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Moderna, Takeda to seek vaccine approval in Japan

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Allow people to have more choices, including Johnson and Johnson's single dose.

9 ( +10 / -1 )

Good news. Bad news is, ministry of health is gonna take their time approving it.

6 ( +7 / -1 )

Why can’t Japan make its own?? Anyone??

3 ( +4 / -1 )

I will take the Pfizer, J&J, Moderna and even the Sputnik vaccines. Certainly not one produced in China nor Japan

-2 ( +2 / -4 )

Why can’t Japan make its own?? Anyone??

The vaccines being developed in Japan are still at an earlier stage of devleopment and trials. I found reference to vaccines being developed by Osaka University/AnGes/Takara Bio, Shionogi and a couple of candidates from Takeda.

3 ( +4 / -1 )

Good. Even if its 3 months away its another one on the way.

@Ptownsend - You don't get a choice anywhere. That's been the problem in Germany where people (stupidly) didn't turn up for their shots after discovering that it was going to be AstraZeneca on the day.

@robert maes: I understand that you wouldn't want to have SinoVax - considering the reported efficacy rates. IF and when a Japanese produced vaccine became available, why would you not take it? That's a pretty big statement to make when there isn't one!

4 ( +6 / -2 )

The Pfizer vaccine may have been responsible for deaths and the research has still not been conclusive either way on why.

Since I have only a possible mortality rate of 0.4, I see no need to rush to take a vaccine that may do me harm...

-5 ( +5 / -10 )

Why can’t Japan make its own?? Anyone??

Main reason? because it is a huge and costly enterprise that will not bring benefits unless you get good results in a short window of time. By this point any new vaccine would have to be much better than what is already available and be ready on time for people to still want it, this is a huge hurdle, It is been quite long since Japan is not at the spearhead of developing medical therapeutics, so its understandable nobody here wants to compete with the world's top on such low odds.

A secondary reason is that Japan is crazy paranoid about approving anything that could be problematic for the people is used for (enough so it is considered better to let thousands die without it instead of risking a few people with it) That means anything developed locally for use in humans needs to get complicated and time-consuming approval procedures even to begin with the research, then 10 times more to move that research from test tubes into animals and again 10 more to move that into clinical trials (and a final approval ordeal if they want to use it in the population). That can take literally years, any Japanese company actually interested in developing a vaccine would have a much easier time just doing it overseas, getting it all done and approved there and then moving it back to Japan (after extra useless tests).

5 ( +10 / -5 )

The Pfizer vaccine may have been responsible for deaths and the research has still not been conclusive either way on why.

On the other hand not vaccinating is conclusively responsible for huge numbers of deaths without any doubt. Compared to that vaccination has not been shown to even increase the risk of important problems for the population it is targeted, the choice is obvious.

Sure, research has to continue to confirm if vaccination is actually completely free or risks, but it is already sure you are at more risk of death (and long term or permanent health problems) without vaccinating that with it, a 0.4% mortality rate in comparison with the vaccine is huge.

3 ( +8 / -5 )

Allow people to have more choices, including Johnson and Johnson's single dose.

One, please educate yourself to the system here, it's not as easy as one thinks to just add choices. It's not like going to Mc Donald's and picking something off the menu.

The ONLY reason Takeda is involved in the first place is purely about money! Japanese Pharma wants a cut of the pie, because they are light-years behind development of ANY cutting edge medications and vaccinations. They dont put the effort into research, because they can not control prices.

THe government also, only "approved" the vaccine, because Takeda was involved. Consider this, the first shipment of the vaccine was delivered to Japan PRIOR to it being approved, officially.

Think about that a moment.

3 ( +4 / -1 )

I'm thinking about that @Yubaru - but trying to decipher your message. What has been 'approved' so far other than Pfizer? Takeda WILL file for approval of the Moderna Vaccine as have AstraZeneca.

Why would there not be stocks of a vaccine somewhere pre-approval? Do you think the manufacturers suddenly rustle up 500,000+ doses over night?

Vaccines were in production months ago in the US and Europe waiting for approval.

4 ( +4 / -0 )

The Pfizer vaccine may have been responsible for deaths and the research has still not been conclusive either way on why.

Since I have only a possible mortality rate of 0.4, I see no need to rush to take a vaccine that may do me harm...

As a former provaxxer turned vaccine skeptic I also find it troubling that there are no studies on pregnant women or children and just NO LONG TERM studies in general. (pharma: we don't need them - for emergency use authorizations)

We're being herded and rushed into vaccinating through FEAR (cases going up) even though cases are dropping due to revisions in PCR testing (going from 40 cycles (excessive number of false positives) down to 30 cycles per WHO guidance - when it should be below 20 cycles).

