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© Thomson Reuters 2021.Japanese approval of Moderna's COVID-19 vaccine unlikely until May
By Rocky Swift TOKYO©2024 GPlusMedia Inc.
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Fiddlers
Takeda hoped to begin clinical trials of the Novavax candidate next month and, upon approval, it would be mass produced at the company's facility in Yamaguchi Prefecture, Imagawa said.
Seems like the Japanese were hoping this one would be the main vaccine used here but they backed the wrong horse and they still might be holding out for this one so that Japan inc. can profit from the virus.
Kitchener Leslie
Pathetic.
zatoizugoodo
I wish I never came to Japan. Everything, no matter how urgently needed, takes ages to do. No wonder Japan keeps falling behind the rest of the world. If the UK, USA, and other first world countries can approve it without delay, why can't Japan? Even China and Russia have approved a vaccine, however dubious the quality and safety.
kurisupisu
There is a definite lack of something in Japan when it comes dealing within the outside world.
Exporting goods from Japan which I regularly do is a breeze.
However, importing and registering just about anything takes time, stacks of paper, stamps, money and endless patience.And any foreign document needs to be translated and multiple copies made.
This is why Japan is in this embarrassing position and the public are suffering!
thelonius
If Japan requires clinical trials, why are they just starting now?? This is tragically stupid.
kurisupisu
@zatoizugoodo
Having the vaccines approved and the contingent delays are easily understandable.
Japan is a massively protectionist country where it has been said that the snow here is different to other countries which was an excuse used to block the imports of skis.
Where Japan has been the beneficiary of free trade, it has been reluctant to engage in quid pro quo.
This lack of options has moulded the Japanese mentality somewhat.
Why are many Japanese people so reluctant to try and engage with different paradigms-they have literally been told ‘no’ millions of times when making suggestions or forced into a labyrinth with no exit.
Japan has many pluses but engaging in the society in order to make a living outside of basic or menial jobs means overcoming many barriers.
After over 30 years here, I suggest you concentrate your efforts at making a life outside Japan where restrictive practices are fewer.
collegepark30349
Takeda hoped to begin clinical trials of the Novavax candidate next month and, upon approval, it would be mass produced at the company's facility in Yamaguchi Prefecture, Imagawa said.
Yamaguchi - Abe's home prefecture. Move along, nothing to see here.
Jim
It’s just that Japanese Inc. wants to make money out of this...pathetic!
Samit Basu
So US and EU Phase 3 trials are not good enough for Japan?
divinda
I'm beginning to think vaccine approval has to do with the Olympics. Hear me out:
If Japan cancels the event, then the country is on the hook for all the bills.
If the IOC cancels, then Japan has less obligation on the bills, particularly those being paid to the IOC.
Obviously, neither wants to cancel since the IOC wants to be paid, yet Japan doesn't want to be required to pay the IOC under their contract. (Hence why it took so long to "agree" to postpone the games last spring).
So, by way of their arcane vaccine approval requirements (which can actually be deferred in the case of an emergency), it may be that Japan is trying to force the hand of the IOC (and all the member countries). Because if the member countries start to bail out (like what was starting to happen last spring) then the IOC would need to act, and thus take the responsibility for the (inevitable) cancellation.
Tora
Logistical challenges to roll out in Japan: undeveloped infrastructure, lack of clinics/hospitals per capita, corruption, religious reasons, lawless areas, problems with warlords... Wait
kurisupisu
I didn’t mention the abysmal lack of foreign language ability in conjunction with a similar lack of ability to effectively communicate in international situations..
borscht
penfold,
3600 dead Japanese would disagree that Covid-19 is “Just a cold.”
Moderators, why are you allowing misinformation on your site?
HBJ
If a vaccine has been approved in India, Britain, South Korea, USA etc. shouldn’t Japan be able to administer the vaccine to foreign nationals hailing from those countries?
Sure, spend time making sure it’s safe for the local population, but for many people who are not Japanese, the wait for these clinical trials is meaningless - especially when the vaccine has already been deemed safe and approved for ‘them’.
