Japan eyes Sunday approval of Pfizer vaccine, accelerating schedule

Wasn't the Japanese government saying that there had to be a local safety study completed in Japan before they could even consider approving foreign vaccines? What changed?

Pfizer had a press release in the middle of December saying that the second dose of the local clinical trial was already done so it would be safe to think the study has been completed by now.

Maybe you are confused with the Moderna vaccine, that one began the clinical trial on January.

Ahead of the formal approval, a health ministry panel is expected to hold a meeting on Friday night to discuss whether Japan should go ahead with the Pfizer vaccine to deal with the pandemic

Wait, I thought the vaccine was already on the way and it was being discussed and researched so many times before..?

Hang on. . .

Wasn't the Japanese government saying that there had to be a local safety study completed in Japan before they could even consider approving foreign vaccines? What changed?

for the UK one... for the South Africa one... for the Brazilian one... for the new most potent resistant UK one.

You do know that these different variants are only named in this way because these are the locations where they were first discovered? There isn't a 'UK virus', or a 'Brazilian virus'. They are mutations of the same virus, and the currently approved vaccines are so far OK for these mutations.

Suggesting you will need a separate vaccine for each mutation is wrong.

Use most expensive difficult vaccine for the old Covid19 virus, then buy the new vaccine for the UK one, then buy the new vaccine for the South Africa one, then buy the new vaccine for the Brazilian one, then buy the new vaccine for the new most potent resistant UK one.

Waiting for the new Indian variant, and to buy that one.

i just want my job back so I can pay my debt.

I am really curious to see the medium and long term effects of mRNA vaccines, and I am happy you and others are willing to be guinea pigs in this experiment.

Pfizer's vaccine is probably the worst choice.

Because of less than one in a million chances?

The normal incidence of ITP in adults is of 66 cases per million people per year. Rounding up that would mean 5.5 cases per month. If you follow more than 30 million people you would expect to find 33 cases on the same period, that would mean vaccinated people have presented the problem approximately at the same rate as the non-vaccinated population.

One thing is to keep things under close observation, so you can quickly identify if some problems are related to the vaccine, another is to blindly attribute everything you find on it.

Pfizer's vaccine is probably the worst choice.

https://www.nytimes.com/2021/02/08/health/immune-thrombocytopenia-covid-vaccine-blood.html

So the headline is wrong? And the lead of the article misleading?

When a drug is "approved," it's always assumed be approval for the general population, right?

No, it is correct. The vaccine is apparently going to be approved this week, and it will be for the general population. But it will not be used for everybody at this point, so those that are going to be immunized are the ones that will participate in this study. If Japan had enough doses (and infrastructure) to begin vaccinating also people of 65yo and older then those would also be included in the phase IV. Eventually everybody that is going to be vaccinated will participate.

The Covid vaccines have not been approved for children.

So, no.

Approval does not mean everyone.

That is a different matter, approval means that the vaccine can be used for anybody in the general population for which it is indicated. Not being used for a group of people (children, pregnant women, people with allergies, etc.) does not mean that it is not for the "general population". Before approval it can only be used for people that volunteer to participate in trials of phase I, II or III, which obviously is no longer the case anymore.

The real speed of the rollout will not be determined by Japanese bureaucracy (however much they would love pretend it is), but rather how much they can get their hands on. It might be rather slow given the greater need in the countries where these vaccines are being made. So, they can go ahead with their own study and any other rather pointless bureaucratic procedures because the truth is they won't be getting enough to give out the general public for quite some time anyway. The irony is that will be determined by foreign politicians and bureaucrats, and they won't give a damn about the Olympics.

The vaccine approval was expected and planned even before the start of the trial. It has been said for weeks than mid February was the target. So, what was the point of the trial ? Go in line with the local process.

I hope results of this trial will be published

The roughly 20,000 doctors and nurses from 100 hospitals

These numbers do seem to represent a minority of the health sector workforce. It looks like only the main hospitals dealing with covid will be concerned.

Approval does not mean there is enough supply as the article points out. Further vaccinations beyond this initial 20,000 may take time. Can Japan even vaccinate its early planned stage of all over 65s before the next winter let alone the rest o the population. Also how smooth will the rollout be? Does anyone recall the rollout of the free Abemasks? And that was just masks not requiring super freezers.

The Covid vaccines have not been approved for children.

So, no.

Approval does not mean everyone.

And were the first inoculations not scheduled for next couple of days from now?

These articles about approval seem to contradict other news...

@VirusRex

This would be the part we are now.

So the headline is wrong? And the lead of the article misleading?

When a drug is "approved," it's always assumed be approval for the general population, right?

I guess the clinical trials on the Japanese people will begin soon.

i'm confused. The story says "approval," but then says the 20,000 are part of a "study."

Every drug, vaccine, therapy, etc. that is to be used on humans have 4 phases of clinical study.

Phase I, II and III are studies to corroborate safety and efficacy, and it they go well the drug or vaccine is approved and can be applied to the public. This would be the part we are now.

Phase IV happens after that, where the vaccine is already being used by the general population and the vaccinated people are followed to detect any kind of side effect or problem that may have escaped detection before. That is where the 20,000 people will cooperate. All and every kind of problems are recorded as much as possible, then its compared with people that has not been vaccinated to see if the vaccine produces more or less of those problems.

For example, lets say out of those 20,000 doctors and nurses 5 get cancer this year, but checking 20,000 doctors and nurses of around the same age, sex, etc. that were never vaccinated and it is found that 6 got cancer, that would mean it is not something that the vaccine caused but just the normal rates.

i'm confused. The story says "approval," but then says the 20,000 are part of a "study."

Is this the usual Japanese obfuscation? Appearing to do something when in fact you're not. Like banning some outdoor smoking but allowing indoor smoking, and then claiming you've cracked down on public smoking.

The challenge now will be getting people to take it.

Can’t wait to get mine. My father had his in the UK last month. Huge feeling of relief all round. Obviously no side effects, feels safe for the 1st time in 12 months and he feels he’s done his bit too.

‘Lit a fire under their ass’ sadly we can only dream of such events

Don't get too excited folks. The vaccine has to go through yet another study. And if only one person in the 20000 has a negative reaction to the shot, it will be all over the news, and we are back to square one.

This is a sudden turnaround for the Japanese government! For a while there, it looked like it wouldn't happen until March! I guess the pressure from the public and probably the Olympics had lit a fire under their ass. Better late than never.

Late but like snowymoutain said, Better late then never. I agree.

It’s a start? Better late than never? Something is better than nothing? What’s the plan and timeline?

Regardless, good job. “Informative”.  These types of articles are needed so the world can see something his happening here.  Not misdirection & misinformation. Thank you.

”The government has agreements to receive enough vaccine doses for 157 m. people, more than enough to cover Japan's population of 126 million: 72 million doses are from Pfizer. The remainder by AstraZeneca Plc and Moderna Inc.”