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Shionogi says COVID treatment did not meet endpoint in late-stage trial

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pill-based treatment for COVID-19 did not meet the primary endpoint of showing a statistically significant reduction of 15 common symptoms of the illness in a global, late-stage trial.

But

It received full approval in Japan in March 2024. The Japanese government bought 2 million courses of the drug, most of which remain unused and are set to be destroyed, according to a Kyodo report this month.

Nice business for Shionogi.

0 ( +7 / -7 )

The Japanese government bought 2 million courses of the drug, most of which remain unused and are set to be destroyed, according to a Kyodo report this month.Nice business for Shionogi.

> Wow, wonder which LDP bigwigs & cronies benefited from such a sweet deal?

3 ( +8 / -5 )

So the pill didn't work, the jab experiment certainly didn't work. At least Big Pharma are happy.

-2 ( +10 / -12 )

the jab experiment certainly didn't work. 

Which "jab experiment"?

If you are referring to the vaccination programs, it most certainly saved countless lives. All reputable medical professionals confirm this.

-1 ( +12 / -13 )

Shionogi says COVID treatment did not meet endpoint in late-stage trial

Neither did the Vaccines but supposedly they reduced symptoms....and made slot of money for a lot of people .

-9 ( +5 / -14 )

A problem with Covid drug trials carried out later in the pandemic (e.g. this one and IVERMILCO study) is that they were done at a time when the virus was much milder. So they need an extremely large number of participants to see any significant effect. Smaller studies cannot show any effect that is statistically significant, so they cannot that the drugs are effective. But they do not show that they are ineffective.

-7 ( +2 / -9 )

But they do not show that they are ineffective.

But that's exactly what they show. They show that, in the setting of the study, they are ineffective.

-6 ( +4 / -10 )

The Chinese and Russian governments did not let facts stop them. When they could not steal enough data to reverse engineer an effective vaccine, those two governments still gave the less effective national brand to their population, while the wealthy of those two countries travelled to nearby countries to get the more effective western versions. Then those two countries suppressed the large number of COVID-related deaths especially China.

4 ( +10 / -6 )

Japanese government should ask for a refund or at least part of what they paid returned.

-1 ( +2 / -3 )

Japanese government should ask for a refund or at least part of what they paid returned.

They shouldn't have bought 2,000,000 doses of an untested drug.

0 ( +3 / -3 )

The Japanese government bought 2 million courses of the drug, most of which remain unused and are set to be destroyed, according to a Kyodo report this month.

And of course nobody will be made responsible of the corruption that ended costing tax payers money for a completely useless drug. This is corruption between the LDP and Japan Inc operating against the benefits of the population.

-9 ( +4 / -13 )

Nothing ever changes in Japan. Just the methods and the subjects but corruption drives the nation

-11 ( +1 / -12 )

i still did not find news from Astra Zeneca here and their retreat from covid "business"...?

-3 ( +3 / -6 )

For me this is refreshing.

A drug company trying to be unbiased and honest, for better or for worse, when summarizing their results.

Paragraph one, it did not meet expectations as fully as they would have liked.

Paragraph two, it did however show powerful antiviral properties.

Too humble in their approach?

1 ( +2 / -1 )

Nothing ever changes in Japan. Just the methods and the subjects but corruption drives the nation

True, but it ain't any worse than in the US, Canada, Europe...

0 ( +5 / -5 )

Props to Shionogi for taking the honest route!

This is one of those occasions where the Japanese company is actually behaving responsibly compared to its international competitors.

-5 ( +3 / -8 )

So the pill didn't work, the jab experiment certainly didn't work. At least Big Pharma are happy.

Other drugs work without problems, the vaccines are considered by the medical community a huge success that saved millions of lives. The people interested in public health are happy, only the antiscientific antivaxxer groups ended up very unhappy when their conspiracy theories were so completely disproved.

Neither did the Vaccines but supposedly they reduced symptoms

The vaccines greatly surpassed the expected efficacy and safety standards, which were then confirmed when used in the population, being irrationally in denial of the opinion of the medical community of the world do not make their conclusions wrong.

A problem with Covid drug trials carried out later in the pandemic (e.g. this one and IVERMILCO study) is that they were done at a time when the virus was much milder.

In great part thanks to vaccination, and also because good treatments are already available, coming out late in the development race meant Shionogi had to greatly surpass the predecessors, it was not a surprise this did not happen, the Japanese government shares some of the responsibility because of the way it makes unnecessarily complicated to develop new therapeutic interventions (and refrain from using those that he already have access to).

i still did not find news from Astra Zeneca here and their retreat from covid "business"...?

Links were made available before, about how the AZ vaccine is considered by the experts a very successful enterprise that saved uncountable lives, just not as good as other options available, which is why it makes no sense to keep trying to sell it.

