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Jan. 14, 2022 - Epoch Times
19:31
Regulators Probe ‘Rare and Serious’ Blood Clots; FDA Recalls 2M Tests Over False Positives
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Good evening.
Over in Europe, the European Medicines Agency, which is their equivalent to our FDA, they have just confirmed that they are currently in the process of investigating a rare and serious blood condition which has arisen in people who have received the Moderna vaccine.
And frankly, this is not the only challenge that Moderna is currently facing.
That's because four days ago, the French Health Authority, they released a new public advisory recommending that anyone under the age of 30 should not get the Moderna vaccine since there is a heightened risk for heart inflammation.
And then lastly, the FDA here in America, they have just announced a major recall of over 2 million at-home COVID tests because apparently they were producing false positives, meaning that the people who are taking them, they were being told that they were positive for COVID when they actually weren't.
Let's go through it all together.
This is your daily Facts Matter update, and I'm your host, Roman, from the Epoch Times.
And now let's begin today's discussion by talking about Moderna.
Just yesterday, on Thursday, the EMA, which is the European Medicines Agency, they are the large drug regulator for the European Union.
Essentially, they are the European Union's version of the FDA, and they just confirmed that they are in the process of investigating reports of a rare and serious blood condition that has arisen for people who have taken the Moderna mRNA vaccine.
Specifically, according to this bulletin right here that they posted over on the official EMA website, they said that they are currently in the process of reviewing six cases of this very rare disorder.
Here is what the bulletin says in part.
We have started a review of a safety signal to assess reports of capillary leak syndrome in people who are vaccinated with spike vax.
Now, just to pause here for a quick moment, I wanted to mention two things.
First of all, this statement mentions something called SpikeVax, and in case you're not aware of what that is, that is the official name of the Moderna vaccine that's being used over in Europe at this moment.
It's the name it's being sold under, SpikeVax.
And then secondly, in terms of what exactly capillary leak syndrome actually is, here's how the Mayo Clinic website describes it.
"...a rare disorder characterized by repeated flares of massive leakage of plasma from blood vessels into neighboring body cavities and muscles." This results in a sharp drop in blood pressure that, if not treated, can lead to organ failure and death.
And so obviously, capillary leak syndrome is a very serious condition.
So then this bulletin continues, quote, Now, to pause here for another quick moment, this UDRA Vigilance database that is mentioned here in the statement, that is essentially the European Union's equivalent to America's VERA system, which stands for the Vaccine Adverse Event Reporting System.
And so essentially, this is the database which collects all the reports of adverse reactions to the vaccine.
And this bulletin states that the European Union equivalent of this database, they have been getting reports of this capillary leak syndrome in connection with the Moderna vaccine.
And then this bulletin continues, quote, These reports point to a safety signal, information on new or changes in adverse events that may potentially be associated with a medicine or vaccine and that warrant further investigation.
Furthermore, this report then goes on to say that if you go on over to the website for the Udra Vigilance database and you make a search for COVID-19 mRNA vaccine with the specific serial number for the Moderna SXO24414, if you actually go do that, then you can see all of these specific side effect cases that have been reported for spike vacs.
And according to this database, as of October 28th, you have more than 61.6 million doses of spike vax having been given to people in the EU, the European Union.
And in terms of the adverse reactions, there is currently a total of 94,636 cases of suspected side effects that have been reported to this database, with 549 of them having a fatal outcome.
It's worth noting that this bulletin that was released by the European Medicines Agency just a few days ago, it suggests that people should not look at that data and just jump to conclusions.
Here's specifically what they said about these adverse reactions that were noted in the database.
These reports describe suspected side effects in individuals, i.e. medical events observed following the use of a vaccine.
The fact that someone has had a medical issue or died after vaccination does not necessarily mean that this was caused by the vaccine.
This may have been caused, for example, by health problems not related to vaccination.
This report then goes on to say that they are constantly investigating these reports from this database, which, as we mentioned earlier, now includes cases of capillary leak syndrome.
