Tag Archives: TGA

Is The EU Cancelling COVID-19 Vaccines In October 2021?

Is The EU Cancelling COVID-19 Vaccination In October?

Is the EU planning to cancel COVID-19 vaccination in October, after approving FIVE therapies for the coronavirus?

Take a look at the viral claim, and find out what the FACTS really are!

 

Is The EU Cancelling COVID-19 Vaccination In October?

This article has gone viral on WhatsApp, claiming that the EU (European Union) is going to cancel COVID-19 vaccination in October, after approving FIVE therapies for the coronavirus!

It also claims that ivermectin has been scientifically recognised as an effective treatment and prophylaxis of COVID-19 by the Pasteur Institute.

It’s a long article, so just skip to the next section for the facts!

DISTRIBUTE TO EVERYONE who does not want to be “vaccinated”. All vaccines will no longer be justified from 20.10.2021: verified information. The European Union has approved (https://ec.europa.eu/commission/presscorner/detail/fr/ip_21_3299) 5 therapies that will be available in all hospitals in the Member States for the treatment of Covid.

These therapies have been approved by a decree of the European Council (European Parliament) and will be in force from 1/10, so they will be distributed little by little around 20/10. Vaccines were approved on a “temporary experimental basis”. But since the decree will oblige to prescribe these 5 new drugs, the use of the vaccine will cease.

 

Truth : The EU Is NOT Cancelling COVID-19 Vaccination At All!

This is yet another FAKE STORY written by anti-vaxxers in their bid to discourage people from protecting themselves with the COVID-19 vaccines.

Here are the FACTS…

Fact #1 : The EU Press Release Is Available In English

It is instructive to note that the fake article offers a link to the EU press release in French, even though there is an English version.

Whoever wrote the fake article intentionally gave you the French press release, so you won’t be able to read the press release and discover that it’s just fake news.

Fact #2 : They Are Potential Treatments For COVID-19

If you read the EU press release in English, you will realise that what the viral article claimed is COMPLETELY FALSE.

The press release, which was published on 29 June 2021, only announced that the EU had identified the first five therapeutics that have “a high potential” to be approved later.

Nowhere in the press release was it stated that ANY of the five therapeutics were approved.

Fact #3 : The EU Has Not Approved Them

The EU press release stated that these five therapeutics had a high potential to be among the three new COVID-19 therapeutics to receive authorisation by October 2021

  • the immunosuppressant, baricitinib
  • the monoclonal antibody combination of bamlanivimab and etesevimab
  • the monoclonal antibody combination of casirivimab and imdevimab
  • the monoclonal antibody, regdanvimab
  • the monoclonal antibody, sotrovimab

However, the EU has NOT approved any of those five therapeutics for use against COVID-19, of 24 September 2021.

There is no “decree of the European Council” that approved these therapeutics.

So they are unlikely to be in use in October 2021, as the fake article claimed.

Read more : EU Digital COVID Certificate – A Comedy Of Errors!

Fact #4 : Approval Does Not Mean Obligation

Even if any of those five therapeutics are eventually approved by the EU for use against COVID-19, there is NO OBLIGATION to administer them.

It is left to the treating doctor to decide whether to prescribe it to the patient, or not. The patient, of course, can accept or refuse the therapeutic.

Fact #5 : COVID-19 Vaccines Will Remain In Use

Even if new treatments can be found for COVID-19, vaccines will remain in use as the first line of defence.

That’s because they PREVENT people from getting COVID-19, thereby negating the need for hospitalisation and treatment.

Therapeutics are also MORE expensive than vaccines, even without accounting for the manpower (doctors and nurses) and hospitalisation costs!

COVID-19 vaccines will remain in use in the European Union, irrespective of how many COVID-19 treatments is eventually approved.

Fact #6 : COVID-19 Vaccines Were Not Experimental

Once the COVID-19 vaccines successfully completed their clinical trials and received their EUA, they were NO LONGER EXPERIMENTAL.

The conditions to receive the EUA is similar to that of a full approval. The only real difference is the post-study follow-up :

  • EUA : At least half of the participants in the studies must be followed for at least two months after vaccination.
  • Full FDA Approval : All of the participants in the studies must be followed for at least six months.

The EU has never called the COVID-19 vaccines “experimental and provisional”. That’s yet another lie in the fake story.