For me this is refreshing.

Props to Shionogi for taking the honest route!

For good or for bad this is less about a company being honest and more about the regulations and controls already in place making that company unable to get away with a product that is worse than what is already available.

-1 ( +3 / -4 )

For me this is refreshing.

Props to Shionogi for taking the honest route!

Yes, such honesty in a pharma company is extremely unusual. Perhaps they realized they did not have the same level of influence on the regulators as the larger pharma companies...

-3 ( +1 / -4 )

A problem with Covid drug trials carried out later in the pandemic (e.g. this one and IVERMILCO study) is that they were done at a time when the virus was much milder.

In great part thanks to vaccination, and also because good treatments are already available,

Nah, it was widely acknowledged to be a milder virus, even among the unvaccinated who did not take any of those "good treatments".

-3 ( +1 / -4 )

Yes, such honesty in a pharma company is extremely unusual.

No, it is not, specially with the strict controls and rules in place, enough so that when this is not the case it is reported in the news precisely as the exception. The ever ongoing confirmation that comes from the continuous collection of evidence makes dishonesty a losing proposition from the very beginning.

Nah, it was widely acknowledged to be a milder virus, even among the unvaccinated who did not take any of those "good treatments".

Trying to dismiss the effect on the community from vaccination as if it didn't exist is what refutes that as an argument. For any infection for which the inoculum affects the clinical presentation a vaccine that reduces the exposure in general means it also has an effect reducing the burden of the infection in general as well, vaccines and better treatments are recognized as a very important factor that reduced the risks from covid (that are still important to this day).

Failed repurposed drugs like ivermectin on the other hand offered no benefit no matter which variant of the virus they were used against.

0 ( +2 / -2 )

A problem with Covid drug trials carried out later in the pandemic (e.g. this one and IVERMILCO study) is that they were done at a time when the virus was much milder.

In great part thanks to vaccination

That's right, the vaccines promoted the appearance of variants.

-2 ( +1 / -3 )

That's right, the vaccines promoted the appearance of variants.

No they did not, that is a completely mistaken idea born from not understanding basic immunology, vaccines reduce the risk of variants of importance appearing, that has been known for years already.

-1 ( +1 / -2 )

That's right, the vaccines promoted the appearance of variants.

No they did not, that is a completely mistaken idea born from not understanding basic immunology, vaccines reduce the risk of variants of importance appearing, that has been known for years already.

No, actually WP is spot on. And this was predicted by Geert Vanden Bossche who warned us about mass vaccination during a pandemic, and he has an advanced understanding of immunology.

By mass vaccinating during a pandemic you are encouraging the emergence of escape mutants through mutations in the area targeted by the vaccines. That is on of the reasons why the variants have multiple mutations in the spike protein.

-1 ( +1 / -2 )

By mass vaccinating during a pandemic you are encouraging the emergence of escape mutants through mutations in the area targeted by the vaccines.

Any links to scientific consensuses that agree with this supposition, or is this one of those things you made up again and expect us to accept as science? You do have a history of that.

0 ( +2 / -2 )

By mass vaccinating during a pandemic you are encouraging the emergence of escape mutants through mutations in the area targeted by the vaccines.

Vaccination is a selective pressure, of course, but free circulation is a much more powerful incubator for evolutionary selection. The best conditions for the emergence of more dangerous and transmissible variants are when the virus is spreading unchecked all over the world through billions of people.

-3 ( +0 / -3 )

No, actually WP is spot on. And this was predicted by Geert Vanden Bossche who warned us about mass vaccination during a pandemic, and he has an advanced understanding of immunology.

Geert Vanden Bossche never provided any data to support this claim, and could not even refute the mountains of data and scientific arguments that proved the claim was wrong and false, based only on a terribly bad misunderstanding of how immunity works, that means the claim is still demonstrated false. Easy to prove the moment the variants of importance that appeared when only some countries had good vaccination efforts did so on poorly vaccinated populations, exactly the opposite of what would be expected if the vaccines facilitated this.

By mass vaccinating during a pandemic you are encouraging the emergence of escape mutants through mutations in the area targeted by the vaccines

That is of course false, any immunity means an advantage, so unvaccinated people leave more time for the virus to mutate and adapt compared with anybody that have even partial immunity. Escape mutants are positively correlated with lower levels of adaptive immunity, which completely corresponds with what was observed with delta, omicron, etc.

-1 ( +1 / -2 )

By mass vaccinating during a pandemic you are encouraging the emergence of escape mutants through mutations in the area targeted by the vaccines.

Any links to scientific consensuses that agree with this supposition, or is this one of those things you made up again and expect us to accept as science?

