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© KYODOPfizer files request for COVID-19 vaccine approval in Japan
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Japanoob
the PM had recently enjoyed a steak dinner in the company of fellow geriatrics, contrary to guidelines and common sense, for someone meant to be showing leadership.
didou
The sense of urgency in Japan does mean it takes a few months to setup things, the necessary delay to review details and confirming no rust will damage the process.
That’s like the emergency cars running at a low speed. Better to be close from an hospital in case of heart attack.
AEDs now can substitute the failure of speedy intervention.
Penfold
article fails to mention that the “experimental “ vaccine manufacturers will not be held liable if something goes wrong.
theFu
How many Japanese were in the trials?
Seems like that would be a key factor in approval for wide deployment within a country. Lifestyle, foods, and common medical practices could be material, yes?
Yes, we are all human, but there are differences. There are some Asian-specific issues with some treatments.
Hopefully, if there are any differences, those aren't important, but wouldn't they want to find those before broad deployment to everyone. After all, there were important differences in how Americans needed treatment compared to Chinese.
Luddite
“As early as March.” I keep seeing and hearing this nonsense. March is very late, vaccinating the most vulnerable needs to start ASAP.
kaimycahl
This virus has no end!
AgentX
So long as it's optional, that's great news. Maybe.
divinda
To everyon complaining about starting no earlier than March:
They can't get delivery until at least March. The first several million (maybe 100+ million) doses have already been bought and alotted to the US, UK, and possibly others.
Japan, like every other country on earth, has to wait in the queue since the role out of any vaccine is first come (wiuth their checkbook) and first served.
JJ Jetplane
@Penfold
There are risks associated with just about all vaccines. As long as the data highlights those risks and the government deems them an acceptable amount of risks, then they usually get approved. These vaccines are the first mRNA vaccines that have ever been approved for human trials. mRNA vaccines are only 30 years old. So the long term affects of vaccines that don't carry the genetic code of the virus are not properly known. Uncharted waters.
i@n
For countries where vaccines have been approved maybe the respective embassies could arrange for vaccinations of their citizens here so some people could be vaccinated already
Monty
I dont expect anything before summer.
In my home country, they said they will start vaccinate the population in January, but yesterday evening my brother in my home country said, hopefully June.
These days I dont give any serious hope that vaccination will start earlier than summer.
But you should never give up hope, right?
Bob Fosse
They need to consider speeding up the process.
virusrex
Japanese approval process is ultra-protectionist, and for some reason it prioritize having as little lives lost for anything approved, this seems to be positive, but in reality it just mean that having a much higher amount of lives lost for something not approved opportunely is not seen as a problem.
Since it is not true, that would explain why is not included, it is desirable that false or misleading information is not mixed with reality in an article.
That is incorrect, vaccines patents last only 10 years, and any competent company has to register as soon as the technology to produce it is developed (before the pre-clinical trials), if this were true nobody would make any new vaccine, since by the time billions of dollars were invested in the clinical trials anybody could make it without paying anything.
In reality vaccines have traditionally taken many years to develop in order to overcome some special difficulty or to improve over what is already available, for COVID-19 none of those 2 things are necessary. The main time consuming part is the phase III clinical trial, but 6 months of trials have been already used for vaccines in use before without problems, so the "emergency approval" acceleration is mostly on the paperwork.
Luddite
@divinda. Rubbish. Japan ordered the Pfizer vaccine earlier this year and they have had months to prepare, just like other countries. Pfizer manufactured huge amounts of vaccine while waiting for trials and licensing to finish. Japan won’t start the vaccination programme as they are waiting for a ‘Japanese’ vaccine. Must keep the Party donors happy.
Oxycodin
At least it’s not forcing inoculation and I’m hoping this is really the key to stopping the spread.
divinda
Bit of a paradox you are describing there. So you'd prefer Japan to "take a gamble", and that in regards to the lives of the Japanese people they should not be "all too scared to make decisions that involve any risk" ?
If that happened, I'd be pretty confident that many of the same people here complaining about how "late" March is (as well as across the Japanese citizenry) would then be complaining that the government was going too quickly to approve an experimental vaccine and that they were gambling with people's lives.