Read more : What’s The Difference Between Full FDA Approval vs EUA?

Fact #7 : Ivermectin Was NEVER Approved For Use Against COVID-19

The fake story claimed that ivermectin was just “re-approved”. That’s completely FALSE.

Ivermectin was NEVER approved by any major health authority, including the WHO, CDC, FDA, EMA or the TGA, for use against COVID-19. Never mind getting “re-approved”…

Fact #8 : Pasteur Institute Study Was Conducted On Mice

The Pasteur Institute press release and the published study are both in English.

However, the fake story creator shared a link to the French biography of a French antivaxxer – Dominique Rueff instead, to mislead you.

That’s because the Pasteur Institute study DID NOT actually recognise ivermectin as an effective drug against COVID-19 in humans…

  • The study was conducted on mice, not humans
  • Ivermectin reduced inflammation in the respiratory tract of mice, with reduced symptoms.
  • Ivermectin reduced risk of loss of smell in mice.
  • Ivermectin did NOT have any impact on the viral replication of SARS-CoV-2.

The chief author of the study, Guilherme Dias de Melo said, “Surprisingly, we observed that treatment with ivermectin did not reduce viral replication; the models that received treatment had similar quantities of viral load in the nasal cavity and the lungs as those that did not receive treatment. Our results reveal that ivermectin has an immunomodulatory effect rather than an antiviral effect.”

Therefore, the Guilherme said that, “these data provide crucial evidence to support clinical trials in humans“.

In other words, the Pasteur Institute is only advocating for clinical trials in humans, not the use of ivermectin against COVID-19 in humans.

Antivaxxers are not interested in the truth, or even your lives. These human viruses are only interested in spreading lies and misinformation about vaccines.

Please SHARE this fact check with your family and friends, and protect yourself and your family – get vaccinated against COVID-19!

 

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He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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Did Australia Approve Ivermectin Treatment For COVID-19?

Did Australia just approve a breakthrough ivermectin treatment for COVID-19?

Take a look at the viral message, and find out what the FACTS really are!

 

Claim : Australia Approved Ivermectin Treatment For COVID-19!

This message has gone viral on social media, including WhatsApp and Telegram, claiming that Australia just approved a breakthrough ivermectin treatment for COVID-19.

It’s quite long, so just skip to the next section for the facts.

BREAKTHROUGH  IVERMECTIN TREATMENT ACCEPTED BY TGA (Australian Therapeutic Goods Adminstration) TO TREAT COVID 19

Fantastic news today worthy of celebration!

The Sydney outbreak could be under control much sooner with this treatment protocol. Get onto it peeps
Australian GPs Can Legally Prescribe Ivermectin Triple Therapy Protocol — Professor Thomas Borody.

 

Truth : Australia Did NOT Approve Ivermectin Treatment For COVID-19!

This is really a rehash of the old, disputed ivermectin claims by Professor Thomas Borody.

Here are the FACTS about his Ivermectin Triple Therapy, and the WhatsApp message above :

Fact #1 : That Was From 19 August 2020

While the message claims to be “Fantastic news today”, it’s really OLD NEWS.

The article was posted in August 2020, after Professor Thomas Borody released his Ivermectin Triple Therapy protocol on 19 August 2020.

Fact #2 : TGA Did Not Approve Ivermectin For Use Against COVID-19

As of 8 August 2021 – almost a year later, Australia’s TGA (Therapeutic Goods Administration) have NOT approved ivermectin for use against COVID-19.

They also did NOT approve Professor Borody’s ivermectin triple therapy for use against COVID-19, either as a treatment or a prophylaxis.

The Australian Department of Health advised that (as of 1 June 2021), ivermectin, doxycycline and zinc should only be used in “properly conducted clinical trials with appropriate ethical approval”.

Fact #3 : TGA Opened An Investigation Into His Claim

Right after Professor Borody issued that press statement, the Australian Therapeutic Goods Administration (TGA) opened an investigation, as it may potentially breach the ban on advertising COVID-19 treatments.

In February 2021, the TGA ordered former Australian senator David Leyonhjelm to take down his tweet advertising ivermectin. As his case showed, the TGA forbids :

  • all advertising of therapeutic goods containing the active ingredient ivermectin
  • making claims or representations in advertisements for any therapeutic goods that those goods [ivermectin] have any effect on COVID-19 (including that said therapeutic goods are capable of preventing, treating or alleviating COVID-19).