It was proposed by Geert Vanden Bossche, a leading vaccination expert. Plus, it makes perfect sense to anyone with any understanding of immunology. Also, the outcome of the pandemic ended up supporting his warning.

Note that the variants are highly mutated in the area targeted by the vaccine....

By mass vaccinating during a pandemic you are encouraging the emergence of escape mutants through mutations in the area targeted by the vaccines

That is of course false, any immunity means an advantage

That might be true if immunity was achieved immediately after injection, which is far from what actually happens (you're only considered vaccinated 2 weeks after injection). Its like treating a bacterial infection with an extremely low antibiotic concentration and then very gradually increasing it -- perfect way to encourage escape mutants!

-1 ( +1 / -2 )

It was proposed by Geert Vanden Bossche, a leading vaccination expert.

... in a letter that other vaccination experts variantly describe to be somewhere between "inprecise", "blatantly wrong" and "downright bizarre". Vanden Bossche is not doing anything particularly novel, though; The same wildly speculative claims have been made by Andrew Wakefield for the MMR vaccine, and before that for antibiotics (a claim you cheerfully picked up, too). You're basically quoting a "best of antivax" bullet point list.

Except ... none of the claims have ever been substantiated.

However, the most glaring omission of the argument is the answer to the question: If not during a pandemic, and not after a pandemic, when exactly should we vaccinate? The implied answer is, of course: never.

Because vaccines kill people, mutate viruses, lead to autism, turbo-cancer, most recently even to The Gay and The Trans. In antivax world there's really nothing vaccines cannot do ... except, of course, prevent disease.

-2 ( +1 / -3 )

It was proposed by Geert Vanden Bossche, a leading vaccination expert.

And disproved by the evidence collected in the world, that is the whole point of science, that evidence can prove anybody is wrong, if the person disproved fails to act professionally and insist on disproved theories that rely on deeply flawed understanding of immunology that on that person, it does nothing to disprove the consensus.

 Plus, it makes perfect sense to anyone with any understanding of immunology

No it does not, not even a single organization related to immunology says this makes any sense, only discredited people that have been demonstrated wrong with scientific arguments. There is no point in pretending every medical association of immunology does not understand the field, it is beyond irrational.

Note that the variants are highly mutated in the area targeted by the vaccine....

And the area targeted by natural immunity as well, that is the point of all adaptive immunity and escape mutants, this is like being surprised that survivors of violence have injuries in non-lethal organs.

That might be true if immunity was achieved immediately after injection

No it does not, a vaccine recieved 1 hour before the infection means the person have one hour of advantage producing immunity (in reality much more since replication takes much longer than the stimulus from vaccines) that is just another serious misunderstanding of how immunity works, The comparison is not between a person in the middle of producing immunity and someone that coursed by the full infection but between that incomplete adaptive immunity and someone that has none of it. 1% of immunity because of vaccines means 1% more than the person that has just been infected.

That is again why there was no surprise in finding variants of importance appearing in poorly vaccinated populations, to the great shame of Vanden Bossche that predicted the opposite would happen, and ended up being totally wrong.

-1 ( +1 / -2 )

That might be true if immunity was achieved immediately after injection

No it does not, a vaccine recieved 1 hour before the infection means the person have one hour of advantage producing immunity

Yeah, just enough to place some selection pressure to mutate, but not enough to prevent or slow down infection or replication. Just like giving an extremely small dose of antibiotic and gradually increasing it.

Note that the variants are highly mutated in the area targeted by the vaccine....

And the area targeted by natural immunity as well, that is the point of all adaptive immunity and escape mutants,

Natural immunity targets much more than just the spike protein. But whenever they describe the mutations in the new variants, they generally (exclusively?) fall within the area targeted by the shot.

-1 ( +1 / -2 )

Yeah, just enough to place some selection pressure to mutate

Which would still happen without the vaccine, except that vaccinated people will control the infection sooner therefore making the appearance of escape mutants a much less likely possibility, which again is exactly what happened as observed by variants of interest appearing in populations with low vaccinations rates.

but not enough to prevent or slow down infection or replication

Yes, slow down infection and replication, the comparison is again against uninfected patients, that have zero reduction, so any reduction due to vaccination is still an advantage, this is not that difficult to understand.

Natural immunity targets much more than just the spike protein

Which makes it irrelevant when it still lets scape mutants appear with higher probability, which (again) is exactly what happened and why Geert Vanden Bossche was humiliated when his predictions turned up being completely wrong and the variants appeared in populations not yet vaccinated.

The problem is that you are trying to misrepresent neutralizing antigenic regions as if the immunity gained from infection did not target exactly the same regions, that is false, escape mutants appeared on unvaccinated populations precisely because immunity gained from infection facilitate changes in the same regions, just giving the virus much more opportunities to survive and be transmitted to other people.

-1 ( +1 / -2 )

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