Tag Archives: Moderna

How Safe Is The Manufacturing Of The Vaccine?

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On Sunday (updated Monday), The Epoch Times posted an article about manufacturing violations in the production of the Moderna Covid-19 vaccine.

The article reports:

U.S. Food and Drug Administration (FDA) inspectors uncovered problems at a Moderna plant used to manufacture a substance that is part of the company’s COVID-19 vaccine, according to a newly released document.

Moderna failed to meet multiple requirements, including rules aimed at minimizing the potential for contamination, according to the document.

FDA inspectors performed inspections at the plant in Norwood, Massachusetts from, Sept. 11 to Sept. 21, visiting nine times in total.

They found that equipment used to manufacture the substance was not cleaned properly before usage, that a mock cleaning done for manufacturing did not adequately simulate the actual process, that written alarm procedures were not followed, and that neither the equipment nor the plant were designed in a way that would make contamination less likely.

Inspectors also learned that Moderna used materials beyond their expiration date.

“There are more than two thousand expired items stored in your … warehouse and cold storage at time of inspection,” Unnee Ranjan, the FDA’s lead investigator, wrote in a summary of the inspections.

The article concludes:

Another part of the FDA report, dated Sept. 21, described how the Norwood facility did not have adequately designed air handling systems to “assure appropriate air quality in the … cleanroom in which the mRNA drug substance is manufactured.”

Inspectors also said they found positive air pressure was not “consistently maintained” between cleanrooms and airlocks and that monitoring data showed the cleanroom pressure turned negative between January and September. That development was “not assessed for potential impact,” they said.

“At face value, it appears multiple controls designed to prevent contamination were deficient,” Mr. Lynn said.

Another recently released document, produced by the nonprofit Informed Consent Action Network on orders from a federal judge, showed the FDA detected in Andover, Massachusetts, issues with the manufacture of a substance used in the Pfizer-BioNTech vaccine. Pfizer said in response it had taken actions to correct the issues.

The government is still putting ads up on television encouraging Americans to take the vaccine, even after there have been numerous reports of serious side effects. Now we find out there are manufacturing problems also? It’s time for the Covid vaccine to go away.

 

 

Breaking Faith With Our Veterans

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This is a story you probably won’t hear anyone else. As the wife of a Navy veteran, I find it disturbing but not surprising.

On September 27th, Revolver posted the following (Shared from Twitter):

Working out at the gym this morning and a follower came up to say hi

He served in the Navy, is now 24 years old, and a very fit guy

Told me they forced him to take Moderna – he resisted but didn’t want to get discharged so he complied

Got myocarditis.

Navy discharged him anyway b/c his heart is so damaged

He’s applying for VA disability benefits and he said they’re pushing back on his vax injury saying it’s “not service related”

WHAT

This is the most heartbreaking and infuriating story I’ve heard in a long time

Not only have thousands of soldiers been severely injured by Biden’s unnecessary vax mandates, but now the VA is playing games with their livelihoods

Seeing the heartbreak in this guy’s eyes changed me

I’ll make this a core issue going into 2024 and beyond

We can’t un-inject these brave Americans, but we can certainly pay them for their injuries acquired against their will in service of our country.

It should be noted that 6 US Senators sent letter to Dept. of Veteran Affairs investigating why they’re denying disability claims for C19 vax injuries.

I will admit that I have my own gripe with the VA. My husband is a disabled veteran (nothing overly serious, but nevertheless disabled). He has access to the nearby base–commissary privileges, exchange privileges, etc. He is allowed to go on to the base to use these privileges. However, he is not allowed to bring me (his wife) on the base with him unless I get a day pass (which is a pain in the neck). This makes no sense to me. I am told it is for security purposes. Since when are wives of disabled veterans security risks. To me this is simply another example of a nation that drafted its young men into the service during the war in Vietnam and then turned its back on them.