-7 ( +3 / -10 )

Why would there not be stocks of a vaccine somewhere pre-approval?

Here in Japan, approval for medicines and what not, typically takes years and years, if ever, particularly one's manufactured overseas.

Japan is totally unaccustomed to accepting anything "new" prior to the approval process. What would have happened if they didnt come to the conclusion to "approve" the vaccine? Send it back?

Japan would not have approved it, on it's own merit and value, WITHOUT a connection to a Japanese pharmaceutical company being involved. The reasons are totally self serving.

0 ( +1 / -1 )

Such coercive tactics beings used to get people to take the jab in the US and UK.

Dangling carrots whilst at the same time holding healthy people ransom to get their freedom back does not bode well

-3 ( +5 / -8 )

As a former provaxxer turned vaccine skeptic I also find it troubling that there are no studies on pregnant women or children and just NO LONG TERM studies in general. (pharma: we don't need them - for emergency use authorizations)

Why troubled? There are no studies for them because of the same reason there are no studies for people undergoing cancer treatment, with multiple autoimmune problems or transplant recipientes (for example), and that reason is that they are not the target population, if there is ever need to vaccinate them then it will become also necessary to study them. For now this is not the case, so there is no need for studies.

Also, for long term studies it would be necessary to act unethically, by allowing huge numbers of unnecessary deaths happen (directly and indirectly because of the pandemic) just to wait years to see if something ever comes up, there is not problem reported with the mRNA technology even after hundreds of trials over many years, and the viral protein is expressed a million times less than in the natural infection, so it is not logical nor rational to ask for more people to die just to eliminate completely this irrational possibility.

An extra reason is that the natural infection is already linked to long-term and even permanent problems happening days or weeks after the infection, that is already a difference with vaccination (where this has not happened) that means vaccines are already safer in the long term than the infection and will remain so until those problems are found (if ever).

We're being herded and rushed into vaccinating through FEAR (cases going up) even though cases are dropping due to revisions in PCR testing (going from 40 cycles (excessive number of false positives) down to 30 cycles per WHO guidance - when it should be below 20 cycles).

Both things are false, we are being informed, by scientific knowledge about the safety of the vaccine and how it greatly improves the chances of surviving the infection and avoid important health problems and risks, Fear is what antivaxxers try to do to mislead people into unnecessary anxiety from the vaccines. With less and less effects fortunately.

The number of cases is dropping for many reasons, changes in the PCR are not one of them. The number of cycles is just the most primitive way to control for false positives, and any country using technology from the last 20 years can put any of the many others mechanisms to control for it without problem, you could do hundreds of cycles without ever increasing false positives because of those multiple other failsafe mechanisms available.

3 ( +8 / -5 )

What is the problem here? The world is currently owned by USA, Russia and China. So that’s also where the only reliable sources of the virus release and the countermeasures like vaccines can be estimated and be found. It’s not so difficult, still is it?

-7 ( +0 / -7 )

*Why troubled? There are no studies for them because of the same reason there are no studies for people undergoing cancer treatment, with multiple autoimmune problems or transplant recipientes (for example), and that reason is that they are not the target population, if there is ever need to vaccinate them then it will become also necessary to study them. For now this is not the case, so there is no need for studies.*

Oh my god, you're joking right? This is incredible logic. Inject first. Study the "guinea pigs" later. Everything else doesn't matter as vaccines are 500% effective. Pharma based science at its best

The number of cases is dropping for many reasons, changes in the PCR are not one of them. The number of cycles is just the most primitive way to control for false positives, and any country using technology from the last 20 years can put any of the many others mechanisms to control for it without problem, you could do hundreds of cycles without ever increasing false positives because of those multiple other failsafe mechanisms available.

This is false. The number of false positives increase exponentially with each additional cycle. We can end the entire pandemic of "cases" FEAR by reducing the number of cycles to below 20. You can create a MASSIVE PANDEMIC by increasing the cycles to 100. Good on WHO for revising the PCR cycles downward (which they should have done sooner but it is still too high). Right now influenza, cold viruses = a positive test for COVID through PCR which then equals an unwarranted quarantine.

-6 ( +3 / -9 )

Why can’t Japan make its own?? Anyone??

@viruseex's reasons are correct but a few more problems add to it.

Nearly all the vaccines out now are based on exclusive intellectual property rights owned mostly by the big western pharmaceutical companies that mostly refuse others use or ask far to high a price for others to use.

This should be unacceptable but is how things are today no more humanitarian moves like with the Polio Vaccine.