There are 200+ countries on the planet, all vying to get this Pfizer vaccine with their own deals and reservations, and not even a dozen have already approved it (and many of those that did have done so in the past week).
Canada apporoved it a week ago and may start taking delivery in March as well. Thats because it takes actual time to produce hundreds of million doses of vaccines. Not to mention the logistics of delivery, storage, and injection (there aren't even the billions of glass viles needed in physical existence yet on earth to even put this vaccine into).
So all things considered, March ain't that slow, not to mention how dozens of countries have a much much much more dire need for vaccine relief right now than Japan.
virusrex
But mRNA vaccines DO contain the genetic code of the virus, actually that is the only thing they contain. Of course they don't include the part of the code for proteins that are toxic to the cells, or that mess with the immune system or the part that allow the virus to keep replicating. In general mRNA has been used commercially for decades, and has been tried in humans for many years already. No general negative effects have been observed for the technology itself.
No, viruses mutate all the time, and for RNA viruses like the coronaviruses even more, you can find many different versions of the virus even on a single patient. Fortunately not all mutations allow the virus to escape the immune system, and for SARS-CoV-2 the part that is recognized and attacked is apparently fixed, if the virus changes it it cannot infect properly, and its cleared. If a new variant could escape immunity we would see clusters of secondary infections but that has not happened.
Monty
Does anybody has a positive feedback from The UK?
They started already to vaccinated the people, right?
How is it going?
Raw Beer
If this vaccine is truly safe and effective, then more lives will be lost because of this delay. If they discover serious side effects, then this delay could save lives. The vaccine might increase the rate of other infectious diseases (e.g. influenza) so taking it in the middle of flu season might not be a good idea.
virusrex
On one side you have already demonstrated long term effects produced by the infection, on the other side you have only the possibility that something that did not happen with tens of thousands of volunteers (nor with previous vaccines) suddenly occurring; it is obvious which option is rationally the better.
If somebody said that maybe the infection will make you irrationally aggressive 5 years from now (even if nothing indicates this is a realistic possibility) would this be a rational argument to try to convince people to vaccinate?
PerformingMonkey
I wouldn't worry too much. Japan is a gerontocracy, so any undue delay would hit those with all the power, all the money and all the political influence hardest of all.
Nasakenai
Spot on. Japan ordered these vaccines at the same time as the rest of the world and the rest of the world has finished their preparations whereas Japan hasn't even started and is still holding out for a Japanese vaccine (which will never come obviously).
Haaa Nemui
virusrex... your vote score makes it quite clear how many people have been affected by garbage information. Keep up the good fight.
robert maes
“ could “ and “ as EARLY as March ??? Good one. Even if it is March that is 3 months after any other developed country
divinda
You have no idea what you are talking about.
Canada, who approved it last week, will get their delivery in March.
The EU has not approved it yet, including Germany, which is where this vaccine was partly developed and tested. Therefore their delivery dates are still unknown.
NZ and Australia also did not approve it yet. Therefore their delivery dates are also still unknown.
Several Middle Eastern and Latin American countries did approve it in the past week or so (do you consider them "developed"?) but their first deliveries will also be staggered over the next several months.
Bob Fosse
Well, this one’s a mess. The silent voices are speaking apparently.
iraira
If (Because) extensive regulatory review is required for a vaccine or any medicine to receive the ok for use, patent term extensions are possible (usually 5 years, but can vary). So the patent can last 25 years (20 + the 5 year PTE) from the initial filing date of the application (this can also vary among countries but I believe is the same regardless of the filing route).
iraira
Some people don't like it when they have "that complicated science stuff" thrown in their face, especially on the Internet.
So much easier to just click "Dislike" than actually try to do some "re-surch". An NO, that usually doesn't include a "I watched a YouTube video".
alceste
VUI-202012/01 variant reported in UK is defined by a set of multiple mutations, most significantly by a spike mutation (N501Y) in the receptor binding domain and a couple of deletions, which may increase affinity of the virus to human ACE2 receptor. (1,2,*3)
At this stage, it is not known if VUI-202012/01 variant is responsible for the sharp increase in the number of cases, but one expects the virus to become more infectious and less lethal under evolutionary stress and more stable variants will emerge in time.