Kobe White Bar Owner
@HBJToday 07:43 am JST
If a vaccine has been approved in India, Britain, South Korea, USA etc. shouldn’t Japan be able to administer the vaccine to foreign nationals hailing from those countries?
you think they care about foreign nationals?..,,
kurisupisu
@Troy
No, of course not.
However, you are missing the point.
This is not about foreign companies trying to open up the Japanese market for profit, it is about the Japanese needing something beneficial which many countries already have.
And the Japanese people are needlessly waiting.
The reasons for that I have already mentioned in previous posts.
Kumagaijin
This sounds familiar. Japan needs to do "its own" study. Just like with other things that are totally obvious, whether it be relating to child custody, or medical marijuana, the Japanese government just delays and postpones urgent issues because it has no backbone.
virusrex
Approval of the WHO recommended vaccines has not been rushed, anybody that follows vaccine news would already know that the same schedule have been followed before on vaccines that did not have any problems of safety nor efficacy.
What was "rushed" was development, and that was thanks to a lot of money, decades of advancement of technology and low hurdles to surpass, advanced sped on these conditions is desirable.
No, it is not reasonable when the consequences of delaying approval are dire and the information to be gained by the local trials is redundant. See the number of hospitalizations and deaths by influenza this season, that will let you understand COVID-19 is hugely more important for the Japanese public health, specially because we are not at the end of the peak.
The main reason why no Japanese company came up with a vaccine is that even approval for the trials is extremely complicated and slow, even more for approval to go into the market even with good results. Japanese companies would have a much better chance developing, testing and producing their vaccines overseas first, and then come back a year later to search for domestic approval, that is what Japanese "venture" companies end up doing.
So was also last year, and the year before, etc. But obviously hugely crippling social and economic measures have not been put in order to stop suicides. Comparing numbers as if COVID-19 cases and fatalities were product of living a normal life is irrational.
By the time it is projected that herd immunity could interrupt transmission the money "wasted" on vaccines would be a tiny spec compared with the rest of the economic loses.
No, it is well recognized that cost/benefit of every measure is what let you know if something should or not be. Redundant, irrelevant red tape is not free, it has a cost on the health and lives of the population. Losing 100 lives a month doing nothing to make sure you don't lose 1 life doing something is not a rational way of action.
factchecker
Can't want to keep their precious Olympics too badly dragging the chain like this then.
kohakuebisu
China has a vaccine that has been developed for, tested on, and implemented on East Asian people. The latest news was that it was found to be 80% effective in Brazil, an ethnically very diverse country.
Not that I expect Japan to be in any hurry to recognize Chinese achievements....
i@n
It's clearly Japan's fault.
The vaccine companies must have thought testing and approval take only a few days but the govt didn't tell them it takes quite some time
SandyBeachHeaven
Maybe herd immunity will occur before the vaccine arrives.
What would they do with the 500,000,000 procured bottles of vaccines?
RGsilence
May? Really Japan? That's not enough to safe the Olympics, sorry! You can't start vaccinating millions of people a month before the event, it won't work! Just a quick reminder of how long it took for Britain, the only example I know of, to vaccinate most of its people. Oh wait, scratch most ...
I quote from itv.com, news from Thursday January 7:
And as far as i know the process started on December 7th with the vaccination of a 90-year-old woman. Now everything is fine in the UK right?!
Hey Suga! Are you guys sure you've really thought this through?
robert maes
It is not only pathetic and scandalous but criminal what the Japan InC and government is doing by delaying vaccin approvals.
of course they are waiting for Japanese vaccine copies as they were not even able to come close to developing a Japanese vaccine.
But as foreigners living in Japan we have to accept their ways, no one living here more then 3 years can act surprised
The Japan Upper layer of people has never cared about the lower part of society. Never. And foreigners do not even register on the scale in what is a glorified cast system
thelonius
Hopefully, this is a strategic announcement targeted at the PM, but I doubt it will make any difference. Japan must do things its own way, regardless of the consequences.
Strangerland
Um, they don't get the second shot until three weeks.
Did whatever propaganda you didn't bother to fact-check leave out that little tidbit?
virusrex
That is still a very lousy excuse, "Japanese" is not such a unique ethnicity that a special reaction is realistically expected. Epidemiologically speaking a much higher degree of evidence is required to begin thinking that this possibility has any real risk of appearing, and even more to outweigh the risks from not vaccinating the population.