Not certain countries either do not subscribed to certain international agreements on intellectual property rights or have laws that permits using these technologies without agreement if it is a national emergency/health crisis.

India being one of those countries, it has basically said long ago it will use whatever it wants if the health of it's people are at risk.( This was done because of the HIV medication being far to high in cost for just about everyone in the country). In most of these cases the western pharmaceutical companies folded and either provided the needed meds at the government's set price or reluctantly let Indian companies produce the products under a very tiny royalty agreement.

So for Japan and others that tried and failed to create their own Vaccines doing so without using these proprietary technologies becomes that much more difficult.

Best example is the USA J&J Vaccine will now also be produced by a rival company using the defense production act. This is basically the government saying forget who owns it we need it Now so you, you and you will start making it and to the owner of the vaccine you will give them all the information they need to do it.

I can just imagine the outrage from the USA if Japan ordered AZ,Moderna, Pfizer, etc.. to give the info to Japanese companies to start production immediately.

4 ( +5 / -1 )

Why can’t Japan make its own?? Anyone??

Long story short, funding and willingness of pharmaceuticals to look beyond the bottom line.

They are unwilling to take risks on potential failure and the corporate structure limits ingenuity.

It's hard to motivate the people who are scientists and researchers to come up with a new "anything" here when they know they will never see any worthy compensation for their achievements.

-1 ( +1 / -2 )

@Yubaru

Very much not true.

In fact a quick look at the USA TV advertising and one sees many ads from Japanese pharmaceutical companies for cancer meds, diabetes meds, and many more.

Japan is one of the world leaders in many medical and pharmaceutical sectors just not in Vaccine research.

2 ( +5 / -3 )

Oh my god, you're joking right? This is incredible logic. Inject first. Study the "guinea pigs" later. Everything else doesn't matter as vaccines are 500% effective. Pharma based science at its best

Are you pretending not to understand it? it is completely different from your analogy. The closer would be "Inject never, study later, and depending on the results maybe then inject" There is no point in delaying the application of a safe and effective measure just to study a population that is being actively exempted from vaccination.

This is false. The number of false positives increase exponentially with each additional cycle. We can end the entire pandemic of "cases" FEAR by reducing the number of cycles to below 20. You can create a MASSIVE PANDEMIC by increasing the cycles to 100. Good on WHO for revising the PCR cycles downward (which they should have done sooner but it is still too high). Right now influenza, cold viruses = a positive test for COVID through PCR which then equals an unwarranted quarantine.

No, that is a misunderstanding from your part because you don't know how the reaction is performed. Amplification (not false positives) may increase after every cycle, but not even that is inevitable.

A very simple inclusion of a negative control can eliminate systematic false positives, any sample that gives amplification at the same level than the negative control is eliminated, so it never becomes a false positive, it just becomes unspecific amplification.

You can also let everything amplify for 500 cycles and then run a "melting curve analysis" on the products and everything with a value different from the true positives (that you already know) automatically gets eliminated.

You can even switch from intercalated dye system (that reports every amplification as a positive, even if it is mistaken) to a fluorescent probe system (that will only report amplification if the probe is destroyed during the reaction).

There are many other ways to systematically eliminate amplification that is not a true positive, and any technician trained for a couple of hours can use them, because at this point the machines have these kind of failsafe installed from the beginning since they are very useful. You can have 1000 cycles (waste of time and electricity but you could do it) and it would be still trivially easy to see which ones are true positives or not.

True fear mongering come from people that just repeat what others tell them without even understanding what they are trying to talk about. The specificity of the test can be corroborated scientifically with samples already known to be false, thinking that science stopped half a century ago and a terribly obvious flaw has not been corrected is simply not understanding the test.

1 ( +5 / -4 )

virusrex and neowave, please stop this daily bickering on vaccine stories. Otherwise...

Way too many conflicts of interest in the COVID diagnosis business.

actually the inventor of the PCR test Kary Mullis stated before his untimely death in August 2019 that it is not intended for diagnosing disease.

-2 ( +3 / -5 )

actually the inventor of the PCR test Kary Mullis stated before his untimely death in August 2019 that it is not intended for diagnosing disease.

Of course, that is why for COVID-19 is it used to diagnose infection cases, not disease cases. To diagnose the disease the full set of signs, symptoms, interrogation and laboratory results are necessary.

This is like saying that antibody tests should not be used used (alone) to diagnose AIDS, which is not a problem because they are used to diagnose HIV infection.

-1 ( +3 / -4 )

n fact a quick look at the USA TV advertising and one sees many ads from Japanese pharmaceutical companies for cancer meds, diabetes meds, and many more.