Since approved SARS-CoV-2 vaccines are targeting multiple epitopes on the spike protein, it is highly unlikely that VUI-202012/01 variant will cause a vaccine escape.
*1) https://www.bmj.com/content/371/bmj.m4857
*2) https://www.sciencemediacentre.org/expert-reaction-to-the-new-variant-of-sars-cov-2/?cli_action=1608000129.559
*3) https://twitter.com/GuptaR_lab/status/1338610126291349508
anon99999
Clearly powers to be would prefer a Japanese vaccine. Less money to be made, favours gained etc, etc with a foreign vaccine and I am sure it hurts to have to pay and rely on foreigners. Maybe hold out longer for the Japanese vaccine in hope.
BTW this vaccine apparently only stops serious development of the virus in those vaccinated. Likely they still can get the virus asymptomatically and pointedly still transmit the virus to t others. Begs the question of do people under 30, or whatever, even need to be vaccinated with this vaccine, since they already have a rather minute chance of getting the virus seriously anyhow, already far less than the vaccine's 90% protection.
virusrex
Thanks for the correction.
The developer has a lot of products in trials, in theory the technology is similar between all of them, targets are many kinds of cancer, influenza, tuberculosis.
https://biontech.de/science/pipeline
All vaccines act like this, primary infection is realistically impossible to prevent, but if the infection is interrupted before its completely stablished it can importantly reduce transmission, many previous vaccines act like this. Even if the transmission is not reduced completely, just making the carrier asymptomatic already reduces transmission by around 2/3 compared with symptomatic patients. The vaccine can make the period of spreading shorter, the quantity of virus expelled lower, etc. It is widely expected by professionals to be the case but that cannot be proved only with the phase III trials.
Also, the chance of getting a serious complication from the virus is also susceptible of the 90% reduction, so if for example somebody in their 20 has 1 in 1,000 chances of a serious complication from the infection being vaccinated would make that 1 in 10,000 chances. That is quite a benefit.
Well, pfizer is the one asking for approval, so obviously they themselves are the ones to decide, the question makes no sense. Sputnick has not applied for approval, it has not even made the whole production and testing related information open, obviously it cannot be used on Japan until they get permission.
And the government is the one taking responsibility, the same as it does with every vaccine that is recommended according to the japanese health system. That is why every single lot of vaccines used on humans is tested for safety and efficacy before it can be put on the market.
trinijap
@virusrex is correct and great answers -- Thank you. Pfizer needs to apply for approval, however before it can be approved, the vaccine has to be tested for efficacy for this demographic. To be honest, having the vaccine to be ready to arms by March 2021 is quick.
trinijap
SputnikV has made its Phase 1 and Phase 1.5 test result available to any country. I think went directly to Phase 3 and the population demographic it was tested has only been on Russians.
I am also hoping that Moderna will apply for approval with the Japan government soon.
trinijap
I have to disagree here, what you describe is the traditional method of creating vaccines - influenza, yellow fever and such. This is the reason why some people have fever after getting an influenze vaccine for example.
mRNA vaccines have been studied and developed for awhile, the first in use is for rabies in 2017 (I am sure there are others out there being developed) and very new technology and this what makes it so interesting and exciting. As far as I know, COVID-19 mRNA vaccine is the first to go in full use. For those who are interested in knowing how it works, below are some good reads:
https://www.nature.com/articles/nrd.2017.243
https://www.nature.com/articles/nrd.2017.243
From Lancet on Phase 3 On COVID Vaccines: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32137-1/fulltext
Enjoy !
nandakandamanda
In the meantime China (with four vaccines available) has started inoculations in two Arab countries, and is already shipping to Indonesia. But they do not get any free advertising in the West, and I cannot see Japan asking for supplies, particularly as these vaccines are being tested even during the rollouts.
longtimenosee
Virusrex, thank you for taking time to always write sensible responses.
I don't understand why you get so many downvotes, but it worries me.
Goodlucktoyou
Obviously targeting rich countries before all the side effects become known, and as they can’t be sued, massive $$$
virusrex
I describe precisely what this vaccine is, the traditional methods are quite different.