And by the way, it is also worth noting that this, meaning this statement, is not the first time that capillary leak syndrome has been detected within those who have gotten vaccinated.
That's because earlier this year, back in June, the same agency, this EMA agency, they actually officially added capillary leak syndrome as a potential side effect of the AstraZeneca vaccine.
Meaning that although they are currently investigating this in regards to the Moderna vaccine, they have already recognized that the AstraZeneca vaccine has the potential to cause capillary leak syndrome.
And by the way, it's not just in the European Union either.
That's because earlier this year, the Canadian Health Agency, they likewise updated their label for the AstraZeneca vaccine, and they added capillary leak syndrome as a possible side effect.
Meaning that if you are either a European citizen or you're a citizen of Canada and you have a history of this particular ailment, then there is an actual label.
There's a warning label that has been added by the government suggesting that you should not take the AstraZeneca vaccine because you can develop capillary leak syndrome and potentially die.
And depending on how this investigation goes over in Europe, perhaps the Moderna vaccine will get a similar warning label as well.
Only time will tell.
However, regardless of this and any other potential side effects, the EMA released a statement just yesterday saying that the benefits of the Moderna vaccine outweigh any potential risks.
Here's in fact what that statement said.
Like all medicines, this vaccine can cause side effects, although not everybody will experience them.
The most common side effects known for Moderna's vaccine are usually mild and moderate and get better within a few days after vaccination.
Now, we here at the Epoch Times, we did reach out to Moderna for comment on this case, but we have yet to hear back.
Regardless, if you'd like to read more about this capillary leak syndrome as it relates to the Moderna vaccine, I'll throw several links to it into the description box below this video so you can check them out at your own leisure.
And I'll ask in return is that you take a quick moment to smash, smash, smash that like button for the YouTube algorithm.
And now, before we move on over and discuss how the French Health Authority has just recommended that all young people, those who are under the age of 30, avoid taking the Moderna vaccine altogether, I would like to take a quick moment and introduce our sponsor for today's episode, which is an awesome company called Pfizer.
Nah, I'm just kidding.
I'll introduce our real sponsor quickly from the sound booth.
That's right, Roman.
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And so what they say is that as our fundamental freedoms here in this country are being threatened by politicians who don't even necessarily know how to balance their own checking accounts, And as there is a concerted effort to censor conservatives by this woke ideology, one thing that you can do to fight back is to join the two million people who are already members of AMAC. And by joining, you'll have access to three main benefits.
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So, AMAC, thank you so much for sponsoring this episode.
Now, Roman in the studio, back to you.
Now, since we're on the topic of Moderna, let's move on over to the nation of France.
Four days ago, France's health authority, they released a new public advisory which recommends that young people, those under the age of 30, should not get the Moderna vaccine at all, and instead, they recommend that young people get the Pfizer vaccine instead.
The reason for this particular recommendation is that according to newly released data, it shows that the risk of heart inflammation from the Moderna vaccine is around five times higher than from the Pfizer vaccine.
Here's specifically what the French Health Authority published on their official website.
Within the population aged under 30, this risk appears to be around five times lesser with Pfizer's Comirnaty jab compared to Moderna's Spikevax jab.
And then, more specifically, according to the data that they cited in their opinion statement, cases of myocarditis, which is this particular type of heart inflammation, it usually manifests within seven days of getting the shot, and typically it comes after the second dose has been administered.
In the data, it shows that most of the patients who experience it are men under the age of 30.
Furthermore, this new guidance from the French Health Authority is not an isolated incident.
Instead, it is the latest in similar pushback that the Moderna vaccine has been receiving from around the world.
For instance, last month, the health officials in several Nordic countries, including in Finland, Norway, Sweden, and Iceland, they suspended the use of the Moderna vaccine for young people due to the risk of them developing myocarditis as a possible side effect.
Now last month we did a more in-depth report about these four Nordic countries' decision.