Fact #4 : Ivermectin Triple Therapy Not Proven To Work

The Australian Department of Health also pointed out that Professor Borody’s Ivermectin Triple Therapy protocol has not been proven to be safe or effective against COVID-19.

There is currently insufficient evidence to support the safe and effective use of ivermectin, doxycycline and zinc (either separately, or in combination) for the prevention or treatment of COVID-19.

More robust, well-designed clinical trials are needed before they could be considered an appropriate treatment option.

Fact #5 : Borody Was Working On Patentable Ivermectin Triple Therapy

Back in August 2020, Professor Borody announced that he was involved in a Phase 2 study in the US to potentially develop the triple therapy as a single “blister pack” compliance product.

This appears to be a patentable ivermectin triple therapy product by Topelia Therapeutics, with the study funded and run by ProgenaBiome.

Professor Borody has “corporate affiliation” with both ProgenaBiome LLC and Topelia Therapeutics.

Fact #6 : Borody Phase 2 Trial Stalled

Professor Borody’s Phase 2 study (ClinicalTrials.gov ID NCT04482686) appears to have stalled.

Despite kicking off on 22 July 2020, it was still in the Recruiting stage, as of their last update – 14 May 2021, even though they were supposed to start the trial on 9 December 2020!

Fact #7 : Borody Switched To An Even Smaller Trial

After the Phase 2 trial stalled, Professor Borody moved to an even smaller trial, whose results were released on 7 July 2021 as a pre-print (not peer-reviewed).

The study reported “a highly effective ICT (Ivermectin Combination Therapy) which led to 100% survival and cure” in “moderately to severely ill COVID-19 patients with hypoxia”.

However, there are a few immediate concerns over that study :

  • It was a very small study, with just 24 participants – two of whom refused the treatment.
  • It was not a randomised controlled trial – the researchers picked who could participate
  • It was not a double-blinded trial, so patients knew they were receiving the ICT, not a placebo
  • The subjects were treated remotely, so compliance is uncertain.
  • The subjects were asked to self-monitor and self-record symptoms, and medical readings (EKG, blood pressure, temperature and SpO2), so accuracy of those data is uncertain.
  • The subjects were asked to perform their own swab tests for SARS-CoV-2, so test accuracy is uncertain.

Fact #8 : Australian GPs Always Had Right To Prescribe Off-Label

Professor Borody claimed that the release of his Ivermectin Triple Therapy allows Australian GPs to legally prescribe ivermectin. That’s not true.

Australian doctors have long had the ability to prescribe medicine off-label. As Richard Day in Australian Prescriber notes :

There is no legal impediment to prescribing off label, however the onus is on the prescriber to defend their prescription for an indication that is not listed in the product information.

Fact #9 : Ivermectin Did Not Help Australia Control Pandemic

When Professor Borody claimed that ivermectin could end the COVID-19 pandemic in 6-8 weeks, Australia was already handling the pandemic very well though contact tracing, interstate border closures, travel bans, as well as curfews and lockdowns.

They maintained a very low number of cases over the last 11 months, even without using Professor Borody’s Ivermectin Triple Therapy.

Fact #10 : Ivermectin Did Not Help Other Countries Control COVID-19

To be fair to Professor Borody, Australians ignored his Ivermectin Triple Therapy.

So let’s take a look at India and Peru where pro-Ivermectin proponents claim have successfully controlled COVID-19 with ivermectin.

Despite the use of ivermectin, India suffered a massive and disastrous wave of COVID-19 infections and deaths from March 2021 onwards. That’s why India stopped using ivermectin on 27 March 2021.

Peru continues to suffer high numbers of COVID-19 cases over the last 18 months. Does it look like ivermectin is working for them???

Read more : India Drops Ivermectin, HCQ + Favipiravir As COVID-19 Drugs!

Fact #11 : Ivermectin Triple Therapy Fuelling Online Scams

Ivermectin and ivermectin protocols like I-MASK+ (from the FLCCC) and Borody’s own Ivermectin Triple Therapy, have NOT been proven to work against COVID-19.

Unfortunately, Professor Borody’s promotion of his ivermectin triple therapy protocol has allowed online scams to proliferate.

Case in point – the Ziverdo Kit online scam, which is made by Windlas Biotech in India using the same combination of ivermectin, doxycycline and zinc that Borody recommended.

