SARS CoV-2 coronavirus / Covid-19 (No tin foil hat silliness please)

Wibble said:
I thought that normally drug companies don't release commercially in a particular region until their own and another regulatory body approve it e.g. in Europe EMEA and another one, for the US FDA plus another one - could be wrong but I thought I'd read that somewhere.

Maybe I dreamed it.

I also thought that therapeutic drugs usually required 2 separate stage 3 trials but vaccines didn't. Again could be making it up as I go along.
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You must have dreamed it!

Drug companies will always launch in whatever region they get approval, whether or not it has been approved somewhere else. It’s actually quite common to have differing timelines with a drug widely available in one region but not yet licensed in another.

Something else which complicates this is “the fourth hurdle”, which is cost effectiveness. Governments won’t typically make a drug available immediately after it’s licensed. They will refer it to their health economics body (NICE in the UK) to see if it provides value for money. Which might involve a lot of back and forth with the company regarding price and quality of data. Sometimes they even request new clinical trials. This can delay patient access for a year or longer after license. I suspect the manufacturer of a successful vaccine might find this particular hurdle a lot easier to get over than usual!
 
711 said:
Not in special measures areas. Here in Preston everyone is encouraged to take one.
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Really? That’s interesting. Literally everyone who lives in a certain area is being asked to go and get tested? That’s a very rigorous approach and actually quite impressive. Is it all test at home kits?
 
Pogue Mahone said:
Really? That’s interesting. Literally everyone who lives in a certain area is being asked to go and get tested? That’s a very rigorous approach and actually quite impressive. Is it all test at home kits?
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They opened a new, additional, testing centre in the town market (walk-in) and advised in the local paper and facebook etc sites that everyone was encouraged to use it, no symptoms needed. I suppose they think the more cases they're aware of the more tracing they can do to reduce the spread.
 
711 said:
They opened a new, additional, testing centre in the town market (walk-in) and advised in the local paper and facebook etc sites that everyone was encouraged to use it, no symptoms needed. I suppose they think the more cases they're aware of the more tracing they can do to reduce the spread.
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Makes sense and sounds like a good initiative. Be interesting to see how many people use it.

In other news, who the hell signed off this campaign?!?

 
One Night Only said:
Some of this is to do with people hoarding tests and testing themselves every week for no feckin reason, also those wanting some free time off work "think I've got it boss, ordered a test so I'll let you know Friday" boom, free week off.
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Oh give it a rest Dominic.
 
re young peope getting covid - you can't open up pubs and restaraunts and other entertainment venues asking people to try and get back to some degree of normality, and then blame young people when the cases rise in that age group (and the ones who most frequetly use said pubs and restaraunts). it's a natural consequence of the balacing act being undertaken.
 
Was talking with a friend and he's sure there'll be a vaccine by April next year, while I'm sure there won't be. We were both so confident you could nearly mistake us for people who know anything about this sort of stuff.

So, people in this thread who do know about this, whose confidence was more misplaced?
 
fergieisold said:
That's interesting, didn't realise that! I'm in Oldham...might be the same here? I'm only recently back from France so could be worth it.
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Well it will find more cases. Prior to being put in special measures a close friend was sent for a test by her company after someone in her office got it, I'm guessing the company paid for the test, but when I checked what I had to do it just said nothing unless I had symptoms. If that happened now I would take a test.
 
Pogue Mahone said:
Makes sense and sounds like a good initiative. Be interesting to see how many people use it.

In other news, who the hell signed off this campaign?!?

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Love the way receptionist is not the job you're going back to.

Plus 'taking the lift' is not a selling point during a pandemic. Proper bants.
 
zing said:


India is in big trouble. This is the official reported numbers, and they have no way of expanding testing capacity to the hundreds of small villages and towns all over. These numbers are fudged as well -- my state has reported like 5980 infections for 4 weeks straight with a standard deviation of about 10, which is clearly not possible.
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This was always going to be the case. Sheer amount of people
 
BD said:
Was talking with a friend and he's sure there'll be a vaccine by April next year, while I'm sure there won't be. We were both so confident you could nearly mistake us for people who know anything about this sort of stuff.