 

Some Important Information On The Covid Booster

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On Thursday, Dr. Marty Makary and Tracy Beth Hoeg wrote an article for The New York Post about the new Covid booster. Dr. Makary is a health care expert at Johns Hopkins University.

The article reports:

Pfizer’s version, approved this week as well, also has zero efficacy data and has not been tested on humans at all. We only have data about antibody production from 10 mice.

The FDA, or Moderna (frankly, it’s hard to tell the difference sometimes), should disclose what happened to the patient who took the new vaccine and had a complication that required medical attention.

The public has a right to know.

The last time the Biden administration approved and recommended a novel COVID bivalent booster, last fall, with no human-outcomes data, it was an epic fail.

Only 17% of Americans took it (and some of those were forced to do so by their employer or school).

Not foreseeing such weak public support for the booster last year, the Biden administration had prepaid pharma $4.9 billion for 171 million doses — many of which were tossed in the wastebasket.

Now it is making the same mistake.

Two weeks ago, the Biden administration upped its orders for the pediatric version of the new COVID vaccines from 14.5 million doses at $1.3 billion to 20 million doses for $1.7 billion, which is more than four times as many pediatric doses as were used last year.

There clearly seems to be a special push this time to give it to children — the same group European regulators are not supporting.

In fact, the original Moderna vaccine was banned in parts of Europe for people under age 30.

European doctors are not alone.

Dr. Paul Offit, a vaccine-mandate supporter and FDA adviser from the University of Pennsylvania, told The Atlantic this week that he’s not going to take the new COVID vaccine.

He didn’t take the bivalent booster last fall either, despite being 72 years old.

While he disagreed with Jha on the booster, he recently confessed, “Yes, he was wrong, but you know you can’t say that exactly.”

Yes, you can.

The article also notes:

Unlike influenza, COVID-19 is constantly circulating, so there is ample opportunity to run a trial; indeed, Moderna already ran a randomized trial.

Its trial of just 50 people began four months ago and oddly only reported 14-day side effects.

Why didn’t it enroll more people in its trial? Why didn’t it report three-month effectiveness and do a proper trial?

Conducting a placebo-controlled trial in people during this time would not only yield useful information; it would enable further study of those subjects three and six months from now, when a winter surge may occur.

Let’s be honest: Follow-up studies of COVID vaccines in general have revealed a disappointing truth — mild efficacy against infection is transient, lasting just a few months.

Perhaps Pfizer and Moderna knew the FDA regulatory process was greased for them and they didn’t have to.

Please follow the link to read the entire article. Our government is not doing us any favors by encouraging Covid booster shots.

The Pfizer Trials Of The Covid Vaccine Were Rigged

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On Tuesday, The Conservative Review reported the following:

According to new provisional data from the Scottish government, there were 7,314 deaths registered in January 2023, an increase of 17.7% compared to the average of 6,212. For the second week of January, there were more deaths in Scotland than ever before, including during the peak of the pandemic. Concurrently, there were 4,159 births registered in January 2023, a decrease of 6.8% compared to the average of 4,463. In other words, between a dearth of births and a plethora of deaths, there were roughly 1,400 fewer souls, the equivalent of roughly 86,000 in the United States. This is long after COVID. Why is there zero concern?

What on earth will it take to pull these death shots from the market?

Die Welt, a paper based in the home country of Pfizer partner BioNTech, revealed last week in a long expose what many of us have long known. All those sudden deaths, heart attacks, and strokes we’ve been witnessing over the past two years were indeed observed during the Pfizer clinical trial that supposedly showed the shots to be 100% safe and effective. The company simply covered up the severe adverse events by kicking those participants out of the trial and/or suggesting without evidence that the deaths had nothing to do with the experiment.

So why is our government still encouraging people to get Covid shots?

