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

But why does this tarring have to happen? (Not referring to you but the general consensus). Young people some of whom that have been working their butt off during the height of this pandemic are being pigeonholed because of a minority.

No other age group seems to suffer from this type of thing, to pluck random examples I didn't see it with people in their 30's once Ian Huntley made the news, or pensioners once the hideous nature of Jimmy Saville was exposed.

It's not tarring unfortunately, WHO are highlighting from their own analysis that young people are driving the spread. The whataboutery regarding Ian Huntley & Jimmy Saville is just pointless.
 
Interesting paper. They’ve done an amazing job with their testing in Iceland. Also worth noting they come up with an IFR of just 0.3%. That really is getting close to the “bad flu” mortality rate.

It does look like we are reducing mortality with better treatment as long as hospitals don't get overwhelmed and you can keep it away from the elderly. Victoria's death rate is largely due to aged care facilities becoming infected.
 
:lol: Seriously? Young people - as a group - are being mentioned in connection with the recent upsurge because young people - as a group - are getting infected more than other age groups. That’s just the reality we’re all facing. It’s not about scapegoats, it’s about facts.

Agreed. The I'm alright jack attitude of a significant minority sadly.
 
I'm not, but I'm a youth worker who's been trying to fight the narrative against young people for quite some time and we were finally getting somewhere in recent times but all that work has likely been undone now.
Just a suggestion but the best way to counter this would be to promote positive stories of the good things young people do. Sounds like you're in a good position to do that yourself.
 
So many u-turns. Has any government ever flipped on this many issues in such a short space of time?

Localised restrictions really do need to become a devolved issue if central government can't adequately oversee the situation from afar.

For Trafford in particular, the government were given several days warning that easing restrictions was the wrong thing to do. The borough tipped into 'amber' on the day the announcement came that restrictions would be lifted.
 
Big words from Fauci. Predicts a safe and effective vaccine by the end of the year, and says that the testing of the vaccine is going so well, that it will likely take a few weeks less than thought.

This is really nice.
 
Interesting paper. They’ve done an amazing job with their testing in Iceland. Also worth noting they come up with an IFR of just 0.3%. That really is getting close to the “bad flu” mortality rate.
Seems so. In places with good medical system, who have done a lot of testing (so IFR is not inflated), the mortality rate seems somewhere there. In fact, Singapore, is doing even better, it has a 0.047% death rate (27 deaths on 56901 infections). This is actually flu-level mortality rate, though of course, much more contagious than the flu.

As long as you're able to protect the old and those with pre-conditions, this gets stopped from being a tragedy. Most people seem to do alright even if infected (of course, most does not mean all, and even very healthy people might die from it).
 
Big words from Fauci. Predicts a safe and effective vaccine by the end of the year, and says that the testing of the vaccine is going so well, that it will likely take a few weeks less than thought.

This is really nice.


Great news this if it goes to plan and dare to say he will be in Trumps good books again now.
 
Great news this if it goes to plan and dare to say he will be in Trumps good books again now.
I don't think that Fauci really gives a shit about that. He is not gonna say things just to please Trump, so it gives me confidence that what he is saying is true.
 
I don't think that Fauci really gives a shit about that. He is not gonna say things just to please Trump, so it gives me confidence that what he is saying is true.

Yup, if Fauci has said it then it will be correct. More the fact Trump will roll Fauci and the cure out in the election campaign after giving him the cold shoulder.
 
Hasn't he already said things to please Trump? I'm sure there was a press-conference where he was doing that a while back.
Not really (or at least I don't remember). Often, he had gone totally against what Trump said, which is why Trump seems to dislike him (and has even attacked him).
 
Inappropriate Behavior
But why does this tarring have to happen? (Not referring to you but the general consensus). Young people some of whom that have been working their butt off during the height of this pandemic are being pigeonholed because of a minority.

No other age group seems to suffer from this type of thing, to pluck random examples I didn't see it with people in their 30's once Ian Huntley made the news, or pensioners once the hideous nature of Jimmy Saville was exposed.
Maybe because they did not infect other people with paedophilia. Young people are ignorant cnuts that ignore the rules as a large group. I hope they pass it to their grandparents.
 

Agreed. @Revan is misinterpreting what he said. Every RCT of this size would have an independent DSMB who can suggest the trial stops early if the results are so good that it would be unethical to keep randomising patients to placebo. This is quite unusual and only happens when the results are far better than you’d expect based on all the available evidence when the trial was designed. Fauci is really just stating the obvious.