In some the virus is inactivated and any protein in their structure becomes an antigen (for coronavirus those would be 4 different proteins)
in other vaccines the virus is still "alive" but weakened so also the proteins involved in the process of producing more copies of the genetic information of the virus are produced. (for corona that would be more of a dozen extra proteins).
And finally in some newer vaccines just a single protein is made and injected to the body so antibodies are produced against it.
This vaccine consist on one part of the RNA of the virus, with zero proteins around, that is used by the cell to produce one single protein that will become the antigen to be recognized. All the rest of the genetic information is not included because it can increase risks and its not necessary, and obviously no other protein is included. This mRNA is part of what is produced in the natural infection of the virus.
The fever is completely independent of the vaccine type, as long as there is immune system activation some people will get a fever, that happens with "dead" viruses, "weakened" viruses, proteins or RNA.
Tommy Eddy Kookabura
Pfizer... Billion dollar law suit in the past..no thanks I will trust my immune system
Raw Beer
Good idea. A number of people have already reacted badly to the vaccine. Who knows what side effects will emerge later.
Haaa Nemui
A lot of people are lost on the misinformation highways and it’s too much of an inconvenience to ask for help finding an exit.
A lot of people are just trolls trying to force people over their bridges on the misinformation highways. For some people it’s difficult not to cross.
englisc aspyrgend
Given the circumstances it is surprising that they can’t speed up the process, at least two competent regulatory authorities have reviewed this, surely they could access that information to cut down the time? Otherwise it looks like they are going through the whole process just to justify their own pay cheque.
Well done virusrex, informative and useful as always. And as all too often you are down voted; why I fail to comprehend.
Tommy Eddy Kookabura
Never had any vaccination never been sick... Got the best doctor in the universe... Called immune system
Raw Beer
Which side are you implying is spreading misinformation? Is the Big Pharma narrative or the skeptical narrative?
Jimizo
The ‘skeptical narrative’. Lol.
As far as I can see, you are on board with every conspiracy theory on the hymn sheet.
Try being skeptical of the conspiracy theory angle for a change.
neowave
Health-care worker in Alaska has severe allergic reaction to coronavirus vaccine (Pfizer/BioNTech)
"The Alaska case echoes two similar cases in Britain in which health-care workers had serious but nonfatal allergic reactions to the vaccine. But the British workers had histories of severe allergic reactions, whereas the Alaska woman had none, state health officials said. She is now stable and was discharged from a hospital where she was kept overnight.
In randomized trials, Pfizer reported no such allergic responses, known as anaphylaxis, but people with a history of such severe reactions were excluded from participating."
"But because of her severe allergic reaction, she would not receive a second vaccine dose in three weeks as is the normal protocol with this vaccine."
"Scientists do not know precisely why the new vaccine is triggering, in rare instances, a severe reaction."
https://www.washingtonpost.com/health/allergic-reaction-covid-vaccine-alaska/2020/12/16/cf8f5c56-3fcb-11eb-8db8-395dedaaa036_story.html
theFu
Neowave - thanks for the reputable link.
The woman lives in Juneau, which doesn't have any roads into. Boat or plane is how you get there. She was a nurse and disappointed that she won't be getting the 2nd shot due to her reaction from the first. She said that everyone who can, should be vaccinated.
The protocol includes being monitored for 15 - 30 minutes after vaccination to see if any severe issues arise. Out of the tens of thousands inoculated in the US already, 1 ... just 1, had a serious reaction. We are mostly the same, until we aren't. What is different about her biology will be interesting to discover.
Pfizer and the CDC are following up on her case.
Strangerland
There's your proof. The vaccine is a deep-state big-pharma plot to mind control us all with Autism.
virusrex
There is nothing rushed about the development, there is no special kind of problem to surpass, there is no alternative already in use to beat. A couple of weeks is enough to have the vaccine candidate, a couple of months to have the preclinical trials ready, 6 months for the phase III, and a few billion dollars to have the production system in place for large scale manufacturing.
