Daiichi Sankyo seeks approval for Japan's 1st home-grown mRNA vaccine

"Home grown?" Sounds more like a vegetable than a vaccine!

Better (three years) late than never.

One of its rivals, Shionogi & Co, applied with the ministry last November for approval of its recombinant protein-based preventive vaccine

Btw, why is this taking so long?

Why not a traditional vaccine?

The mRNA developed injectables have been shown to cause clotting, inflammation and to target other organs within the body.

These side effects are being noticed by doctors and sufferers all around the world.

Traditional vaccine please !

Why not a traditional vaccine?

Cost production limitation handling and safety issues

Among others

The mRNA injectables have been shown to have plenty of side effects

Ok.

Drugs and vaccines usually have side effects, up to governing bodies how much is acceptable, hence trials before approval

Approval can be withdrawn also

Traditional vax requires culture of virus, afaik, to begin with you want that?

Anyway you can't produce nearly enough as needed(for covid)

Btw, why is this taking so long?

Because they are asking for approval in Japan, a country where it has been traditionally much more "justifiable" to let peopple die for lack of action but no to have any kind of problem caused by actually doing something.

Why not a traditional vaccine?

The mRNA developed injectables have been shown to cause clotting, inflammation and to target other organs within the body.

Because the risk coming from the best available vaccines are still a tiny fraction of the actual benefits they produce, "traditional" vaccines have up until now been vastly underperforming, which means they don't reduce as much the complications and end up letting people be exposed to higher risks overall, better than not being vaccinated but less safe than the best vaccines.

These side effects are being noticed by doctors and sufferers all around the world.

But epidemiologically proved to be much less important than the benefits they provide, the differences in efficacy with subpar vaccines being a much more pertinent worry for the health care professionals.

The mRNA injectables have been shown to have plenty of side effects

So are all vaccines, but for the efficacy they have demonstrated this is still a much better deal than bad vaccines.

This lipid nano particle genetic altering bio technology has never been used for vaccination in the past. There is no sufficient study conducted to see its effectiveness and safety. Approval normally takes ten years or more. And the cells are not supposed to produce the protein spikes which continues to reproduce for a prolonged period of time and goes to all organs, tissues, muscles and veins. Corona has mutated into a milder virus so there are more risks to the jab than the virus itself. The virus keeps on mutating constantly so there is no way the jab can keep up to the constant changes of the virus.

Corona has mutated into a milder virus so there are more risks to the jab than the virus itself.

Milder maybe but killing far more now.

If jab isriskier it should have killed more than the virus by now

The virus keeps on mutating constantly so there is no way the jab can keep up to the constant changes of the virus.

Let's suppose this is true.

What do you propose then , let the virus run through the population without using vaccines?

This lipid nano particle genetic altering bio technology has never been used for vaccination in the past.

It is not gene altering (the virus has much higher chances to do that than any of the approved vaccines) and the technology has been used in human patients since the 90s without any specific problems attributed to it, so both those claims can be demonstrated as false.

There is no sufficient study conducted to see its effectiveness and safety. 

The experts that work professionally evaluating vaccines safety and efficacy say the opposite, and they have the data to prove it, not only from tens of thousands of volunteers in the trials but from millions of vaccinated people in the world.

Approval normally takes ten years or more.

False, that would make every drug or vaccine approved become unprofitable because togheter with development would make impossible to approve them before they become open to fabrication as generics.

And the cells are not supposed to produce the protein spikes which continues to reproduce for a prolonged period of time and goes to all organs, tissues, muscles and veins. 

All in a much more limited way than what happens with the infection, which is the whole point, cells are not "supposed" to be exposed to safe portions of the pathogens so the organism can mount a defense safely against them, but technology lets us do that for the benefit of public health.

Corona has mutated into a milder virus so there are more risks to the jab than the virus itself. 

False according to the scientific and medical consensus, there is no recognized institution of science or medicine that says the infection is safer than vaccinating.

The virus keeps on mutating constantly so there is no way the jab can keep up to the constant changes of the virus.

The original vaccines still produce a significant degree of protection even against the current variants, this completely contradict your claim.

I wonder how they got IP clearance since Moderna and Pfizer have so many patents in this area?

Daiichi Sankyo has several products in development that use artificial nucleotides and lipid nanoparticles with propietary formulations, in theory they could use them for the purpose of vaccination without relying on Moderna or Pfizer. According to another article published here they could even make a virus delivery version.

TemyongToday  08:31 am JST

This lipid nano particle genetic altering bio technology has never been used for vaccination in the past. There is no sufficient study conducted to see its effectiveness and safety. Approval normally takes ten years or more.

This is true in the United States where it takes 5, 10 years or even longer to receive approval for a vaccine.

No one would believe Japan would make this process faster than the US'.

This is true in the United States where it takes 5, 10 years or even longer to receive approval for a vaccine.

There is a huge difference with approving a vaccine meant to be better than another that is already available,

another to approve a vaccine that prevents complications of an infection for which there is no other vaccine. The obvious example that disproves your claim is the full approval of covid vaccines that obviously took much less than 5-10 years.