How many drugs/vaccines/treatments do you think have proven to be below the safety cut off level to be used but only on the Japanese population? What real life case can you use to say not testing on Japanese can mean a risk even comparable with the COVID-19 infection?
Such a secret information that you had to go all the way to the same page to find it?
Allergic people are allergic, it is well known and part of the reason why the vaccine is not just distributed by mail but that require a visit to the doctor. Have you considered that nobody is talking about it because it is completely expected?
So you have 1 in 100,000 chances of having a dangerous immediate reaction, that is expected and treatable, if you vaccinate. On the other hand you have 2-3,000 in 100,000 chances of dying if you get the disease without the vaccine, its irrational to panic so much about the lower risk that you keep the population on the higher one.
InspectorGadget
This is a classic example of Japan erecting protectionist measures designed to prevent competion with its own domestic industries.
Alex
I have no words.....
virusrex
What if a healthy doctor died two weeks after not getting the vaccine? would this indicate that not getting vaccinated is a risk of death? should this be used to convince people to get vaccinated?
This is not how risk evaluation works, people die (or get sick, etc.) all the time, specially if you begin to follow millions, unless you can show that vaccinated people are at a higer risk of something then this is not an argument to delay vaccinations. Of course you have to keep notes, but immediately jump to invalid conclusions is the opposite of what you have to do to protect lives.
Mr Kipling
That foreign medicines and vaccines have to be tested in Japan is a great example of “hidden protectionism”...its for safety but in reality is to give Japanese manufacturers an advantage. However, kind of backfires when you need something in a hurry.
blahblah222
Japan's vaccine is one of the most protected industries.
Even pfizer's deal was made by the PM rather than the health ministry. If you leave it to the MHLW, they will never approve anything before their domestic vaccine makers stand to make significant money and give them kickbacks/bribes.
Currently not only is the MHLW creating multiple hurdles to approval, they are also actively sabotaging distribution and logistics to attempt to slow down the roll out of the foreign vaccine, just so that they can time it to their domestic vaccine makers who will get an easy approval with just 500 person phase 3 which will not even prove any efficacy.
virusrex
Again, the point is that those "extra checks" are paid in human lives and huge damage to the economy.
There is such a thing as unnecessary and superfluous steps that provide no distinguishable increase in safety while exposing people to much higher risks.
In a sense is like filling your walls with asbestos to reduce the risk of dying in a theoretical fire.
happyhere
Can I volunteer?
Otherwise I'll just go back home and get one there. Hope vaccinated people can travel without quarantine.
i@n
And of course, the moment these vaccines are approved, supplies will magically appear =)
N.M.
@divinda I hope that's not the case. Because that would mean trading the life of people for econompic or political gain.
No, I think this can be explain more easily: the utter incompetence of the Japanese government at every level. It has been known for years but is now at full display.
BlackFlagCitizen
For a country pushing real hard for the Olympics to happen, they surely are dragging their feet on distributing the vaccine.
Sven Asai
You’re already complaining about ‘May’, but still don’t know of what year....lol
oyatoi
Japanese markets are case studies in multiple levels of regulation (kisei) overkill designed to thwart foreign competitors on trade. The vocabulary of regulation here provides a glimpse of how markets are totally governed by a web of regulatory controls and procedures designed to curtail their free operation. Horitsu, Seirei, Shorei, Tsutatsu and Kisei, then under Kisei there's Kyoka, Ninka, Menkyo, Shonin, Shitei, Shodaku, Nintei, Kakunin, Shomei, Ninsho, Shiken, Kensa, Kentei, Toroku, Shinsa, Todokede, Teishutsu, Hokoku, Kofu, Shinkoku. Plus there's Naiki, and Gyosei Shido and Jorei. So many, many, many varieties of regulations and restrictions, that attaching English equivalents becomes problematical.
HBJ
Not at all. Just stating the obvious I guess!
virusrex
So, that is how you think you proved your point? by your personal uninformed opinion about what is or not a COVID-19 death contrary to the opinion of all experts? Is it because you consider yourself an expert?