The only people who are allowed to see the preliminary results while the trial is still ongoing are the members of the DSMB. Not the investigators, not the trial subjects, not the drug company manufacturing the vaccine and definitely not Fauci.
 
Agreed. @Revan is misinterpreting what he said. Every RCT of this size would have an independent DSMB who can suggest the trial stops early if the results are so good that it would be unethical to keep randomising patients to placebo. This is quite unusual and only happens when the results are far better than you’d expect based on all the available evidence when the trial was designed. Fauci is really just stating the obvious.

The only people who are allowed to see the preliminary results while the trial is still ongoing are the members of the DSMB. Not the investigators, not the trial subjects, not the drug company manufacturing the vaccine and definitely not Fauci.

I wonder why the trials take so long. The USA has been averaging 50,000 infections per day. The test and control groups have 15,000 each and they should be seeing 2.5 infections a day on average at that rate. Even with 50 infections(20 days) in the placebo group, a 50% efficacy vaccine would have significance.

I do see that the trials are not fully enrolled but the N seems sufficiently large to me. There'll be some regional nuances to the infection rates but I cannot imagine that playing a big role.
 
I wonder why the trials take so long. The USA has been averaging 50,000 infections per day. The test and control groups have 15,000 each and they should be seeing 2.5 infections a day on average at that rate. Even with 50 infections(20 days) in the placebo group, a 50% efficacy vaccine would have significance.

I do see that the trials are not fully enrolled but the N seems sufficiently large to me. There'll be some regional nuances to the infection rates but I cannot imagine that playing a big role.

I assume it’s because seeing the effects over a longer period is as important as seeing the effects on a wide range of people. You don’t want to put a vaccine out which is great for 6 weeks and kills people in 6 months.
 
I assume it’s because seeing the effects over a longer period is as important as seeing the effects on a wide range of people. You don’t want to put a vaccine out which is great for 6 weeks and kills people in 6 months.

Yes - true. I have to say that the phase 3 taking 3 months instead of 1 month does not allay my concerns any. The sample size is also concerning from that point of view. 15,000 people only tells me what happens if 100 people with the vaccine get exposed to the virus. That may prove safe, but it doesn't tell you anything about events with <1% probability. I would like to know how the experts know that it is safe at scale to billions.
 
Yes - true. I have to say that the phase 3 taking 3 months instead of 1 month does not allay my concerns any. The sample size is also concerning from that point of view. 15,000 people only tells me what happens if 100 people with the vaccine get exposed to the virus. That may prove safe, but it doesn't tell you anything about events with <1% probability. I would like to know how the experts know that it is safe at scale to billions.

Well, exactly. Which is why developing vaccines takes far longer than developing treatments. You need huge numbers and long follow up to pick up rare safety signals. And safety is much more important for vaccines than for treatments. Because you’re asking healthy people to take them.

A small risk of a nasty side effect is going to be much more acceptable to people who would die without a treatment than people who would be completely well if you left them alone.

One thing’s for sure. Whatever vaccine gets approved will need to commit to massive post-authorisation safety studies (PASS) to closely monitor the safety profile in the months/years ahead. You could end up with vaccines getting licensed, rolled out, then withdrawn a year or two later if a serious, rare side effect gets uncovered. If not withdrawn, they could end up prohibiting the vaccine from being used in certain patient groups (e.g. elderly)
 
Yes - true. I have to say that the phase 3 taking 3 months instead of 1 month does not allay my concerns any. The sample size is also concerning from that point of view. 15,000 people only tells me what happens if 100 people with the vaccine get exposed to the virus. That may prove safe, but it doesn't tell you anything about events with <1% probability. I would like to know how the experts know that it is safe at scale to billions.

Again I’m speculating and have absolutely no knowledge on this whatsoever but I wonder if post phase 3 trials when the vaccine is released is still a beta phase of sorts where it’s closely monitored and gradually ramped up as confidence grows?
 


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.
 
Again I’m speculating and have absolutely no knowledge on this whatsoever but I wonder if post phase 3 trials when the vaccine is released is still a beta phase of sorts where it’s closely monitored and gradually ramped up as confidence grows?

Impressive speculation! That’s exactly what will happen. See post above re PASS.
 
Big words from Fauci. Predicts a safe and effective vaccine by the end of the year, and says that the testing of the vaccine is going so well, that it will likely take a few weeks less than thought.

This is really nice.

According to Dr John Campbell, we are set to have the first-ever approved RNA vaccine, and these could be used to treat cancer in the future.

@Pogue Mahone could you shed some light on the cancer part?
 