The article concludes:

Amid all the existential threats to our security, civilization, culture, and economy – and there are certainly many – can you think of anything that matches the severity of this issue? From died suddenly to plummeting birth rates, how is the vaccine issue not the top concern of all public policy, given that it was injected in 5.5 billion people and officials are on the cusp of approving more mRNAs? So we’re now supposed to believe Moderna’s own published phase 3 trial results of its RSV shot that it’s 84% effective and absolutely no serious adverse events occurred? Within months, if we don’t stop it, this shot will be in the arms of every senior and then, eventually, in the arms of every newborn baby.

After Pfizer purposely fabricated its clinical trial, the company must now be on the hook for a different sort of trial – one Steve Deace and I lay out in “Rise of the Fourth Reich.” Unless we begin holding pharma companies accountable and erecting legal firewalls to protect the people from their endless experimentation, they will do this again and again.

Please follow the link above to read the entire article. It lists specific instances of serious consequences from the vaccine.

Shouldn’t They Have Done This First?

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On Sunday, The Conservative Review reported:

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on Dec. 11, 2020. A week later, the FDA issued an EUA for Moderna’s COVID-19 vaccine. Now, nearly two years later, Pfizer and Moderna will launch clinical trials to track adverse health issues stemming from the COVID-19 vaccines, such as myocarditis – inflammation of the heart muscle.

Pfizer is in the infancy of beginning clinical trials to determine if there are any health risks associated with their own vaccine. In a partnership with the Pediatric Heart Network, the trial will focus on vaccine recipients who have suffered heart issues following being jabbed with the COVID-19 vaccine. The clinical trials will monitor patients for five years.

Enrollment for the study in the U.S. and Canada has not started yet. However, the research team has already identified more than 250 patients with myocarditis, according to Dr. Dongngan Truong – a pediatrician at the University of Utah Health and a co-lead on the Pfizer study.

NBC News reported on Friday, “The team will also compare the patients to a subset of patients with multisystem inflammatory syndrome in children, also known as MIS-C, which is associated with a COVID infection.”

The article concludes:

In July 2021, the Centers for Disease Control and Prevention (CDC) released a report that stated: “An elevated risk for myocarditis among mRNA COVID-19 vaccinees has been observed, particularly in males aged 12–29 years.”

The report found, “Myocarditis reporting rates were 40.6 cases per million second doses of mRNA COVID-19 vaccines administered to males aged 12−29 years.”

The CDC added, “Myocarditis and pericarditis have rarely been reported. When reported, the cases have especially been in adolescents and young adult males within several days after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna).”

In April, an Israeli large-population study of 196,992 unvaccinated adults who were post-COVID-19 infection were “not associated with either myocarditis or pericarditis.”

“We did not observe an increased incidence of neither pericarditis nor myocarditis in adult patients recovering from COVID-19 infection,” the authors wrote.

I believe that the federal government wants to include the Covid vaccine in its list of vaccines required for children to attend school. Until this study is completed, that is not a good idea.

This Isn’t Working The Way It’s Supposed To Work

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This is one of those articles I don’t claim to understand, but I am posting it because I think it is important.

On Wednesday, The Epoch Times posted an article based on information about the Covid-19 vaccine. The information was provided by Dr. Harvey Risch.

The article reports:

The antibodies triggered by COVID-19 vaccines are interfering with people’s immune systems as newer virus variants emerge, Dr. Harvey Risch said.

The two most widely-used vaccines in the United States, produced by Pfizer and Moderna, both work by sending messenger RNA into muscle cells, where they produce a piece of the spike protein from the virus that causes COVID-19. The spike protein triggers the production of antibodies, which are believed to help prevent infection by SARS-CoV-2, which causes COVID-19, and fight illness if one still gets infected.

But the vaccines are based on the spike protein from the original virus variant, which was displaced early in the pandemic. Since then, a series of newer strains have become dominant around the world, with the latest being BA.5.

“The vaccines only make a very narrow range of antibodies to the spike protein,” compared to the broader exposure experienced when one gets infected, Risch, an epidemiology professor at the Yale School of Public Health, told EpochTV’s “American Thought Leaders.”

