70 Percent of Americans Say They Won’t Vote for Candidate Who Supports Transgender Procedures for Youth
  • 77 Percent of Voters Say They’re Not Voting for Candidates Who Support Democrat Policies Preventing Police from Effectively Dealing with Violent Crime
  • 56 Percent Less Likely to Vote for Candidate Who Supports President Biden’s Student Loan Forgiveness Plan

Fallout Over Biden Admin and One-Party Rule from Democrats

  • Two-Thirds of Independents Believe Their Friends and Neighbors are Afraid to Say Who They Will Vote for in Midterms
  • Less Than One-Third of Voters Feel as Safe in America Today as They Did Two Years Ago
  • 59 Percent of Voters Say President Who Promised to Unite the Country has Instead Divided It
  • 62 Percent of IND and 89% of GOP Voters Called Biden Primetime Speech ‘Dangerous Escalation in Rhetoric,’ Believe it is Designed to Incite Conflict

Work Cut Out for Republicans: Voters Back Republican Ideas, But Not Leaders

  • Only 33.9 Percent of Voters Believe Republican Leader McCarthy Made a Strong Enough Case for Republicans to Earn Support in Midterms. But Majority Backs Republican Policies

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