So, people in this thread who do know about this, whose confidence was more misplaced?
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Yours most likely. Not 100% of course.

There are vaccines in stage 3 testing that have a very high % change of being effective. However, they haven't got there yet.

There are so many vaccines being developed using different approaches that it is getting close to a certainty that we will get an effective vaccine. If we are lucky this year.
 
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Wibble said:
Yours most likely. Not 100% of course.

There are vaccines in stage 3 testing that have a very high % change of being effective. However, they haven't got there yet.

There are so many vaccines being developed using different approaches that it is getting close to a certainty that we will get an effective vaccine. If we are lucky this year.
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Absolutely no chance. Assuming by “getting a vaccine” you mean people getting injected then that’s completely off the table for 2020.

It’s highly unlikely we’ll have any convincing Phase 3 data by the end of the year. Then there needs to be a Marketing Authorisation Application (MAA) pulled together (thousands of pages of data). Which the regulators need to digest, identify areas that need work and start some back and forth dialogue with the manufacturers. The usual timeframe for this is 210 days, with two “stop clock” stages where time stands still while one of the parties gets to work on the next round of questions and answers.

Then, after approval, we need to deal with the monumental head-feck of manufacturing and distribution to the whole of the planet. With an inevitable horrific political bun-fight between all the countries trying to jump the queue.

Obviously there’s a huge desire to fast-track everything to do with this vaccine but there’s also a huge desire to make sure we don’t cut any corners in approving a medicine that will be taken by billions of people. From day one, the timelines talked about for vaccines have been insanely optimistic. I don’t think it helps anyone to keep talking in such unrealistic terms. All this “Operation Warp Speed” stuff is politically motivated un-scientific bollox. Whatever strategy we use to cope with this virus should consider the middle of next year as the absolute best case scenario to start sticking needles in arms. And even then, we might not be in a position to give it to the young or - those that need it most - the elderly (additional data likely to be needed for these cohorts)

In conclusion, @BD don’t make a bet with your friend, you’ll lose your money!
 
Pogue Mahone said:
Absolutely no chance. Assuming by “getting a vaccine” you mean people getting injected then that’s completely off the table for 2020.

It’s incredibly unlikely we’ll have any convincing Phase 3 data by the end of the year. Then there needs to be a Marketing Authorisation Application (MAA) pulled together (thousands of pages of data). Which the regulators need to digest, identify areas that need work and start some back and forth dialogue with the manufacturers. The usual timeframe for this is 210 days, with two “stop clock” stages where time stands still while one of the parties gets to work on the next round of questions and answers.

Then, after approval, we need to deal with the monumental head-feck of manufacturing and distribution to the whole of the planet. With an inevitable horrific political bun-fight between all the countries trying to jump the queue.

Obviously there’s a huge desire to fast-track everything to do with this vaccine but there’s also a huge desire to make sure we don’t cut any corners in approving a medicine that will be taken by billions of people. From day one, the timelines talked about for vaccines have been insanely optimistic. I don’t think it helps anyone to keep talking in such unrealistic terms. Whatever strategy we use to cope with this virus should consider the middle of next year as the absolute best case scenario to start sticking needles in arms. And even then, we might not be in a position to give it to the young or - those that need it most - the elderly (additional data likely to be needed for these cohorts)
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Probably in that passing stage 3 testing plus manufacturing and distribution is likely to stretch into 2021
 
Wibble said:
Probably in that passing stage 3 testing plus manufacturing and distribution is likely to stretch into 2021
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Likely?!? It’s September, Wibbs. If one of the vaccine manufacturers released the best phase 3 results in the history of drug development ever this morning, the vaccine still wouldn’t even be licensed until 2021.
 
Pogue Mahone said:
Likely?!? It’s September, Wibbs. If one of the vaccine manufacturers released the best phase 3 results in the history of drug development ever this morning, the vaccine still wouldn’t even be licensed until 2021.
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Really? I thought pretty much everything was being fast tracked.

How long do you think it'll take between some company releasing data on a successful phase 3 and people starting to get vaccinated?
 