In fact, here is a short excerpt from that particular report.
For instance, in both Denmark as well as Sweden, they paused the Moderna vaccine for anyone under the age of 30.
Here's in fact a statement from the Swedish Health Agency which explains their reasoning.
We've decided to pause the use of Moderna's vaccine, Spikevax, for everyone born in 1991 and later for precautionary reasons, given that there is an increased risk of side effects such as inflammation of the heart muscle or heart sac.
Likewise, over in Finland, health officials there said that males under the age of 30 should not receive the shot.
Here's a statement from the director of the Finnish Health Institute.
A Nordic study involving Finland, Sweden, Norway, and Denmark found that men under the age of 30 who received Moderna spike vax had a slightly higher risk than others of developing myocarditis.
And then over in Iceland, well, they took a more hardline stance.
That's because the health authorities over in Iceland, they suspended the use of the Moderna shot altogether for people of any age.
Here's a statement from the Icelandic director of health.
As the supply of the Pfizer vaccine is sufficient in the territory, the chief epidemiologist has decided not to use the Moderna vaccine in Iceland.
This move was handed down due to the increased incidence of myocarditis and pericarditis after vaccination with the Moderna vaccine, as well as with vaccination using Pfizer or Biotech.
And so, as you can see by the statements that were given by these different Nordic countries, they have either partially or completely suspended the use of the Moderna vaccine due to the risk of developing heart inflammation that is especially present for young people.
However, the irony of all this is that as these different countries are reining in the use of the Moderna vaccine in young people, Moderna itself, Moderna the company, is actually pushing for the European EMA to authorize their vaccine for kids between the ages of 6 to 11.
Let me just repeat that.
As the French Health Authority is suggesting that people under the age of 30 should not even take the Moderna vaccine, as Sweden has stopped providing the Moderna vaccine to anyone born after the year 1991, as Denmark has just stopped distributing it to anyone under the age of 18, Moderna is still pushing ahead, and they are requesting that the EMA authorize their vaccine to be marketed to children between the ages of 6 to 11 years old.
Here's in fact a statement from Moderna's CEO on their authorization bid.
We are pleased to announce the submission of this variation to the EMA for use of our COVID vaccine in children ages 6 to 11 in the European Union.
This marks our first submission for the use of our vaccine in this age group.
We are encouraged that the Moderna COVID vaccine at the 50 micrograms dose level help prevent SARS-CoV-2 infection in children.
We plan to submit this data to other regulatory agencies around the world to protect this important younger age population with our COVID-19 vaccine.
However, it's not exactly clear whether the EMA will actually authorize this application.
Because for one, according to this earlier statement that we read about capillary leak syndrome, it has a whole other section about myocarditis and pericarditis, and they are requesting more data from Moderna in order to evaluate whether these two heart inflammation cases are in fact serious in teenagers.
And then secondly, as the European Union is considering whether or not to authorize the Moderna vaccine for children over here in America, the FDA is currently investigating whether the Moderna vaccine can cause heart problems in teenagers.
Specifically, whether it can cause inflammation of the heart muscle, otherwise, as we mentioned earlier, known as myocarditis.
And so we'll just have to wait and see what these different regulators, both in Europe as well as here in America, will decide to do.
If you'd like to read more about either the French health authorities' recommendation or about Moderna's bid to get approval to vaccinate European children, I'll throw all that into the description box below this video for you to check out.
And I'll ask again in return, if you haven't already, take a quick moment to smash that like button for the YouTube algorithm.
And now let's move on over and talk about COVID test kits.
Now, imagine this scenario for a quick moment.
For some reason, you need to take a COVID test.
Maybe you need to travel somewhere, or you have some kind of a gig lined up, and you need to take a test, but it's not a big problem.
You just go over to the pharmacy, you buy an at-home test kit, you give yourself a nasal swab, you wait 15 minutes, and then lo and behold, you test positive for COVID. You look at it and you think to yourself, that's weird, I don't really feel sick, I haven't really been anywhere within the last week or the last month, I haven't really been hanging out with people who are positive for COVID, and yet I'm tested positive.