Even though this combination only only US$2 per kit, scammers are selling at highly inflated prices to gullible people online.

Read more : Scam Alert : Ziverdo Kit To Treat COVID-19!

 

Please Support My Work!

Support my work through a bank transfer /  PayPal / credit card!

Name : Adrian Wong
Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
Credit Card / Paypal : https://paypal.me/techarp

Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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Fact Check : Ivermectin Triple Therapy By Professor Borody!

Can the Ivermectin Triple Therapy by Professor Thomas Borody really cure and prevent COVID-19?

Let’s take a look at his Ivermectin Triple Therapy, and see what the FACTS really are!

 

Professor Borody : Ivermectin Therapy Can End Pandemic In 6-8 Weeks!

This message on Ivermectin Triple Therapy by Professor Thomas Borody is being circulated on WhatsApp.

It’s quite long, so just skip to the next section for the facts.


Latest fantastic news

Sharon Stambolieff

Fantastic news today worthy of celebration!

The Sydney outbreak could be under control much sooner with this treatment protocol. Get onto it peeps
Australian GPs Can Legally Prescribe Ivermectin Triple Therapy Protocol — Professor Thomas Borody.
By COVEXIT

The Centre for Digestive Diseases issued today a press release titled “Ivermectin Triple Therapy Protocol for COVID-19 Released to Australian GPs for Infected Elderly and Frontline Workers.”

As we previously covered, this early treatment protocol combines ivermectin with doxycycline and zinc.

“Triple therapy specialist Professor Thomas Borody, famous for curing peptic ulcers using a triple antibiotic therapy saving millions of lives, today released the COVID-19 treatment protocol to Australian GPs, who can legally prescribe it to their COVID-19 positive patients. They can also prescribe it as a preventative medication. Borody says this could be the fastest and safest way to end the pandemic in Australia within 6-8 weeks.”

 

Fact Check : Ivermectin Triple Therapy By Professor Borody

Australian gastroenterologist, Professor Thomas Borody, has been actively promoting his Ivermectin Triple Therapy to cure COVID-19.

Here are the FACTS about his Ivermectin Triple Therapy, and the WhatsApp message above :

Fact #1 : That Was From 19 August 2020

While the message claims to be “Latest fantastic news”, it’s really OLD NEWS.

Professor Thomas Borody first released his Ivermectin Triple Therapy protocol on 19 August 2020.

Fact #2 : TGA Opened An Investigation Into His Claim

Right after Professor Borody issued that press statement, the Australian Therapeutic Goods Administration (TGA) opened an investigation, as it may potentially breach the ban on advertising COVID-19 treatments.

In February 2021, the TGA ordered former Australian senator David Leyonhjelm to take down his tweet advertising ivermectin. As his case showed, the TGA forbids :

  • all advertising of therapeutic goods containing the active ingredient ivermectin
  • making claims or representations in advertisements for any therapeutic goods that those goods [ivermectin] have any effect on COVID-19 (including that said therapeutic goods are capable of preventing, treating or alleviating COVID-19).

Fact #3 : Ivermectin Triple Therapy Still Not Approved

Almost a year after Professor Borody “released” his Ivermectin Triple Therapy protocol, it is still NOT approved for use against COVID-19, either as a treatment or a prophylaxis.

The Australian Department of Health advised that (as of 1 June 2021), ivermectin, doxycycline and zinc should only be used in “properly conducted clinical trials with appropriate ethical approval”.

Fact #4 : Ivermectin Triple Therapy Not Proven To Work

The Australian Department of Health also pointed out that Professor Borody’s Ivermectin Triple Therapy protocol has not been proven to be safe or effective against COVID-19.

There is currently insufficient evidence to support the safe and effective use of ivermectin, doxycycline and zinc (either separately, or in combination) for the prevention or treatment of COVID-19.

More robust, well-designed clinical trials are needed before they could be considered an appropriate treatment option.

Fact #5 : Borody Was Working On Patentable Ivermectin Triple Therapy

Back in August 2020, Professor Borody announced that he was involved in a Phase 2 study in the US to potentially develop the triple therapy as a single “blister pack” compliance product.

This appears to be a patentable ivermectin triple therapy product by Topelia Therapeutics, with the study funded and run by ProgenaBiome.