Pogue Mahone said:
Likely?!? It’s September, Wibbs. If one of the vaccine manufacturers released the best phase 3 results in the history of drug development ever this morning, the vaccine still wouldn’t even be licensed until 2021.
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Trump is definitely trying to push a vaccine for November. CDC have written to all states telling them to plan for mass vaccinations from November. There was a Times article today about Hancock removing red tape around who can administer vaccines for mass vaccinations to take place this year. Also mentioned previously on this thread how local authorities had to submit mass vaccination plans to Welsh government this month. The political pressure due to the economic fallout to cut corners with this thing is huge.
 
One Night Only said:
Can you explain this response to me? It makes absolutely feck all sense.
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Its exactly the sort of narrative the government has been pushing during the pandemic and Cummings is given credit for. ”The reason the NHS is running out of PPE is because doctors and nurses are abusing the supplies”
 
Mickeza said:
Trump is definitely trying to push a vaccine for November. CDC have written to all states telling them to plan for mass vaccinations from November. There was a Times article today about Hancock removing red tape around who can administer vaccines for mass vaccinations to take place this year. Also mentioned previously on this thread how local authorities had to submit mass vaccination plans to Welsh government this month. The political pressure due to the economic fallout to cut corners with this thing is huge.
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I know. And that worries me. The consequences of rushing out a vaccine that is less safe/effective than we think are horrendous. Both in terms of getting people to take vaccines in the future and for this pandemic. I’m sure we both know why Trump is pushing for November vaccinations and it’s got feck all to with any scientific timelines.

Fortunately, my experience with the regulatory authorities has been that they take their responsibilities incredibly seriously and won’t be pushed around. I’m reasonably confident they’ll ignore the politician’s bluster and do the right thing.
 
prateik said:
Really? I thought pretty much everything was being fast tracked.

How long do you think it'll take between some company releasing data on a successful phase 3 and people starting to get vaccinated?
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I’d say at least 3 or 4 months. Most likely 6 months+. And that would be fast tracked!
 
Trump will push the FDA for early approval of a vaccine and then if it kills some he’ll just say they died but more were saved. “It is what it is.”
 
Mickeza said:
Trump is definitely trying to push a vaccine for November. CDC have written to all states telling them to plan for mass vaccinations from November. There was a Times article today about Hancock removing red tape around who can administer vaccines for mass vaccinations to take place this year. Also mentioned previously on this thread how local authorities had to submit mass vaccination plans to Welsh government this month. The political pressure due to the economic fallout to cut corners with this thing is huge.
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I might be biased against Hancock but I'm not sure I trust anyone using the phrase 'red tape' when it comes to health. I'll give more weight to what the health authorities say than the politicians on this one.
 
The interesting thing about all this is that I am someone who absolutely believes in the effectiveness of stable vaccines, marvels at the technology and modern medicine involved and, its' fair to say, has been very worried by the whole pandemic, with my anxiety levels being sky high and crippling at times. However, If a vaccine is available this year or even early next, I will still think long and hard over if I would have it. There's just a niggling feeling, based on no solid foundations at all, that is telling me I should not.
 
Can anyone please confirm that in England, countries are added or removed from the quarantine requirement list on a Thursday (I've just read the latest update, no new countries have been added for England)? We have a personal interest, we're flying back from Italy on Tuesday.
 
Penna said:
Can anyone please confirm that in England, countries are added or removed from the quarantine requirement list on a Thursday (I've just read the latest update, no new countries have been added for England)? We have a personal interest, we're flying back from Italy on Tuesday.
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I think you'll be fine, I would have expect Scotland and Wales to have added Italy already if it was going to be an issue by the time you fly.
 
F-Red said:
I think you'll be fine, I would have expect Scotland and Wales to have added Italy already if it was going to be an issue by the time you fly.
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Thanks, Italy's doing a little better than the UK but that's no indicator, I think!
 
Pexbo said:
Its exactly the sort of narrative the government has been pushing during the pandemic and Cummings is given credit for. ”The reason the NHS is running out of PPE is because doctors and nurses are abusing the supplies”
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Ah, yeah, but I'm not saying it about the supplies, I'm saying they're having to divert tests due to irresponsible people. It's not just the ones having raves and parties who are messing stuff up.
 
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