So therefore you think to yourself, maybe this is a mistake.
And in fact, if you were using the Illume brand COVID test, it very well might have been.
That's because this company is now facing a major recall.
Now, about a month ago, we already reported that about 200,000 Illum brand COVID tests, they were recalled because they were producing false positives.
However, just earlier this week, just two days ago, the FDA came out and they revealed that they are now actually recalling over 2 million of these at-home Illum brand COVID tests because they were once again producing false positives.
In their statement...
The FDA identified this as what they refer to as a Class 1 recall, the most serious type of recall, as use of these tests may cause serious adverse health consequences or even death.
In their statement, the FDA added that the reason this is so serious is because these false positives They can lead to, for one, a delayed diagnosis or treatment of the actual cause of a person's illness, as well as potentially receiving unnecessary COVID treatments, which might lead to serious side effects.
Now, the tests in this particular recall, they include those that were manufactured between February 24th and August 11th, and then they were distributed between April 13th and August 26th.
Meaning, essentially, that if you purchased an Illume brand COVID test sometime between April and August, then your test, the one that's sitting in your cupboard, is included in the recall.
Now, to give you a bit of background on this particular case, this company, Illum, is actually an Australian manufacturer, and back in December, December of 2020, they were given emergency use authorization to sell at-home COVID tests here in America.
And then, shortly after they were given that authorization, the Biden administration signed a $231 million deal with this company in order to produce over 633,000 tests every single day.
However, it looks like out of the 3.5 million test kits that they shipped here to America, thus far, 2 million of them, or close to 60% of these tests, they are now being recalled.
And in terms of how this all affects the COVID statistics in this country, meaning how many of these false positives have been added to the tally, well, that is not exactly clear.
However, here's a statement from Illum's CEO. We understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Illum to help them manage their health and to take back a bit of control of their lives during this pandemic.
In that same statement, the CEO also mentioned that they have now corrected their manufacturing issues and they are being closely monitored by federal regulators.
And along that line, here is a statement from the FDA. The FDA is continuing to work with Ellume to assess the company's corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue and to help ensure that it is resolved and will not recur.
And frankly, I can imagine that the executives over at this company, over at Allume, they are likely biting their nails.
That's because just last month, the White House announced that they're going to be earmarking an additional $1 billion in order to get more at-home test kits to Americans.
Meaning that if Allume is not able to fix their manufacturing issues, they will lose access to those sweet, sweet federal dollars.
If you'd like to read more about this particular Illum recall, including a list of the serial numbers for the effective tests, that way, in case you have any of them at home, you can check to see whether they are on the recall list.
I'll throw all that into the description box below this video for you to check out.
And again, all I ask in return is that if you haven't already, take a quick moment to smash, smash, smash that like button.
Now lastly, since you've completed this episode of Facts Matter, I would highly recommend that you go on over to Epic TV and check out an awesome, awesome episode of Counterpunch with Trevor Loudon, where Trevor examines why bona fide security risks are leading the congressional investigation into the January 6th quote-unquote insurrection.
Here's a trailer for that awesome episode.
In July this year, the U.S. House of Representatives set up a special committee, the House Select Committee, to investigate the January the 6th attack.
Is it going to be an honest assessment, or is it going to be used as an excuse to clamp down on conservatives, Trump supporters, etc.?
Well, if you look at the composition, the leadership of this committee, one would have to have some suspicions.
Schiff has worked closely with the Committee of 100.
Now that was set up in the early 90s by Henry Kissinger to serve as a lobby group for communist Chinese interests in this country.
I think this select committee is being designed to give the Democrats, the left, the communists an excuse to crack down on their opposition.
What do you think?
If you want to check out that phenomenal episode, as well as all the other great content over on Epic TV, I'll throw a link to it.
It'll be right there at the very top of the description box.
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