If the clinical trials are conducted according to an approved schedule (used in other previously approved vaccines like against rotavirus) there is nothing wrong with reducing the time spent on red tape. That Japanese companies are unlikely to streamline the process has more to do with inappropriate loss of time in the process followed by the PMDA and the much higher standard of proof requirede for the Japanese vaccines that do not only need to demonstrate efficacy, they need to demonstrate benefits when compared with the best approved vaccines.

so another piece of game this time made in Japan?

sure someone may be interested to get jabbed by that...and feel...protected?

Made in Japan so probably a lot will prefer that from made in other countries

Daiichi Sankyo's is tailored for previously dominant variants and intended for third jabs.

Whoahhhhhh. Slow down there. What's the rush?

kurisupisu - Why not a traditional vaccine?

dan - Traditional vaccine please !

"One of its rivals, Shionogi & Co, applied with the ministry last November for approval of its recombinant protein-based preventive vaccine, the same type as the vaccine developed by Novavax Inc, which differs from vaccines using messenger RNA technology."

history and a whole lot of injured and dead people will have the final word on mRNA.

When? if the technology has been used on human for decades already without causing specific problems this is just a meaningless appeal that the future will disprove what the currently available evidence (coming from the 90s) is wrong for no reason.

There is already a whole lot of injured and dead people thanks to the infection, vaccines have helped reduce this which is why they are considered a huge success by the medical and scientific professionals that work preserving public health.

The UK has also struck a 10 year deal with 'Moderna' to produce 250 million vaccine doses per year by building a ' State of the art vaccine manufacturing centre '....The www.gov.uk web site, and news papers proclaimed 2 weeks ago.

I wonder how they got IP clearance since Moderna and Pfizer have so many patents in this area?

The original patents for using mRNA lipid nanoparticles for vaccine applications are over 30 years old, held by Robert Malone. That patent protection ran out.

It will be interesting to see the results for the long term safety of this vaccine for males under 30.

It will be interesting to see the results for the long term safety of this vaccine for males under 30.

Indeed, but for that age group, I doubt anything will be safer and more effective than the current variants (virus).

@Raw Beer

Agreed.

Indeed, but for that age group, I doubt anything will be safer and more effective than the current variants (virus).

Even now this has been disproved, people vaccinated with mRNA vaccines do better than unvaccinated people for infection with the current variants, which completely disproves your beliefs. On top of that vaccinating after being infected once also produces benefits, meaning that the protection produced by the vaccines is not only less risky than what is gained from the infection (obviously since the infection comes with all the risks you are trying to avoid) it is also better to prevent further risks from subsequent infections.

The UK has also struck a 10 year deal with 'Moderna' to produce 250 million vaccine doses per year by building a ' State of the art vaccine manufacturing centre '.

Yeah, I heard about that. I believe Canada and perhaps another country is also doing that. What are they thinking? Seems they are planning something; perhaps getting ready for SEERS25...

@VirusRex

Source for men under 30 please.

Even now this has been disproved, people vaccinated with mRNA vaccines do better than unvaccinated people for infection with the current variants

Current numbers in Japan totally disprove your allegation. Most people dying are 4 or 5 times MRNA vaccinated.

At minima, the MRNA doesn't work for old people. Data from Australia suggests even a negative correlation which could span from straining the immune system.

Current numbers in Japan totally disprove your allegation. Most people dying are 4 or 5 times MRNA vaccinated.

At minima, the MRNA doesn't work for old people. Data from Australia suggests even a negative correlation which could span from straining the immune system.

There's a way for that to be convincing

Source for men under 30 please.

It is very easy to find out health care professionals or whole organizations promoting vaccination in young people as a way to reduce their risk, for example:

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html

https://www.northeastlondonhcp.nhs.uk/ourplans/covid-19-vaccine-faqs-for-younger-adults.htm

https://theconversation.com/five-reasons-why-young-people-should-get-a-covid-booster-vaccine-189411

https://www.healthychildren.org/English/health-issues/conditions/COVID-19/Pages/Heres-why-healthy-young-people-need-the-COVID-19-vaccine.aspx

This means that the professionals that deal with the topic coincide in saying that there is no merit in claiming that any population for whom the vaccines are recommended are better without it, what would make you think they are all wrong? what authority has provided any evidence that says vaccinating young male adults is more risky than the infection? obviously appeals to expertise from anonymous accounts in the internet is not something that has any weight.

Current numbers in Japan totally disprove your allegation

No, it does not, vaccinated people are at a much lower risk compared with unvaccinated people.

Most people dying are 4 or 5 times MRNA vaccinated.

Which is what is expected when everybody is already vaccinated, specially those at a much higher risk, without equalizing demographics you don't have an argument. Because it is like comparing 100 unvaccinated elementary school children with 100 vaccinated seniors over 80yo and saying vaccines don't work because more of the latter died.

Data from Australia suggests even a negative correlation which could span from straining the immune system.

No, it does not as the authors clearly say in their study, that baseless claim come from people contradicting the authors of the study and making unwarranted conclusions based on incomplete data. As long as vaccinated people keep being at lower risk (at equivalent demographics) this is clearly disproved.

After the recent mRNA vax experiment, who in their right mind would even consider this 'home grown' version. Doesn't prevent infection or transmission, only gives long lasting side effects.

The risk of severe complications for men in their teens and 20s is negligible. For that same age group a there is a warning about the risk of myocarditis and pericarditis on the MHLW's website. A risk/benefit analysis for that age group is warranted.