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Japan postpones decision to approve 1st domestic oral COVID-19 drug

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Large size ? Wonder how some of the Off-the-Shelf Supplements managed to get approved for use in Japan ?

3 ( +6 / -3 )

Funny the Pfizer vaccine trials for 6mth to 4 years olds didn't submit any efficacy data to the CDC but still got approved...As long as the side effects are minimal doesn't seem to matted what the efficacy is anymore...

-3 ( +9 / -12 )

My partner with 4x mRNA vaccines got Rona symptoms worse then me with only two non mRNA jabs-amazing vaccines!

2 ( +13 / -11 )

vaccines used in Japan are proof that these are completely useless against covid virus.

no one ever cared about their effectiveness since it was good business for someone from very start to make a fortune from peoples fear.

here is new way how to possible stop virus but yes-"meetings"...maybe Shionogi id not offer enough of pocket money to oyajis in charge?

1 ( +12 / -11 )

Effectiveness of vaccines? Don't make me laugh!!!!!!!!!!!!!!!

-1 ( +12 / -13 )

vaccines used in Japan are proof that these are completely useless against covid virus.

How so?

-4 ( +6 / -10 )

Not enough bribe, I assume...

2 ( +11 / -9 )

Good job to everyone who has recovered from the Covid without jabs etc , and RIP those who ,well you know ...

5 ( +8 / -3 )

India developed a drug against CoVid19. Why not Japan? BECAUSE Once the drug is approved, the elites who capitalize on the fear of the people will lose their grip, control and authority. They wouldn’t let it happen. They want to continue to use the pandemic and climate change to control and oppress.

-3 ( +7 / -10 )

India developed a drug against CoVid19. Why not Japan? BECAUSE Once the drug is approved, the elites who capitalize on the fear of the people will lose their grip, control and authority. They wouldn’t let it happen. They want to continue to use the pandemic and climate change to control and oppress.

What do you propose we do?

-1 ( +5 / -6 )

Hopefully, study up and lay off the conspiracy theories...

India developed a drug against CoVid19. Why not Japan? BECAUSE Once the drug is approved, the elites who capitalize on the fear of the people will lose their grip, control and authority. They wouldn’t let it happen. They want to continue to use the pandemic and climate change to control and oppress.

What do you propose we do?

2 ( +5 / -3 )

Funny the Pfizer vaccine trials for 6mth to 4 years olds didn't submit any efficacy data to the CDC but still got approved...As long as the side effects are minimal doesn't seem to matted what the efficacy is anymore...

Any source for this? because the FDA communications say otherwise.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children

 In this analysis, among participants 6 through 23 months of age, 64% of whom had blinded follow-up for more than two months after the second dose, the vaccine was 50.6% effective in preventing COVID-19. Among participants 2 through 5 years of age, 72% of whom had blinded follow-up for more than two months after the second dose, the vaccine was 36.8% effective in preventing COVID-19.

So, who is in the right here? the FDA and their panel of experts of a nameless person of the internet?

My partner with 4x mRNA vaccines got Rona symptoms worse then me with only two non mRNA jabs-amazing vaccines!

N=2 underpowered, uncontrolled, study without details is not enough to contradict actual clinical studies of efficacy of the vaccines.

vaccines used in Japan are proof that these are completely useless against covid virus.

Studies made in Japan say exactly the opposite, do you have any evidence those studies are wrong?

India developed a drug against CoVid19. Why not Japan? BECAUSE Once the drug is approved, the elites who capitalize on the fear of the people will lose their grip, control and authority.

There are dirt cheap drugs used for covid complications since 2020, this demonstrate the supposed conspiracy do not exists, if it were real drugs like dexamethasone would not be well recognized and popular options to treat it.

-1 ( +7 / -8 )

Japanese government said they will manage to be possible for people to use the oral medicine against Cov-19 last year as the manifest.

it is much needed in Japan right now. I hope they will hurry to do medical test and approve to use it.

0 ( +4 / -4 )

it is much needed in Japan right now. 

Not if it's not effective

3 ( +6 / -3 )

"" amid concerns the Japanese pharmaceutical firm was unable to demonstrate the drug's efficacy in its clinical trials.""

Butter be safe than sorry, if two other drugs are already available and hardly being used !! why is this firm trying to to get it's product approved?? sounds like a waste of efforts and time to me.

0 ( +1 / -1 )

Just remembered, has anybody stumbled into any update at all regarding the trial in Japan of what's that repurposed drug called?

3 ( +4 / -1 )

it is much needed in Japan right now. 

Not if it's not effective

That hasn't stopped them approving mulnupiravir. When it recieved an EUA from the FDA, it had undergone two small trials. The first (pre-Delta) appeared effective and that was reported everywhere, the second, during Delta showed no effect (less effective than placebo). Despite its lack of effectiveness, and its high toxicity (teratogen and carcinogen), the FDA gave it an EUA because there wasn't any alternative. The Japanese authorities followed and immediately approve it....

Just remembered, has anybody stumbled into any update at all regarding the trial in Japan of what's that repurposed drug called?

Yes, many of us are still waiting for the Japanese ivermectin trial results. I already stocked up with some I ordered from India, just in case I get a symptomatic infection before it finally becomes the recommended treatment...