How about the rest of the comment that you "simply ignored"? Is that how you accept being wrong?
At the end in a single comment you did all of the things that you complained about.
Fanny Greene
clinical trials done overseas. trials need to be done here because Japanese people are 'special'.
Luddite
Why not start the testing process now? The government has no sense of urgency to deal with a horrible pandemic. That is scandalous.
Ed Rowe
I don't understand why they don't fast track it but just give a warning that side effects are still undetermined..
that would allow the public to choose for themselves...
sf2k
May is just a best case scenario. So more like August
Samit Basu
@Matej
There is no "Japanese" vaccine.
Takeda is distributing a vaccine from US company Novavax and this one is in trial in Japan right now.
What Takeda is saying is that no vaccine can skip a Phase 3 trial in Japan and a US and EU approval alone isn't enough.
Most other countries will take at least US FDA approval when approving medicine on emergency base.
lostrune2
If you mean profit, not AstraZeneca, at least. Being developed from public Oxford University, the British government required that any manufacturing partner be not use it for profit from the crisis
That's why it took AstraZaneca, a relatively smaller drug manufacturer that doesn't usually make vaccines, who agreed not to make profits
sf2k
think time allocation. 3 minutes per person average to get a jab? For a population of 14 million, 42 million minutes or 29,166 days. Multiple by 2 for 12 hour days. 58,334 minute-days. So now we know what the staffing scale has to meet. There will only be a few thousand people who can give you a shot. It's not the same as taking swabs. Also clinic setup, scheduling, vaccine availabilities, delivery, refrigeration, training, second doses. Lots of people.
This is going to take many months longer if not most of the year.
Japan better start planning and ramping up now instead of waiting the last minute given the much larger population. That time allocation should be pretty daunting.
Getting the testing ramping up to meet the need would have prepared Tokyo to learn about this kind of scale problem, but with so few tests even now there are few lessons learned.
Unfortunately this means vaccination will languish behind those that learned from building up the testing capacity.
virusrex
Sure, of course you can quote me on that, right? just copy and paste anything where my personal opinion is what supports what I write. It is not like you pulled that out of the thin air
If you skip reading every time I prove false something born from ignorance, like "We need to see testing through to make sure it doesn't kill hundreds..." even when the testing is much smaller and less significative than what has already been done, that is the opposite of ignoring evidence, that would be trying to ignore when something proves you wrong.
I am still waiting to see the thousands of people that are supposedly coming back to life in the US because they surpassed the 0.1% fatality rate that you so desperately want to believe.
garypen
Take your time, J-Gov. No rush. It's not like there's a deadly pandemic that especially affects seniors in a country with a majority population of seniors.
jiji Xx
so, do I have this right? 'Japan', has handed over the testing of drugs manufactured by foreign drug companies, to a Japanese drug company? if so... (◎-◎;)
divinda
I also don't think they are intent to trade the life of people for econompic or political gain.... but "gain" of anything not the case here.
They are looking cover their buttocks and avoid responsibility. And you know that Japanese politicians will do just about anything to save face.
dmhondz
With so many meetings, brainstorming and status report on each level of the hierarchy and the only real time they can do work is during overtime until the last train due to whole day of talking and creating powerpoint presentations, yeah I guess May sounds about right.
Mark_McCracken
120 million doses, starting in February, from Pfizer would be enough for 60 million people, or roughly enough for every person in Japan 55 years and older.
didou
What are the said requirements for local clinical trials ?
foreignbrotherhoodarmy
Utterly pathetic. Not suprised though.
Pukey2
At this rate, the Olympic Games are going to take place before any vaccination programme starts. (Not that I think the games will go ahead anyway).
nandakandamanda
Yes, allow millions of volunteers, at their own responsibility, to take it first, during this lo.o.o.o.ng interlude.
Why not? That would save two birds with one shot.
nandakandamanda
Troy, that was the Pfizer vaccine the good Miami doctor took, not this Moderna one under discussion.
A Johnson
How is Japan going to generate significant efficacy data of the Western vaccines without a mass vaccination trial? As the reports stand, Japan has so few cases, few cases = few data points / # participants.