“The problem with that is, of course, that when the spike protein changes because of new strains of the virus, that the ability of the immune system to make antibodies that correlate to the new strains becomes reduced to the point where it may be almost ineffective over longer periods of time,” he added.

That leads to the antibodies being triggered by the vaccines not binding strongly enough to neutralize.

“What that means is they become interfering antibodies, instead of neutralizing antibodies,” Risch said. “And that’s the reason I believe that we’ve seen what’s called negative benefit—negative vaccine efficacy over longer time—over four to six to eight months after the last vaccine dose, that one sees the benefit of the vaccines turn negative.”

A number of recent studies have indicated that people who were vaccinated are more likely to get infected with COVID-19 after a period of time, including Pfizer’s clinical trial in young children (pdf). Some real-world data also show higher rates of infection among the vaccinated. Other research indicates vaccines still provide some protection as time wears on after getting a shot, but the protection does wane considerably. The research all deals with the Omicron variant, which became dominant in late 2021, and its subvariants.

Please follow the link to read the entire article. The bottom line is fairly simple–the vaccine over time creates more problems than it solves. Studies in other countries are now finding that because the Covid virus has mutated, vaccinated people are more likely to get the virus than those with natural immunity. We don’t seem to know as much as we think we do.

Now They Tell Us

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On Monday, Townhall posted an article with the following headline:

CDC Makes Major Admission About Rushed Vaccine Timeline and Heart Inflammation

The article explains:

The Centers for Disease Control is considering changing the timeline for the administration of a second Moderna and Pfizer Wuhan coronavirus vaccine dose. The consideration comes after a rushed timeline caused heart inflammation in a number of patients. 

“Dr. Sara Oliver, an official at the U.S. Centers for Disease Control and Prevention (CDC), said the agency was considering making the recommendation for Moderna (MRNA.O) and Pfizer (PFE.N)/BioNTech shots during a meeting of the Advisory Committee on Immunization Practices, a panel of outside advisers to the CDC,” Reuters reports.

Currently, the CDC recommends individuals receive their second dose of the Moderna and Pfizer vaccines three and four weeks after an initial dose. The government agency may now recommend a second dose eight weeks after the first. 

In October a number of European countries limited Moderna’s use due to an alarming number of myocarditis cases. 

The article concludes:

Meanwhile an Oxford University study show the risk of myocarditis for young people is higher from the vaccine than it is from natural infection.

…”In under 40-year-old people…dose two of Moderna has exceeded the risk of myocarditis after infection with a second dose,” Dr. Vinay Prasad said about the study. “There have been many people who have been reluctant to take serious the risks of myocarditis after the Moderna product.”

“If you’re under 40 and if you pool men and women together, there is more myocarditis associated with dose two of Moderna than there is with an infection. That is a bombshell finding,” he continued.

This is information that anyone who has not yet taken the shot needs to know. This is also information that should end the vaccine mandates if indeed we are going to ‘follow the science.’

Following The Science

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On Friday, PJ Media posted an article about the dangers of giving the Covid vaccines to children.

The article reports:

If you’re a parent of young children and are feeling pressure to get them vaccinated against COVID, I urge you to stand firm.

Or move to Sweden.

Health officials in Sweden have decided against recommending COVID vaccines for kids aged 5-12, arguing that the benefits don’t outweigh the risks.

“With the knowledge we have today, with a low risk for serious disease for kids, we don’t see any clear benefit with vaccinating them,” Health Agency official Britta Bjorkholm said Thursday.

Studies have shown that the Moderna and Pfizer vaccines are more likely to cause myocarditis in young men than natural infection from COVID.

Kids in high-risk groups can get the vaccine, and Swedish health official could change their recommendations in the future if a new variant makes it worthwhile.

Imagine that? A nation that is following the science, not promoting fear. I’m guessing that health officials in Sweden did what conservative pundits have been doing in the United States for two years now: looked at the data. The data shows that COVID is less deadly to kids than the seasonal flu. Also, a recent study out of the United Kingdom found that unvaccinated kids are at a lower risk of death from COVID than fully vaccinated adults of any age.