-2 ( +4 / -6 )

Yes, many of us are still waiting for the Japanese ivermectin trial results

The experts do not expect anything from the trials, much bigger, better controlled, detailed and extensive trials have already corroborated ivermectin has no usefulness against covid and only offers extra toxicity for the patients. The only clinical trial registered on the JRCT began in September 2020, is only a phase II of a hundred patients in the treated and placebo group and has published nothing about the results in a very long time. The obvious conclusion is that Japanese people are normal humans and the same results already obtained for everybody else also apply, so no benefit. If there was any significant effect the trial would have stopped early for ethical considerations.

Shionogi had a much better chance than Kitasato of finding anything, but unfortunately it appears the decades that the Japanese pharmaceutical institutions are lagging behind the rest of the developed world thanks to the impossible requirements the government puts to all kinds of clinical trials in the country.

1 ( +6 / -5 )

Probably it’s only a placebo, right and ready from the production to the garbage can.

pharmaceutical firm was unable to demonstrate the drug's efficacy in its clinical trials

But someone ordered, someone paid and lot of money involved. My guess is, more than its zero efficacy the involved big money streams and bribing would be interesting.

-3 ( +0 / -3 )

That's a death sentence for shionogi....they had huge amounts of cash from doctors over prescribing antibiotics in the 80s and 90s and the patents on their blockbusters are nearly expired.... They have no big products in the pipeline and are investing heavily in entering the Chinese mark through a joint venture..... They were really banking in this to work...

4 ( +4 / -0 )

One problem with testing Covid drugs now is that the current variants are so mild that you would need to test a very large number of people to see any significant effect.

-2 ( +3 / -5 )

Shionogi seems to have gambled by switching lanes to a potential fast track

That is not a surprise, traditial approval is a much more complicated and slow process that can take even years just to approve the phase III clinical trials, much more than that until the drug can be used in the public. For any company trying to get any drug or vaccine for the pandemic there is no other realistic option.

Lowering viral titers is not a main clinical outcome for drugs against covid, it is just an indicator to be used so easy numerical comparisons can be done, but if a treatment do not have clinical advantages there is no justification for the approval. A company can say their drug lower viral titers 10 times, but for a virus like SARS-CoV-2 that is just one cycle of replication. If the main clinical outcome is that symptoms are reduced in average from 4 days 6 hours to 4 days 3 hours then there is no real advantage.

One problem with testing Covid drugs now is that the current variants are so mild that you would need to test a very large number of people to see any significant effect.

Hospitalizations are frequent enough even for Omicron to have valid comparisons, much more if the clinical outcomes are evaluated according to symptoms as written in the article. There is no difficulty in finding people having mild symptoms to be included in the trials.

2 ( +4 / -2 )

A Japanese health ministry panel on Wednesday postponed a decision to approve the use of the oral COVID-19 drug "Xocova" developed by Shionogi & Co, the second time for the decision to be delayed following a meeting last month.

Surprising this drug has not been yet approved, since the agency the WHO recently gave the green light to a malaria vaccine with less than 35% efficacy.

I guess it shows that actual health and medical experts use real scientific data to make a decision, rather than playing politics with the health of people in poor nations like the WHO does.

-5 ( +0 / -5 )

True, but Shionogi did not apply for a slow traditional approval before either, they switched from one expedited approval ("conditional early approval") to a newly created different one ("urgent approval").

For Shionogi purposes is the same difference, avoiding the traditional process which would be beneficial if they had a product that was effective, but it is not.

True, but that is also not the case here. In previous trials, Shionogi has already proven that clinical advantage, that their drug reduces viral load by 60-80% by day 4 of the treatment, and shortens recovery time by around two days.

Viral loads are NOT a clinical advantage, this means an effect that can be detected clinically, not something that only produce differences on a laboratory test without making any difference on signs nor symptoms.

Shortening of recovery could be a good argument, but if it is only observed on the smallest trial and disappears when more people are tested it is indicative the effect was not real.

Surprising this drug has not been yet approved, since the agency the WHO recently gave the green light to a malaria vaccine with less than 35% efficacy.

That is a terribly bad argument, not only because the drug is much worse than something with a 35% efficacy, but because there is no alternative for the vaccine while there are already better drugs than Xocova, limited efficacy is much better than nothing, and no efficacy is much worse than what is already available for covid.

0 ( +3 / -3 )

That is a terribly bad argument, not only because the drug is much worse than something with a 35% efficacy, but because there is no alternative for the vaccine while there are already better drugs than Xocova, limited efficacy is much better than nothing, and no efficacy is much worse than what is already available for covid.

This makes no sense, and shows the comment was not read in full because it mistakes totally the conclusion that:

I guess it shows that actual health and medical experts use real scientific data to make a decision, rather than playing politics with the health of people in poor nations like the WHO does.

So, Japan's decision is contrasted with that of the WHO's recent decision (and in light of their many mishaps lately, such as advising NOT to wear masks).

https://edition.cnn.com/2020/03/30/world/coronavirus-who-masks-recommendation-trnd/index.html

-3 ( +2 / -5 )

This makes no sense, and shows the comment was not read in full because it mistakes totally the conclusion that:

The conclusion is the one that makes no sense. How is approving a useful vaccine "playing politics"? if anything both cases are equivalent in the sense of doing something according to scientific data. Approving a vaccines that demonstrates usefulness, not approving a drug that falied to do the same.

1 ( +1 / -0 )

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