MY RECOMMENDATION:
Tomorrow - They should just start rolling out all vaccine candidates as fast as their fax machines can print. Do so under the guise of “trials”. This way they might have a shot at a significant data-set by April, and may have an effective means to distribute by... June or July???
May - announce they are considering the data
June - announce they will be announcing approvals.
July - Roll out the vaccines to Japanese & International community at the Olympic venues. Face saved!
*Trials & Dat will require testing though. And Suda-san is going to squash this 3rd wave by February... Nah, this just won’t ever work.
A Johnson
@virusrex
Exceptionally good commentary/insights/rebuttals on this news thread. Thank you.
Most of your points should be obvious, but I get the feeling many JT readers rely a bit too much on Japanese news sites for general information on the virus, pandemic, immunology etc.
Blitzwing
Maybe they can toss it in the ocean together with the nuclear waste water from Fukushima :P
natsu823
Sad.. sorry for Japanese people put up with lame leaders.
didou
Maybe that was true for skis a long time ago. I have only seen foreign brand skis here.
Nevertheless, Japan paid millions to secure contracts with foreign firms. Then millions in subsidies for vaccine developpement here. At the end, the Japanese pharma makers should make business, money and secure jobs. If foreign vaccines do work, nothing left for J makers. The plan is to slow the process, using foreign vaccines for priority people, the J one for the masses. Just some thoughts.
Is that the journalist sentence ? Again the Games dictate things
rainyday
I get the feeling the government has been able to get away with mostly ignoring Covid for so long since by sheer luck Japan avoided the worst case scenarios until recently that they never bothered to pay any serious attention to getting the vaccines approved in a timely manner. Probably they were just gambling that the situation would continue as it was a few months ago and they wouldn't face an urgent need for them. Having the bloody government so distracted by the Olympics (again) likely hasn't helped either. This is in contrast to countries in Europe and the US which have been hit really badly for a long time by it and really made an effort to get the vaccines as soon as possible.
Its a total disgrace now that we really F'ing need those vaccines to be rolling out NOW. I don't even want to think about how many people are going to die between now and whenever they get their bloody act together.
HenryK
When some politicians retire they will be on Takeda's board.
I'll never take a Japanese vaccine. haha
Ah_so
Then all you would need is a few TV talk shows to do some specials on the side effects to send the whole country into hysteria, and then the government will withdraw it, just as they did with the HPC vaccine.
Kevin
I'm guessing that after a few more weeks of this exponential growth of the COVID cases in Japan that the vaccine may start to become a bit more of a priority. All of the "close by 8pm" nonsense is not going to stop this beast.
Ameila Leary
All the World is Suffering because of China. China knows that the reality of the origin of corona virus. They first lied about the spread of the virus, then blamed the origin on various countries. China has never revealed exact information about the virus, or even about how to stabilize the Wuhan market where the infection first started.
carpslidy
More than when it starts, when is it expected to finish?
Even at a million does a day it would take 240 days to give everyone two does.
I have no idea if 240 million does are needed to get back to normal or if a million does a day is possible.
Anyone have any idea?
Rob-3
I agree with you. Speaking with friends and family that live in Japan (Tokyo, Fukuoka, Osaka, and Akita), I can assure you that no one is viewing this just a cold.
However they did say that if COVID doesn't kill them, these shutdowns will. I know they mean that jokingly but it just reinforces the situation.
Leo
I am shocked at the delay.
virusrex
So you do think you are more qualified than the experts that actually determinate the number of COVID deaths, and also keep ignoring every argument that prove you wrong.
That would mean that yes, you do everything you keep accusing others to do, just with bad excuses about it.
Mike James
@troy
"clinical trials done overseas. trials need to be done here because Japanese people are 'special'." not special but different: It is a a given fact the medicines affect different racial groups differently."
Did you read the article? It is NOT a given fact the medicines will always affect different racial groups differently. And in case, the vaccine is not a "medicine," s your point is mute.
To quote your article.... "Race is a crude proxy to genetic ancestry and falls short of explaining the variation in response to medication." Thus, it is not a question of being a Japanese national or not.