What a joke, if you use TV advertising as the yardstick for what a company does, you have much to learn. You also do not realize that just because it is marketed as a Japanese product does not make it "made in Japan" either.

Takeda is a multinational, and it gained research and development through purchase of foreign pharmacueticals and research companies, and not from it's own research. It sold a part of itself off to AstraZeneca, the very company that has developed one of the vaccines on the market now.

You should do some reseach into Japanese companies and watch less TV

-1 ( +0 / -1 )

Way too many conflicts of interest in the COVID diagnosis business.

actually the inventor of the PCR test Kary Mullis stated before his untimely death in August 2019 that it is not intended for diagnosing disease.

Agreed and also read that as well. We can tweak the PCR to turn up the number of cases (increase the fear on society) and down (show that vaccines are working).

But very hopeful news from Professor Marty Makary:

"According to an OP-Ed in the Wall Street Journal by Professor Marty Makary at Johns Hopkins, this rapid decline means "Herd Immunity" will be attained by April and Covid will be over."

-4 ( +3 / -7 )

if you use TV advertising as the yardstick for what a company does

Ok here it goes.

Japan's health system is far more based in preventative measures than reactive.

In this system example flu shots are gotten by about 30% to 40% of the population mostly the elderly.

The rest is based around proper hygiene sanitation protocols like masks, hand washing, gargling, etc.. and it works well.

The same for heart disease, prevention is top.

This means very little need for Japanese research or manufacturing of heart meds locally because low amounts.

On the other side Japan has endemic problems with type 2 diabetes and a problem with gastric type cancers.

So prevention education is a big part but heavy research and development of treatments is very big.

Now compare that to the USA which does very little in prevention and relies on nearly 100% treatment after the fact.

People in the west know their diet is not good they know the Sugar, salt, fat is not good but don't want to change and expect the drug companies to fix any problems.

So the USA big pharma have a lot of financial incentives to make more drugs to fix more problems.

Japan due to the types of problems that affect its people locally concentrate on those so Japanese doctors and pharmaceutical companies are some of the top in diabetic treatments and gastric cancers such as colon cancer.

Which many of the meds used around the world first being developed in Japan.

This is the nature of how things are.

Japanese companies saw no need to invest in Vaccines as up until covid this was not a top priority.

I know the general rule here is to complain about everything and anything in Japan or that is Japanese but jn fact Japan isn't stupid nor our it's people, doctors or pharmaceutical companies.

For things that are rarely needed Japanese companies have good partnerships with foreign companies to obtain those meds and in this case Vaccines.

2 ( +4 / -2 )

Agreed and also read that as well. We can tweak the PCR to turn up the number of cases

I dont want to get into the middle of your discussions with virusrex i just want to add my view for readers to consider if thet want.

The problem as i understand it is that the number of ct cycles is not being taken into consideration when making a decision/diagnosis, not that ct thresholds are

being tweaked to manipulate results.

So the results of the tests are basically just positive and negative, the implications of ct levels to viral loads arent being considered.

For me this shoukd not been a problem if those who were being tested were mostly suspected and probable cases. But testing anybody including perfectly healthy individuals combined with the sensitive equipment results in many false positives

4 ( +4 / -0 )

if scientists cannot adequately prove the virus exists (isolate it in a lab) then how can they provide a test for it?.

There is a reward on offer of over 200,000 euro at the Isolat Truth Fund. Nobody has claimed it to date. A good chance to get rich for all the conspiracy realists isn’t it!

and by the way, the flu is officially down to zero cases according to the Daily Mail and Independent. Hmmm?

-3 ( +3 / -6 )

PCR cycles?

the virus never been isolated?

Herd immunity around the corner?

Since when the comment section became a collection of debunked lies? Sad to see what is being allowed to be repeated here without having any relevance to the content of the news article.

At least the votes say that the users have a better idea of which comments are rubbish.

2 ( +4 / -2 )

@penfold

Take you Q conspiracies and go some place else.

How any sane adult can believe the stuff you repeat is amazing.

2 ( +4 / -2 )

if scientists cannot adequately prove the virus exists (isolate it in a lab) then how can they provide a test for it?.

Sigh. Professor Zhang Yongzhen working from his lab at Shanghai Public Health Clinical Center succeeded in mapping the complete genome of the SARS-CoV2 virus on 5 January 2019. Zhang uploaded the genome to the U.S. National Center for Biotechnology Information (NCBI) on Jan. 5, a fact confirmed by the submission date listed on the US Government's "Genebank". Zhang traveled to Wuhan to consult with top public health officials there. The genome was then published on the website Virological.org on 11 January 2019.

2 ( +2 / -0 )

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