Professor Borody has “corporate affiliation” with both ProgenaBiome LLC and Topelia Therapeutics.

Fact #6 : Borody Phase 2 Trial Stalled

Professor Borody’s Phase 2 study (ClinicalTrials.gov ID NCT04482686) appears to have stalled.

Despite kicking off on 22 July 2020, it was still in the Recruiting stage, as of their last update – 14 May 2021, even though they were supposed to start the trial on 9 December 2020!

Fact #7 : Borody Switched To An Even Smaller Trial

After the Phase 2 trial stalled, Professor Borody moved to an even smaller trial, whose results were released on 7 July 2021 as a pre-print (not peer-reviewed).

The study reported “a highly effective ICT (Ivermectin Combination Therapy) which led to 100% survival and cure” in “moderately to severely ill COVID-19 patients with hypoxia”.

However, there are a few immediate concerns over that study :

  • It was a very small study, with just 24 participants – two of whom refused the treatment.
  • It was not a randomised controlled trial – the researchers picked who could participate
  • It was not a double-blinded trial, so patients knew they were receiving the ICT, not a placebo
  • The subjects were treated remotely, so compliance is uncertain.
  • The subjects were asked to self-monitor and self-record symptoms, and medical readings (EKG, blood pressure, temperature and SpO2), so accuracy of those data is uncertain.
  • The subjects were asked to perform their own swab tests for SARS-CoV-2, so test accuracy is uncertain.

Fact #8 : Australian GPs Always Had Right To Prescribe Off-Label

Professor Thomas Borody claimed that the release of his Ivermectin Triple Therapy allows Australian GPs to legally prescribe ivermectin. That’s not true.

Australian doctors have long had the ability to prescribe medicine off-label. As Richard Day in Australian Prescriber notes :

There is no legal impediment to prescribing off label, however the onus is on the prescriber to defend their prescription for an indication that is not listed in the product information.

Fact #9 : Ivermectin Did Not Help Australia Control Pandemic

When I watched the recent MAECC briefing, where they claimed ivermectin can end the COVID-19 pandemic in 6-8 weeks, I wondered how did they come to this conclusion?

I now realise that they plucked that claim from Professor Borody, who said on 19 August 2020 that ivermectin could end the COVID-19 pandemic in Australia within 6-8 weeks.

When Professor Borody made that claim, Australia was already handling the pandemic very well though contact tracing, interstate border closures, travel bans, as well as curfews and lockdowns.

They maintained a very low number of cases over the last 11 months, even without using Professor Borody’s Ivermectin Triple Therapy.

Fact #10 : Ivermectin Did Not Help Other Countries Control COVID-19

To be fair to Professor Borody, Australians did not take up his Ivermectin Triple Therapy.

So let’s take a look at India and Peru where pro-Ivermectin proponents claim have successfully controlled COVID-19 with ivermectin.

Despite the use of ivermectin, India suffered a massive and disastrous wave of COVID-19 infections and deaths from March 2021 onwards. That’s why India stopped using ivermectin on 27 March 2021.

Peru continues to suffer high numbers of COVID-19 cases over the last 18 months. Does it look like ivermectin is working for them???

Read more : India Drops Ivermectin, HCQ + Favipiravir As COVID-19 Drugs!

Fact #11 : Ivermectin Triple Therapy Fuelling Online Scams

Ivermectin and ivermectin protocols like I-MASK+ (from the FLCCC) and Borody’s own Ivermectin Triple Therapy, have NOT been proven to work against COVID-19.

Unfortunately, Professor Borody’s promotion of his ivermectin triple therapy protocol has allowed online scams to proliferate.

Case in point – the Ziverdo Kit online scam.

Made by Windlas Biotech in India, the Ziverdo Kit uses the same combination of ivermectin, doxycycline and zinc that Borody recommended.

Even though this combination only only US$2 per kit, scammers are selling at highly inflated prices to gullible people online.

Read more : Scam Alert : Ziverdo Kit To Treat COVID-19!

 

Please Support My Work!

Support my work through a bank transfer /  PayPal / credit card!

Name : Adrian Wong

Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
Credit Card / Paypal : https://paypal.me/techarp

Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

Recommended Reading

Go Back To > Health | Fact CheckTech ARP

 

Support Tech ARP!

Please support us by visiting our sponsors, participating in the Tech ARP Forums, or donating to our fund. Thank you!