Further, most medications can be controlled by dosing, but the two vaccines are not medications, they are mRNA. There is a big difference, Further, unlike other vacancies, the mRNA does not contain eggs or preservatives as a flu shots do. All it is is a tiny piece of genetic code to stimulate a coronavirus immune response. It does not contain C19.
Read up before jumping to conclusions.
Goodlucktoyou
Good idea. The CEO is saying it may only work for 6 months.
PerformingMonkey
I'd rather have the AstraZeneca one anyway.
Wick's pencil
If the US had few casualties like Japan, they would not have hsf Operation Warpspeed.
Troy
"clinical trials done overseas. trials need to be done here because Japanese people are 'special'."
not special but different:
It is a a given fact the medicines affect different racial groups differently. ( How does race/ethnicity influence pharmacological response https://www.tandfonline.com/doi/abs/10.1080/17425255.2018.1449833) and ( Do medical drugs, including vaccines, work differently for different ethnic groups? https://www.quora.com/Do-medical-drugs-including-vaccines-work-differently-for-different-ethnic-groups)
Blitzwing
Feel free to leave :)
Joe Blow
There's a reason that hasn't happened; hint: population control of poor people.
Seth M
Thousands of Americans have fell sick after taking the covid vaccines.
Keep them out! Suga
Troy
Um, they don't get the second shot until three weeks.
Did whatever propaganda you didn't bother to fact-check leave out that little tidbit?
LOL. he didn't die of covid 19, but possibly because of the vaccine itself?????
bob
Terrified foreigner; "Give me the damn vaccine now!!!!!"
Japan; "Hold up. We need to see testing through to make sure it doesn't kill hundreds of...."
Terrified foreigner; "Shut up!! Give me the vaccine!!!"
bob
Shocking. Where is the proof of this shocking statement?
bob
Imagine thinking at this point that all those Covid deaths were actually Covid deaths!
The blinders that one needs to believe an 82 year old with 3 or more co-morbidities died because of Covid is stunning.
as the kids say these days...You do you.
bob
Yet another person who thinks the length of a post equals gravitas and truth.
He hasn't made one proclamation other than he considers himself an expert. Simply ignores all available evidence that runs counter to his wished-upon narratives.
Troy
"And the Japanese people are needlessly waiting."
No they are not. Vaccines have to go thru the approval b process to protect the people.
It is a a given fact the medicines affect different racial groups differently. ( How does race/ethnicity influence pharmacological response https://www.tandfonline.com/doi/abs/10.1080/17425255.2018.1449833) and ( Do medical drugs, including vaccines, work differently for different ethnic groups? https://www.quora.com/Do-medical-drugs-including-vaccines-work-differently-for-different-ethnic-groups)
Troy
By the way, I guess you have not heard of deaths linked to the covid 19 vaccine. For example:
A ‘healthy’ doctor died two weeks after getting a COVID-19 vaccine
https://www.sun-sentinel.com/coronavirus/fl-ne-miami-doctor-vaccine-death-20210107-afzysvqqjbgwnetcy5v6ec62py-story.html
I think Japan has it about right.
Troy
"If a vaccine has been approved in India, Britain, South Korea, USA etc. shouldn’t Japan be able to administer the vaccine to foreign nationals hailing from those countries?"
LOL, I guess you feel you are above Japanese Law?
Troy
"It’s just that Japanese Inc. wants to make money out of this...pathetic!"
and western companies are not making any money from it?
Troy
"I didn’t mention the abysmal lack of foreign language ability in conjunction with a similar lack of ability to effectively communicate in international situations.."
LOL. I guess it is asking too much for foreign companies who want to do business in Japan to speak Japanese. Everyone must speak English? LOL
Troy
Moderna Inc's COVID-19 vaccine is unlikely to win approval in Japan until May due to requirements for local clinical trials,
As it should be.
Wick's pencil
Just because other countries rushed the approval of these vaccines doesn't mean Japan should do the same.
And Japan doesn't have the same casualties.
Penfold
It’s completely reasonable that the Japanese government want to do local trials.
One thing to consider is that Japanese generally have a healthier diet than UK or US population so don’t have as many underlying conditions.
Even if they get sick with COVID it won’t be much different for them from having a bad cold or flu.