Maybe because they did not infect other people with paedophilia. Young people are ignorant cnuts that ignore the rules as a large group. I hope they pass it to their grandparents.
So the young lad employed by a supermarket chain who worked his butt off to keep you fed deserves to be shammed snd pigeonholed because someone went to a rave miles away from where he lives?

Got it!
 
According to Dr John Campbell, we are set to have the first-ever approved RNA vaccine, and these could be used to treat cancer in the future.

@Pogue Mahone could you shed some light on the cancer part?
This pre-covid article article about Moderna (the company making the front-running American RNA vaccine) describes how it might work for cancer. It sounds like this would be "personalised medicine"; they would take a biopsy of your tumor and compare to healthy tissue. Presumably coming up with markers that can target the immune system to cancerous but not heathy cells.

You could also do this with protein based vaccines, but RNA is so much easier and faster to manufacture, plus more stable. Making this personalised approach more feasible.

Hope that sounds right, I haven't read a lot about this.
 
Impressive speculation! That’s exactly what will happen. See post above re PASS.
I was trying to find out how long phase 3 trials for vaccines usually run for. I was under the impression that they are designed to look for rare, acute, negative reactions over a short period, by vaccinating a large number of people. If they are found to be safe then the longitudinal follow up is done in PASS and that is what should pick up any negative long term effects. Or I suppose any even more rare effects that were missed in 30,000 people but might be seen in 3,000,000 people.

So if the covid vaccine-candidates are tested on enough people, is the length of the phase 3 trial that important? I don't really know how long they would normally last vs. the expedited covid timeline.

The good news is that historically vaccines that have passed stage 3 trails and been approved by the FDA have an excellent track record in PASS. Retrospective analysis of post-authorisation safety studies .
 
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So the young lad employed by a supermarket chain who worked his butt off to keep you fed deserves to be shammed snd pigeonholed because someone went to a rave miles away from where he lives?

Got it!
Pigeonholing is what the caf does best, along with tarring certain groups with the same brush. I'm just following protocol.
 
I was trying to find out how long phase 3 trials for vaccines usually run for. I was under the impression that they are designed to look for rare, acute, negative reactions over a short period, by vaccinating a large number of people. If they are found to be safe then the longitudinal follow up is done in PASS and that is what should pick up any negative long term effects. Or I suppose any even more rare effects that were missed in 30,000 people but might be seen in 3,000,000 people.

So if the covid vaccine-candidates are tested on enough people, is the length of the phase 3 trial that important? I don't really know how long they would normally last vs. the expedited covid timeline.

The good news is that historically vaccines that have passed stage 3 trails and been approved by the FDA have an excellent track record in PASS. Retrospective analysis of post-authorisation safety studies .

I though stage 3 trials normally only need to be appropriate for the length of the normal usage e.g. stage 3 trials for chemotherapy would need to be much longer than for a vaccine? Stage 4 are always in the market.

I'd guess the difference might be (assuming I've got the right end of the stick) that most drugs (presumably including vaccines) are normally approved by more than one regulatory body e.g. US and European, before companies distribute. I'm guessing most places will run with just the approval of their own regulatory body if necessary.
 
I though stage 3 trials normally only need to be appropriate for the length of the normal usage e.g. stage 3 trials for chemotherapy would need to be much longer than for a vaccine? Stage 4 are always in the market.

I'd guess the difference might be (assuming I've got the right end of the stick) that most drugs (presumably including vaccines) are normally approved by more than one regulatory body e.g. US and European, before companies distribute. I'm guessing most places will run with just the approval of their own regulatory body if necessary.

I think you might have the wrong end of the stick. Every drug needs regulatory approval in the territory in which it will be used. That won’t change with this vaccine.

The FDA looks after the US. Japan Have their own regulators. For Europe the EMEA oversees a centralised process to approve a single application, which makes licensing more straightforward for EU countries (post-Brexit the UK will be excluded from this process - another feather in Boris’ cap). It is possible to apply for a national license in individual European countries but pharma companies have very little interest in this approach when they can access a much bigger market with a single, centralised application.
 
I think you might have the wrong end of the stick. Every drug needs regulatory approval in the territory in which it will be used. That won’t change with this vaccine.

The FDA looks after the US. Japan Have their own regulators. For Europe the EMEA oversees a centralised process to approve a single application, which makes licensing more straightforward for EU countries (post-Brexit the UK will be excluded from this process - another feather in Boris’ cap). It is possible to apply for a national license in individual European countries but pharma companies have very little interest in this approach when they can access a much bigger market with a single, centralised application.

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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Boris and his chums doing a great job as always...

Coronavirus testing rationed amid outbreaks

https://www.bbc.co.uk/news/health-53990068

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.