Evidently the ruling class in Sweden is not in the pocket of the big pharmaceutical companies.

Follow The Money

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As I have previously stated, I have wondered why the emphasis in dealing with the coronavirus is on vaccines (and now booster shots) rather than treatments and the natural immunity people have from having recovered from the virus. I think I have found at least part of the answer to that question.

One America News posted an article today with the following headline, “Pfizer, Moderna seen reaping billions from COVID-19 vaccine booster market.”

The article reports:

Drugmakers Pfizer Inc, BioNTech and Moderna Inc are expected to reap billions of dollars from COVID-19 booster shots in a market that could rival the $6 billion in annual sales for flu vaccines for years to come, analysts and healthcare investors say.

For several months, the companies have said they expect that fully inoculated people will need an extra dose of their vaccines to maintain protection over time and to fend off new coronavirus variants.

Now a growing list of governments, including Chile, Germany and Israel, have decided to offer booster doses to older citizens or people with weak immune systems in the face of the fast-spreading Delta variant.

Late on Thursday, the U.S. Food and Drug Administration authorized a booster dose of vaccines from Pfizer Inc and Moderna Inc for people with compromised immune systems.

Pfizer, along with its German partner BioNTech, and Moderna have together locked up over $60 billion in sales of the shots just in 2021 and 2022. The agreements include supply of the initial two doses of their vaccines as well as billions of dollars in potential boosters for wealthy nations.

Going forward, analysts have forecast revenue of over $6.6 billion for the Pfizer/BioNTech shot and $7.6 billion for Moderna in 2023, mostly from booster sales. They eventually see the annual market settling at around $5 billion or higher, with additional drugmakers competing for those sales.

The vaccine makers say that evidence of waning antibody levels in vaccinated people after six months, as well as an increasing rate of breakthrough infections in countries hit by the Delta variant, support the need for booster shots.

Some early data suggests that the Moderna vaccine, which delivers a higher dose at the outset, may be more durable than Pfizer’s shot, but more research is needed to determine whether that is influenced by the age or underlying health of the people vaccinated.

As a result, it is far from clear how many people will need boosters, and how often. The profit potential of booster shots may be limited by the number of competitors who enter the market. In addition, some scientists question whether there is enough evidence that boosters are needed, particularly for younger, healthy people. The World Health Organization has asked governments to hold off on booster shots until more people worldwide receive their initial doses.

The article concludes:

There’s still a lot of uncertainty around how boosters would be rolled out in the United States. Still, it is possible or even likely that people will be boosted with different vaccines than they were originally vaccinated with. The National Institute of Allergy and Infectious Diseases is already testing mixed boosting, and other countries that have used so-called mix and match vaccination have not had problems with that strategy.

One factor that could curb prices is if the U.S. government continues paying for most or all of the shots administered in the country, rather than leave it in the hands of private health insurers. In that scenario, the government would still be negotiating prices directly with vaccine makers, and could use its buying power to stave off price increases.

Bijan Salehizadeh, managing director at healthcare investment firm Navimed Capital, said the U.S. government is likely going to want to keep paying in order to keep vaccination rates high and prevent new COVID surges, particularly if a Democratic administration is still in power.

“It’s going to be paid for until the virus disappears or mutates to be less virulent,” Salehizadeh said.

Whatever happened to herd immunity?

The Dog Ate My Homework

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Yesterday The Conservative Treehouse posted an article with the following headline:

What!?

The article reports:

The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine.  However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated.  Almost all the control group were then given the vaccine.

Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues.  Without a control group there is nothing to compare the vaccinated group against.  According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:

(Via NPR) […] “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.

“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.  “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots. (read more)

The article notes:

Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials.  As noted in the example above, the control group was intentionally lost under the auspices of  “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.

There’s no one left within the control group, of a statistically valid value, to give an adequate comparison of outcomes for vaxxed -vs- non-vaxxed.