That "doctor" is losing thousands and thousands of patients to COVID-19
There is no need of implications, which kind of "opinions" have been clearly demonstrated as false here? so clearly that the posters don't even try to defend those opinions afterwards.
well, duh! they are excluded from participation because they are excluded from the vaccination. This is one of the valid medical conditions that contraindicate the immunization. Are you going to be surprised they excluded patients undergoing transplants or with immunodeficiency?
Allergic people have allergies, happens with vaccines, happen with drugs, happens with food, pollen and a huge lot of other things. Bad for the patients and one of the reasons why vaccines are not just mailed to be put in your home but done by a doctor that specifically warns about this possibility. That is much more than what is done for food.
Haaa Nemui
It’s a concerted effort by nefarious multinationals working with recently announced aliens to aerosolize a compound deliverable by contrails which is why all the air travel had to slow to a crawl while the aircraft are being outfitted with the equipment needed.
neowave
2 Alaska Health Workers Got Emergency Treatment After Receiving Pfizer's Vaccine
https://www.nytimes.com/2020/12/16/health/covid-pfizer-vaccine-allergic-reaction.html
Looks like there is a risk of ana
...and don't forget that vaccine companies will not be liable for negative adverse events, side effects short term or long term, death, disability, etc. under the National Childhood Vaccine Injury Act of 1986:
https://www.hrsa.gov/vaccine-compensation/about/index.html
Latest CDC stats - Updated Infection Fatality - Survival Rates for COVID19:
Parameter Values vary among the five COVID-19 Pandemic Planning Scenarios.
CDC Scenario 5: 'Current Best Estimate'
AGE GROUP - INFECTION FATALITY RATE - SURVIVAL RATE
0-19 years old - 0.00003% INFECTION FATALITY RATE - 99.997% SURVIVAL RATE
20-49 years old - 0.0002% INFECTION FATALITY RATE - 99.98% SURVIVAL RATE
50-69 years old - 0.005% INFECTION FATALITY RATE - 99.5% SURVIVAL RATE
70 years old - 0.054% INFECTION FATALITY RATE - 94.6% SURVIVAL RATE
Whatever happens to you or your family...you're on your own...do your own research for the sake of your own family and friends. Those 70 years and older OR people with comorbidities need to BOOST THEIR IMMUNE system and look into Ivermectin (Pharma can't make money so they're trying to bury it/discredit it):
Listen to their Senate discussing Ivermectin:
https://www.youtube.com/watch?v=sZhYpw3mqtI&t=7m27s
virusrex
Yes, that is still the same non-problem that was discussed before, allergic people are allergic, they are not the target for vaccination and that risk is present every time something is introduced to the body, including eating something you have eaten all your life.
That is still false, the same as the last time you copy-pasted it and was debunked, you yourself accepted it was false since you did not even tried to defend it. As before, being not the target from particulars lawsuits is completely different from being free from liabilities, they completely are, as sure as their vaccines are still under strict vigilance from the different governments of the world precisely to subject the companies to liabilities for problems.
neowave
Unfortunately it is true. If you yourself are vaccine injured (God forbid) you have no recourse (of course you'll claim that you won't need compensation because vaccines are 100% safe...OR ARE THEY?)
https://www.cnbc.com/amp/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html
The PREP Act also authorizes a United States Treasury (not the vax companies) fund that compensates eligible individuals for serious physical injuries or deaths directly caused by administration or use of a countermeasure covered by the Declaration.
https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx
virusrex
Can you quote where did I said that vaccines are 100% safe? sorry but you are also mistaken in that, vaccines are safer than the natural infection. Also, why would I need anything from the US treasury if I get any damage? do you think the US funds the whole world?
Your comment does nothing to prove every other form of liability is not applicable for vaccines, they are still tested, companies can still be punished for defective products, people all over the world can still get their compensation from the government even for problems unrelated to vaccines (as long as there is any possibility of this being the case). So no, it is still not true, even if you write it again.
runner3
In response to Zichi,
The world was able to develop COVID-19 vaccines so quickly because of years of previous research on related viruses and faster ways to manufacture vaccines, enormous funding that allowed firms to run multiple trials in parallel, and regulators moving more quickly than normal