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CDC Now Refusing New COVID Vaccine Adverse Event Reports In Its V-Safe Program

CDC Now Refusing New COVID Vaccine Adverse Event Reports In Its V-Safe Program

Authored by David Gortler via The Brownstone Institute,

The…

Published

6 months ago

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CDC Now Refusing New COVID Vaccine Adverse Event Reports In Its V-Safe Program

Authored by David Gortler via The Brownstone Institute,

The Centers for Disease Control and Prevention (CDC) V-safe website quietly stopped collecting adverse event reports with no reason or explanation.

The V-safe website simply states: “Thank you for your participation. Data collection for COVID-19 vaccines concluded on June 30, 2023.” If you go there today, V-safe directs users to the FDA’s VAERS website for adverse event reporting, even though officials continually derided VAERS as “passive” and “unverified.” 

VAERS and V-safe are mutually exclusive safety collection databases operated by the FDA and CDC, respectively. VAERS is an older way of collecting safety data where one can fill out a form online, or manually, or by calling a toll-free number, whereas V-safe is a device “app” which requires online registration. Both VAERS and V-safe collect personal information, lot numbers, dates and associated information, but V-safe was an active collection system geared towards a younger app-using demographic. 

Here is the last report before deletion.

Does this mean that the CDC believes that the mRNA Covid-19 injections are so safe, there is no need to monitor adverse event reports any longer? What is the argument against continued monitoring, especially since the V-safe website was already up and paid for? 

While CDC’s V-safe was stealthily and abruptly turned off, refusing to accept new safety reports, to this very day the CDC continues to urge everyone ages 6 months and older to stay up to date with COVID-19 vaccines and boosters. 

As a drug safety expert, I personally can’t cite another example of any agency or manufacturer halting collection of safety data. It seems even worse because mRNA technology is relatively new with long-term manifestations unknown. On top of this, both manufacturers and the FDA refuse to share the list of ingredients, such as lipid nanoparticles, which could affect individuals differently and take a long time to manifest clinically. 

Safety Data Collection Should Never Stop

Now, contrast that with the fact that the National Highway Traffic and Safety Administration (NHTSA) will still accept a safety report for a 30-year-old Ford Bronco II. Indeed, this is an oddly specific example, but only because I drove this exact vehicle as a family hand-me-down as a student, through my residency, fellowship, for my tenure as a Yale professor on the mean streets of New Haven and even during my years at the FDA as a medical officer /senior medical analyst. 

Like mRNA shots, Bronco IIs are still available on the market and people are still using them up to this very day. My Bronco became an intermittent topic of conversation with friends and FDA colleagues. One day, I was informed by a patrolling security guard at the FDA that it was the oldest car on campus.

I didn’t know much about cars (or mRNA technology) back then, but when a fellow FDA-er informed me that my Bronco II had noteworthy safety problems and that the NHTSA still had their eye on this vehicle (rollover accidents were more common and more fatal) I addressed the problem: I got rid of the reliable relic, even though I really liked it. 

NHTSA is still accepting safety reports on things like my 30-year-old Ford Bronco II, but the CDC isn’t accepting new safety reports on 2-year old novel mRNA vaccines.

CDC No longer accepting safety reports despite rapidly increasing safety findings:

Unlike my old Bronco, mRNA injections have only been on the market for about two years, and according to the FDA Vaccine Adverse Event Reporting System (VAERS) database, mRNA “vaccines” have been named the primary suspect in over 1.5 million adverse event reports, of which there are >20,000 heart attacks and >27,000 cases of myocarditis and pericarditis just in the USA alone. Worldwide numbers would be greater. According to many references, including an FDA-funded study out of Harvard, VAERS reports represent fewer than 1 percent of vaccine adverse events that actually occur. 

Interestingly, the NHTSA link above on my Ford Bronco II only shows: one parts recall, one investigation and 23 complaints, and still features a button in the upper right hand corner for submitting new complaints. 

Wikipedia defines an humanitarian crisis or humanitarian disaster as a: “singular event or a series of events that are threatening in terms of health, safety or well-being of a community or large group of people.” Based on VAERS and previous V-safe findings, adverse events from mRNA shots in the USA alone could be considered a humanitarian crisis. 

Despite those alarming clinical findings, the CDC has concluded that collecting new safety reports is somehow no longer in the interest of America’s public health. Existing data from the V-safe site showed around 6.5 million adverse events/health impacts out of 10.1 million users, with around 2 million of those people unable to conduct normal activities of daily living or needing medical care, according to a third-party rendering of its findings. In other words, despite mRNA shots still being widely available and the CDC promoting its continued use, it’s “case closed” with regards to collecting new safety reports, under today’s federal public health administration. 

Will the CDC opine on the existing data or justify its halting of collecting new safety data? To the best of my knowledge, stopping the collection of public health information doesn’t have a clinical justification or scientific precedence — especially when it comes to an actively marketed product. 

In George Orwell’s 1984, characters were told by The Party to “reject the evidence of your eyes and ears.” Now, the CDC isn’t even allowing that evidence to be collected for viewing (and prospective rejecting). It’s a terrible idea for any product, let alone novel mRNA technologies. 

Dr. David Gortler, a 2023 Brownstone Fellow, is a pharmacologist, pharmacist, research scientist and a former member of the FDA Senior Executive Leadership Team who served as senior advisor to the FDA Commissioner on matters of: FDA regulatory affairs, drug safety and FDA science policy. He is a former Yale University and Georgetown University didactic professor of pharmacology and biotechnology, with over a decade of academic pedagogy and bench research, as part of his nearly two decades of experience in drug development. He also serves as a scholar at the Ethics and Public Policy Center

Tyler Durden Tue, 08/29/2023 - 22:45

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate…

Published

3 hours ago

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March 9, 2024

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.

(Shutterstock)

A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.

Long COVID Patients Have Low Iron Levels

Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.

In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.

According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.

But it can jeopardize a person’s recovery.

“When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”

The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.

“It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”

The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.

1 in 5 Still Affected by Long COVID

COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.

Tyler Durden Sat, 03/09/2024 - 12:50

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Walmart joins Costco in sharing key pricing news

The massive retailers have both shared information that some retailers keep very close to the vest.

Published

5 hours ago

on

March 9, 2024

By

As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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Walmart has really good news for shoppers (and Joe Biden)

The giant retailer joins Costco in making a statement that has political overtones, even if that’s not the intent.

Published

6 hours ago

on

March 9, 2024

By

As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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