Whiskey – Tango – Foxtrot !!!  This is nuts.

That NPR article is one to bookmark when people start claiming the vaccination is effective.

How can the vaccine not be considered effective when there is no group of non-vaccinated people to compare the results to?

Somehow I don’t believe this fits the requirement of “follow the science.” Please follow the link to read the entire article. We are definitely being played.

We Can Expect More Of This In The Future (Unfortunately)

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Yesterday The New York Post posted an article about the Port Washington High School Senior Prom. The prom will host about 500 people at the Village Clubs of Sandpoint.

The article notes some of the rules for the event:

Forget popular kids and dorks — seniors at one Long Island high school dance will be divided by whether they are vaccinated or unvaccinated against COVID-19, The Post has learned.

The school said that, per state and CDC guidelines, kids who are vaccinated will be able to attend maskless — while those who aren’t will need to wear a face covering.

Students will need to show proof of inoculation to attend mask-free, and will be given wristbands to signify they’ve gotten the jab, Dr. Ira Pernick, the school’s principal, said in a video sent to the senior class this week and seen by The Post.

In addition to wearing masks, those who haven’t been vaccinated will need to show proof of a negative COVID-19 test before the party, Pernick said.

The article concludes:

The state Department of Health said that their implementation of the CDC guidelines “does not require vaccinated and unvaccinated attendees to remain in separate sections.”

Dr. Michael Hynes, superintendent of the Port Washington Union Free School District, said the year-end celebration was adhering to all state Health Department and federal rules.

“The health and safety of our students, staff and community are the Port Washington School District’s foremost priorities,” Hynes said in a statement. “The district is in close contact with local and state health officials and will continue to regularly monitor any changes in guidance.”

It should be mentioned at this point that none of the vaccines have full FDA approval at this time. The vaccines are approved for emergency use only. Pfizer and BioNTech have already started their application process for full U.S. approval of their Covid-19 vaccine. Rival Moderna is expected to submit for the same process for its shot later this month. Why are we in such a rush to put these vaccines into school populations when school populations are the least impacted by the virus?

 

Wait! What?

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Just the News posted an article yesterday about Pfizer’s coronavirus vaccine.

The article reports:

With three promising vaccines for COVID-19 in the pipeline, there’s still uncertainty about how effective they will be.

Albert Bourla, chairman and CEO of Pfizer Pharmaceutical – which has applied to the Food and Drug Administration for emergency use authorization for its vaccine – sat down with CBS’s Lester Holt on “Dateline NBC” for an interview that will air Thursday night.

Holt said: “And then what about the question, Albert, of even though I’ve had the protection, am I still able to transmit it to other people?” according to transcript provided by the network.

“I think this is something that needs to be examined,” Bourla said. “We are not certain about that right now with what we know.”

Biotech firm Moderna on Monday said it will ask the FDA to approve its experimental COVID-19 vaccine for emergency use. Moderna said new data showed the vaccine was 94.1% effective in its late-stage clinical trial, just under Pfizer’s efficacy rate of 95%. The Moderna vaccine was developed in conjunction with the Trump administration’s Operation Warp Speed.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death,” Moderna CEO Stéphane Bancel said in a statement. Bancel said last week that 20 million doses will be available by the end of the year.

So the vaccine can prevent a person from getting the coronavirus, but the manufacturers are unsure if it will prevent a person from spreading the coronavirus. I wonder if they know how long the vaccine will last. I am asking these questions because I have had the coronavirus. I have been told that I should be immune to the virus for an unspecified amount of time and that there are questions as to whether I can transmit the virus while being immune to it. I have also been told that if I decide to get the vaccine, I should wait at least 90 days from the time I recovered from the virus. Frankly, at this point, I am not convinced that the vaccine is going to get the result that is needed. It is probably a good idea for people who have not had the coronavirus to get the vaccine–at least that will slow if not stop the spread-but how long will that protection last and how thorough is the protection provided by the vaccine?